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(Mark
One)
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þ
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ANNUAL REPORT PURSUANT TO
SECTION 13
OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For
the fiscal year ended March 31, 2010
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
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For
transition period from _________________
to _________________
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Delaware
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68-0423298
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(State
or other jurisdiction
of
incorporation or organization)
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(I.R.S.
Employer
Identification
No.)
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Title of Each Class
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Name of Each Exchange on Which
Registered
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common
stock, $0.0001 par value
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The
NASDAQ Stock Market LLC
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Large accelerated filer
o
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Accelerated filer
o
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Non-accelerated filer
o
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Smaller
reporting company
þ
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(Do not check if
a smaller reporting company)
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Page
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PART I
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||
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ITEM
1.
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Business
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3
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ITEM
1A.
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Risk
Factors
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24
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ITEM
2.
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Properties
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36
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ITEM
3.
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Legal
Proceedings
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37
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ITEM
4.
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(Removed
and Reserved)
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PART II
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||
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ITEM
5.
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Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
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37
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ITEM
6.
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Selected
Financial Data
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38
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ITEM
7.
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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38
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ITEM
7A.
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Quantitative
and Qualitative Disclosures About Market Risk
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44
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ITEM
8.
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Consolidated
Financial Statements and Supplementary Data
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45
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ITEM
9.
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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74
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ITEM
9A(T).
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Controls
and Procedures
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74
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ITEM
9B.
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Other
Information
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74
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PART III
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||
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ITEM
10.
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Directors,
Executive Officers and Corporate Governance
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75
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ITEM
11.
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Executive Compensation
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75
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ITEM
12.
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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75
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ITEM
13.
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Certain
Relationships and Related Transactions, and Director
Independence
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75
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ITEM
14.
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Principal
Accounting Fees and Services
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75
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PART IV
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||
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ITEM
15.
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Exhibits,
Financial Statement Schedules
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76
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Signatures
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82
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1)
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moistening
and lubricating absorbent wound dressings for traumatic wounds requiring a
prescription;
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2)
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moistening
and debriding acute and chronic dermal lesions requiring a
prescription;
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3)
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moistening
absorbent wound dressings and cleaning minor cuts as an over-the-counter
product;
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4)
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management
of exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers and
for the management of mechanically or surgically debridement of wounds in
a gel form and required as a
prescription;
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5)
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debridement
of wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post
surgical wounds, first and second degree burns, grafted and donor sites as
a preservative, which can kill listed bacteria such as MRSA & VRE
and required as a prescription;
and
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6)
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as
a hydrogel, for management of wounds including itch and pain relief
associated with dermal irritation, sores, injuries and ulcers of dermal
tissue as a prescription. As an over-the-counter product, the
hydrogel is intended to relieve itch and pain from minor skin irritations,
lacerations, abrasions and minor burns. It is also indicated for
management of irritation and pain from minor
sunburn.
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|
•
|
We
may move forward into the pivotal phase of our U.S. clinical program
for Microcyn Technology.
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•
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There
were no safety issues relative to moving into this next clinical phase
immediately, and carcinogenicity studies will not be required for product
approval; and
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•
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Clinical
requirements for efficacy and safety for a new drug application will be
appropriately accounted for within the agreed upon pivotal trial
designs.
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•
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antibiotics
and antiseptics can kill bacteria and cure infection but do not
independently accelerate wound
healing;
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•
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many
antiseptics, including Betadine, hydrogen peroxide and Dakin’s solution,
are toxic, can destroy human cells and tissue, may cause allergic
reactions and can impede the wound healing
process;
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•
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silver-based
products are expensive and require precise dosage and close monitoring by
trained medical staff to minimize the potential for tissue toxicity,
allergic reactions and bacterial
resistance;
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|
•
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the
increase in antibiotic-resistant bacterial strains, such as MRSA, VRE, and
C. diff have compromised the effectiveness of some widely used topical and
systemic antibiotics, including Neosporin and
Bacitracin;
|
|
|
•
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oral
and systemic antibiotics often are not effective in treating topical
infections especially if the patient does not have adequate blood flow to
the wound and they can also cause serious side
effects; and
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•
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growth
regulators, skin substitutes and vacuum-assisted closure accelerate wound
healing but do not cure infection.
