Minnesota
|
3842
|
33-1007393
|
||
(State
or other jurisdiction
of incorporation or organization) |
(Primary
Standard Industrial
Classification
Code
Number) |
(I.R.S.
Employer
Identification
No.)
|
Ryan
Hong, Esq.
RICHARDSON
& PATEL LLP
10900
Wilshire Boulevard, 5th Floor
Los
Angeles, California 90024
Telephone:
(310) 208-1182
Facsimile:
(310) 208-1154
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer (Do not check if a smaller reporting company) ¨
|
Smaller
reporting company x
|
Title of each class of
securities to be registered
|
|
|
Amount to
be
Registered
|
|
Proposed
maximum
offering
price
per share
|
|
Proposed
maximum
aggregate
offering
price |
|
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Amount of
registration
fee
|
||||||
Common stock, $0.01
par value (1)
|
7,101,266
|
.46
|
$
|
3,266,582
|
$
|
182.28
|
||||||||||
Common
stock underlying warrants to purchase common
stock (2)
|
4,689,291
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$
|
.46
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$
|
2,157,074
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$
|
120.36
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|||||||||
Common
stock underlying convertible debentures (1)
|
620,095
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.46
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$
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285,244
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$
|
15.92
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||||||||||
Common
stock underlying warrants (1)
|
620,095
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$
|
.46
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$
|
285,244
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$
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15.92
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|||||||||
TOTAL
|
13,030,747
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N/A
|
$
|
5,994,144
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$
|
334.47
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(1)
|
Estimated
solely for the purpose of calculating the registration fee pursuant to
Rule 457(o) under the Securities Act of 1933, as amended. As a result,
only the title of class of securities to be registered, the proposed
maximum aggregate offering price and the amount of registration fee need
to appear in this Calculation of Registration Fee
table.
|
(2)
|
Calculated
in accordance with Rule 457 (g) under the Securities Act on the basis of
an exercise price of $.46 per share.
|
|
•
|
7,101,266 shares of common
stock;
|
|
•
|
5,309,386 shares of common stock
underlying common stock purchase warrants, which includes 4,689,291 and
620,095 shares of common stock underlying warrants issued in conjunction
with an October 2008 financing and bridge loans we undertook in July 2007,
respectively; and
|
|
•
|
620,095 shares of common stock
underlying the convertible
notes.
|
Page
|
||
Prospectus
Summary
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1
|
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Risk
Factors
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3
|
|
Special
Note Regarding Forward-Looking Statements
|
13
|
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Use
of Proceeds
|
14
|
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Determination
of Offering Price
|
14
|
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Market
Price of and Dividends on the Registrant’s Common Equity and Related
Stockholder Matters
|
15
|
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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19
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Description
of Business
|
34
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|
Legal
Proceedings
|
57
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|
Description
of Property
|
57
|
|
Directors,
Executive Officers, Promoters and Control Persons
|
58
|
|
Executive
Compensation
|
61
|
|
Corporate
Governance
|
69
|
|
Certain
Relationships and Related Transactions
|
70
|
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Selling
Security Holders
|
70
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|
Plan
of Distribution
|
74
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|
Security
Ownership of Certain Beneficial Owners and Management
|
76
|
|
Description
of Securities
|
78
|
|
Disclosure
of Commission Position on Indemnification for Securities Act
Liabilities
|
81
|
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Where
You Can Find More Information
|
84
|
|
Experts
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84
|
|
Legal
Matters and Interests of Named Experts
|
85
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|
Financial
Information
|
F-1
|
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Exhibits
|
II-8
|
|
Signatures
|
II-12
|
|
•
|
5,804,606 shares of common
stock issuable upon the exercise of warrants having a range of exercise
prices from $.02 to $1.67 per share (consisting of 5,309,386 shares of
common stock underlying the warrants we are registering pursuant to this
registration statement; 495,220 shares of common stock reserved for
issuance upon the exercise of outstanding warrants granted to certain
investors and
consultants.
|
|
•
|
outstanding options to
purchase 1,291,174 shares of our common
stock;
|
|
•
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975,405 shares of common stock
reserved for issuance under our 2008 Equity Incentive
Plan;
|
|
•
|
620,095 shares of common stock
issuable in conjunction with a bridge loan we undertook in July 2007;
and
|
|
•
|
297,142 shares subject to
issuance upon conversion of certain
notes.
|
|
•
|
7,101,266 shares of common
stock;
|
|
•
|
5,309,386 shares of common stock
underlying common stock purchase warrants, which includes 620,095 shares
of common stock underlying warrants issued in conjunction with a bridge
loan we undertook in July 2007;
and
|
|
•
|
620,095 shares of common stock
underlying the convertible
notes.
|
|
•
|
Raise
capital;
|
|
•
|
Develop and implement our
business plan in a timely and effective
manner;
|
|
•
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Be successful in uncertain
markets;
|
|
•
|
Respond effectively to
competitive pressures;
|
|
•
|
Successfully address intellectual
property issues of others;
|
|
•
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Protect and expand our
intellectual property rights;
and
|
|
•
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Continue to develop and upgrade
our products.
|
|
•
|
the willingness and ability of
customers to adopt new
technologies;
|
|
•
|
our ability to convince
prospective strategic partners and customers that our technology is an
attractive alternative to conventional methods used by the medical
industry;
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|
•
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our ability to select and
execute agreements with effective distributors and manufacturers
representatives to market and sell our product;
and
|
|
•
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our ability to assure customer
use of the proprietary cleaning fluid we license from an exclusive
supplier.
|
|
•
|
our ability to raise capital when
we need it;
|
|
•
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our
ability to market and distribute or sell
our
|
|
Fluid
Management System (FMS) and related products;
and
|
|
•
|
our ability to protect our
intellectual property and operate our business without infringing upon the
intellectual property rights of
others.
|
(i)
|
incentive stock options, as
defined in Section 422 of the Internal Revenue Code of 1986 (the
“Code”);
|
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(ii)
|
nonqualified stock options,
defined as any option granted under the Plan other than an incentive stock
option;
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(iii)
|
stock appreciation rights
(“SARs”), defined as an award granted under the Plan that is exercisable
either in lieu of options, in addition to options, independent of options
or in any combination thereof, which, upon exercise, entitles the holder
to receive payment of an amount determined by multiplying (a) the
difference between the fair market value of a share on the date of
exercise and the exercise price established by the administrator of the
Plan on the date of grant by (b) the number of shares with respect to
which the SAR is exercised, the payment of which will be made in cash or
stock; or
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|
(iv)
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restricted stock, defined as
stock granted under the Plan that is subject to restrictions on sale,
transfer, pledge, or
assignment.
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Expense
Item
|
Amount
|
Total
|
||||||
Expected
expenses in connection with our current offering
|
225,200
|
|||||||
SEC
registration fee
|
200
|
|||||||
Printing
fees
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30,000
|
|||||||
Legal
fees and expenses
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80,000
|
|||||||
Accounting
fees and expenses
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60,000
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|||||||
Miscellaneous
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55,000
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|||||||
Financing
fees owed in connection with our current offering (1)
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0
|
|||||||
Outstanding
debt payments to:
|
710,000
|
|||||||
Carl
and Roy Moore
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100,000
|
|||||||
Marshall
C. Ryan
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100,000
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|||||||
Richardson
& Patel LLP
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150,000
|
|||||||
Complete
Automation
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25,000
|
|||||||
TriVirix
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65,000
|
|||||||
Evergreen
Medical
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20,000
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|||||||
Olsen
Thielen, CPAs
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25,000
|
|||||||
Larkin
Hoffman
|
75,000
|
|||||||
Various
accounts payable
|
100,000
|
|||||||
Andcor
Companies, Inc.
|
50,000
|
|||||||
Other
operating expenses
|
1,200,000
|
|||||||
Market
expansion to Europe and Pacific Rim
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500,000
|
|||||||
Personnel
additions
|
200,000
|
|||||||
Miscellaneous
|
100,000
|
|||||||
Total
|
$
|
2,710,000
|
Payment Due by Period as of December 31
|
||||||||||||||||||||
Total
|
Less than 1
Year |
1-3 Years
|
4-5 Years
|
After 5
Years |
||||||||||||||||
Long
Term Debt
|
$
|
322,183
|
$
|
197,620
|
$
|
24,463
|
$
|
100,000
|
—
|
|||||||||||
Operating
Leases
|
150,000
|
35,000
|
59,000
|
56,000
|
—
|
|||||||||||||||
Capital
Leases
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||
Total
Contractual Cash Obligations
|
$
|
472,183
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$
|
232,620
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$
|
83,563
|
$
|
156,000
|
—
|
December
31,
|
||||||||
2008
|
2007
|
|||||||
Notes
payable to seven individuals due April 2008 including 8% fixed interest
and is now overdue. The notes are convertible into 620,095 shares of the
Company’s common stock and automatically convert at the effective date of
this registration statement.
|
$ | 170,000 | $ | 170,000 | ||||
Note
payable to bank in monthly installments of $1,275/including variable
interest at 2% above the prevailing prime rate (5.25% at December 31,
2008) to August 2011 when the remaining balance is payable. The note is
personally guaranteed by executives of the Company.
|
38,183 | 48,308 | ||||||
Note
payable to NWBDC with interest only payments at 8% to December 2008 when
the remaining balance is payable. The note is personally guaranteed by
executives of the Company. This note was paid in full in June
2008.
|
— | 18,000 | ||||||
Notes
payable to two individuals with interest only payments at 12% to March
2012 when the remaining balance is payable. The note has a face amount of
$100,000 and a remaining unamortized discount of 24,955. The notes are
convertible into 285,715 shares of stock in the Company at $.35 per
share.
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(1) 75,045 | 100,000 | ||||||
Notes
payable to four shareholders of the Company that are overdue. The notes
are convertible into 11,429 shares of stock in the Company at $.35 per
share.
|
4,000 | 4,000 | ||||||
Total
|
287,228 | 340,308 | ||||||
Less
amount due within one year
|
187,620 | 203,800 | ||||||
Long-Term
Debt
|
$ | 99,608 | $ | 136,508 |
|
(1)
|
This
loan has a $100,000 face value and is shown net of the debt discount
determined by applying a black-scholes model to the value of warrants
issued in connection with that
debt.
|
|
|
Stock Options (1)
|
|
|
Warrants (1)
|
|
||||||||||
|
|
Number of
Shares
|
|
|
Average
Exercise
Price
|
|
|
Number of
Shares
|
|
|
Average
Exercise
Price
|
|
||||
Outstanding
at December 31, 2005
|
17,956
|
$
|
1.67
|
20,950
|
$
|
2.62
|
||||||||||
Issued
|
23,942
|
1.67
|
71,826
|
0.85
|
||||||||||||
Outstanding
at December 31, 2006
|
41,898
|
$
|
1.67
|
92,776
|
$
|
1.25
|
||||||||||
Issued
|
5,985
|
1.67
|
28,502
|
0.35
|
||||||||||||
Outstanding
at December 31, 2007
|
47,882
|
$
|
1.67
|
121,278
|
$
|
1.04
|
||||||||||
Issued
|
1,243,293
|
0.20
|
5,695,299
|
0.44
|
||||||||||||
Expired
|
(11,971)
|
3.76
|
||||||||||||||
Outstanding
at December 31, 2008
|
1,291,174
|
$
|
0.26
|
5,804,606
|
0.45
|
Range of Exercise Prices
|
Shares
|
Weighted
Average
Remaining
Life
|
||||||
At
December 31, 2007:
|
||||||||
Options:
|
||||||||
$ .35
|
11,970 | 4.37 | ||||||
$ 1.67
|
41,898 | 3.31 | ||||||
Warrants:
|
||||||||
$ 0.02
|
35,913 | 5.45 | ||||||
$ 0.35
|
28,502 | 4.17 | ||||||
$ 1.67
|
44,892 | 3.69 | ||||||
$ 3.34
|
11,971 | 0.79 | ||||||
At
December 31, 2008:
|
||||||||
Options:
|
||||||||
$ .01
|
543,292 | 9.43 | ||||||
$ .35
|
700,000 | 4.46 | ||||||
$ 1.67
|
47,882 | 2.50 | ||||||
Warrants:
|
||||||||
$ 0.02
|
71,826 | 5.45 | ||||||
$ 0.35
|
798,597 | 3.29 | ||||||
$ 0.46
|
4,889,291 | 2.57 | ||||||
$ 1.67
|
44,892 | 2.69 |
Reverse Stock Split Table
|
||||||||||||
|
Number of Shares
|
Reverse
|
||||||||||
|
Outstanding
|
Split Ratio
|
||||||||||
|
Before
|
After
|
||||||||||
As
of June 30, 2008:
|
||||||||||||
-
original shareholders
|
1,376,105 | (1) | 1,096,935 | 1.2545 | ||||||||
-
new investors, other
|
3,720,293 | 3,720,293 | ||||||||||
Total
|
5,096,398 | 4,817,228 | ||||||||||
As
of September 30, 2008:
|
||||||||||||
-
original shareholders
|
1,096,935 | 1,096,935 | ||||||||||
-
new investors, other
|
6,997,842 | 6,997,842 | ||||||||||
Total
|
8,094,237 | 8,094,237 | ||||||||||
As
of October 20, 2008:
|
||||||||||||
-
original shareholders
|
1,096,935 | 823,676 | 1.3317696 | |||||||||
-
new investors, other
|
7,307,165 | 7,307,165 | ||||||||||
Total
|
8,403,560 | 8,130,841 | ||||||||||
As
of October 30, 2008 (closing date):
|
||||||||||||
-
original shareholders
|
823,676 | |||||||||||
-
new investors, other
|
7,307,165 | |||||||||||
Total
|
8,130,841 |
(1)
|
1,376,105
divided by 1.670705 equals
823,676.
|
Key Feature Comparison
|
||||||||||
Feature
|
BioDrain
Medical, Inc.
|
Stryker
Instruments
|
DeRoyal
|
Dornoch
Medical
Systems, Inc.
|
MD
Technologies,
Inc.
|
|||||
Portable to Bedside vs. Fixed
Installation
|
Fixed
|
Portable
|
Fixed
|
Portable
|
Fixed
|
|||||
Uses Canisters
|
No
|
Yes
|
Yes
|
Yes
|
No
|
|||||
Secondary Installed Device Required for Fluid
Disposal
|
No
|
Yes
|
Yes
|
Yes
|
No
|
|||||
Numeric Fluid Volume
Measurement
|
Yes
|
Yes
|
No
|
Yes
|
Optional
|
|||||
Unlimited Fluid Capacity
|
Yes
|
No
|
No
|
No
|
Yes
|
|||||
Installation Requirements
|
||||||||||
■Water
|
No
|
Yes
|
Yes
|
Yes
|
No
|
|||||
■Sewer
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
|||||
■Vacuum
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
•
|
Minimal
Human Interaction. The wall-mounted FMS provides for a small
internal reservoir that keeps surgical waste isolated from medical
personnel and disposes the medical waste directly into the hospital
sanitary sewer with minimal medical personnel interaction. This minimal
interaction is facilitated by the automated electronic controls and
computerized LCD touch-screen allowing for simple and safe single touch
operation of the FMS.
|
|
•
|
Minimizes Exposure. The FMS
minimizes surgical team and cleaning crew exposure to bloodborne
pathogens, as the system is hands-free and fully automated with electronic
controls with regards to handling any waste fluid. The FMS provides
advanced fluid management technology in that it eliminates the use of
canisters, traditional or powered, for fluid collection, is directly
connected to the hospital sanitary sewer, provides continuous flow of
waste fluids from the operative field, allows visualization of those
fluids prior to disposal and provides measurement of disposed fluids. It
does not require any transport to and from the operating room or any
secondary procedure such as attachment to a companion device for disposal
of the waste
fluids
|
•
|
Fluid
Measurement. The FMS volume measurement allows for
in-process, accurate measurement of blood/saline suctioned during the
operative procedure, and eliminates much of the estimation of fluid loss
currently practiced in the operating room. This will be particularly
important in minimally invasive surgical procedures, where accounting for
all fluids, including saline added for the procedure, is vital to the
operation. The surgical team can view in real time the color of the
extracted or evacuated fluid through the viewing window on the
FMS.
|
|
•
|
Disposable Cleaning Kit. A
single-use, disposable cleaning kit that is used for the automated
cleaning cycle at the conclusion of each procedure prepares the FMS for
the next use, reducing operating room turnover time. The cleaning kit
includes a BioDrain proprietary cleaning fluid that we have licensed from
a third party for cleaning the internal tubing, pathways and chamber
within the FMS unit and a disposable external manifold required for each
surgical procedure. The cleaning solution bottle is attached to the FMS
with a cleaning fluid adapter which is designed to mate with the special
connector on the FMS. One manifold will be supplied with each bottle of
cleaning fluid, attached to the bottle for user convenience in securing
all consumables needed for each use of the FMS. The disposable cleaning
fluid bottle collapses at the end of the cleaning cycle rendering it
unusable; therefore it cannot be refilled with any other solution. The
instructions for use clearly state that the FMS cleaning fluid, and only
the FMS cleaning fluid, must be used with the FMS following each surgical
case. The cleaning fluid should be a substantial revenue generator for the
life of the FMS.
|
|
•
|
Ease of
Use. The FMS simply connects to the existing suction tubing
from the operative field (causing no change to the current operative
methods). Pressing the START button on the FMS
touch screen causes the suction tip to operate similarly to preexisting
systems, thereby minimizing the learning curve for operation at the
surgical site.
|
|
•
|
Installation. BioDrain will arrange
installation of the FMS through a partnership or group of partnerships.
Such partnerships will include but not be limited to being executed with
distribution partners, manufacturer's representatives, hospital supply
companies and the like. We will train our partners and standardize the
procedure to ensure the seamless installation of our products. The FMS is
designed for minimal interruption of operating room and surgical room
utilization. Plug-and-play features of the design allow for almost
immediate connection and hook up to hospital utilities for wall-hung units
allowing for quick start-up post installation.
|
|
•
|
Sales
Channel Partners. The FMS will be sold to end-users through
a combination of independent stocking distributors, manufacturers’
representatives and, possibly later, direct sales personnel. All personnel
involved in direct contact with the end-user will have extensive training
and will be approved by BioDrain. Exclusive agreements will be in place
between BioDrain and the sales channel partners outlining stocking
expectations, sales objectives, target accounts, and the like. Contractual
agreements with the sales channel partners will be reviewed on an annual
basis and could possibly be terminated at any time by BioDrain based on
certain specified conditions.
|
|
•
|
Competitive Pricing. Estimated
end-user pricing is expected to be in the range of $12,000 - $15,000 list
per system (one per operating room - installation extra) and $15 - $20 per
unit retail for the proprietary cleaning kit to the U.S. hospital market.