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•
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Cures
Infection.
Our Phase II results and several
physician-based studies suggest that Microcyn may be effective in curing
and improving the signs and symptoms of
infections.
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•
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Accelerates Wound
Healing.
Based on numerous physician-based studies and
usage feedback from doctors, we believe that Microcyn may accelerate the
wound healing process independently of the benefits of curing the
infection.
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•
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Wound Care Solution.
Our FDA 510(k) approved products are cleared as a medical
device for sale in the United States in wound cleaning, or debridement,
lubricating, moistening and dressing. Laboratory testing and physician
clinical studies further suggest that our 510(k) Microcyn products are
effective against a wide range of bacteria that causes infection in a
variety of acute and chronic wounds. In addition, because of its mechanism
of action, we believe Microcyn does not target specific strains of
bacteria, the practice of which has been shown to promote the development
of resistant bacteria. In physician clinical studies, our 510(k)
Microcyn has been used in conjunction with other wound care
therapeutic products. Data from these studies suggest that patients
generally experienced less pain, improved mobility and physical activity
levels and better quality of life.
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•
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Non-irritating.
Our 510(k) product labels states that our 510(k) product,
which is based on our Microcyn , is non-irritating and non-sensitizing to
the skin and eyes. Throughout all our clinical trials and physician
clinical studies to date and since our first commercial sale of Microcyn60
in Mexico in 2004, we have received no reports of serious adverse events
related to the use of Microcyn products when used according to label
instructions.
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•
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Ease of Use.
Our 510(k) product labels states that our 510(k) products
require no special handling precautions. Our products require no
preparation before use or at time of disposal, and caregivers can use our
products without significant training. In addition, Microcyn can be stored
at room temperature. Unlike other oxychlorine solutions, which are
typically stable for not more than 48 hours, our laboratory tests
show that Microcyn has a shelf life ranging from one to two years
depending on the size and type of packaging. Our products are also
designed to be complementary to most advanced technologies to treat
serious wounds, such as negative-pressure wound therapy, jet lavage and
tissue-engineered skin
substitutes.
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•
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Cost-Effectiveness.
The treatment of many wounds requires extended hospitalization
and care, including the use of expensive systemic antibiotics. Infection
prolongs the healing time and necessitates increased use of systemic
antibiotics. We believe that Microcyn has the potential to cure infection,
accelerate healing time and, in certain cases, may help reduce the need
for systemic antibiotics, reduce the need for amputation and lead to
earlier hospital discharge, thereby lowering overall patient
cost.
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Region
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Approval
or
Clearance Type
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Year
of Approval
or Clearance
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Summary Indication
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|||
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United
States
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510(k)
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2005
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Moistening
and lubricating absorbent wound dressings for traumatic
wounds.
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|||
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510(k)
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2005
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Moistening
and debriding acute and chronic dermal lesions.
|
||||
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510(k)
|
2006
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Moistening
absorbent wound dressings and cleaning minor cuts.
|
||||
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510(k)
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2009
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Management
of exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers and
for the management of mechanically or surgically debridement of
wounds.
|
||||
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510(k)
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2009
|
Debridement
of wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post
surgical wounds, first and second burns, grafted and donor
sites.
|
|
510(k)
|
2010
|
Management
of dermal irritation, sores, injuries and ulcers of dermal tissue
including itch and pain relief
|
||||
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European
Union
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CE
Mark
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2004
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Debriding,
irrigating and moistening acute and chronic wounds in comprehensive wound
treatment by reducing microbial load and creating moist
environment.
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|||
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Mexico
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Product
Registration
|
2004
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Antiseptic
treatment of wounds and infected areas.
|
|||
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Product
Registration
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2003
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Antiseptic
disinfection solution for high level disinfection of medical instruments,
and/or equipment and clean-rooms, areas of medical instruments, equipment
and clean room areas.
|
||||
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Canada
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Class II
Medical Device
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2004
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Moistening,
irrigating, cleansing and debriding acute and chronic dermal lesions,
diabetic ulcers and post-surgical wounds.
|
|||
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India(1)
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Drug
License
|
2006
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Cleaning
and debriding in wound management.
|
|||
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China
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Medical
Device
|
2008
|
Reduces
the propagation of microbes in wounds and creates a moist environment for
wound healing.
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(1)
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Drug
license held by Indian distributor as required by Indian
law.
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Physician
|
Country
|
Number of
Patients |
Publication
|
|||
|
David
E. Allie, M.D.(1)
|
U.S.
|
40
|
Allie
D. Super-Oxidized Dermacyn in Lower-Extremity Wounds.
Wounds,
2006, 18
(Suppl), 3-6.
|
|||
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Tom
Wolvos, M.D.(2)
|
U.S.
|
26
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Wolvos
TA. Advanced Wound Care with Stable, Super-Oxidized Water. A look at how
combination therapy can optimize wound healing.
Wounds
, 2006, 18
(Suppl), 11-13.
|
|||
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Cheryl
Bongiovanni, Ph.D.(3)
|
U.S.
|
8
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Bongiovanni
CM. Superoxidized Water Improves Wound Care Outcomes in Diabetic Patients.
Diabetic Microvascular
Complications Today
, 2006, May-Jun: 11-14.
|
|||
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3
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Bongiovanni
CM. Nonsurgical Management of Chronic Wounds in Patients with Diabetes.
Journal of Vascular
Ultrasound
, 2006, 30: 215-218,
|
|||||
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Luca
Dalla Paola, M.D.(4)
|
Italy
|
218
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Dalla
Paola L, Brocco E, Senesi, A, Merico M, De Vido D, Assaloni R, DaRos R.
Super-Oxidized Solution (SOS) Therapy for Infected Diabetic Foot Ulcers.
Wounds,
2006,
vol. 18: 262-270
Dalla
Paola, L. Treating diabetic foot ulcers with super-oxidized water.
Wounds
, 2006, 18
(Suppl), 14-16
|
|||
|
Alberto
Piagessi, M.D.(5)
|
Italy
|
33
|
Goretti
C, Mazzurco S, Ambrosini Nobili L, Macchiarini S, Tedeschi A, Palumbo F,
Scatena A, Rizzo L and Piaggesi A. Clinical Outcomes of Wide Postsurgical
Lesions in the Infected Diabetic Foot Managed With 2 Different Local
Treatment Tegimes Compared Using a Quasi-Experimental Study Design: A
Preliminary Communication.
Int. J. Lower
Extremity Wounds,
2007
6: 22-27.
|
|||
|
Ariel
Miranda, M.D.(5)
|
Mexico
|
64
|
Miranda-Altamirano
A. Reducing Bacterial Infectious Complications from Burn Wounds. A look at
the use of Oculus Microcyn60 to treat wounds in Mexico.
Wounds,
2006, 18
(Suppl), 17-19.
|
|||
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Lenka
Veverkova, M.D.(3)
|
Czech
Republic
|
27
|
Veverkova
L, Jedlicka V, Vesely M, Tejkalova R, Zabranska S, Capov I,
Votava M. Methicilin-resistent Staphylococcus aureus — problem in
health care.
J Wound
Healing
2005, 2:201-202.
|
|||
|
Elia
Ricci M.D.(6)
|
Italy
|
40
|
Ricci
E, Astolfi S, Cassino R. Clinical results about an antimicrobial solution
(Dermacyn Wound Care) in the treatment of infected chronic wounds.
17th Conference. EWMA Meeting 2005. Glasgow, UK. May 2-4, 2007. In
preparation for publication.
|
|||
|
Alfredo
Barrera MD(5)
|
Mexico
|
40
|
Barrera-Zavala
A, Guillen-Rojas M, Escobedo-Anzures J, Rendon J, Ayala O &
Gutiérrez AA. A pilot study on source control of peritonitis with a
neutral pH — super oxidized solution16th World Congress of the
International, Association of Surgeons and Gastroenterologists (IASG).
Madrid, Spain. 25th-27th May, 2006.
|
|||
|
D
Peterson MD
|
U.S.
|
5
|
Peterson
D, Hermann K, Niezgoda J, Dermacyn Effective in Treatment of Chronic
Wounds with Extensive Bioburden While Reducing Local Pain Levels.