The distributor or channel partner then sets the final retail price based
on quantity discounts for multiple
installations.
|
n
|
Develop a
complete line of wall-installed fluid evacuation systems (“FMS”) for use
in hospitals and free standing surgery centers as well as clinics and
physicians’ offices. Initially, we have developed the
FMS to work in hospital operating rooms and surgical centers. This device
was developed for use with the wall vacuum suction currently installed in
hospitals. Opportunities for future products include an FMS developed for
post-operation and recovery rooms with multiple inlet ports and multiple
volume measurements.
|
n
|
Provide
products that greatly reduce worker and patient exposure to harmful
materials present in infectious fluids and that contribute to an adverse
working environment. As one of the few stand-alone
surgical fluid disposal systems directly connected to the sanitary sewer,
the FMS could advance the manner in which such material is collected,
measured and disposed of in operating rooms, post-operating recovery,
emergency rooms and intensive care settings by eliminating the need to
transport a device to the patient bedside and remove it for emptying and
cleaning at the end of the procedure. The cost of such exposures, measured
in terms of human suffering, disease management costs, lost productivity,
liability or litigation, will be, when properly leveraged, the strongest
motivating factor for facilities looking at investing in the FMS line of
products..
|
n
|
Utilize
existing medical products independent distributors and manufacturers
representatives to achieve the desired market penetration. Contacts have been established
with several existing medical products distributors and manufacturers’
representatives and interest has been generated regarding the sales of the
BioDrain FMS and cleaning kits. In addition to their normal sales
practices, the distributors will carry a significant inventory of cleaning
kits for their current customers and could purchase an FMS for
demonstration to new potential
customers.
|
n
|
Continue to
utilize operating room consultants, builders and architects as referrals
to hospitals and day surgery centers. To date, referrals have been
received from this group resulting in several potential sales and a
potential beta site. These referrals have shortened the time frame for
contacting and demonstrating the FMS to potential customers as well as
providing us with valuable responses to the FMS from the customer base,
the vast majority of which have been extremely positive to
date.
|
n
|
Utilize a
Medical Advisory Board to assist in market penetration. We have a Medical Advisory Board
consisting of a pioneering surgeon, two operating room consultants and a
nurse anesthetist to assist us in understanding the needs of our market
and ways to better serve that market. From time to time executive
management may elect to change the composition of the Medical Advisory
Board, including but not limited to, expanding the size of the Medical
Advisory Board.
|
n
|
Employing a lean operating
structure, while utilizing the latest trends and technologies in
manufacturing and marketing, to achieve both market share growth and
projected profitability.
|
n
|
Providing a leasing program
and/or “pay per use” program as purchasing
alternatives.
|
n
|
Providing service contracts to
establish an additional revenue
stream.
|
n
|
Utilizing management team
contacts in global sourcing of key sub-assemblies to drive significant per
unit cost reduction at
volume.
|
n
|
Offering an innovative
warranty program that is contingent on the exclusive use of our disposable
cleaning kit to insure the success of our after-market disposable
products.
|
•
|
Direct
Disposal Through the Sanitary Sewer. In virtually all municipalities,
the disposal of liquid blood may be done directly to the sanitary sewer
where it is treated by the local waste management facility. This practice
is approved and recommended by the EPA. In most cases these municipalities
specifically request that disposed bio-materials not be treated with any
known anti-bacterial agents such as glutalderhyde, as these agents not
only neutralize potentially infectious agents but also work to defeat the
bacterial agents employed by the waste treatment facilities themselves.
Disposal through this method is fraught with potential exposure to the
service workers, putting them at risk for direct contact with these
potentially infectious agents through spillage of the contents or via
splash when the liquid is poured into a hopper - a specially designated
sink for the disposal of infectious fluids. Once the infectious fluids are
disposed of into the hopper, the empty canister is sent to central
processing for re-sterilization (glass and certain plastics) or for
disposal in the biohazardous/infectious waste generated by the hospital
(red-bagged).
|
•
|
Conversion to
Gel for Red-Bag Disposal. In many hospital systems the
handling of this liquid waste has become a liability issue due to worker
exposure incidents and in some cases has even been a point of contention
during nurse contract negotiations. Industry has responded to concerns of
nurses over splash and spillage contamination by developing a powder that,
when added to the fluid in the canisters, produces a viscous, gel-like
substance that can be handled more safely. After the case is completed and
final blood loss is calculated, a port on the top of each canister is
opened and the powder is poured into it. It takes several minutes for the
gel to form, after which the canisters are placed on a service cart and
removed to the red-bag disposal area for disposal with the other
infectious waste. There are four major drawbacks to this
system:
|
|
o
|
It does not ensure protection for
healthcare workers, as there remains the potential for splash when the top
of the canister is opened.
|
|
o
|
Based on industry pricing data,
the total cost per canister increases by approximately
$2.00.
|
|
o
|
Disposal costs to the hospital
increase dramatically as shipping, handling and landfill costs are based
upon weight rather than volume in most municipalities. The weight of an
empty 2,500 ml canister is approximately one pound. A canister and its
gelled contents weigh approximately 7.5
pounds.
|
|
o
|
The canister filled with gelled
fluid must be disposed; it cannot be cleaned and re-sterilized for future
use.
|
|
•
|
OSHA (Occupational Safety and
Health Administration)
|
|
•
|
EPA (Environmental Protection
Agency)
|
|
•
|
DOT (Department of
Transportation)
|
|
•
|
JCAHO (Joint Commission of
Accreditation of Hospitals)
|
|
•
|
NFPA (National Fire Protection
Association)
|
|
•
|
AIA (American Institute of
Architects)
|
|
•
|
AORN (Association of Operating
Room Nurses)
|
|
•
|
Specific state, county, hospital
or institution guidelines
|
|
1.
|
Our contracted FDA consultant
compiled the following
documents:
|
a.
|
Electrical safety testing
report and conclusions from TUV SUD America,
Inc.,
|
|
|
b.
|
Risk and hazard analysis documentation, |
c.
|
BioDrain FMS product labeling such as the instructions for use, preventative, maintenance schedules, troubleshooting guidelines, | |
d. | Documentation regarding the proprietary cleaning fluid and the labeling and instructions for use related to the use of the proprietary cleaning fluid, | |
f. | Other documentation the FDA deems necessary. |
2.
|
Upon compiling these documents, a
510(k) Submittal Document was drafted in the format instructed by the
FDA and the FDA consultant. This entire package, upon completion
by the BioDrain FDA consultant and approval by BioDrain management, was
submitted to a contracted third party 510(k) reviewer, Mark Job
of Regulatory Technical
Services.
|
3.
|
Mr. Job reviewed the BioDrain
submittal and a question and answer iteration took place between us and
Regulatory Technical Services until he was satisfied with the BioDrain
submittal. Once satisfied, Mr. Job submitted the BioDrain 510(k) Submittal
Document and all necessary, related documentation directly to the FDA
on March 23, 2009.
|
4.
|
The FDA has thirty days to review
and respond to the BioDrain 510(k) Submittal. Similarly, a question and
answer iteration may take place between the FDA and Mr. Job or
Regulatory Technical Services regarding the submittal. BioDrain, at the
request and as needed by Mr. Job or Regulatory Technical Services,
will take all necessary steps and actions to provide the answers to any
and all FDA inquires specific to the 510(k) submittal.
|
5.
|
Upon successfully addressing the
FDA’s questions, BioDrain received FDA 510(k) clearance for the FMS device
on April 1, 2009.
|
Investors
|
|
|||||||
Name
|
|
Number of
Shares
|
|
|
Percentage of
Common Stock
Outstanding
|
|
||
Investors:
|
||||||||
Caron
Partners LP
|
246,500
|
3.0
|
%
|
|||||
Marc
I. Abrams
|
28,571
|
0.3
|
%
|
|||||
Douglas
Gold
|
203,571
|
2.5
|
%
|
|||||
Stuart
A. Liner
|
71,429
|
0.9
|
%
|
|||||
Steven
M & Sheila A. Gold
|
71,429
|
0.9
|
%
|
|||||
Tangiers
Investors, L.P.
|
142,857
|
1.7
|
%
|
|||||
MLPF&S:
Jerome Cowan
|
71,429
|
0.9
|
%
|
|||||
Jeremy
Roll
|
28,572
|
0.3
|
%
|
|||||
Bernard
& Twyla Vosika
|
71,429
|
0.9
|
%
|
|||||
Sally
& Naomi Maslon JTWROS
|
28,571
|
0.3
|
%
|
|||||
Michael
Sobeck
|
14,286
|
0.2
|
%
|
|||||
Cavalier
Consulting Corp.
|
71,429
|
0.9
|
%
|
|||||
RP
Capital
|
183,991
|
2.2
|
%
|
|||||
Brian
Weitman
|
42,599
|
0.5
|
%
|
|||||
Bellajule
Partners LP
|
102,429
|
1.3
|
%
|
|||||
Morris
Esquenazi
|
100,000
|
1.2
|
%
|
|||||
Schwartz
Holding
|
500,000
|
6.1
|
%
|
|||||
Jack
& Thelma Farbman
|
100,000
|
1.2
|
%
|
|||||
Morrie
R. Rubin
|
50,000
|
0.6
|
%
|
|||||
Lee
M. Terpstra & Orlando Stephenson
|
100,000
|
1.2
|
%
|
Investors
|
|
|||||||
Name
|
|
Number of
Shares
|
|
|
Percentage of
Common Stock
Outstanding
|
|
||
Bernard
Puder Revocable Trust
|
430,000
|
5.3
|
%
|
|||||
Thomas
J. Klas
|
71,429
|
0.9
|
%
|
|||||
Chad
Ruwe
|
571,429
|
7.0
|
%
|
|||||
Peter
Abramowicz
|
57,143
|
0.7
|
%
|
|||||
Scott
R. Storick
|
100,000
|
1.2
|
%
|
|||||
James
Dauwalter Living Trust
|
571,429
|
7.0
|
%
|
|||||
CGMI
as IRA Custodian FBO John D. Villas
|
71,429
|
0.9
|
%
|
|||||
Stan
Geyer Living Trust
|
71,429
|
0.9
|
%
|
|||||
James
Taylor, IV
|
571,429
|
7.0
|
%
|
|||||
Gregory
B, Graves
|
42,857
|
0.5
|
%
|
|||||
Fenton
Fitzpatrick
|
8,571
|
0.1
|
%
|
|||||
Peter
Persad
|
71,429
|
0.9
|
%
|
|||||
Thomas
M. Pronesti
|
55,964
|
0.7
|
%
|
|||||
Craig
Kulman
|
38,821
|
0.5
|
%
|
|||||
Kulman
IR LLC
|
125,000
|
1.5
|
%
|
|||||
Cross
Street Partners, Inc.
|
125,000
|
1.5
|
%
|
|||||
Namaste
Financial, Inc.
|
125,000
|
1.5
|
%
|
|||||
Ryan
Hong
|
57,404
|
0.7
|
%
|
|||||
Richardson
& Patel LLP
|
60,714
|
0.7
|
%
|
|||||
Sean
Fitzpatrick
|
150,000
|
1.8
|
%
|
|||||
David
Baker
|
225,000
|
2.8
|
%
|
|||||
Si
Phillips
|
50,000
|
0.6
|
%
|
|||||
Cameron
Broumand
|
35,000
|
0.4
|
%
|
|||||
Sylvia
Karayan
|
11,646
|
0.1
|
%
|
|||||
Jason
Cavalier
|
15,000
|
0.2
|
%
|
|||||
Greg
Suess
|
104,114
|
1.3
|
%
|
|||||
Ben
Padnos
|
100,000
|
1.2
|
%
|
|||||
Nimish
Patel
|
412,411
|
5.0
|
%
|
|||||
Erick
Richardson
|
399,543
|
4.9
|
%
|
|||||
Mark
Abdou
|
32,907
|
0.4
|
%
|
|||||
Addison
Adams
|
8,227
|
0.1
|
%
|
|||||
Michael
Cavalier
|
8,227
|
0.1
|
%
|
|||||
Mick
Cavalier
|
8,227
|
0.1
|
%
|
|||||
Francis
Chen
|
2,334
|
0.0
|
%
|
|||||
Doug
Croxall
|
6,170
|
0.1
|
%
|
|||||
Jennifer
& Michael Donahue
|
28,009
|
0.3
|
%
|
|||||
Egatniv
LLC
|
13,710
|
0.2
|
%
|
|||||
Dan
Estrin
|
823
|
0.0
|
%
|
|||||
Kevin
Friedmann
|
1,440
|
0.0
|
%
|
|||||
Abdul
Ladha
|
4,114
|
0.1
|
%
|
|||||
Jody
Samuels
|
8,227
|
0.1
|
%
|
|||||
Yossi
Stern
|
10,284
|
0.1
|
%
|
|||||
Steve
Yakubov
|
10,284
|
0.1
|
%
|
|||||
Total
|
7,101,266
|
86.8
|
%
|
Founders
|
|
|||||||
Name
|
|
Number of
Shares
|
|
|
Percentage of
Common Stock
Outstanding
|
|
||
Lawrence
W. Gadbaw
|
139,163
|
1.7
|
%
|
|||||
Peter
L. Morawetz
|
107,739
|
1.3
|
%
|
|||||
Gerald
D. Rice
|
85,294
|
1.0
|
%
|
|||||
Jay
D. Nord
|
102,336
|
1.3
|
%
|
|||||
Sophia
M. Nord, Trust
|
29,928
|
0.4
|
%
|
|||||
Emily
A. Nord, Trust
|
29,928
|
0.4
|
%
|
|||||
Jeffrey
K. Drogue
|
53,870
|
0.7
|
%
|
|||||
Jonathon
N. Drogue, Trust
|
29,928
|
0.4
|
%
|
|||||
Samantha
N. Drogue, Trust
|
29,928
|
0.4
|
%
|
|||||
Staci
M. Lauer (Spade)
|
35,913
|
0.4
|
%
|
|||||
Wisconsin
Rural Enterprise
|
37,709
|
0.5
|
%
|
|||||
Richard
E. & Carol A. Thurk
|
5,986
|
0.1
|
%
|
|||||
Thomas
W. Gadbaw
|
599
|
0.0
|
%
|
|||||
Gail
C. & Ginger L. Smith
|
2,993
|
0.0
|
%
|
|||||
Charles
W. Gadbaw
|
300
|
0.0
|
%
|
|||||
Judith
A. Bright
|
1,497
|
0.0
|
%
|
|||||
Marshall
C. Ryan
|
71,906
|
0.9
|
%
|
|||||
Alice
I. North
|
399
|
0.0
|
%
|
|||||
Arliss
A. Gadbaw
|
400
|
0.0
|
%
|
|||||
Gaynelle
A. Templin
|
399
|
0.0
|
%
|
|||||
Kevin
R. Davidson
|
29,928
|
0.4
|
%
|
|||||
Mark
K. Lawlis
|
9,577
|
0.1
|
%
|
|||||
Wisconsin
Business Innovation Corporation
|
2,993
|
0.0
|
%
|
|||||
Andcor
Companies, Inc.
|
78,571
|
1.0%
|
%
|
|||||
Wisconsin
Rural Enterprise Fund
|
142,291
|
1.7
|
%
|
|||||
Total
|
1,029,575
|
12.7%
|
%
|
Name
|
|
Age
|
|
Position Held
|
Lawrence
W. Gadbaw
|
71
|
Chairman
of the Board of Directors
|
||
|
||||
Kevin
R. Davidson
|
49
|
|
President,
Chief Executive Officer, Interim Chief Financial Officer and
Director
|
|
Chad
A. Ruwe
|
44
|
Executive
Vice President of Operations and Director
|
||
Kirsten
Doerfert
|
52
|
Vice
President of Sales and Marketing
|
||
Peter
L. Morawetz
|
81
|
Director
|
||
Thomas
J. McGoldrick
|
67
|
Director
|
||
Andrew
P. Reding
|
38
|
Director
|
|
•
|
had any bankruptcy petition filed
by or against any business of which such person was a general partner or
executive officer, either at the time of the bankruptcy or within two
years prior to that time,
|
|
•
|
been convicted in a criminal
proceeding and none of our directors or executive officers is subject to a
pending criminal proceeding,
|
|
•
|
been subject to any order,
judgment, or decree, not subsequently reversed, suspended or vacated, of
any court of competent jurisdiction, permanently or temporarily enjoining,
barring, suspending or otherwise limiting his involvement in any type of
business, securities, futures, commodities or banking activities,
or
|
|
•
|
been found by a court of
competent jurisdiction (in a civil action), the Securities and Exchange
Commission or the Commodity Futures Trading Commission to have violated a
federal or state securities or commodities law, and the judgment has not
been reversed, suspended, or
vacated.
|
Name and principal
position
|
Year
|
Salary
($)
|
Bonus
($)
|
Stock
Awards
($)
|
Option
Awards
($) (4)
|
Non-
Equity
Incentive
Plan
Compen-
sation
($)
|
Nonquali-
fied
Deferred
Compen-
sation
Earnings
($)
|
All
Other
Compen-
sation
($)
|
Total ($)
|
|||||||||||||
Kevin
R. Davidson,
|
2008
|
160,000 | 25,000 | 185,806 | 370,806 | |||||||||||||||||
President
and Chief Executive Officer
|
2007
|
150,000 | 23,000 | 173,000 | (1) | |||||||||||||||||
Gerald
D. Rice,
|
2008
|
114,250 |
|
114,000 | ||||||||||||||||||
Former
Chief Financial Officer and Secretary (3)
|
2007
|
110,000 | 46,000 | 156,000 | (2) |
(1)
|
In 2008 Mr. Davidson was
entitled to $160,000 in base salary under his employment agreement and a
board approved salary increase, but was paid only $126,650, including a
board approved bonus of $25,000, due to a shortage of
cash. In 2007, although Mr. Davidson was entitled to $150,000
in base salary under his employment agreement, he received $59,375 in base
salary due to lack of funds. . In December 2007 we reduced
accrued payroll liabilities by a total of $346,714 (of which Mr. Davidson
waived compensation in the aggregate amount of $70,000 for 2007 and prior
years). In addition, Mr. Davidson waived $58,250 in underpaid compensation
in 2008. In exchange therefore, Mr. Davidson will be granted a
one-time cash bonus of $23,000 as well as an option to purchase 80,000
shares of common stock at $.35 per share when the Company raises an
additional $3 million of funding subsequent to the financing completed in
October 2008.
|
(2)
|
In 2008 Mr. Rice was entitled
to 114,250 in base salary under his employment agreement and board
approved salary increase, but was paid only $73,525 due to a shortage of
cash. In 2007, although Mr. Rice was entitled to $110,000 in
base salary under his employment agreement, he received $43,542 in base
salary due to lack of cash. In December 2007 we reduced accrued payroll
liabilities by $346,714 (of which Mr. Rice waived compensation in the
aggregate amount of $125,000 relating to 2007 and prior years). In
addition, Mr. Rice waived $40,725 in underpaid compensation for
2008. In exchange therefore, Mr. Rice will be granted a
one-time cash bonus of $46,000 as well as an option to purchase 160,000
shares of common stock at $.35 per share when we raise an additional $3
million of funding subsequent to the financing completed in October
2008.
|
(3)
|
Mr.