Symposium on Advanced Wound Care and Wound Healing Society, Tampa, FL,
April 28-May 1, 2007.
|
|
Steenvoorde,
P.M.D, Van
Doorn,
L.P., M.A.,
Jacobi,
C.E, PhD &
Oskam,
J., M.D., PhD.(3)
|
Netherlands
|
10
|
An
unexpected effect of Dermacyn on infected leg ulcers,
J Wound Care
2007, 16:
60-61.
|
|||
|
Fermin
Martinez M.D.
|
Mexico
|
45
|
Martínez-De
Jesús FR, Ramos-De la Medina A, Remes-Troche JM, Armstrong DG, Wu SC,
Lázaro Martínez JL, Beneit-Montesinos JV. Efficacy and safety of neutral
pH superoxidised solution in severe diabetic foot infections.
Int Wound J
. 2007,
4:353-362.
|
|||
|
Hadi
SF MD(3)
|
Pakistan
|
100
|
Hadi
SF, Khaliq T, Bilal N, Sikandar I, Saaiq M, Zubair M, Aurangzeb S.
Treating infected diabetic wounds with superoxidized water as anti-septic
agent: a preliminary experience.
J Coll Physicians Surg
Pak.
2007, 17:740-743.
|
|||
|
BT
Monaghan DPM(3)
|
Ireland
|
10
|
Monaghan
BT & Cundell JH. Dermacyn as the Local Treatment for Infected
Diabetic Foot Wounds. A case series. 5th Int. Symp. On the Diabetic
Foot. Noordwijkerhout. 2007, The Netherlands. May 9-12,
2007.
|
|||
|
Fernando
Uribe MD(6)
|
Mexico
|
80
|
Uribe
F. Effect of neutral pH Superoxidized solution in the healing of diabetic
foot ulcers. 47(th) ICAAC Meeting. Poster L-1144. Chicago, IL. USA. Sept
17-20, 2007.
|
|||
|
Ning
Fanggang MD(3)
|
China
|
20
|
Fanggang
N, Guoan Z. The clinical efficacy of Dermacyn on deep partial thickness
burn wounds.
|
|||
|
Amar
Pal Suri DPM(6)
|
India
|
100
|
Suri
AP. The Effectiveness of Stable Neutral Super-oxidized Solution for the
Treatment of Infected Diabetic Foot Wounds. Diabetic Foot Global
Conference. Hollywood, CA. 13-15 March. 2008.
Submitted
for publication Jan, 2008.
|
|||
|
Alberto
Piaggesi M.D.(5)
|
Italy
|
40
|
Piaggesi
A et al. A Randomized Controlled Trial to Examine the Efficacy
and Safety of Microcyn® Technology on wide post-surgical lesions in the
infected diabetic foot. The International Journal of Lower Extremity
Wounds, March 9, 2010 .
|
|||
|
Robert
G. Frykberg, DPM, MPH(6)
|
U.S.
|
23
|
RG.
Frykberg, RG, Tallis A, Tierney, E.: Wound Healing in Chronic Lower
Extremity Wounds Comparing Super-Oxidized Solution (SOS) vs. Saline.
Diabetic Foot Global Conference. Hollywood, Ca. 13-15 March.
2008.
|
|
Matthew
Regulski DPM(5)
|
U.S.
|
18
|
Regulski
M, Floros R, Petranto R, Migliori V, Alster H, Pfeiffer D. Efficacy
and Compatibility of Combination Therapy with Super-Oxidized Solution and
a Skin Substitute for Lower Extremity Wounds. Symposium on Advanced Wound
Care and Wound Healing Society, San Diego, CA, April 24-28,
2008.
|
|||
|
Adam
Landsman DPM PhD,(5)
Andres
A Gutierrez MD PhD(1) &
Oculus
Collaborative Group
|
U.S.
|
48
|
Landsman
A, Blume P, Palladino M, Jordan D, Vayser DJ, Halperin G, Gutierrez AA and
Oculus Collaborative Group. An Open Label, Three Arm Study of the Safety
and Clinical Efficacy of Topical Wound Care vs. Oral Levofloxacin vs.