Rice terminated his employment as our Chief Financial Officer and
Secretary on January 15, 2009
|
|
Option awards
|
Stock awards
|
|||||||||||||||||||||||||||||||
Name
|
Number of
securities
underlying
unexercised
options
(#)
exercisable
|
Number of
securities
underlying
unexercised
options
(#)
unexercisable
|
Equity
incentive
plan
awards:
Number of
securities
underlying
unexercised
unearned
options
(#)
|
Option
exercise
price
($)
|
Option
expiration
date
|
Number
of
shares
or units
of stock
that
have
not
vested
(#)
|
Market
value
of
shares
of
units
of
stock
that
have
not
vested
($)
|
Equity
incentive
plan
awards:
Number
of
unearned
shares,
units or
other
rights
that have
not
vested
(#)
|
Equity
incentive
plan
awards:
Market
or
payout
value of
unearned
shares,
units or
other
rights
that have
not
vested
($)
|
||||||||||||||||||||||||
(a)
|
(b)
|
(c)
|
(d)
|
(e)
|
(f)
|
(g)
|
(h)
|
(i)
|
(j)
|
||||||||||||||||||||||||
|
|
|
|
|
|||||||||||||||||||||||||||||
Kevin
R. Davidson, President and Chief Executive Officer
|
- | 80,000 | (1) | - | $ | .35 |
12/31/13
|
- | - | - | - | ||||||||||||||||||||||
543,292 | (2) | .01 |
06/05/18
|
||||||||||||||||||||||||||||||
Gerald
D. Rice, Chief Financial Officer and Secretary
|
- | 160,000 | (1) | - | $ | .35 |
12/31/13
|
- | - | - | - |
(1)
|
Vesting of these stock options is
contingent upon the Company achieving $3 million in total investment
funding.
|
(2)
|
Mr.
Davidson was entitled to receive 543,292 shares of company stock under
terms of his employment agreement, but agreed to accept a stock option to
purchase 543,292 shares at $.01 per share. The option vested immediately
and has a 10 year term.
|
·
|
Shares underlying convertible
debenture with seven investors who loaned us $170,000 in July 2007. Such
securities are convertible into 620,095shares and the lenders also
received warrants to purchase 620,095 shares at $.35 per
share;
|
·
|
4,552,862 common shares and
4,552,862 common shares underlying warrants (at an exercise price per
share of $0.46) to 33 investors pursuant to an equity private placement
from June 2007 to October 2008 for $0.35 per share for an aggregate of
approximately $1.6
million;
|
·
|
547,285 common shares and 136,429
warrants to consultants who provided services in connection with such
equity private placement;
and
|
·
|
Shares issued pursuant to a
binding term sheet with a consultant pursuant to which the consultant
would assist us in obtaining bridge financing and subsequent equity
financing and the consultant and its assigns received 2,001,119 shares in
satisfaction of such
obligation.
|
Name of Selling Shareholder
|
Number of
Shares
Owned
Before
Offering(1)
|
Number of
Shares
Underlying
Warrants
Owned
Before
Offering
|
Number of
Shares
Offered in
this
Offering(1)
|
Number of
Shares
Owned
After
Offering(2)
|
Percentage
Owned
After
Offering(2)
|
|
||||||||||||||
Caron
Partners LP(3) (25)
|
246,500
|
100,000
|
246,500
|
0
|
0
|
|||||||||||||||
Alan
Topchik (25)
|
200,000
|
100,000
|
200,000
|
0
|
0
|
|||||||||||||||
Marc
I. Abrams (25)
|
57,142
|
28,571
|
57,142
|
0
|
0
|
|||||||||||||||
Douglas
J. Gold (21) (25) (27)
|
232,142
|
28,571
|
232,142
|
0
|
0
|
|||||||||||||||
Stuart
A. Liner (25)
|
142,858
|
71,429
|
142,858
|
0
|
0
|
|||||||||||||||
Steven
M. Gold and Sheila A. Gold (25)
|
142,858
|
71,429
|
142,858
|
0
|
0
|
|||||||||||||||
Tangiers
Investors, L.P.(4) (25)
|
285,714
|
142,857
|
285,714
|
0
|
0
|
|||||||||||||||
Jerome
M. Cowan (25)
|
142,858
|
71,429
|
142,858
|
0
|
0
|
|||||||||||||||
Jeremy
Roll (25) (26)
|
68,573
|
40,001
|
68,573
|
0
|
0
|
|||||||||||||||
Bernard
Vosika and Twyla Vosika (25)
|
142,858
|
71,429
|
142,858
|
0
|
0
|
Name of Selling Shareholder
|
Number of
Shares
Owned
Before
Offering(1)
|
Number of
Shares
Underlying
Warrants
Owned
Before
Offering
|
Number of
Shares
Offered in
this
Offering(1)
|
Number of
Shares
Owned
After
Offering(2)
|
Percentage
Owned
After
Offering(2)
|
|
||||||||||||||
Sally
Maslon & Naomi Maslon JTWROS
(25)
|
57,142
|
28,571
|
57,142
|
0
|
0
|
|||||||||||||||
Michael
Sobeck (25)
|
28,572
|
14,286
|
28,572
|
0
|
0
|
|||||||||||||||
Cavalier
Consulting Corp.(5) (25)
|
142,858
|
71,429
|
142,858
|
0
|
0
|
|||||||||||||||
RP
Capital(6) (21) (25)
|
326,848
|
142,857
|
326,848
|
0
|
0
|
|||||||||||||||
Brian
Weitman (25)
|
64,028
|
21,429
|
64,028
|
0
|
0
|
|||||||||||||||
Bellajule
Partners LP(7) (25)
|
173,858
|
71,429
|
173,858
|
0
|
0
|
|||||||||||||||
Morris
Esquenazi (25)
|
200,000
|
100,000
|
200,000
|
0
|
0
|
|||||||||||||||
Schwartz
Holding (25)(28)
|
1,000,000
|
500,000
|
1,000,000
|
0
|
0
|
|||||||||||||||
Jack
Farbman and Thelma Farbman (25)
|
200,000
|
100,000
|
200,000
|
0
|
0
|
|||||||||||||||
Morrie
R. Rubin (25)
|
225,000
|
50,000
|
100,000
|
125,000
|
1.5
|
% | ||||||||||||||
Lee
M. Terpstra and Orlando Stephenson (25)
|
200,000
|
100,000
|
200,000
|
0
|
0
|
|||||||||||||||
Bernard
Puder Revocable Trust (25)
|
860,000
|
430,000
|
860,000
|
0
|
0
|
|||||||||||||||
Thomas
J. Klas (25)
|
142,858
|
71,429
|
142,858
|
0
|
0
|
|||||||||||||||
Chad
A. Ruwe(22) (25)
|
1,192,858
|
571,429
|
1,142,858
|
50,000
|
(8)
|
*
|
||||||||||||||
Peter
Abramowicz (25)
|
114,286
|
57,143
|
114,286
|
0
|
0
|
|||||||||||||||
Scott
R. Storick (25)
|
200,000
|
100,000
|
200,000
|
0
|
0
|
|||||||||||||||
James
R. Taylor, IV(25)
|
1,142,858
|
571,429
|
1,142,858
|
0
|
0
|
|||||||||||||||
Citigroup
Global Markets Inc. as IRA Custodian FBO John D. Villas
(25)
|
142,858
|
71,429
|
142,858
|
0
|
0
|
|||||||||||||||
Gregory
B. Graves (25)
|
85,714
|
42,857
|
85,714
|
0
|
0
|
|||||||||||||||
James
E. Dauwalter Living Trust dated 12/11/01(9) (25)
|
1,142,858
|
571,429
|
1,142,858
|
0
|
0
|
|||||||||||||||
Stan
Geyer Living Trust dated 10/15/2001, as amended, Stan Geyer & Beverly
Geyer, Trustees(10) (25)
|
142,858
|
71,429
|
142,858
|
0
|
0
|
|||||||||||||||
Fenton
Fitzpatrick (25)
|
17,142
|
8,571
|
17,142
|
0
|
0
|
|||||||||||||||
Peter
Persad (25)
|
142,858
|
71,429
|
142,858
|
0
|
0
|
|||||||||||||||
Nimish
Patel(11) (21) (24)
|
503,601
|
45,595
|
503,601
|
0
|
0
|
|||||||||||||||
Erick
Richardson(12) (21) (24)
|
490,733
|
45,595
|
490,733
|
0
|
0
|
|||||||||||||||
Core
Fund Management, LP(13) (24)
|
364,762
|
182,381
|
364,762
|
0
|
0
|
|||||||||||||||
James
Jensen(14) (24)
|
364,762
|
182,381
|
364,762
|
0
|
0
|
|||||||||||||||
Steve
Andress(15) (24)
|
72,952
|
36,476
|
72,952
|
0
|
0
|
|||||||||||||||
Kendall
Morrison(16) (24)
|
72,952
|
36,476
|
72,952
|
0
|
0
|
|||||||||||||||
Egatniv
LLC(17) (24)
|
196,092
|
91,191
|
196,092
|
0
|
0
|
|||||||||||||||
Thomas
Pronesti(23) (26)
|
55,964
|
55,964
|
0
|
0
|
||||||||||||||||
Craig
Kulman(23) (26)
|
38,821
|
38,821
|
0
|
0
|
||||||||||||||||
Kulman
IR LLC(18)(23) (26)
|
125,000
|
125,000
|
0
|
0
|
||||||||||||||||
Cross
Street Partners, Inc.(19)(23) (26)
|
125,000
|
125,000
|
0
|
0
|
||||||||||||||||
Bill
Glaser(23) (26)
|
250,000
|
125,000
|
250,000
|
0
|
0
|
|||||||||||||||
Ryan
Hong(21) (27)
|
57,404
|
57,404
|
0
|
0
|
||||||||||||||||
Richardson
& Patel, LLP(20) (27)
|
60,714
|
60,714
|
0
|
0
|
||||||||||||||||
Sean
Fitzpatrick (27)
|
150,000
|
150,000
|
0
|
0
|
||||||||||||||||
David
Baker (27)
|
225,000
|
225,000
|
0
|
0
|
||||||||||||||||
Si
Phillips (27)
|
50,000
|
50,000
|
0
|
0
|
||||||||||||||||
Cameron
Broumand (27)
|
35,000
|
35,000
|
0
|
0
|
||||||||||||||||
Sylvia
Karayan(21) (27)
|
10,000
|
10,000
|
0
|
0
|
||||||||||||||||
Jason
Cavalier (27)
|
15,000
|
15,000
|
0
|
0
|
||||||||||||||||
Greg
Suess (27)
|
104,114
|
104,114
|
0
|
0
|
||||||||||||||||
Ben
Padnos (27)
|
100,000
|
100,000
|
0
|
0
|
||||||||||||||||
Mark
Abdou (27)
|
32,907
|
32,907
|
0
|
0
|
||||||||||||||||
Addison
Adams(21) (27)
|
8,227
|
8,227
|
0
|
0
|
||||||||||||||||
Michael
Cavalier (27)
|
8,227
|
8,227
|
0
|
0
|
||||||||||||||||
Mick
Cavalier (27)
|
8,227
|
8,227
|
0
|
0
|
||||||||||||||||
Francis
Chen(21) (27)
|
2,334
|
2,334
|
0
|
0
|
||||||||||||||||
Doug
Croxall (27)
|
6,170
|
6,170
|
0
|
0
|
||||||||||||||||
Jennifer
& Michael Donahue(21) (27)
|
28,009
|
28,009
|
0
|
0
|
Name of Selling Shareholder
|
Number of
Shares
Owned
Before
Offering(1)
|
Number of
Shares
Underlying
Warrants
Owned
Before
Offering
|
Number of
Shares
Offered in
this
Offering(1)
|
Number of
Shares
Owned
After
Offering(2)
|
Percentage
Owned
After
Offering(2)
|
|
||||||||||||||
Dan
Estrin (27)
|
823
|
823
|
0
|
0
|
||||||||||||||||
Kevin
Friedmann(21) (27)
|
1,440
|
1,440
|
0
|
0
|
||||||||||||||||
Sylvia
Karayan(21) (27)
|
1,646
|
1,646
|
0
|
0
|
||||||||||||||||
Abdul
Ladha (27)
|
4,114
|
4,114
|
0
|
0
|
||||||||||||||||
Jody
Samuels(21) (27)
|
8,227
|
8,227
|
0
|
0
|
||||||||||||||||
Yossi
Stern (27)
|
10,284
|
10,284
|
0
|
0
|
||||||||||||||||
Steve
Yakubov
|
10,284
|
10,284
|
0
|
0
|
||||||||||||||||
TOTAL
|
13,030,747
|
5,309,386
|
13,030,747
|
0
|
*
|
Name of Beneficial Owner
|
Amount and
Nature of
Beneficial
Ownership
|
Percent
of
Class
|
||||||
Lawrence
W. Gadbaw (1)
|
139,563
|
1.7
|
%
|
|||||
Kevin
R. Davidson (2)
|
573,219
|
6.5
|
%
|
|||||
Gerald
D. Rice (3)
|
84,994
|
1.0
|
%
|
|||||
Chad
A. Ruwe (4)
|
621,429
|
7.5
|
%
|
|||||
Peter
L. Morawetz (5)
|
107,739
|
1.3
|
%
|
|||||
Thomas
J. McGoldrick (6)
|
23,942
|
*
|
%
|
|||||
Andrew
P. Reding (7)
|
23,942
|
*
|
%
|
|||||
Carl
Schwartz (8)
|
500,000
|
6.1
|
%
|
|||||
Bernard
Puder Revocable Trust (9)
|
430,000
|
5.2
|
%
|
|||||
James
Dauwalter Living Trust (10)(14)
|
581,429
|
7.0
|
%
|
|||||
James
R. Taylor IV (11)
|
571,429
|
6.9
|
%
|
|||||
Nimish
Patel (12)
|
687,592
|
8.2
|
%
|
|||||
Erick
Richardson (13)
|
674,724
|
8.1
|
%
|
|||||
All
directors and executive officers as a group (7
persons)
|
1,574,828
|
17.7
|
%
|
(1)
|
Includes 139,563 shares of common
stock. Mr. Gadbaw does not currently have any options to acquire
additional shares of common stock of the
Company.
|
(2)
|
Includes (i) 29,927 shares of
common stock and (ii) options to acquire up to an additional 543,292
shares of common stock of the Company, all of which are presently
exercisable.
|
(3)
|
Includes 84,994 shares of common
stock. Mr. Rice does not currently have any options to acquire additional
shares of common stock of the
Company.
|
(4)
|
Includes 571,429 shares of common
stock and options to acquire up to an additional 50,000 shares of common
stock that are presently exercisable. Does not include (i) 571,429 shares
of common stock underlying warrants that are not exercisable within 60
days and (ii) options to purchase 200,000 shares of common stock that are
not exercisable until achievement of certain performance targets as
provided for in Mr. Ruwe’s employment
agreement.
|
(5)
|
Includes 107,739 shares of common
stock. Mr. Morawetz does not currently have any options to acquire
additional shares of common stock of the
Company.
|
(6)
|
Includes options to acquire up to
23,942 shares of common stock, which are presently exercisable, granted
pursuant to a director stock option agreement by and between Mr.
McGoldrick and the
Company.
|
(7)
|
Includes options to acquire up to
23,942 shares of common stock, which are presently exercisable, granted
pursuant to a director stock option agreement by and between Mr. Reding
and the Company.
|
(8)
|
Includes 500,000 shares of common
stock. Does not include 500,000 shares of common stock underlying warrants
that are not exercisable within 60
days.
|
(9)
|
Includes 430,000 shares of
common stock. Does not include 430,000 shares of common stock underlying
warrants that are not exercisable within 60
days.
|
(10)
|
Includes 571,429 shares of
common stock. Does not include 571,429 shares of common stock underlying
warrants that are not exercisable within 60
days.
|
(11)
|
Includes 571,429 shares of
common stock. Does not include 571,429 shares of common stock underlying
warrants that are not exercisable within 60
days.
|
(12)
|
Includes 412,411 shares of
common stock, 45,595 shares of common stock underlying warrants and,
45,595 shares of common stock underlying convertible notes. Also includes
183,991 shares of common stock held by RP Capital LLC, for which Nimish
Patel and Erick Richardson have shared voting and dispositive control.
Does not include a warrant for 142,857 shares held by RP Capital LLC
because these warrants are not exercisable within 60 days. Does not
include 60,714 shares of common stock held by Richardson & Patel LLP.
The voting and dispositive control of such shares are held by Mr. Douglas
Gold. Mr. Patel does not currently have options to acquire additional
shares of common stock of the
Company.
|
(13)
|
Includes
399,543 shares of common stock, 45,595 shares of common stock underlying
warrants and, 45,595 shares of common stock underlying convertible notes.
Also includes 183,991 shares of common stock held by RP Capital LLC, for
which Nimish Patel and Erick Richardson have shared voting and dispositive
control. Does not include a warrant for 142,857 shares held by RP Capital
LLC because these warrants are not exercisable within 60 days. Does not
include 60,714 shares of common stock held by Richardson & Patel LLP.
The voting and dispositive control of such shares are held by Mr. Douglas
Gold. Mr. Richardson does not currently have options to acquire additional
shares of common stock of the
Company.
|
(14)
|
Includes
an option to purchase 10,000 shares held by David Dauwalter, the son of
James Dauwalter. Does not include an option to purchase 40,000
held by David Dauwalter because they vest only upon achieving certain
performance conditions and are, therefore, not exercisable within 60
days.
|
(1)
|
has not been indemnified by
another organization or employee benefit plan for the same judgments,
penalties, fines, including, without limitation, excise taxes assessed
against the person with respect to an employee benefit plan, settlements,
and reasonable expenses, including attorneys’ fees and disbursements,
incurred by the person in connection with the proceeding with respect to
the same acts or omissions;
|
(2)
|
acted in good
faith;
|
(3)
|
received no improper personal
benefit and Section 302A.255, if applicable, has been
satisfied;
|
(4)
|
in the case of a criminal
proceeding, had no reasonable cause to believe the conduct was unlawful;
and
|
(5)
|
in the case of acts or omissions
occurring in the person’s performance in the official capacity of director
or, for a person not a director, in the official capacity of officer,
board committee member or employee, reasonably believed that the conduct
was in the best interests of the corporation or, in the case of
performance by a director, officer or employee of the corporation
involving service as a director, officer, partner, trustee, employee or
agent of another organization or employee benefit plan, reasonably
believed that the conduct was not opposed to the best interests of the
corporation. If the person’s acts or omissions complained of in the
proceeding relate to conduct as a director, officer, trustee, employee, or
agent of an employee benefit plan, the conduct is not considered to be
opposed to the best interests of the corporation if the person reasonably
believed that the conduct was in the best interests of the participants or
beneficiaries of the employee benefit
plan
|
(1)
|
by the board by a majority of a
quorum, if the directors who are at the time parties to the proceeding are
not counted for determining either a majority or the presence of a
quorum;
|
(2)
|
if a quorum under clause (1)
cannot be obtained, by a majority of a committee of the board, consisting
solely of two or more directors not at the time parties to the proceeding,
duly designated to act in the matter by a majority of the full board
including directors who are
parties;
|
(3)
|
if a determination is not made
under clause (1) or (2), by special legal counsel, selected either by a
majority of the board or a committee by vote pursuant to clause (1) or (2)
or, if the requisite quorum of the full board cannot be obtained and the
committee cannot be established, by a majority of the full board including
directors who are parties;
|
(4)
|
if a determination is not made
under clauses (1) to (3), by the affirmative vote of the shareholders
required by Section 302A.437 of the Minnesota Statutes, but the shares
held by parties to the proceeding must not be counted in determining the
presence of a quorum and are not considered to be present and entitled to
vote on the determination;
or
|
(5)
|
if an adverse determination is
made under clauses (1) to (4) or under paragraph (b), or if no
determination is made under clauses (1) to (4) or under paragraph (b)
within 60 days after (i) the later to occur of the termination of a
proceeding or a written request for indemnification to the corporation or
(ii) a written request for an advance of expenses, as the case may be, by
a court in this state, which may be the same court in which the proceeding
involving the person’s liability took place, upon application of the
person and any notice the court requires. The person seeking
indemnification or payment or reimbursement of expenses pursuant to this
clause has the burden of establishing that the person is entitled to
indemnification or payment or reimbursement of
expenses.
|
Page
|
||
Financial
Statements:
|
F-1
|
|
Report
of Independent Registered Public Accounting Firm
|
F-3
|
|
Balance
Sheets
|
F-4
|
|
Statements
of Operations
|
F-5
|
|
Statements
of Changes in Stockholders’ Deficit
|
F-6
|
|
Statements
of Cash Flows
|
F-7
|
|
Notes
to Financial Statements
|
F-8
|
BIODRAIN
MEDICAL, INC.
|
(A
DEVELOPMENT STAGE COMPANY)
|
BIODRAIN
MEDICAL, INC.
(A
DEVELOPMENT STAGE COMPANY)
BALANCE
SHEET
YEARS
ENDED DECEMBER 31, 2008 AND 2007
|
2008
|
2007
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
|
$
|
463,838
|
$
|
4,179
|
||||
Prepaid
expenses
|
7,974
|
4,558
|
||||||
Restricted
cash in escrow
|
163,333
|
—
|
||||||
Total
current assets
|
635,145
|
8,737
|
||||||
Fixed
assets, net
|
11,689
|
—
|
||||||
Intangibles,
net
|
142,023
|
113,056
|
||||||
Total
assets
|
$
|
788,857
|
$
|
121,793
|
||||
LIABILITIES AND STOCKHOLDERS’
DEFICIT
|
||||||||
Current
liabilities:
|
||||||||
Current
portion of long-term debt (See Note 7)
|
$
|
17,620
|
$
|
33,800
|
||||
Current
portion of convertible debt (See Note 7)
|
170,000
|
170,000
|
||||||
Accounts
payable
|
497,028
|
207,657
|
||||||
Accrued
expenses
|
280,248
|
226,429
|
||||||
Notes
payable (See Note 6)
|
10,000
|
10,000
|
||||||
Total
current liabilities
|
974,896
|
647,886
|
||||||
Long-term
debt and convertible debt, net of discounts of $24,955 and
$0.
(See
Note 7)
|
99,608
|
136,508
|
||||||
Commitments
and contingencies (See Note 8)
|
-
|
-
|
||||||
Stockholders’
equity (deficit):
|
||||||||
Common
stock $0.01 par value; 40,000,000, 11,970,994 shares authorized; 8,130,841
and
823,676
shares issued and outstanding
|
81,308
|
8,237
|
||||||
Additional
paid-in capital
|
2,171,080
|
117,833
|
||||||
Deficit
accumulated during development stage
|
(2,538,035
|
)
|
(788,671)
|
|||||
Total
stockholders’ deficit
|
(285,647
|
) |
(662,601
|
) | ||||
Total
liabilities and stockholders’ deficit
|
$
|
788,857
|
$
|
121,793
|
April 23,
2002
(Inception)
To December
31,
|
||||||||||||
2008
|
2007
|
2008
|
||||||||||
Operating
expenses
|
$ | 1,449,219 | $ | 125,284 | $ | 2,051,696 | ||||||
Product
development expense
|
$ | 182,983 | $ | 1,400 | $ | 315,652 | ||||||
Interest
expense
|
$ | 117,162 | 33,238 | 170,687 | ||||||||
Net
loss available to common shareholders
|
$ | 1,749,364 | $ | 159,922 | $ | 2,538,035 | ||||||
Loss
per common share
|
||||||||||||
Basic
and diluted
|
$ | (0.40 | ) | $ | (0.19 | ) | $ | (2.00 | ) | |||
Weighted
average shares used in computation Basic and diluted
|
4,335,162 | 823,627 | 1,266,454 |
Common
Stock
|
Additional
|
Accumulated
|
||||||||||||||||||
Shares
|
Amount
|
Paid-in
Capital
|
Deficit
|
Total
|
||||||||||||||||
Issuance
of common stock 9/1/02 at $.0167/share (1)
|
598,549 | $ | 5,985 | $ | 4,015 | $ | — | $ | 10,000 | |||||||||||
Issuance
of common stock 10/23/02 at $1.67/share
|
2,993 | 30 | 4,970 | 5,000 | ||||||||||||||||
Net
loss
|
— | — | — | (51,057 | ) | (51,057 | ) | |||||||||||||
Balance
on December 31, 2002
|
601,542 | $ | 6,015 | $ | 8,985 | $ | (51,057 | ) | $ | (36,057 | ) | |||||||||
Issuance
of common stock 2/12/03 at $.0167/share (2)
|
23,942 | 239 | 161 | — | 400 | |||||||||||||||
Issuance
of common stock 6/11-12/3/03 (3) at
$1.67/share
|
21,548 | 216 | 34,784 | 35,000 | ||||||||||||||||
Net
loss
|
— | — | — | (90,461 | ) | (90,461 | ) | |||||||||||||
Balance
on December 31, 2003
|
647,032 | $ | 6,470 | $ | 43,930 | $ | (141,518 | ) | $ | (91,118 | ) | |||||||||
Issuance
of common stock 5/25/04 at $.0167/share (4)
|
6,567 | 66 | 44 | — | 110 | |||||||||||||||
Net
loss
|
— | — | — | (90,353 | ) | (90,353 | ) | |||||||||||||
Balance
on December 31, 2004
|
653,599 | $ | 6,536 | $ | 43,974 | $ | (231,871 | ) | $ | (181,361 | ) | |||||||||
Issuance
of common stock 12/14/05 at $.0167/share (5)
|
14,964 | 150 | 100 | — | 250 | |||||||||||||||
Vested
stock options and warrants
|
— | — | 2,793 | — | 2,793 | |||||||||||||||
Net
loss
|
— | — | — | (123,853 | ) | (123,853 | ) | |||||||||||||
Balance
on December 31, 2005
|
668,563 | $ | 6,686 | $ | 46,867 | $ | (355,723 | ) | $ | (302,161 | ) | |||||||||
Issuance
of common stock 5/16, 8/8/06 at $.0167/share (6)
|
86,869 | 869 | 582 | — | 1,451 | |||||||||||||||
Issuance
of common stock 10/23/06 at $.0167/share (7)
|
38,906 | 389 | 261 | — | 650 | |||||||||||||||
Issuance
of common stock 12/01/06 at $1.67/share (8)
|
28,730 | 287 | 44,523 | — | 44,810 | |||||||||||||||
Vested
stock options and warrants
|
— | — | 13,644 | — | 13,644 | |||||||||||||||
Net
loss
|
— | — | — | (273,026 | ) | (273,026 | ) | |||||||||||||
Balance
on December 31, 2006
|
823,077 | $ | 8,231 | $ | 105,877 | $ | (628,749 | ) | $ | (514,641 | ) | |||||||||
Issuance
of common stock 1/30/07 at $1.67/share (9)
|
599 | 6 | 994 | — | 1,000 | |||||||||||||||
Vested
stock options and warrants
|
— | — | 10,962 | — | 10,962 | |||||||||||||||
Net
loss
|
— | — | — | (159,922 | ) | (159,922 | ) | |||||||||||||
Balance
on December 31, 2007
|
823,676 | $ | 8,237 | $ | 117,833 | $ | (788,671 | ) | $ | (662,601 | ) | |||||||||
Issuance
of common stock 6/11 - 9/30//08 at
$.35/share (10)
|
4,552,862 | 45,528 | 1,547,974 | — | 1,593,502 | |||||||||||||||
Shares
issued to finders, agents and attorneys
|
2,298,404 | 22,984 | (22,984 | ) | — | — | ||||||||||||||
Shares
issued to pay investor relations services, 6/23/08
$.35
|
250,000 | 2,500 | 85,000 | — | 87,500 | |||||||||||||||
Issuance
of common stock due to anti-dilution provisions
|
205,899 | 2,059 | (2,059 | ) | — | — | ||||||||||||||
Vested
stock options and warrants
|
— | — | 353,596 | — | 353,596 | |||||||||||||||
Value
of equity instruments issued in connection with debt
|
— | — | 91,720 | — | 91,720 | |||||||||||||||
Net
loss
|
— | — | — | (1,749,364 | ) | (1,749,364 | ) | |||||||||||||
Balance
on December 31, 2008
|
8,130,841 | $ | 81,308 | $ | 2,171,080 | $ | (2,538,035 | ) | $ | (285,647 | ) |
2008
|
2007
|
April
23,
2002
(Inception)
To December
31
2008
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (1,749,364 | ) | $ | (159,922 | ) | $ | (2,538,035 | ) | |||
Adjustments
to reconcile net loss to net
cash used in operating activities:
|
||||||||||||
Depreciation
and amortization
|
569 | 47 | 919 | |||||||||
Vested
stock options and warrants
|
353,596 | 10,962 | 353,596 | |||||||||
Stock
issued for consulting services
|
87,500 | 87,500 | ||||||||||
Amortization
of debt discount
|
66,765 | — | 66,765 | |||||||||
Changes
in assets and liabilities:
|
||||||||||||
Prepaid
expenses
|
(3,416 | ) | (4,287 | ) | (7,974 | ) | ||||||
Restricted
cash in escrow
|
(163,333 | ) | — | (163,333 | ) | |||||||
Notes
Payable to Shareholder
|
(10,973 | ) | (10,973 | ) | ||||||||
Accounts
payable
|
289,371 | 127,125 | 497,028 | |||||||||
Accrued
expenses
|
53,819 | (187,092 | ) | 280,248 | ||||||||
Net
cash used in operating activities
|
(1,064,493 | ) | (224,140 | ) | (1,406,860 | ) | ||||||
|
||||||||||||
Cash
flows from investing activities:
|
||||||||||||
Purchases
of fixed assets
|
(12,258 | ) | — | (12,258 | ) | |||||||
Purchases
of intangibles
|
(28,967 | ) | (46,092 | ) | (142,373 | ) | ||||||
Net
cash used in investing activities
|
(41,225 | ) | (46,092 | ) | (154,631 | ) | ||||||
|
||||||||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
on long-term debt
|
— | 274,000 | 421,505 | |||||||||
Principal
payments on long-term debt
|
(28,125 | ) | (1,592 | ) | (88,349 | ) | ||||||
Issuance
of common stock (1)
|
1,593,502 | 1,000 | 1,692,173 | |||||||||
|
||||||||||||
Net
cash provided by financing activities
|
1,565,377 | 273,408 | 2,025,329 | |||||||||
|
||||||||||||
Net
increase in cash and cash equivalents
|
459,659 | 3,176 | 463,838 | |||||||||
|
||||||||||||
Cash
at beginning of period
|
4,179 | 1,003 | — | |||||||||
|
||||||||||||
Cash
at end of period
|
$ | 463,838 | $ | 4,179 | $ | 463,838 |
|
(1)
|
All funds collected were a
part of the October 2008 financing at $.35 per unit, which included one
share of common stock and one warrant to purchase an equal number of
shares at $.46 per
share.
|
Years
|
||||
Computers
and office equipment
|
|
3
|
||
Furniture
and fixtures
|
5
|
Stock Options (1)
|
Warrants (1)
|
|||||||||||||||
Number
of
Shares
|
Average
Exercise
Price
|
Number
of
Shares
|
Average
Exercise
Price
|
|||||||||||||
Outstanding
at December 31, 2005
|
17,956
|
$
|
1.67
|
20,950
|
$
|
2.62
|
||||||||||
Issued
|
23,942
|
1.67
|
71,826
|
0.85
|
||||||||||||
Outstanding
at December 31, 2006
|
41,898
|
$
|
1.67
|
92,776
|
$
|
1.25
|
||||||||||
Issued
|
5,985
|
1.67
|
28,502
|
0.35
|
||||||||||||
Outstanding
at December 31, 2007
|
47,882
|
$
|
1.67
|
121,278
|
$
|
1.04
|
||||||||||
Issued
|
1,243,292
|
0.20
|
5,695,299
|
0.45
|
||||||||||||
Expired
|
(11,971)
|
3.76
|
||||||||||||||
Outstanding
at December 31, 2008
|
1,291,174
|
$
|
0.26
|
5,804,606
|
0.45
|
Range of Exercise Prices
|
Shares
|
Weighted
Average
Remaining
Life
|
||||||
Options
|
||||||||
$ 0.01
|
$ | 543,292 | $ | 9.43 | ||||
$ 0.35
|
700,000 | 4.46 | ||||||
$ 1.67
|
47,882 | 2.50 | ||||||
Total
|
1,291,174 | |||||||
Warrants
|
||||||||
$ 0.02
|
71,826 | 5.45 | ||||||
$ 0.35
|
798,597 | 3.29 | ||||||
$ 0.46
|
4,889,291 | 2.57 | ||||||
$ 1.67
|
44,892 | 2.69 | ||||||
Total
|
5,804,606 |
Year
|
Shares
|
Price
|
||||||
2005
|
17,956 | $ | 1.67 | |||||
2006
|
23,941 | 1.67 | ||||||
2007
|
5,985 | .35-1.67 | ||||||
2008
|
1,243,292 | .01-.35 | ||||||
Total
|
1,291,174 | $ | .01-$1.67 |
Warrants:
|
||||||||
Year
|
Shares
|
Price
|
||||||
2005
|
8,979 | 1.67 | ||||||
2006
|
71,826 | .02-1.67 | ||||||
2007
|
28,502 | .35 | ||||||
2008
|
5,695,299 | .02-.46 | ||||||
Total
|
5,804,606 | .02-1.67 |
Year
Ended
December
31,
|
From
|
|||||||||||
2008
|
2007
|
Inception
|
||||||||||
Numerator:
|
||||||||||||
Net
Loss available in basic and diluted
calculation
|
$ | 1,749,364 | $ | 159,922 | $ | 2,538,035 | ||||||
Denominator:
|
||||||||||||
Weighted
average common shares oustanding-basic
|
4,335,162 | 823,627 | 1,266,454 | |||||||||
Effect
of dilutive stock options and warrants (1)
|
na
|
na
|
na
|
|||||||||
Weighted
average common shares outstanding-diluted
|
4,335,162 | 823,627 | 1,266,454 | |||||||||
Loss
per common share-basic and diluted
|
$ | 0.40 | $ | 0.19 | $ | 2.00 |
December
31,
|
||||||||
2008
|
2007
|
|||||||
Deferred
Tax Asset:
|
||||||||
Net
Operating Loss
|
$ | 584,000 | $ | 196,000 | ||||
Total
Deferred Tax Asset
|
584,000 | 196,000 | ||||||
Less
Valuation Allowance
|
584,000 | 196,000 | ||||||
Net Deferred Income
Taxes
|
$ | — | $ | — |
December
31,
|
||||||||
2008
|
2007
|
|||||||
Notes
payable to several individuals due April 2008 including 8% fixed interest
and is now delinquent. The notes are convertible into 620,095 shares of
the Company’s common stock and automatically convert at the effective date
of this registration statement.
|
$ | 170,000 | $ | 170,000 | ||||
Note
payable to bank in monthly installments of $1,275/including variable
interest at 2% above the prevailing prime rate (5.25% at December 31,
2008) to August 2011 when the remaining balance is payable. The note is
personally guaranteed by executives of the Company.
|
38,183 | 48,308 | ||||||
Note
payable to NWBDC with interest only payments at 8% to December 2008 when
the remaining balance is payable. The note was personally guaranteed by
executives of the Company. The note was paid in full on
June 24, 2008.
|
— | 18,000 | ||||||
Notes
payable to two individuals, net of discounts of $24,955 and $0, with
interest only payments at 12% to March 2012 when the remaining balance is
payable. The notes are convertible into 285,715 shares of stock in the
Company at $.35 per share.
|
75,045 | 100,000 | ||||||
Notes
payable to four shareholders of the Company that are overdue. The notes
are convertible into 11,429 shares of stock in the Company at $.35 per
share.
|
4,000 | 4,000 | ||||||
Total
|
287,228 | 340,3081 | ||||||
Less
amount due within one year
|
187,620 | 203,800 | ||||||
Long-Term
Debt
|
$ | 99,608 | $ | 136,508 |
2009
-
|
$ | 197,620 | ||
2010
-
|
$ | 14,353 | ||
2011
-
|
$ | 10,210 | ||
2012
-
|
$ | 100,000 | ||
2013
-
|
$ | 0 |
2009
|
$ | 35,000 | ||
2010
|
29,000 | |||
2011
|
30,000 | |||
2012
|
30,000 | |||
2013
|
26,000 |
(1)
|
has not been indemnified by
another organization or employee benefit plan for the same judgments,
penalties, fines, including, without limitation, excise taxes assessed
against the person with respect to an employee benefit plan, settlements,
and reasonable expenses, including attorneys’ fees and disbursements,
incurred by the person in connection with the proceeding with respect to
the same acts or omissions;
|
(2)
|
acted in good
faith;
|
(3)
|
received no improper personal
benefit and Section 302A.255, if applicable, has been
satisfied;
|
(4)
|
in the case of a criminal
proceeding, had no reasonable cause to believe the conduct was unlawful;
and
|
(5)
|
in the case of acts or omissions
occurring in the person’s performance in the official capacity of director
or, for a person not a director, in the official capacity of officer,
board committee member or employee, reasonably believed that the conduct
was in the best interests of the corporation or, in the case of
performance by a director, officer or employee of the corporation
involving service as a director, officer, partner, trustee, employee or
agent of another organization or employee benefit plan, reasonably
believed that the conduct was not opposed to the best interests of the
corporation. If the person’s acts or omissions complained of in the
proceeding relate to conduct as a director, officer, trustee, employee, or
agent of an employee benefit plan, the conduct is not considered to be
opposed to the best interests of the corporation if the person reasonably
believed that the conduct was in the best interests of the participants or
beneficiaries of the employee benefit
plan.
|
|
(1)
|
by
the board by a majority of a quorum, if the directors who are at the time
parties to the proceeding are not counted for determining either a
majority or the presence of a
quorum;
|
|
(2)
|
if a quorum under clause (1)
cannot be obtained, by a majority of a committee of the board, consisting
solely of two or more directors not at the time parties to the proceeding,
duly designated to act in the matter by a majority of the full board
including directors who are
parties;
|
|
(3)
|
if a determination is not made
under clause (1) or (2), by special legal counsel, selected either by a
majority of the board or a committee by vote pursuant to clause (1) or (2)
or, if the requisite quorum of the full board cannot be obtained and the
committee cannot be established, by a majority of the full board including
directors who are parties;
|
|
(4)
|
if a determination is not made
under clauses (1) to (3), by the affirmative vote of the shareholders
required by Section 302A.437 of the Minnesota Statutes, but the shares
held by parties to the proceeding must not be counted in determining the
presence of a quorum and are not considered to be present and entitled to
vote on the determination;
or
|
|
(5)
|
if an adverse determination is
made under clauses (1) to (4) or under paragraph (b), or if no
determination is made under clauses (1) to (4) or under paragraph (b)
within 60 days after (i) the later to occur of the termination of a
proceeding or a written request for indemnification to the corporation or
(ii) a written request for an advance of expenses, as the case may be, by
a court in this state, which may be the same court in which the proceeding
involving the person’s liability took place, upon application of the
person and any notice the court requires. The person seeking
indemnification or payment or reimbursement of expenses pursuant to this
clause has the burden of establishing that the person is entitled to
indemnification or payment or reimbursement of
expenses.
|
Amount
|
||||
SEC
Registration Fee
|
$ | 200 | ||
Printing
Fees
|
$ | 30,000 | ||
Legal
Fees and Expenses
|
$ | 80,000 | ||
Accounting
Fees and Expenses
|
$ | 60,000 | ||
Miscellaneous
|
$ | 55,000 | ||
Total
|
$ | 225,200 |
3.1
|
Articles
of Incorporation of the Registrant, as amended**
|
|
3.2
|
Bylaws
of the Registrant, as amended**
|
|
5.1
|
Opinion
of Richardson & Patel LLP***
|
|
10.1
|
Form
of Employment Agreement by and between the Registrant and Kevin R.