Combined Therapy for Mild Diabetic Foot Infections. Diabetic Foot Global
Conference. Hollywood, CA. 13-15 March. 2008.
|
|||
|
Christopher
Gauland, DPM(3)
|
U.S.
|
5
|
Gauland
C., Sickle Cell Disease, Symposium on Advanced Wound Care and Wound
Healing Society, San Diego, CA, April 24-28, 2008.
|
|||
|
Hadi,
SF
|
Pakistan
|
100
|
Hadi
SF, Khaliq T, Bilal N, Sikandar I, Saaiq M, Zubair M, Aurangzeb S.
Treating infected diabetic wounds with superoxidized water as anti-septic
agent
J Coll Physicians
Surg
Pak.
2007, 17:740-743.
|
|||
|
Chittoria
RV
|
India
|
20
|
Chittoria
RK, Yootla M, Sampatrao LM, Raman SV. The role of super oxidized solution
in the management of diabetic foot ulcer: our
experience.
|
|||
|
Nepal Med Coll J.
2007,
9:125-128.
|
||||||
|
Anand
A
|
India
|
50
|
Anand,
AR Comparative Efficacy and Tolerability of Oxum against Povidone Iodine
Topical Application in the Post-caesarean Section Wound Management
Indian Medical Gazette
December 2007, 498-505.
|
|||
|
Dharap
SB
|
India
|
30
|
Dharap
SB, Ghag GS, Kulkarni KP, Venkatesh V. Efficacy and safety of Oxum in the
treatment of the venous ulcer.
J Indian Med Assoc
2008, 106:326-330.
|
|||
|
Dhusia
H
|
India
|
41
|
Dhusia
H, Comparative Efficacy and Tolerability of Microcyn Superoxidized
Solution (Oxum) against Povidone Iodine Application in Orodental
Infections.
Indian
Medical Gazette
February 2008, 68-75.
|
|||
|
Khairulasri
MG
|
Malaysia
|
178
|
Khairulasri
MG, Ramzisham ARM, Ooi JSM, Zamrin DM. Dermacyn irrigation in reducing
sternotomy wound infection following coronary artery bypass graft surgery
11th Scientific Conference. Kota Bharu, Malaysia
2008.
|
|||
|
Christopher
J. Gauland DPM (3)
|
U.S.
|
16
|
Comparison
of Microcyn and Amerigel in the Podiatric Clinical
Setting
|
|
(1)
|
indicates
that the physician is a stockholder and was a member of our Medical and
Business Advisory Board that we dissolved in April 2007, and was a paid
consultant and received research grants, expense payments, honorarium and
Microcyn to complete the study.
|
|
(2)
|
indicates
that the physician was a paid consultant, received expenses in connection
with corporate development and licensing evaluations and is a warrant
holder.
|
|
(3)
|
indicates
that the physician received Microcyn to complete the
study.
|
|
(4)
|
indicates
that the physician is a paid consultant, was a member of our Medical and
Business Advisory Board, which we dissolved in April 2007, and received
expense payments and Microcyn to complete the
study.
|
|
(5)
|
indicates
that the physician received payments, expense payments and Microcyn to
complete the study.
|
|
(6)
|
indicates
that the physician received reimbursement of travel expenses and received
Microcyn to complete the study.
|
|
Researchers
|
Country
|
Publication
|
||
|
Landa-Solis,
González-Espinosa D.,
Guzman
B, Snyder M, Reyes-Terán G.,
Torres
K, and Gutiérrez AA(1)
|
Mexico
|
Microcyn™
a novel super-oxidized water with neutral pH and disinfectant activity.
J Hosp
Infect
(UK) 2005, 61:
291-299.
|
||
|
Gutiérrez,
AA(1)
|
U.S.
|
The
science behind stable, super-oxidized water. Exploring the various
applications of super-oxidized solutions.
Wounds,
2006, 18
(Suppl), 7-10.
|
||
|
Dalla
Paola L,Faglia E(2)
|
Italy
|
Treatment
of diabetic foot ulcer: an overview. Strategies for clinical approach.
Current Diabetes
Reviews,
2006, 2, 431-447 431.
|
||
|
González-Espinosa
D, Pérez-Romano L,
Guzman
Soriano B, Arias E,
Bongiovanni,
CM, Gutiérrez AA(1),(3)
|
Mexico,
U.S.
|
Effects
of neutral super-oxidized water on human dermal fibroblasts in vitro.