Davidson dated October 4, 2006**
|
|
10.2
|
Form
of Employment Agreement by and between the Registrant and Gerald D. Rice
dated October 18, 2006**
|
|
10.3
|
Form
of Employment Agreement by and between the Registrant and Chad A. Ruwe
dated June 16, 2008**
|
|
10.4
|
Form
of Confidential Separation Agreement and Release by and between the
Registrant and Lawrence W. Gadbaw dated August 13,
2008**
|
|
10.5
|
Form
of Nondisclosure and Noncompete Agreement by and between the Registrant
and Lawrence W. Gadbaw dated October 18, 2006**
|
|
10.6
|
Form
of Stock Option Agreement by and between the Registrant and Kevin R.
Davidson dated June 5, 2008**
|
|
10.7
|
Form
of Director Stock Option Agreement between the Registrant and Thomas
McGoldrick dated August 22, 2006**
|
|
10.8
|
Form
of Director Stock Option Agreement between the Registrant and Andrew P.
Reding dated November 11, 2006**
|
|
10.9
|
Form
of Consulting Agreement by and between the Registrant and Jeremy Roll
dated February 29, 2008**
|
|
10.10
|
Form
of Consulting Agreement by and between the Registrant and Namaste
Financial, Inc. dated June 30, 2008**
|
|
10.11
|
Form
of Consulting Agreement by and between the Registrant and Marshall C. Ryan
and Mid-State Stainless, Inc. dated June 2008**
|
|
10.12
|
Form
of Investor Relations Agreement by and between the Registrant and Kulman
IR, LLC dated April 15, 2008**
|
|
10.13
|
Form
of Finder Agreement by and between the Registrant and Thomas Pronesti
dated March 10, 2008**
|
|
10.14
|
Form
of Patent Assignment by Marshall C. Ryan in favor of the Registrant dated
June 18, 2008**
|
|
10.15
|
Form
of Convertible Debenture by and between the Registrant and Kevin R.
Davidson dated February 2, 2007**
|
|
10.16
|
Form
of Convertible Debenture by and between the Registrant and Peter L.
Morawetz dated February 2, 2007**
|
|
10.17
|
Form
of Convertible Debenture by and between the Registrant and Andrew P.
Reding dated February 2, 2007**
|
|
10.18
|
Form
of Convertible Debenture by and between the Registrant and Thomas
McGoldrick dated January 30, 2007**
|
|
10.19
|
Form
of Convertible Debenture by and between the Registrant and Andcor
Companies, Inc. dated September 29, 2006**
|
|
10.20
|
Form
of Convertible Debenture by and between the Registrant and Carl Moore
dated March 1, 2007**
|
|
10.21
|
Form
of Convertible Debenture by and between the Registrant and Roy Moore dated
March 1, 2007**
|
|
10.22
|
Form
of Advisory Board Warrant Agreement by and between the Registrant and
Debbie Heitzman dated August 31, 2005**
|
|
10.23
|
Form
of Advisory Board Warrant Agreement by and between the Registrant and Mary
Wells Gorman dated August 31,
2005**
|
10.24
|
Form
of Advisory Board Warrant Agreement by and between the Registrant and
David Feroe dated August 31, 2005**
|
|
10.25
|
Form
of Advisory Board Warrant Agreement by and between the Registrant and Dr.
Arnold S. Leonard dated June 12, 2006**
|
|
10.26
|
Form
of Advisory Board Warrant Agreement by and between the Registrant and
Karen A. Ventura dated December 7, 2006**
|
|
10.27
|
Form
of Advisory Board Warrant Agreement by and between the Registrant and
Nancy A. Kolb dated December 20, 2006**
|
|
10.28
|
Form
of Advisory Board Warrant Agreement by and between the Registrant and Kim
Shelquist dated December 20, 2006**
|
|
10.29
|
Form
of Warrant Agreement by and between the Registrant and Wisconsin Rural
Enterprise Fund, LLC dated December 1, 2006**
|
|
10.30
|
Form
of Stock Purchase and Sale Agreement by and between the Registrant and
Wisconsin Rural Enterprise Fund, LLC dated July 31,
2006**
|
|
10.31
|
Form
of Subscription Agreement**
|
|
10.32
|
Form
of Registration Rights Agreement**
|
|
10.33
|
Form
of Escrow Agreement**
|
|
10.34
|
Form
of Warrant**
|
|
10.35
|
2008
Equity Incentive Plan**
|
|
10.36
|
Office
Lease Agreement by and between the Registrant and Roseville Properties
Management Company, as agent for Lexington Business Park,
LLC**
|
|
10.37
|
Form
of Employment Agreement by and between the Registrant and David Dauwalter
dated August 11, 2008**
|
|
10.38
|
Form
of Amendment No. 1 to Employment Agreement by and between the Registrant
and David Dauwalter dated September 11, 2008**
|
|
10.39
|
Form
of Consulting Agreement by and between the Registrant and Andcor
Companies, Inc. dated September 15, 2008**
|
|
10.40
|
Form
of Consulting Agreement by and between the Registrant and Taylor &
Associates, Inc. dated August 15, 2008**
|
|
10.41
|
Form
of Consulting Agreement by and between the Registrant and Gregory Sachs
dated October 20, 2008**
|
|
10.42
|
Form
of Restructuring Agreement dated June 9, 2008**
|
|
10.43
|
Form
of Secured Convertible Note Purchase Agreement dated July 23,
2007**
|
|
10.44
|
Form
of Secured Convertible Note dated July 2007**
|
|
10.45
|
Form
of Secured Convertible Note Security Agreement dated July
2007**
|
|
10.46
|
Independent
Contractor Agreement dated as of February 2, 2009, between Belimed, Inc.
and BioDrain Medical, Inc.*(1)
|
|
10.47
|
Supply
Agreement dated as of February 20, 2009 by and between Oculus Innovative
Sciences, Inc., and BioDrain Medical, Inc.*(1)
|
|
10.48
|
Employment
Agreement made and entered into effective the 1st of February, 2009 by and
between Kirsten Doerfert*
|
|
10.49 | Term Sheet by and among the Registrant and Longport Holdings, as amended | |
14
|
Code
of Ethics**
|
|
21
|
Subsidiaries
of the Registrant**
|
|
23.1
|
Consent
of Olsen Thielen & Co., Ltd.*
|
|
23.2
|
Consent
of Richardson & Patel LLP (See Exhibit
5.1)***
|
*
|
Filed
herewith.
|
|
|
**
|
Previously
filed
|
|
|
***
|
To
be filed by amendment.
|
(1) | Portions of this Exhibit have been omitted and are subject to a request for confidential treatment. |
|
i.
|
Include any prospectus required
by section 10(a)(3) of the Securities Act of
1933;
|
|
ii.
|
Reflect in the prospectus any
facts or events which, individually or together, represent a fundamental
change in the information in the registration statement. Notwithstanding
the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that
which was registered) any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of
prospectus filed with the Securities and Exchange Commission pursuant to
Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than a 20% change in the maximum aggregate offering
price set forth in the “Calculation of Registration Fee” table in the
effective registration statement;
and
|
|
iii.
|
Include any additional or changed
material information on the plan of
distribution.
|
|
(i)
|
Any
preliminary prospectus or prospectus of the undersigned registrant
relating to the offering required to be filed pursuant to Rule
424;
|
|
(ii)
|
Any
free writing prospectus relating to the offering prepared by or on behalf
of the undersigned registrant or used or referred to by the undersigned
registrant;
|
|
(iii)
|
The
portion of any other free writing prospectus relating to the offering
containing material information about the undersigned registrant or its
securities provided by or on behalf of the undersigned registrant;
and
|
|
(iv)
|
Any
other communication that is an offer in the offering made by the
undersigned registrant to the
purchaser.
|
BIODRAIN
MEDICAL, INC.
|
||
By:
|
/s/ Kevin R. Davidson
|
|
Kevin
R. Davidson
|
||
President
and Chief Executive
Officer
|
Name
|
Title
|
Date
|
||
*
|
Chairman
of the Board of Directors
|
April
3, 2009
|
||
Lawrence
W. Gadbaw
|
||||
/s/ Kevin R.
Davidson
|
President,
Chief Executive Officer (Principal
|
April
3, 2009
|
||
Kevin
R. Davidson |
Executive
Officer), Interim Chief Financial Officer
(Principal
Financial Officer)and
|
|||
|
Director.
|
|||
*
|
Director
|
April
3, 2009
|
||
Gerald
D. Rice
|
||||
*
|
Director
|
April
3, 2009
|
||
Chad
A. Ruwe
|
||||
*
|
Director
|
April
3, 2009
|
||
Peter
L. Morawetz
|
||||
*
|
Director
|
April
3, 2009
|
||
Thomas
J. McGoldrick
|
||||
*
|
Director
|
April
3, 2009
|
||
Andrew
P. Reding
|
* /s/ Kevin
Davidson
|
Chief Executive Officer and Power of
Attorney
|
|
|
|
|
a.
|
General
Business purposes.
|
|
|
|
|
b.
|
To manufacture, buy, sell, deal
in, and to engage in, contact, and carry on the business of manufacturing,
buying, selling and dealing in, goods, wares and merchandise of every class and
description.
|
|
|
|
|
c.
|
To purchase, acquire, hold,
improve, sell, convey, assign, release, mortgage, encumber, lease, hire and deal
in and otherwise dispose of real and personal property of every kind, name
and nature, within or without the state, including stocks, securities and
obligations, and to loan money and take securities for the payment of all
sums due the corporation, and to sell, assign and release such securities,
and to take real and personal property by Will and
gift.
|
|
|
|
|
d.
|
To carry out the purposes
herein above set forth in any state, territory, district or possession of the United
States, or in any foreign country, to the extent that such purposes are not forbidden
by the laws thereof; and, in the case of any state, territory, district or
possession of the United States, or any foreign country, in which one or more
of such purposes are forbidden by law, to limit, in any certificate for application
to do business, the purpose or purposes which the corporation proposes to
carry on therein to such as are not forbidden by the law
thereof.
|
|
|
|
|
|
|
|
Lawrence W.
Gadbaw
|
|
|
|
|
|
|
|
Peter
L. Morawetz
|
|
|
|
|
|
|
|
j.j.a.w.w., LLC (In the person
of Jeffery K. Drogue, its Governor)
|
|
|
|
|
|
|
|
Gerald
D. Rice
|
|
Authorized
Shares: The total number of par shares which this
Corporation shall have authority to issue is 40,000,000 shares with a par
value of one cent ($.01) per share; all of such shares shall be common
stock.”
|
/s/ Gerald D. Rice
|
||
Jerry
Rice, Secretary
|
|
1.
|
Contractual
Services. The Company hereby retains the services of the
Contractor on a non-exclusive basis as an authorized installation and
maintenance firm. Where Contractor’s service will be required,
the Company will introduce Contractor and allow negotiations for services
to occur between Contractor and the third party
customer(s).). Contractor will provide a written quotation and
receive written authorization from the third party customer(s) prior to
initiating installation services. The Company will be
reimbursed at a rate of *** of the total installation
price. Additionally, Contractor will respond and provide
written quotations to the third party customer(s) for extended Service
Agreements or Preventative Maintenance Agreements (collectively referred
to as “Service Agreements”) services. Upon written acceptance
of Contractor Service Agreements, the Company will be reimbursed at a rate
of *** of the Service Agreements’ price. The Contractor is
responsible for all compensation owing for the assignment performed
including, without limitation, all costs of labor, taxes, third-party
charges, materials, overhead and other costs to the
Contractor. The Company acknowledges and agrees that Contractor
will render such Contractual Services only on a part-time or limited
basis.
|
|
2.
|
Terms. This
Agreement shall be for a period of 3 years commencing on April 1, 2009.
Agreement shall be automatically renewable annually, on the anniversary
date of the Agreement, unless terminated in writing by either party not
less than 90 days prior to expiration in the given
year.
|
|
3.
|
Fees. For
routine repair and preventative maintenance during the Company warranty
period, Contractor shall be paid $*** per hour. Within the
territories defined by Attachment 1, fees are inclusive of all
compensation owing for the assignment performed including, without
limitation, all costs of labor, taxes, third-party charges, materials, and
other costs to the Contractor. All materials and other
purchased items shall be reimbursed at cost by the
Company. Outside of the territories defined by Attachment 1,
and if applicable, the Company is responsible for airfare and hotel
expenses, with the understanding that Contractor will use its best efforts
to maintain reasonable airfare and hotel expenses, as provided for in
Company’s corporate travel policy. The Contractor is to invoice
the Company at the end of each month for hours worked and the Company will
pay the Contractor within 30 days after receipt of an
invoice. Contractor acknowledges that Company shall only be
liable for these expenses during the warranty period (one-year from
purchase date of third party customer). Following the lapse of
the initial warranty period, Contractor will be compensated directly
through the customer, either through the purchase of an extended Service
Agreement, or, if after the warranty, and with no service contract in
place, directly from the third party customer, based on discussions and
negotiations directly with the third party customer and
Contractor.
|
|
4.
|
Independent
Contractor. This Agreement shall not establish an
employment relationship between the parties. Contractor
services shall not be regulated or controlled by the Company, but shall be
that of an independent contractor providing contractual
services. Nothing in this Agreement shall be construed as
creating the relationship of an employer and employee between the Company
and the Contractor or any of Contractor’s employees, subcontractors or
agents for the purposes of any current or future employee benefit plan of
the Company. Accordingly, Contractor agrees that the terms of
this Agreement exclude participation by any employees or agents of the
Contractor in any benefit plan of the Company. Neither
Contractor nor any of Contractor’s employees or agents are required or
permitted to make contributions (including, but not limited to,
contribution by salary deduction agreements) to any benefit plan, and no
contributions are made or required to be made for Contractor’s benefit or
the benefit of Contractor’s employees or agents. Contractor
further agrees that neither Contractor nor any of his employees or agents
accrue any benefits under any Company benefit plan by reason of this
Agreement and that services rendered under this Agreement do not give rise
to any claim for benefits under any Company benefit
plan. Contractor waives any right Contractor’s employees or
agents may otherwise be deemed to have to participate in any Company
benefit plan. In addition, neither Contractor nor any of his
employees or agents shall be considered an employee of the Company for
purposes of any tax or contribution levy by any foreign or U.S. federal,
state or local government.
|
|
5.
|
Contractor’s
Responsibility As Employer. Contractor represents and
warrants that, except as otherwise specifically stated in writing, all
persons who Contractor assigns to perform work in conjunction with an
assignment from the Company under this Agreement shall be employees or
contractors of the Contractor. Contractor agrees to file all
required returns and reports, withhold and/or pay all required federal,
state and local wage or employment-related taxes including, but not
limited to, income taxes, Social Security taxes, unemployment taxes and
taxes measured by gross income and gross receipts with respect to the
amounts received hereunder or paid to such employees in connection with
their performance of an assignment as required by applicable
law. Contractor further agrees that he will be responsible for
any taxes withheld or required to be paid by any foreign government in
relation to services performed by Contractor or his employees or
agents. Contractor agrees to reimburse the Company for any
wage, employment related or other tax not so withheld/or remitted and for
any costs and expenses including reasonable attorney’s fees and interest
which the Company may incur by reason of Contractor’s failure to comply
with the obligations set forth in this
paragraph.
|
|
6.
|
Contractor’s Taxpayer
Identification Number. Contractor shall provide
Contractor’s tax identification number to the
Company.
|
|
7.
|
Representation
Regarding Employees. Contractor represents and warrants
that all of his employees or agents assigned to perform work under this
Agreement are legally entitled to perform such work. Contractor
also agrees to comply with all immigration laws of the United
States.
|
8.
|
Work
Performed. Company
customers and or third party customers are to call their service requests
directly into the Contractor technical support/dispatch office, where
calls may be entered as a matter of record. For service calls
related to a unit under warranty, Contractor will seek written (electronic
or hard copy) authorization from Company prior to dispatching a field
service technician. For installation and work performed in
support of a Service Agreement, Contractor will dispatch the appropriate
personnel and resolve the problem in a timely
manner. Contractor agrees to provide field service personnel
which are competent and trained in their area of
responsibilities. Company agrees to provide tuition free
product training to Contractor’s field service personnel. When
representing Company on an assigned job, contractor agrees to utilize
Company authorized forms and procedures; including; PM & installation
check lists, service reports, training records. Contractor also
agrees to provide quality repair service, supervision of equipment
installation/performance check out at customer locations and other duties
as assigned, in accordance with established Company procedures and
techniques, using proper tools, test equipment and OEM replacement
parts. Contractor further agrees not to modify, substitute or
alter any OEM component, hardware or software, without the written
permission of Company Engineering. At a minimum on a quarterly basis,
Contractor agrees to provide Company with copies of all documentation
pertaining to all service related calls for the life of this
Agreement.
|
|
9.
|
Confidential Business
Information Limitations On Disclosure and Use. It is
understood that in the performance of an assignment, each party
(“Receiving Party”) and his employees or agents will have access to and
may require confidential business information of the other party
(“Disclosing Party”), including, but not limited to, information relating
to the Disclosing Party’s employees, vendors, customers, products,
pricing, and access to the Disclosing Party’s
systems. Receiving Party shall not disclose to anyone not
employed or contracted by the Receiving Party nor use, except on behalf of
the Disclosing Party and with current customers or accounts of Disclosing
Party at the date of signing of this Agreement, any such confidential
information required in the performance of an assignment, except as may be
specifically authorized by the Disclosing Party in
writing. Regardless of the term of this Agreement, Receiving
Party shall be bound by this obligation until the confidential business
information shall lawfully become part of the public domain or the parties
otherwise agree in writing. All business information regarding
customer lists or business arrangements from the Disclosing Party shall be
presumed to be confidential, except to the extent that it shall have been
lawfully published or that it shall have been made freely available to the
general public by the Disclosing Party. Receiving Party agrees
that all tangible forms of the previously mentioned confidential and
proprietary information which Receiving Party requires pursuant to this
Agreement: (i) shall be safeguarded with the same degree of control and
care as a reasonably prudent person would exercise with respect to its own
similar property under similar circumstances and (ii) all copies thereof
shall be returned to the Disclosing Party immediately upon a written
request therefore. Receiving Party further agrees to obligate
Receiving Party’s employees and agents to observe and be bound by the same
confidentiality requirements by which Receiving Party is bound hereunder
by the Disclosing Party.
|
10.
|
Reciprocal Restriction
on Interference with Business Relationships and Notification of
Visit. Contractor agrees it will not solicit, market,
encourage or otherwise interfere with the business relationship of current
customers of Company. Company agrees it will not solicit,
market, encourage or otherwise interfere with the business relationships
of Contractor’s current customers.
|
11.
|
Assignment and
Subcontracting. The rights of each party under this
Agreement are personal to such party and may not be assigned or
transferred to any such person or entity without the prior written consent
of the other party. Notwithstanding the foregoing, the Company
may transfer its rights to an affiliate with the written consent of the
Contractor. Contractor shall not subcontract all or any portion
of an assignment without the prior written approval of the
Company.
|
12.
|
Non-solicitation. Contractor
agrees that for the duration of this Agreement and for a period of one (1)
year following the termination or expiration of this Agreement, it shall
not, directly or indirectly through any other individual, person or
entity, employ or solicit, entice, persuade, or induce any individual who
currently is, or at any time during such period shall be, an employee of
the Company to terminate or refrain from renewing or extending his or her
employment by the Company or to become engaged by or enter into a
contractual relationship with Contractor or any other individual, person
or entity. Company agrees that for the duration of this
Agreement and for a period of one (1) year following the termination or
expiration of this Agreeement, it shall not, directly or indirectly
through any other individual, person or entity, employ or solicit, entice,
persuade, or induce any individual who currently is, or at any time during
such period shall be, an employee of the Contractor to terminate or
refrain from renewing or extending his or her employment by the Contractor
or to become engaged by or enter into a contractual relationship with
Company or any other individual, person or
entity.
|
13.
|
Termination. Upon
termination of this Agreement, Contractor agrees to stop work and to
return to the Company all items relating to an assignment including, but
not limited to, the following: all reports, drawings, hardware,
software, documents and files, including items electronically recorded
generated or stored on personal computers or diskettes. Copies
of such items shall not be retained by Contractor or its employees and
agents in any form, electronic or otherwise unless required to service
existing accounts of the Contractor. If either party breaches a
material portion of this Agreement and does not remedy such breach within
30 days of written notice, the other party may terminate the Agreement for
cause. This Agreement may be terminated by either party without
cause upon 90 days written notice to the other
party.
|
14.
|
Other
Clients. Contractor represents and warrants that the
services for which it has been retained, or other similar services, are
performed for clients other than the
Company.
|
15.
|
Indemnity. Each
party (“Indemnifying Party”) understands and acknowledges that the other
party (“Indemnified Party”) will be relying upon the representations made
in this Agreement and hereby agrees to indemnify and hold the Indemnifying
Party harmless from and against any and all claims, suits, damages,
penalties, costs or fees (including reasonable attorney fees)
(collectively, “Claims”) that may arise as a result of any knowing
misrepresentation including any Claims made by any federal, state or local
taxing entity. This indemnity does not extend to any warranty
either expressed or implied in the equipment of the Indemnifying Party or
the failure thereof.
|
16.
|
Insurance. Contractor
will maintain one million dollars ($1,000,000.00) in liability insurance
and maintains adequate worker’s compensation
insurance.
|
17.
|
Entire
Agreement. This Agreement contains the entire
understanding between the parties. No warranties,
representations or understandings have been made orally or in writing by
either party except those which are expressly set forth in this
Agreement.
|
18.
|
Choice of
Law. This Agreement shall be construed and enforced in
accordance with the substantive laws of the State of South Carolina
(without giving effect to its laws regarding conflict of laws), and the
parties hereto agree to submit the exclusive jurisdiction of the federal
and state courts of the State of South Carolina for any and all purposes
hereof.
|
19.
|
Severability. If
any provision of this Agreement is found by a court or other competent
authority to be void or unenforceable, the provision must be treated as
amended or deleted from the Agreement, without effecting any other
provisions or the validity of the Agreement. The parties will
negotiate in good faith to agree on the terms of a mutually satisfactory
amended provision, if an amended provision is required to carry out the
intent of the parties expressed in the void and unenforceable
provision.
|
20.
|
Mediation of
Issues. In the event of any dispute of this Agreement or
its terms and prior to the filing of any suit or legal action, the parties
agree that they shall submit to mediation to resolve their
differences. Mediation shall take place in South Carolina by a
qualified mediator mutually agreed upon by the
parties.
|
21.
|
Response
Time. In agreement with Contractor standard policies,
once notified by Company office, Contractor agrees to respond to customer
requests over the telephone within (2) hours, make every reasonable effort
to respond on site within (24) hours, and guarantee to respond on site
within (48) hours. Contractor requires ten (10) working days
notice to schedule installation personnel, arrange travel and other
applicable resources.
|
/s/
Pete Koste
|
Contractor
– Belimed, Inc.
|
By:
Pete Koste
|
Title:
Director, Technical Services
|
Dated
this 2nd day of February 2009.
|
/s/
Kevin Davidson
|
Company
– BioDrain Medical, Inc.
|
Title:
CEO
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
CONFIDENTIAL
|
SELLER:
Oculus
Innovative Sciences, Inc.
|
|
Signature:
/s/Robert E. Miller
|
|
Name/Title
(print): Chief Financial Officer
|
|
Date:
3/12/09
|
|
BUYER:
BioDrain
Medical, Inc.,
|
|
Signature:
/s/ Kevin Davidson
|
|
Name/Title
(print): CEO
|
|
Date:
3/16/09
|
CONFIDENTIAL
|
CONFIDENTIAL
|
Load
|
Pallet
|
Case
|
||||||||||
Order
size (case)
|
768 | 32 | 1 | |||||||||
Order
size (bottles)
|
9,216 | 384 | 12 | |||||||||
Price
per case (12 bottles)
|
||||||||||||
Price
per unit (bottle)
|
Load
|
Pallet
|
Case
|
||||||||||
Order
size (cases)
|
768 | 32 | 1 | |||||||||
Order
size (bottles)
|
9,216 | 384 | 12 | |||||||||
Price
per case (12 bottles)
|
||||||||||||
Price
per bottle
|
Calendar
Year
|
2009
|
2010
|
2011
|
2012
|
2013
and calendar
years
thereafter
|
|||||||||||||||
Minimum
bottles purchased
|
15,000 | 175,000 | 500,000 | 1,000,000 | 1,500,000 |
CONFIDENTIAL
|
Bottles
Purchased
|
Per-Bottle
Discount
|
|
500,000
|
*** | |
1,000,000
|
*** | |
1,500,000
|
*** | |
2,000,000
|
*** |
|
1.
|
Employment. The
Company agrees to employ the Employee for a period of two (2) years,
commencing on February 1, 2009, unless Employee violates the terms set
forth in Paragraph 6: Termination by the Company for Cause, or the
Employee voluntarily resigns. The Agreement shall be
automatically renew annually except by action of the President & CEO
or the Board of Directors.
|
|
2.
|
Duties. The Employee
will hold the title of Vice President, Sales and Marketing and shall
report to the President & CEO of the Company. The general
scope of the Employee’s duties shall include but not be limited to
responsibility for developing and implementing the overall sales and
marketing strategy and tactical plans to grow sales revenue and account
penetration supporting the overall business strategy. Sales
channel identification and establishment are key priorities including the
advancement of the Company website and development of Company marketing
collateral. The Employee will be decisive, driven,
hands-on and results-oriented. Market segmentation,
positioning, branding, and business development will be additional
responsibilities for the Employee. The Vice President, Sales
and Marketing will play a significant role in establishing and managing
beta sites for the Company’s product(s). Additionally, the
Employee will drive securing initial purchase orders and obtaining initial
sales and sustaining growth in revenues from the Company’s
product(s).
|
|
3.
|
Extent of Services. The
Employee shall devote her full attention, energy and skills to the
business of the Company and use her best efforts to fully and competently
perform the duties of her office.
|
|
4.
|
Compensation.
|
|
a.
|
Base Salary. $135,000
annual base salary to be
paid through 3 months after both the product’s receipt of FDA approval and
the product being commercially ready and available for sale. At the 3 month timeframe after
both FDA approval and commercially ready and available product has been
secured, annual base salary will move to
$125,000. Payment will be monthly and will be according
to the Company’s salary schedule. Employee will receive annual
salary reviews and potential increases, based on Employee’s
performance.
|
|
b.
|
Commission. Commissions of 7.5% of total
worldwide sales will be paid for sales made in the first 12 months after
both FDA approval and product being commercially ready and available.
Commissions of 5% of total worldwide sales will be paid for sales made in
the second 12 months after both FDA approval and product being
commercially ready and available. Commission to be paid on a monthly basis
in conjunction with scheduled payroll. For purposes of this
Paragraph, “sales made” shall mean sales for which revenues are
booked. Commissions shall be deemed earned, and paid, on booked
revenues with subsequent adjustments made for uncollectible
balances.
|
|
c.
|
Stock
Options/Warrants. The Employee will receive total stock
options to purchase 100,000 shares of the Company’s common stock at $.35
per share. In addition, Employee will receive 15,000 warrants
to purchase Company stock at $.46 per share. The 15,000
warrants will vest as of February 1, 2009 and will have a five-year
term. The options will vest as follows: 20,000 upon
execution of this Agreement, 20,000 upon securing four Beta
sites/POs/testimonials/Letters of Intent, 20,000 upon FDA approval, 20,000
upon sale of the first FMS unit, and 20,000 upon sale of the 50th
FMS unit.
|
|
5.
|
Additional
Benefits.
|
|
a.
|
Automobile. The
Company shall reimburse the Employee for deductible automobile mileage
according to its Expense Reporting
Procedures.
|
|
b.
|
Business
Expense. The Company will reimburse the Employee for all
reasonable, deductible and substantiated business expenses per its Expense
Reporting Procedures. This includes, but is not limited to such
expenses as cell phones, and business meetings,
etc.
|
|
c.
|
Benefits. The
Employee will be eligible for the Company’s benefits package effective on
February 1, 2009.
|
|
d.
|
Vacation. The
Employee will receive a minimum of three (3) weeks of paid vacation per
year.
|
|
e.
|
Education. The Company
will support the Employee in her pursuit of continuing education provided
sufficient cash flows support tuition reimbursement and she meets the
conditions and terms of the tuition reimbursement guidelines as outlined
in the Employee Manual when written. Company and Employee will
annually discuss and mutually determine the affordability to Company of
tuition reimbursement for Employee.
|
|
6.
|
Non-Compete. Throughout
the period of Employee’s employment with the Company, and thereafter for a
period of two (2) years, Employee shall not, for any reason whatsoever,
directly or indirectly, plan, organize, advise, own, manage, operate,
control, be employed by, participate in or be connected in any manner with
the ownership, management, operation or control of any business of the
following type: the development, marketing and sales of medical devises
dedicated or designed to safely manage and dispose of contaminated fluids
generated in the operating room and other similar medical locations, or
any business relating to cleaning, disinfecting or sterilizing of medical
instruments or products using fluids similar to those utilized by the
Company. For purposes of this Agreement, indirect competition
shall be deemed to include any activity by Employee in aid of a competing
Business, including but not limited to, being a partner, shareholder,
officer, director, member, owner, manager, governor, agent, employee,
advisor, consultant or independent contractor of any competing Business,
except that the foregoing will not prevent Employee from holding less than
five percent (5%) of the outstanding capital stock of any publicly traded
company.
|
|
7.
|
Intellectual
Property. Employee agrees that all right,
title and interest of every kind and nature whatsoever, whether now known
or unknown, in and to any “Intellectual Property,” defined to include, but
not be limited to, any patent rights, trademarks, copyrights, ideas,
creations and properties invented, created, written, developed, furnished,
produced or disclosed by Employee in the course of rendering her services
to Company (both before the execution of this Agreement and
thereafter) shall, as between the parties, be and remain the sole and
exclusive property of Company for any and all purposes and uses
whatsoever, and Employee shall have no right, title or interest of any
kind or nature therein or thereto, or in and to any results and proceeds
there from. Employee agrees to assign, and hereby expressly and
irrevocably assigns, to Company all worldwide rights, title and interest,
in perpetuity, in respect of any and all rights Employee may have or
acquire in the Intellectual Property. The assignment of the rights
as above shall not lapse if Company has not exercised its rights under the
assignment for any period of time or in any jurisdiction or
territory. Pursuant to Section 181.78 of the Minnesota
Statutes, the preceding sentence does not apply to an invention for which
no equipment, supplies, facility or trade secret information of Company
was used and which was developed entirely on the Employee's own time,
and (1) which does not relate (a) directly to the business of Company
or (b) to Company's actual or demonstrably anticipated research or
development, or (2) which does not result from any work performed
by Employee for Company. To the extent any of the
rights, title, and interest in and to the Intellectual Property cannot be
assigned to Company (and to the extent any of Employee’s retained
rights under Section 181.78 were incorporated by Employee (directly or
indirectly) in any of Company's past, current or future products or
services), Employee hereby grants to Company an exclusive,
royalty-free, transferable, perpetual, irrevocable, unrestricted,
worldwide license (with rights to sublicense through one or more tiers of
sublicensees) to such non-assignable (or non-assigned)
rights. To the extent any rights, title and interest in and to
Intellectual Property rights can be neither assigned nor so licensed by
Employee to Company, Employee hereby irrevocably waives and agrees
never to assert such non-assignable and non-licensable rights, title and
interest against Company, any of Company's successors in
interest, and the customers and licensees of either. Further,
Employee agrees to waive, and hereby waives, any "moral rights" Employee
may have or may obtain in the Intellectual Property. Employee
further agrees to assist Company in every proper way to apply for,
obtain, perfect and enforce rights in the Intellectual Property in any and
all countries, and to that end Employee will execute all documents for use
in applying for, obtaining and perfecting such rights and enforcing same,
as Company may desire, together with any assignments thereof
to Company or persons designated by it. Employee
appoints Company as its attorney in fact to execute any documents
necessary to achieve such results. To the maximum extent
possible, Company shall be shown in all documentation as the owner of
all rights in the Intellectual
Property
|
|
8.
|
Termination by Company for
Cause. The Company may terminate Employee’s employment for “cause”
at any time during the Term. For purposes of this Paragraph 8.,
the term “cause” shall mean any of the
following:
|
|
o
|
The
material non-compliance by the Employee with written instructions,
directions or regulations of the Board of Directors applicable to
Employee, the breach by Employee of any material term of this Agreement,
or the unsatisfactory performance by Employee of Employee’s duties,
obligations, work and production standards, and the failure of Employee to
correct such non-compliance, breach or unsatisfactory performance within
thirty (30) days after receipt by Employee of written notice of the same
by the Company;
|
|
o
|
Any
willful or grossly negligent act by the Employee having the effect of
injuring in a material way the Company as determined by the affirmative
vote of the majority of the members of the Board of
Directors;
|
|
o
|
The
commission by the Employee of fraud or a criminal act that adversely
affects the business of the Company;
or,
|
|
o
|
The
determination by an affirmative vote of the majority of the members of the
Board of Directors, after a reasonable and good faith investigation by the
Company following a written allegation by another employee of the Company,
that Employee engaged in some form of harassment or other improper conduct
prohibited by law, unless such actions were specifically directed by the
Board.
|
9.
|
Termination by Company without
Cause. In the event the Employee’s employment is
terminated by the Company without cause, as “cause” is defined in
Paragraph 8 hereof, Employee shall be entitled to receive from the Company
as severance pay an amount equal to twelve (12) months of Employee’s Base
Salary then in effect at the time of termination, payable in twelve (12)
equal monthly installments, in accordance with the Company’s payroll cycle
until paid in full, along with unused vacation pay and commissions earned
to the date of termination. Employee’s vested options shall be
exercisable, and any unvested options shall immediately vest and become
exercisable, upon termination under this Paragraph. The
consideration provided in this section is conditioned upon the Employee’s
return to the Company of any and all property belonging to the Company in
Employee’s possession or control and Employee’s disclosure to the Company
of any information known to Employee and necessary for the Company to
access any computer software or programs of the Company controlled by
Employee.
|
10.
|
Termination by Employee for
Good Reason. Employee may, at her option, terminate her
employment at any time during the Term for good reason. For
purposes of this Agreement, “good reason” shall mean (i) any material
breach by the Company of this Agreement that is not cured by the Company
within thirty (30) days after receipt of written notice from Employee of
such material breach, (ii) any material diminution or adverse (to
Employee) change in the duties, responsibilities, rights, privileges or
the reporting relationships, which were applicable to and enjoyed by the
Employee at the time of such diminution of change, without the consent of
the Employee, except as a result of the termination of Employee’s
employment by the Company as provided in Paragraph 8 hereof, (iii) any
requirement from the Board of Directors that the Employee must relocate
her office outside the Twin Cities metropolitan area, or (iv) occurrence
of any event described in Paragraph 12. In the event of a termination by
Employee of her employment as provided in this Paragraph 10, Employee
shall be entitled to severance pay and benefits as provided in Paragraph 9
hereof.
|
11.
|
Termination by
Employee. Employee may terminate employment at any
time during the Term for any reason with one (1) month
notice. In the event of termination under this Paragraph,
Employee shall be paid her base salary, adjusted pro-rata to the date of
such termination, along with unused vacation pay and commissions earned to
the date of termination. Employee agrees to aid in transition
and exit from the Company causing no harm or hardship during such
transition. Employee is bound by Paragraph 6 of this
Agreement. Employee is not eligible for salary continuation or
bonus or additional stock option vesting if she voluntarily resigns for
reasons other than “good reason” as defined in Paragraph
10.
|
12.
|
Sale, Reorganization or
Transfer of Ownership. In the event the Company (or
substantially all of its assets) is sold, or if majority ownership of the
Company should pass from the majority shareholders existing as of the
effective date of this Agreement to a single party or entity, the terms of
this Agreement shall remain in force. Terms of all executive
employment agreements will identify the specifics for sale, reorganization
or transfer of ownership, to be approved by the Compensation
Committee. All non-vested stock options, whether milestone has
been achieved or not, shall become vested with the completion of the sale
of the Company.
|
13.
|
Insolvency or Cessation of
Business. In the event the Company becomes insolvent or
ceases business due to lack of funds, this Agreement is immediately null
and void and the terms and conditions are rendered non-enforceable,
specifically those clauses associated with non-disclosure and
non-competition.
|
14.
|
Governing
Law. This agreement will be governed by and construed in
accordance with the laws of the State of
Minnesota.
|
15.
|
Notices. Any
notice or other communication required or permitted hereunder shall be in
writing and shall be deemed to have been given, when received, if
delivered by hand or by fax, or three (3) working days after deposited, if
placed in the mails for delivery by certified mail, return receipt
requested, postage prepaid and addressed to the appropriate party at the
following address:
|
Company:
|
BioDrain
Medical Inc.
|
Attention: Kevin
R. Davidson, President & CEO
|
|
2060
Centre Pointe Blvd., Suite 7
|
|
Mendota
Heights, MN 55120
|
|
Employee:
|
Kirsten
Doerfert
|
2500
Princeton Court
|
|
Minneapolis,
MN 55416
|
16.
|
Other
Agreements. This Agreement contains the entire agreement
between the parties concerning terms of employment and supersedes at the
effective date hereof any other agreement, written or
oral.
|
17.
|
Parties and
Interest. This Agreement is personal to Employee, and
Employee may not delegate her duties or assign her rights
hereunder. This Agreement shall inure to the benefit of, and be
binding upon, the parties hereto and their respective heirs, legal
representatives, successors and permitted
assigns.
|
18.
|
Modification and
Waiver. A waiver by either party of a breach of any
provision of this Agreement shall not operate as or be construed as a
waiver of any subsequent breach
thereof.
|
19.
|
Binding Effect, Assigns,
Successors, Etc. This Agreement shall be binding upon
the parties hereto and their respective heirs, representatives, successors
and assigns, and shall continue in full force unless and until terminated
by the mutual agreement of all parties
hereto.