International Wound
Journal
, 2007, 4: 241-250.
|
||
|
Medina-Tamayo
J, Balleza-Tapia H,
López,
X, Cid, ME,
González-Espinosa,
D, Gutiérrez AA,
González-Espinosa
C(1)
|
Mexico,
U.S.
|
Super-oxidized
water inhibits IgE-antigen- induced degranulation and cytokine release in
mast cells.
International
Immunopharmacology
2007. 2007, 7:1013-1024.
|
||
|
Le
Duc Q
|
UK
|
Le
Duc Q, Breetveld M, Middelkoop E, Scheper RJ, Ulrich MMW, Gibbs S. A
cytotoxic analysis of antiseptic medication on skin substitutes and
autograft.
Br J
Dermatology
. 2007, 157:33-40.
|
||
|
McCurdy
B
|
U.S.
|
McCurdy
B. Emerging Innovations in Treatment
. Podiatry Today
2006,
19: 40-48.
|
||
|
Zahumensky
E
|
Czech
Republic
|
Infections
and diabetic foot syndrome in field practice.
Vnitr Lek.
2006;52:411-416.
|
||
|
Rose
R., Setlow B., Monroe A., Mallozzi
M.,
Driks A., Setlow P.(5)
|
U.S.
|
Comparison
of the properties of Bacillus subtilis spores made in liquid or on agar
plates. Submitted 2008.
|
||
|
Paul
M., Setlow B. and Setlow P.(5)
|
U.S.
|
The
killing of spores of
Bacillus
subtilis
by
Microcyn(TM), a stable superoxided water. Submitted
2008.
|
||
|
Thatcher
E(4),AA
Gutierrez(1)
|
U.S.
|
The
Anti-Bacterial Efficacy of a New Super-Oxidized Solution. 47(th) ICAAC
Meeting. Chicago, IL. USA. Sept 17-20, 2007.
|
||
|
Michael
Taketa-Graham(5), Gutierrez
AA(1),
Thatcher E(4)
|
U.S.
|
The
Anti-Viral Efficacy of a New Super-Oxidized Solution.. 47th ICAAC
Meeting. Poster L-1144. Chicago, IL. USA. Sept 17-20,
2007.
|
||
|
Dardine
J, Martinez C, Thatcher E(4)
|
U.S.
|
Activity
of a pH Neutral Super-Oxidized Solution Against Bacteria Selected for
Sodium Hypochlorite Resistance. 47th ICAAC Meeting. Poster L-1144.
Chicago, IL. USA. Sept 17-20, 2007.
|
||
|
Sauer
K, Vazquez G, Thatcher E,
Northey
R & Gutierrez AA(1),(4),(5)
|
U.S.
|
Neutral
super-oxidized solution is effective in killing
P. aeruginosa
biofilms. Biofouling, Vol 25, No. 1, January 2009,
45-54.
|
|
(1)
|
Dr. Gutierrez
was our Director of Medical Affairs and conducted the study during his
employment by our Company.
|
|
(2)
|
Dr. Dalla
Paola was a member of our Medical and Business Advisory Board, which we
dissolved in April 2007, and received expense payments and Microcyn to
complete the study.
|
|
(3)
|
Indicates
that investigator received Microcyn to complete the
study.
|
|
(4)
|
Dr. Thatcher
is a full-time consultant to us, is a stockholder, previously served on
our board of directors, and received Microcyn to complete the
study.
|
|
(5)
|
Dr. Northey
is our Director of Research and Development and conducted the study during
his employment by our Company.
|
|
|
•
|
significantly
greater name recognition;
|
|
|
•
|
established
relationships with healthcare professionals, patients and third-party
payors;
|
|
|
•
|
established
distribution networks;
|
|
|
•
|
additional
product lines and the ability to offer rebates or bundle products to offer
discounts or incentives;
|
|
|
•
|
greater
experience in conducting research and development, manufacturing,
obtaining regulatory approval for products and
marketing; and
|
|
|
•
|
greater
financial and human resources for product development, sales and marketing
and patient support.
|
|
|
•
|
fines,
injunctions and civil penalties;
|
|
|
•
|
recall
or seizure of products;
|
|
|
•
|
operating
restrictions, partial suspension or total shutdown of
production;
|
|
|
•
|
refusing
requests for 510(k) clearance or pre-market approval approval of new
products;
|
|
|
•
|
withdrawing
510(k) clearance or pre-market approval approvals already
granted; and
|
|
|
•
|
criminal
prosecution.
|
|
|
•
|
Pre-Clinical
Phase.