|
20.
|
Savings
Clause. If any provision, portion or aspect of this
Agreement is determined to be void, or voidable by any legislative,
judicial or administrative action as properly applied to this Agreement,
then this Agreement shall be construed to so limit such provision, portion
or aspect thereof to render same enforceable to the greatest extent
permitted by or in the relevant
jurisdiction.
|
21.
|
Headings. The
headings of this Agreement are intended solely for convenience and
reference, and shall give no effect in the construction or interpretation
of this Agreement.
|
22.
|
Survival. Employee
understands and agrees that portions of the provisions of this Agreement
extend beyond termination of the Employee’s employment and shall continue
in full force and effect after such termination of employment or
termination of this
Agreement.
|
23.
|
Execution. This
Agreement may be executed in two (2) or more counterparts, and each such
counterpart deemed an original. Original signatures on copies
of the Agreement transmitted by facsimile will be deemed originals for all
purposes hereunder.
|
24.
|
Confidential. Company
and Employee agree to keep the terms and conditions of this Agreement
confidential during the terms of the Agreement and for one (1) year after
termination of Agreement, except to the extent that Employee may be
required to disclose the Agreement or its terms by force of law or in
connection with a prospective employment
search.
|
By:
|
/s/ Kevin R. Davidson |
Kevin
R. Davidson, President & CEO
|
|
By:
|
/s/ Kirsten Doerfert |
Kirsten
Doerfert,
Employee
|
Fully
Diluted Outstanding
|
||||||||
Shares
at Closing
|
||||||||
Number
|
Percent
|
|||||||
BioDrain
Original Shareholders
|
2,400,000 | 18.52 | % | |||||
Bridge
Loan
|
882,353 | 8.81 | % | |||||
Bridge
Loan Warrants
|
882,353 | 8.81 | % | |||||
Option
Pool
|
824,541 | 8.36 | % | |||||
Executive
Management Group Options
|
600,000 | 4.63 | % | |||||
Private
Placement Investors
|
2,824,137 | 21.79 | % | |||||
Private
Placement Warrants*
|
2,824,137 | 21.79 | % | |||||
Deal
Principals
|
1,723,314 | 13.30 | % | |||||
Fully
diluted shares, post merger, post financing*
|
12,960,834 | 100.00 | % |
Pre-Money
|
$ | 2,000,000 | ||
Pre-Money
Per share
|
0.42 | |||
Bridge
Loan Conversion
|
0.17 | |||
Share
Conversion - $150K
|
882,363 | |||
Pipe
Raise
|
$ | 1,200,000 | ||
Shares
issued
|
2,824,137 |
BioDrain Capitalization Table Post Merger, Post
Financing*
|
BioDrain Capitalization Table Post Merger, Post
Financing*
|
|||||||||||||||||
$1.5
Million Pre-Money, $800k PIPE Raise
|
$1.5
Million Pre-Money, $1.2MM PIPE Raise
|
|||||||||||||||||
$150K
Bridge Loan at $750k Pre-Money
|
$150K
Bridge Loan at $750k Pre-Money
|
|||||||||||||||||
Adjusted
for 1.25 reverse split
|
Adjusted
for 1.25 reverse split
|
|||||||||||||||||
Fully
Diluted Outstanding
|
Fully
Diluted Outstanding
|
|||||||||||||||||
Shares
at Closing
|
Shares
at Closing
|
|||||||||||||||||
Number
|
Percent
|
Number
|
Percent
|
|||||||||||||||
BioDrain
Original Shareholders
|
1,920,000 | 18.52 | % |
BioDrain
Original Shareholders
|
1,920,000 | 14.88 | % | |||||||||||
Bridge
Loan
|
620,096 | 5.98 | % |
Bridge
Loan
|
620,096 | 4.81 | % | |||||||||||
Bridge
Loan Warrants
|
620,096 | 5.98 | % |
Bridge
Loan Warrants
|
620,096 | 4.81 | % | |||||||||||
Option
Pool
|
1,180,480 | 11.39 | % |
Option
Pool
|
1,180,480 | 9.15 | % | |||||||||||
Private
Placement Investors
|
2,285,715 | 22.05 | % |
Private
Placement Investors
|
3,428,571 | 26.57 | % | |||||||||||
Private
Placement Warrants**
|
2,285,715 | 22.05 | % |
Private
Placement Warrants**
|
3,428,571 | 26.57 | % | |||||||||||
Deal
Principals
|
1,454,573 | 14.03 | % |
Deal
Principals
|
1,705,444 | 13.22 | % | |||||||||||
Fully
diluted shares, post merger, post financing*
|
10,366,675 | 100.00 | % |
Fully
diluted shares, post merger, post financing*
|
12,903,259 | 100.00 | % | |||||||||||
*all
share counts and percentages subject to change if PIPE raise varies from
$800k,
|
*all
share counts and percentages subject to change if PIPE raise varies from
$1.2million,
|
|||||||||||||||||
Equity
Incentive plan is adjusted or if Bridge amount changes from
$.150M
|
Equity
Incentive plan is adjusted or if Bridge amount changes from
$.150M
|
|||||||||||||||||
Warrants
on bridge loan strike price equal to $0.35 cents
|
Warrants
on bridge loan strike price equal to $0.35 cents
|
|||||||||||||||||
Deal
principal shares equal to 18% of fully diluted shares outstanding at
closing less
|
Deal
principal shares equal to 18% of fully diluted shares outstanding at
closing less
|
|||||||||||||||||
private
placement warrants
|
private
placement warrants
|
|||||||||||||||||
**
Warrants issued are equivalent to 100% of Pipe raise at $0.46 strike
price
|
**
Warrants issued are equivalent to 100% of Pipe raise at $0.46 strike
price
|
|||||||||||||||||
Pre-Money
|
$ | 1,500,000 |
Pre-Money
|
$ | 1,500,000 | |||||||||||||
Pre-Money
Per share
|
0.35 | 0.345569 |
Pre-Money
Per share
|
0.35 | 0.345569 | |||||||||||||
Bridge
Loan Conversion Price
|
0.24 |
Bridge
Loan Conversion Price
|
0.24 | |||||||||||||||
Share
Conversion - $150K
|
620,096 |
Share
Conversion - $150K
|
620,096 | |||||||||||||||
Pipe
Raise
|
$ | 800,000 |
Pipe
Raise
|
$ | 1,200,000 | |||||||||||||
Shares
Issued
|
2,285,715 | 2,285,714.3 |
Shares
Issued
|
3,428,571 | 3,428,571.4 | |||||||||||||
Deal
Principal Shares
|
1,454,573 |
Deal
Principal Shares
|
1,705,444 | |||||||||||||||
Deal
Principal Share % Excluding PIPE Warrants
|
18.00 | % |
Deal
Principal Share % Excluding PIPE Warrants
|
18.00 | % | |||||||||||||
Reverse
Split
|
1.25 |
Reverse
Split
|
1.25 |
Re:
|
BioDrain
Medical, Inc.
Amendment No.
2 Registration Statement on Form S-1
File February
12, 2009
File No.
333-155299
|
|
1.
|
We
will continue to evaluate your response to prior comments one after your
respond to comments in this letter.
|
|
2.
|
Please
tell us how your fee table accounts for the disclosure you added in
response to prior comments 3. We note, for example, the multiple
references to “N/A” in the column captioned “Proposed maximum offering
price per share”.
|
|
3.
|
We
will continue to evaluate your response to prior comment 2 after the
warrants underlying the convertible notes have been
issued.
|
|
4.
|
Please
disclose the second sentence of your response to prior comment
7.
|
|
5.
|
Please
tell us the reasons for the deletions to this risk factor. Does management
no longer believe the factors described in this risk factor raise
substantial doubt about your ability to continue as a going concern? If
so, explain why and what circumstances have changed, particularly given
your stage of development and lack of
revenues.
|
|
6.
|
We
note your response to prior comment
6:
|
|
·
|
Please revise the last
paragraph to clarify how FDA approval may eliminate your
“prospectus”;
|
|
·
|
Clarify how the restructuring changes pose a
risk to potential
investors in this
offering. In this regard, please reconcile your response and disclosed on
page 54 regarding whether investors will own a public company shell after
the reconstructing changes are
implemented.
|
|
·
|
Expand
to disclose whether the “Investors” or your affiliates are engaged in any
discussions or negotiations with respect to a reverse merger;
and
|
|
·
|
Clarify the meaning of the last
sentence in this risk factor. Your other disclosure indicates that your
assets and operations will be transferred to Privco at the time of the
restructuring.
|
|
o
|
Response: This
issue is no longer relevant because the Company received written
confirmation of it 510(k) clearance from the FDA on April 1, 2009 and a
restructuring is no longer
applicable.
|
|
7.
|
We
note the disclosure that you have entered into employment agreements with
all members of your senior management team, including Ms. Doerfert. Please
file your agreement with her as an
exhibit.
|
|
8.
|
We
reissue prior comment 10, given that it appears your disclosure here and
page 28 continue to disclose different numbers of outstanding
warrants.
|
|
9.
|
We
reissue prior comment 12. Please revise to provide a discussion of your
critical accounting policies and estimates. This discussion should present
your analysis of the uncertainties involved in applying an accounting
principle at a given time and the variability that is reasonably likely to
result from its application over time. You should address specifically why
your accounting estimates and assumptions bear the risk of change. Refer
to FR-72.
|
|
10.
|
We
refer to your response to prior comment 15 from our letter dated January
29, 2009 and prior comment 27 from our letter dated December 10, 2008. The
basis in GAAP applied in accounting for the reduction of accrued salaries
continues to be unclear and we have continuing concerns that the
accounting may not comply with GAAP, please respond to the
following:
|
|
·
|
In a written response tell us
the date accrued salary reduction was recorded. Also provide us a schedule
that shows the amounts accrued for each individual before and after the
$346,000 adjustment.
|
|
·
|
In some instances, such as on
page 22, you indicate that the accrued salaries were “deferred”. In other
instances, you indicate that the accrued salaries were “waived”, please
tell us and clarify whether the salaries were deferred or
waived.
|
|
·
|
It appears that the accrued
salaries were for services rendered by your officers who also appear to be
shareholders. Accordingly, to the extent accrued salaries were waived, it
is not clear why there is not a contribution to capital from these
individuals. As well, it is not clear how the
accounting considers the guidelines from SAB Topic 1.B.1., which requires
that the financial statements include all costs of doing business. Please
advise in a complete written
response. Also,
cite the basis in GAAP on which you have
relied.
|
|
·
|
Tell us whether the cash
bonuses and equity instruments to be paid upon raising $3 million are
intended to be compensation for raising the $3 million or payment for the
services rendered prior to the reduction of the
accrual.
|
|
·
|
Tell us why the accrual was not
adjusted to the fair value of the agreed upon future cash and equity
payments in the 2007 financial statements. Tell us why the accounting is
contingent on the future finding. Provide us a complete written response
that explains your view and that explains how that view is consistent with
GAAP. Cite the literature on which
you rely.
|
|
·
|
Tell us how your accounting for
the contingent stock options considers the guidance from paragraphs 47, 48
and Appendix A of SFAS 123(R). Your written response should fully explain
how your applied the guidance applicable to stock options with a
performance condition.
|
|
11.
|
As a related matter, while we
see the disclosure about the accounting applied in the reversal of accrued
salaries under General and Administrative (page 22), the paragraph does
not appear to make understandable accounting disclosure. We may have
further comment on your disclosure upon resolution of the related
accounting issue.
|
|
12.
|
We
note your response to prior comment 13. If the full salary rate has been
accrued as an expense and not actually paid in a timely manner or at all,
as suggested by your response, then revise your disclosure to eliminate
any implication that you “paid”
salaries.
|
|
13.
|
Regarding
your response to prior comment 16:
|
|
·
|
We reissue the first bullet,
given the continued inconsistencies on pages 23, 25 and 26 regarding
outstanding debt payments you are obligated to
make;
|
|
·
|
Expand your response to the
third bullet to disclose the total amount of accrued payroll expense you
have accrued;
|
|
·
|
Expand your response to the
fourth bullet to clarify whether you have sufficient cash to satisfy a
formal payments demand. If you do not, disclose what rights the holders of
debt have; for example, may they seize your assets?;
and
|
|
·
|
We
reissue the eight bullet, which requested disclosure of the nature of the
“other operating expenses” noted on page
23.
|
|
14.
|
We
note your response to prior comment 47 and the second paragraph below the
table on page 29. Please explain the purpose and significance of the
1,920,000 determination mentioned. Also, given your disclosure in this
section, including the table on page 30, explain why the reverse splits
only impacted the securities held by your
founders.
|
|
15.
|
We
reissue prior comment 21. We note, for example, the June 16 and August 11,
2008 transactions mentioned on page 31 do not refer to an exercise
price.
|
|
16.
|
Please
reconcile your response to prior comment 22 with your disclosure here
regarding the identity of your
founders.
|
|
17.
|
Revise
the first paragraph to disclose the products for which you have obtained
patent rights.
|
|
18.
|
We
note your response to prior comment 5. However, your disclosure in this
section and on page 48 continues to cite to data from third- party
sources. Please provide us copies of that data, marking the relevant
sections to support the disclosure.
|
|
19.
|
Please
reconcile your reference to your “proprietary” cleaning fluid in the
fourth bullet on page 40 and on page 53 with your response to prior
comment 28.
|
|
20.
|
Please
expand the second paragraph on page 43 to disclose the first sentence of
your response to prior comment 28.
|
|
21.
|
Please
reconcile your disclosure added to the first paragraph of this section on
page 41 with your disclosure on page 38, which notes that the product made
by MD Technologies also has unlimited fluid
capacity.
|
|
22.
|
Please
tell us where you have disclosed the third and last sentence in your
response to prior comment 33.
|
|
23.
|
We
note the disclosure that your disposable cleaning kit will be sourced
through alternative suppliers. Please reconcile that disclosure with your
disclosure on page 43, which indicates that you have only one supplier of
that product.
|
|
24.
|
Please
provide current disclosure. We note, for example, the disclosure on page
52 that final documentation of testing results is scheduled for January
31, 2009 and that you expect successful testing. If previously disclosed
plans have changed, disclose the material reasons for the change or
delay.
|
|
25.
|
We
note your response to prior comment 37. Your disclosure on pages 7 and 54
continue to state that you entered into the restructuring agreement in
June 2007; however, exhibit 10.42 states that the date of such agreement
was June 9, 2008. Therefore, we reissue prior comment
37.
|
|
26.
|
We
note your response to prior comment
38:
|
|
·
|
It continues to appear that
investors who acquire the shares to be sold pursuant to this registration
statement will not be able to cause the restructuring changes mentioned in
your disclosure. Please revise to disclose this fact, if
true;
|
|
·
|
Your first paragraph continues
to state that the “Investors” will maintain their shares of your common
stock. Clarify how this will occur, as previously requested, given that
those shares are registered here for
resale;
|
|
·
|
Clarify how the “Investors”
will have the same percentage ownership of Privco that they had in the
company before the transaction, given that the “Investors” shares are
registered here for resale. This arrangement appears to result in the
“Investors” owning indirectly a higher percentage of Privco than they
would appear to be entitled, given that the “Investors” shares may be they
would appear to be entitled, given that the “Investors” shares may be
sold. As such, it also appears that the percentage ownership that
potential purchasers of your securities may have will not be based on the
number of shares they actually
hold;
|
|
·
|
Disclose your response to the
third bullet;
|
|
·
|
We reissue the fourth and sixth
bullets of prior comment 38, which requested expanded disclosure regarding
the indentify of the “Company shareholders” and whether a reverse merger
or similar transaction involving you was currently being negotiated or
considered;
|
|
·
|
It appears from your response
to the fifth bullet that you are relying on no authority for your
conclusion that shareholder approval is not required for the transfer to
Privco. Please confirm that understanding. Also tell us how you concluded
that Privco will be a “wholly- owned” subsidiary, given that the
“Founders” will also own Privco shares;
and
|
|
·
|
If only the “[PPM] investors”
will receive the proceeds of a sale or liquidation of Privco, as noted in
your response to the last bullet, then disclose the fact, and highlight
that risk to potential
investors.
|
|
27.
|
We
note your responses to prior comments 40 and
41::
|
|
·
|
You state that the
restructuring agreement was not part of the subscription agreement for
your recent financing and were only a “unilateral acknowledgement” by the
“Founders”. You then state no investor in the financing executed the
agreement and that the “PPM” was modified. Please tell us how investors in
that financing agreed to the terms of the restructuring. Given your
disclosure that they would have actually agreed to the terms of the
restructuring. Also tell us why if the “PPM” was modified per your
response, those modifications are not reflected in exhibit
10.31.
|
|
·
|
Given your deletions in
response to prior comment 40, it is unclear how the “June 2007”
restructuring agreement is “in connection with” your October 2008
financing. Please revise to clarify how those agreements
relate.
|
|
28.
|
We
note your response to prior comment 42. Given your disclosure on page 40
regarding the qualifications and experience of the FDA consultants and
advisors you have retained, it is unclear why you should not provide
disclosure required by Regulation S-K Item 401 as to them. See Item 401(c)
and Rule 408.
|
|
29.
|
Given
your disclosure on page 60, please revise to include Ms. Doerfert in your
table here.
|
|
30.
|
We
reissue the third bullet of prior comment 43, because it is unclear where
you provided the disclosure requested by that
bullet.
|
|
31.
|
We
note your response to prior comment
44:
|
|
·
|
Please reconcile your
disclosures in the notes to the summary compensation table and on pages 64
and 65 regarding the amounts to which Messrs. Davidson and Rice were
entitled to receive pursuant to their employment agreements and whether
they have or have not received options in satisfaction of unpaid salaries.
Your table on page 29 also indicates that such options have already been
issued; and
|
|
·
|
Clarify how the amounts of
salary for 2008 that were unpaid will be addressed: for example, did
Messrs, Rice and Davidson agree to waive such
amounts?;
|
|
32.
|
We
note your response to prior comment 48. Please file as an exhibit the
agreement related to the deferral of consulting fees owed to Mr. Morawetz.