The pre-clinical phase involves the discovery,
characterization, product formulation and animal testing necessary to
prepare an investigational new drug application for submission to the FDA.
The investigational new drug application must be accepted by the FDA
before the drug can be tested in
humans.
|
|
|
•
|
Clinical
Phase.
The clinical phase of development follows a
successful investigational new drug submission and involves the activities
necessary to demonstrate the safety, tolerability, efficacy, and dosage of
the substance in humans, as well as the ability to produce the substance
in accordance with U.S. Current Good Manufacturing Practice
requirements. Data from these activities are compiled in a new drug
application,, or for biologic products a biologics license application,
for submission to the FDA requesting approval to market the
drug.
|
|
|
•
|
Post-Approval
Phase.
The post-approval phase follows FDA approval of
the new drug application or biologics license application, and involves
the production and continued analytical and clinical monitoring of the
product. The post-approval phase may also involve the development and
regulatory approval of product modifications and line extensions,
including improved dosage form, of the approved product, as well as for
generic versions of the approved drug, as the product approaches
expiration of patent or other exclusivity
protection.
|
|
|
•
|
Phase
I.
Phase I human clinical trials are conducted on a
limited number of healthy individuals to determine the drug’s safety and
tolerability and include biological analyses to determine the availability
and metabolization of the active ingredient following administration. The
total number of subjects and patients included in Phase I clinical trials
varies, but is generally in the range of 20 to
80 people.
|
|
|
•
|
Phase
II.
Phase II clinical trials involve administering
the drug to individuals who suffer from the target disease or condition to
determine the drug’s potential efficacy and ideal dose. These clinical
trials are typically well controlled, closely monitored, and conducted in
a relatively small number of patients, usually involving no more than
several hundred subjects. These trials require scale up for manufacture of
increasingly larger batches of bulk chemical. These batches require
validation analysis to confirm the consistent composition of the
product.
|
|
|
•
|
Phase
III.
Phase III clinical trials are performed after
preliminary evidence suggesting effectiveness of a drug has been obtained
and safety (toxicity), tolerability, and an ideal dosing regimen have been
established. Phase III clinical trials are intended to gather
additional information about the effectiveness and safety that is needed
to evaluate the overall benefit-risk relationship of the drug and to
complete the information needed to provide adequate instructions for the
use of the drug. Phase III trials usually include from several
hundred to several thousand
subjects.
|
|
|
•
|
Class I.
Devices
for which safety and effectiveness have been duly proved and are generally
not used inside the body;
|
|
|
•
|
Class II.
Devices
that may vary with respect to the material used for its fabrication or in
its concentration and generally used in the inside of the body for a
period no greater than
30 days; and
|
|
|
•
|
Class III.
New
devices or recently approved devices in the medical practice or those used
inside the body and which shall remain inside the body for a period
greater than 30 days.
|
|
|
•
|
fund
our clinical trials and preclinical
studies;
|
|
|
•
|
sustain
commercialization of our current products or new
products;
|
|
|
•
|
expand
our manufacturing capabilities;
|
|
|
•
|
increase
our sales and marketing efforts to drive market adoption and address
competitive developments;
|
|
|
•
|
acquire
or license technologies; and
|
|
|
•
|
finance
capital expenditures and our general and administrative
expenses.
|
|
|
•
|
the
progress and timing of our clinical
trials;
|
|
|
•
|
the
level of research and development investment required to maintain and
improve our technology position;
|
|
|
•
|
cost
of filing, prosecuting, defending and enforcing patent claims and other
intellectual property rights;
|
|
|
•
|
our
efforts to acquire or license complementary technologies or acquire
complementary businesses;
|
|
|
•
|
changes
in product development plans needed to address any difficulties in
commercialization;
|
|
|
•
|
competing
technological and market
developments; and
|
|
|
•
|
changes
in regulatory policies or laws that affect our
operations.