Also, we reissue the third bullet of prior comment 48 since it is unclear
where you provided disclosure regarding the matters noted in that
bullet.
|
|
33.
|
We
note your response to prior comment 49. That comment, like prior comment
78 in our letter dated December 10, 2008, requested that you clarify your
disclosure here regarding Mr. Morawetz by discussing your relationship
with him separately. Your disclosure in the third paragraph of this
section continues to refer Mr. Morawetz. Therefore, we reissue
prior comment 49.
|
|
34.
|
Regarding
your response to prior comment 50:
|
|
·
|
Please revise the third
paragraph to clarify whether the cash bonuses payable to Messrs, Rice and
Davidson will be paid from the proceeds of the $3 million funding. Also
disclose on an individual and aggregate basis the total amounts to be paid
to your affiliates upon receiving such financing. For example, we note the
reference on page 22 to the deferral of salary- related
expenses until such financing is
received;
|
|
·
|
Reconcile your response and
disclosure here that options have not yet been granted with your
disclosure on page 64 that such options have already been
granted;
|
|
·
|
Revise the fourth paragraph to
clarify the amount of unpaid accrued salaries from December 2007 to April
2008 and from June 2008 to present. Also discuss whether any arrangement
exists for the payment of such accrued and unpaid salaries;
and
|
|
·
|
File as an exhibits any
agreements related to the arrangements mentioned in the third paragraph of
this section.
|
|
35.
|
We
note your response to prior comment 52. That comment requested disclosure
of the information required by Item 404 of Regulation S-K with respect to
the transactions noted in exhibits 10.15-10.18. Because your response does
not address those transactions and it appears you have not provided such
disclosure, we reissue that
comment.
|
|
36.
|
We
note your response to prior comment 54. Expand note 26 to clarify the
nature of the services provided by the “certain consultants” mentioned in
that note. Also expand note 27 to identify the “consultant” who assisted
you in obtaining bridge financing and subsequent equity financing and to
briefly describe the nature of the assistance provided. Also file as an
exhibit the “binding term sheet” with that consultant that is mentioned on
page II-6.
|
|
37.
|
Your
response numbered 55 reproduces the same comment as your response numbered
54. However, comment 55 in our letter dated January 29, 2009 requested
disclosure of the natural persons who exercise voting and/ or dispositive
powers with respect to the shares offered by Schwartz Holding. It appears
that you have not provided such disclosure. Therefore, we reissue prior
comment 55
|
|
38.
|
We
note your response to prior comment 57. However, your disclosure regarding
the first bullet point of this section regarding the number of shares
underlying the convertible debenture continues to be inconsistent with
your disclosure in notes 11-17 regarding the aggregate number of shares
underlying that security. Please revise. In addition, please reconcile
your references in the first bullet, notes 11-17 and note 24 regarding the
nature of the security. In those locations, you refer to such as
“convertible debenture”, “promissory note” and “convertible note”,
respectively.
|
|
39.
|
We
note from your response to prior comment 24 and disclosure added on page
34 that the warrants issued by you in your recent financing are
immediately exercisable. Please reconcile that response and disclosure
with your disclosure in the notes to your table here. It appears from your
selling security holders’ table that Messrs, Ruwe, Schwartz and Taylor and
the two trusts each participated in such financing but your disclosure
here indicates that the warrants held by them are not exercisable within
60 days.
|
|
Response: The
warrants are fully vested. However they include a clause that
prohibit the warrants to be exercised if it would cause the holdings of
such equityholder to be in excess of 4.99% of our total outstanding
shares. The warrantholder may amend this clause to eliminate
this requirement. However, such clause will not take effect
until the 61 day after notice has been given. Consequently they
cannot exercise their warrants within 60 days of a recent date, and those
warrants are not included in the total outstanding and percentage of
outstanding shares.
|
|
40.
|
We
reissue prior comments 60, in part. Contrary to your response, your
disclosure continues to disclose different numbers of shares underlying
warrants held by Mr. Taylor. On page 72, you disclose that he holds
571,429 shares underlying warrants, but disclose in note 11on page 78 that
he holds 571,479 shares underlying
warrants.
|
|
41.
|
Please
disclose the first sentence of your response to prior comment 61, and
indentify the “seven holders” of the convertible securities, as previously
requested.
|
|
·
|
Reconcile your disclosure here
and your response regarding the conversion price of those securities;
and
|
|
·
|
Tell us how you determined that
the convertible notes are convertible into 620,095 common shares. Show us
the calculation underlying your
conclusions.
|
|
·
|
Response: The names
of the convertible promissory note holders, the face amount of the
individual
notes and the number of shares that
the notes will convert into, rounded to the nearest shares, are as
follows:
|
|
·
|
BioDrain
Medical, Inc.
|
||||||||
Bridge
Loan Holders
|
Conversion
Price
|
|||||||
0.274151
|
||||||||
Shares
|
||||||||
Name
|
Amount
|
of Stock
|
||||||
Core
Fund Mgmt LP
|
$ | 50,000 | 182,381 | |||||
C.
James Jensen
|
50,000 | 182,381 | ||||||
Steve
Andress
|
10,000 | 36,476 | ||||||
Kendall
Morrison
|
10,000 | 36,476 | ||||||
EGATNIV
LLC
|
25,000 | 91,191 | ||||||
Erick
Richardson
|
12,500 | 45,595 | ||||||
Nimish
Patel
|
12,500 | 45,595 | ||||||
Total
|
$ | 170,000 | 620,095 |
|
42.
|
Regarding
your response to prior comment 62:
|
|
·
|
Your disclosure here regarding
the number of shares held and offered by Nimish Patel, Erick Richardson
and RP Capital continues to differ from the number of shares held and
offered by these holders as disclosed on page 72. Please revise. Also
revise your calculations here regarding the aggregate number of shares
held and offered by Richardson& Patel and its affiliates, as
appropriate;
|
Nimish
Patel
|
503,601
Shares
|
Erick
Richardson
|
490,733
Shares
|
RP
Capital
|
326,848
Shares
|
Shareholder
|
Shares
|
Warrants
|
Conv
Debt
|
Total
|
||||||||||||
Nimish
Patel
|
412,411 | 45,595 | 45,595 | 503,601 | ||||||||||||
Erick
Richardson
|
399,543 | 45,595 | 45,595 | 490,733 | ||||||||||||
RP
Capital
|
183,991 | 148,857 | 0 | 326,848 |
|
·
|
It is unclear how your
disclosure here includes the debt you owe to Richardson & Patel that
is mentioned on page 23. For example, is that debt different or related to
the convertible notes mentioned here? Please revise, as appropriate;
and
|
|
·
|
Expand your response to clarify
how you reached your conclusion regarding the lack of material risks. For
example, describe the impact that the number and percentage of shares held
and offered by the law firm and its affiliates, as well as the penalty
provisions described on page 79, may have on its interests in the
transaction currently
registered.
|
|
43.
|
Please
update the audited financial statements in the next amendment. Refer to
Rule 8-09 of Regulation S-X.
|
|
44.
|
Your
response to prior comments 17 and 18 indicate that “other current assets”
is solely comprised of restricted cash. Please tell us why you should not
revise the label for the referenced caption to more accurately describe
the composition of the account. In that regard, please also provide
footnote disclosure that describes the nature and terms of the
restriction.
|
|
45.
|
If
the item “product development” is research and development as described in
MD&A and in financial statement Note 1, please revise to use a
consistent title.
|
|
46.
|
Your
responses to prior comments 17 and 18 indicate that “other current assets”
is solely comprised of restricted cash. Please tell us why the change in
restricted cash is appropriately classified as an operating activity for
cash flow statement purposes. In that regard, tell us how you applied the
relevant classification guidance from
SFAS95.
|
|
47.
|
We
refer to the response to prior comment 71. As previously requested, please
revise the disclosure about the transaction with Mr. Ryan to state the
date of the agreement and to describe how you accounted for the cash paid
and warrants issued. Also disclose the fair value assigned to the
warrant.
|
|
48.
|
As
a related matter, we refer to your response to prior comment 72. Please
disclose how you valued the warrants issued to Mr. Ryan, including the
model and significant assumptions. As Mr. Ryan does not appear to be an
employee as defined in SFAS 123(R), please also disclose how your
accounting considers the guidance from EITF 96-18 and EITF 00-18. In that
regard, as indicated in your response, disclose that the warrants were
fully vested at issuance.
|
|
49.
|
Disclosure
in this footnote is not limited to stock options and warrants. Please
revise the footnote title in the updated audited financial statements to
more accurately describe the components of the footnote. A title such as
“Stockholders’ Equity (Deficit)” may be appropriate for that
purpose.
|
|
50.
|
At
the bottom of page F-8 you disclose that: “Warrants issued in connection
with the $170,000 in convertible debt were not issued as of September 30,
2008 and, therefore, the debt discount was not recorded as of that date.”
The sentence is not clear because it states that warrants issued were not
issued. In that regard:
|
|
·
|
Tell
us and make disclosure about these warrants, including all relevant terms
and conditions.
|
|
·
|
Tell us and disclose when you
expect to issue the
warrants.
|
|
·
|
Tell us about and disclose any
investor performance or other conditions precedent to
issuance.
|
|
·
|
Tell us how your accounting for
these warrants considers the accounting guidance from EITF 96-18. We
specifically refer you to Issue 1 which describes how to determine the
appropriate measurement date. That is, please explain to us why the fact
that you have not formally issued the warrants is relevant to the timing
of the accounting under SFAS 123(R) and EITF
96-18.
|
|
51.
|
Show
us how the number of warrants granted in 2008 reconciles to the narrative
disclosures under the caption
“Warrants”.
|
Warrants
Issued in
2008
|
||||
Shares
underlying warrants issued to consultants
|
385,913 | |||
Shares
underlying warrants issued in October 2008 Financing
|
4,689,291 | |||
Shares
underlying warrant in connection with bridge loan
|
620,095 | |||
Total
shares underlying warrants issued in 2008
|
5,695,299 |
|
52.
|
Please
disclose the fair value assigned and how you determined the fair value
assigned to common shares issued for each other than cash. Refer paragraph
11d of SFAS7.
|
|
53.
|
You
disclose that; “On August 22, 2005, we issued an option to purchase 17,957
shares of our common stock at $1.67 per share to a member of our board of
directors, Thomas McGoldrick, for his services as a director. The options
were grantable annually at 10,000 per year starting in 2008. On August 22,
2006, we issued an option to purchase 5,986 shares of common stock at $.46
per share to beginning in 2008 is related to the options granted to Mr.
McGoldrick in 2005 and 2006. Please also clarify the similar disclosure
with respect to the arrangement with Mr.
Reding.
|
|
54.
|
You
disclose that: “On March 10, 2008, we entered into a finder agreement for
referral services for the Company’s funding that was completed on August
31, 2008”. Please expand to provide disclosure about the funding completed
on August 31, 2008. If you intended to refer to what you have described as
the “October 2008” financing, please clarify. Please also disclose how you
accounted for the fair value assigned to the equity instruments issued as
a finder’s fee.
|
|
55.
|
Please
disclose how you accounted for the fair value assigned to the 250,000
shares issued for the investor relations arrangement with
Kulman.
|
|
56.
|
You
disclose that Namaste Financial is “entitled” to receive 125,000 shares
and a related warrant for consulting services. Please revise to state
whether you have actually issued the equity instruments. Tell us and
disclose the fair value assigned to the arrangement and how you are
accounting for that fair value. In a written response, show is that your
accounting for this arrangement is appropriate in GAAP. We refer to SFAS
123(R), EITF 96-18 and EITF 00-18.
|
|
57.
|
Please
show us where the 50,000 shares granted to Mr. Davidson in 2006 are
included on the statement of the stockholders’ equity. The equity
statement does not appear to show an issuance under an employment
agreement for 50,000 shares in
2006.
|
|
58.
|
Please
disclose the fair value assigned to the 543,292 options granted to Mr.
Davidson on September 12, 2008. Also disclose the assumptions specific to
that grant.
|
|
59.
|
We
refer to your response to prior comment 77. With respect to the options
granted to Mr. Ruwe and Mr. Dauwalter
please:
|
|
·
|
Tell us about and fully
disclose the underlying performance conditions. Refer to paragraph A240 of
SFAS 123(R).
|
|
·
|
In a complete written response,
tell is how your accounting considers the guidance about stock options
with performance conditions as described in paragraphs 47, 48 and Appendix
A of SFAS 123(R). You written response should fully demonstrate that you
have appropriately applied the accounting guidance relevant to stock
options with performance
conditions.
|
|
60.
|
We
refer to your response to prior comment 78. It continues to be unclear why
it is appropriate in GAAP to reverse the $85,000 accrued for services
rendered by Mr. Morawetz between 2002 and 2006. Please provide a written
response to the following:
|
|
·
|
Please explain to us the basis
in GAAP for concluding that it is appropriate to reverse the accrued
liability. Cite the specific literature on which you
relied.
|
|
·
|
You indicate that Mr. Morawetz
has agreed to “defer” the amount owed to him for the service he rendered
during 2002 to 2006. Explain to us why you believe it is appropriate to
reverse the accrual for a liability that has been “deferred”. Cite the
specific literature on which you
relied.
|
|
·
|
You indicate that you will
expense an amount for the services rendered from 2002 to 2006 once you
reach an agreement on a renegotiated amount. Please tell us why you
believe this accounting is appropriate in GAAP. In that regard, explain to
us why you believe it is appropriate in GAAP to expense cost of services
rendered from 2002 to 2006 in some future period. Cite the basis in GAAP
on which you relied.
|
|
61.
|
We
refer to the paragraph addressing the arrangements with the human
resources consulting firms. You indicate that Andcor will not earn its
75,000 warrants until a candidate is hired and remains an employee for one
year. Please also disclose the terms of grant for the 75,000 warrants
under the arrangement with Taylor &
Associates.
|
|
62.
|
With
respect to the arrangements with Andcor, Taylor & Associates and Mr.
Sachs, please tell us and disclose how you are accounting for the
arrangements under SFAS 123(R) and EITF
96-18.
|
|
63.
|
While
we see your response to prior comment 79 it continues to be unclear how
the paragraph at the top of page F-11 makes meaningful accounting
disclosure. In a written response to this comment please tell us how this
referenced paragraph makes meaningful accounting disclosure. Unless you
can explain the accounting relevance of this disclosure, please delete the
referenced paragraph.
|
|
64.
|
While
we see your response to prior comment 81, you continue to disclose that
notes totaling $284,000 are “passed their due dates and could be called by
the holders”. Accordingly, please tell us why the full $284,000 is not
classified as current in the balance sheet. If the second sentence in the
first paragraph under the table on page F-12 is not accurate, please
appropriately revise.
|
|
65.
|
We
refer to your response to prior comment 82. As previously requested,
please provide an accounting policy disclosure for damages provisions
under registration rights agreements. Refer to FSP EITF
00-19-2.
|
|
66.
|
We
note your response to prior 83 and may have further comment once we review
your updated audited financial statements and
MD&A.
|
|
67.
|
Please
provide earnings per share on the face of the statements of operations for
each annual and interim period presented. Please ensure that the notes to
financial statements also include all relevant disclosures required by
SFAS 128.
|
|
68.
|
Please
provide a statements of stockholder’s equity that is cumulative from
inception as required by paragraph 11d of SFAS 7 and as referred to in
your audit report.
|
|
69.
|
We
re-issue comment 86. Please remove the caption “unaudited” from the
sub-totals for all annual periods.
|
|
70.
|
Please
revise to clarify how the footnotes directly below the statement of
stockholders’ equity on page F-18 are connected to the presentation. In
that regard, it appears that a portion of the required financial statement
is not presented.
|
|
71.
|
We
re-issue prior comment 90. Please reconcile the numerical disclosures of
the amounts of research and development expense in 2007 and 2006 as
presented in this footnote with the corresponding numerical disclosures of
the amounts of research and development expense in 2007 and 2006 as
presented in MD& A on page 22.
|
|
·
|
Please
reconcile the disclosure from page F-20 with your representation in
response to prior comment 14 that you did not know the amount until
2008.
|
|
·
|
Based
on your disclosures, it appears that you were aware that a third party was
performing services on your behalf and you were informed of the amount
prior to December 31, 2007. Accordingly, please explain to us why the
$100,000 (for some other reasonable estimate of the amount owed) was not
expensed prior to delivery of the invoice in 2008. Your response should
fully explain how the accounting complies with GAAP, including the
principles of accrual accounting. Cite the specific literature on which
you have relied.
|
|
·
|
Response: The
Company accrued $75,000 in 2007 as its estimate of the amount that would
ultimately be due Marshall Ryan but the amount agreed to in 2008 was
$175,000. The difference was an error in accounting
estimate.
|
|
74
|
We
re-issue prior comment 92. Please tell us whether the numerical
disclosures of vested options and warrants described in the sentence
appearing directly under the stock option/warrant roll- forward were
updated for the stock splits. In that regard, as of December 31, 2007, the
number of currently exercisable warrants in the referenced sentence
exceeds the number of outstanding warrants in the
table.
|
|
75
|
We
refer to your response to prior comment 93. You previously disclosed that
you applied a volatility factor of zero for stock options and warrants.
You now disclose that you used a volatility factor of 45%, apparently for
all periods. Please respond to the
following:
|
|
·
|
Tell
us how you determined the volatility factor of 45%. Explain how your
measure is appropriate in your specific circumstances and Under SFAS
123(R).
|
|
·
|
Tell
us why the volatility factor does not vary from period to period. That is,
explain to us why the volatility measure is 45% for each year and for the
2008 interim period.
|
|
·
|
Quantify
how the change in volatility impacted the fair value assigned to the
instruments for each period.
|
|
·
|
In
that regard, if you did not apply a volatility factor for options and
warrants in the prior filings, tell us why you have not reported a
correction of an error under SFAS
154
|
|
·
|
Response: The
Company does not have any trading history for its own stock and,
therefore, had to look for alternative means to arrive at expected
volatility. The company observed the historical volatility of
other public medical device companies and used their recent volatility as
guidance for its own expected volatility. Based upon these observations we
arrived at 45% as our estimate of future volatility. We did not
vary the volatility estimate from year to year or in the interim periods
because that would imply a level of precision in our estimate that is not
present. We will continue to evaluate the company’s volatility
as the stock begins trading and will update it over time as
applicable.
|
|
76
|
Please
disclose how you determine each of the assumptions applied in valuing
stock options and warrants under SFAS 123(R). In that regard, also
indentify the sector index used in determining volatility and disclose why
you believe that is in appropriate index. Please refer to paragraph A240
of SFAS 123(R).
|
|
77
|
We
re-issue prior comment 94. SFAS 123(R) calls for numerous disclosures as
set forth in paragraphs A240 and A241 that are required for both employee
and non- employee transactions. Also note that you should comply with all
disclosures applicable to a public company as a result of your
registrations statement. Your disclosures do not appear complete under the
cited guidance. Please appropriately revise. In response to this comment
provide us a cross reference to paragraph A240 of SFAS 123(R) that shows
us where you have made the required disclosure or that explains why the
disclosure is not applicable.
|
|
78
|
We
note your response to prior comment 97. However, it continues to appear
that you have not provided the information required by Item 701 of
Regulation S-K with respect to the stock options grants during 2007 to
your executive officers that are mentioned on page 64. In this regard, we
note the conflicting disclosure throughout your document that such options
“will be” granted to such officers, but your table on page 64 indicates
that those options have already been granted. Please revise and ensure
that your document accurately discloses the total all past option
grants.
|
|
79
|
Please
reconcile your response to prior comment 98 with the first paragraph under
Note 7 on page F-13. If shares were issued subsequent to September 30,
2008, ensure that these shares are accounted for in disclosing the total
number of shares you have
outstanding.
|
|
80
|
We
reissue prior comment 100. Despite your response to the contrary, your
filing continues to lack the first clause of Regulation S-K Item 512(a)
(5); specifically, the phrase beginning “That, for the purpose of
determining liability…” In addition, the undertaking set forth in
Regulation S-K Item 512(a) (6) is required for all initial public
offerings of
securities.
|
|
81
|
We
note that response to prior comment 10. Please reconcile your disclosures
here and in the table on page 59 regarding whether Mr. Davidson serves as
your chief financial officer. Also disclose below the second paragraph of
text on this page which individual signed in the capacity of principal
accounting officer or
controller.
|
|
82
|
Prior
comment 102 requested that you file as an exhibit a complete copy
of your articles of incorporation as amended. Exhibit 3.3 merely reflects
an amendment to those articles. Therefore, we reissue prior comment
102.
|
RICHARDSON
& PATEL, LLP
|
|
Ryan
Hong,
Esq.
|