|
|
|
•
|
insufficient
funds to continue our clinical
trials;
|
|
|
•
|
the
FDA requirements for approval, including requirements for testing efficacy
or safety, may change;
|
|
|
•
|
the
FDA or other regulatory authorities do not approve a clinical trial
protocol;
|
|
|
•
|
patients
do not enroll in clinical trials at the rate we
expect;
|
|
|
•
|
delays
in reaching agreement on acceptable clinical trial agreement terms with
prospective sites;
|
|
|
•
|
delays
in obtaining institutional review board approval to conduct a study at a
prospective site;
|
|
|
•
|
third
party clinical investigators do not perform our clinical trials on our
anticipated schedule or consistent with the clinical trial protocol and
good clinical practices, or the third party organizations do not perform
data collection and analysis in a timely or accurate
manner; and
|
|
|
•
|
governmental
regulations or administrative actions are
changed.
|
|
|
•
|
the
price of our products relative to other treatments for the same or similar
treatments;
|
|
|
•
|
the
perception by patients, physicians and other members of the health care
community of the effectiveness and safety of our products for their
indicated applications and
treatments;
|
|
|
•
|
our
ability to fund our sales and marketing
efforts; and
|
|
|
•
|
the
effectiveness of our sales and marketing
efforts.
|
|
|
•
|
we
were the first to invent the inventions described in patent
applications;
|
|
|
•
|
we
were the first to file patent applications for
inventions;
|
|
|
•
|
others
will not independently develop similar or alternative technologies or
duplicate our products without infringing our intellectual property
rights;
|
|
|
•
|
any
patents licensed or issued to us will provide us with any competitive
advantages;
|
|
|
•
|
we
will develop proprietary technologies that are
patentable; or
|
|
|
•
|
the
patents of others will not have an adverse effect on our ability to do
business.
|
|
|
•
|
local
political or economic instability;
|
|
|
•
|
changes
in governmental regulation;
|
|
|
•
|
changes
in import/export duties;
|
|
|
•
|
trade
restrictions;
|
|
|
•
|
lack
of experience in foreign markets;
|
|
|
•
|
difficulties
and costs of staffing and managing operations in certain foreign
countries;
|
|
|
•
|
work
stoppages or other changes in labor
conditions;
|
|
|
•
|
difficulties
in collecting accounts receivables on a timely basis or at
all; and
|
|
|
•
|
adverse
tax consequences or overlapping tax
structures.
|
|
|
•
|
develop
and patent processes or products earlier than we
will;
|
|
|
•
|
develop
and commercialize products that are less expensive or more efficient than
any products that we may develop;
|
|
|
•
|
obtain
regulatory approvals for competing products more rapidly than we
will; and
|
|
|
•
|
improve
upon existing technological approaches or develop new or different
approaches that render our technology or products obsolete or
non-competitive.
|
|
|
•
|
demand
by physicians, other medical staff and patients for our Microcyn-based
products;
|
|
|
•
|
reimbursement
decisions by third-party payors and announcements of those
decisions;
|
|
|
•
|
clinical
trial results and publication of results in peer-reviewed journals or the
presentation at medical
conferences;
|
|
|
•
|
the
inclusion or exclusion of our Microcyn-based products in large clinical
trials conducted by others;
|
|
|
•
|
actual
and anticipated fluctuations in our quarterly financial and operating
results;
|
|
|
•
|
developments
or disputes concerning our intellectual property or other proprietary
rights;
|
|
|
•
|
issues
in manufacturing our product candidates or
products;
|
|
|
•
|
new
or less expensive products and services or new technology introduced or
offered by our competitors or us;
|
|
|
•
|
the
development and commercialization of product
enhancements;
|
|
|
•
|
changes
in the regulatory environment;
|
|
|
•
|
delays
in establishing new strategic
relationships;
|
|
|
•
|
costs
associated with collaborations and new product
candidates;
|
|
|
•
|
introduction
of technological innovations or new commercial products by us or our
competitors;
|
|
|
•
|
litigation
or public concern about the safety of our product candidates or
products;
|
|
|
•
|
changes
in recommendations of securities analysts or lack of analyst
coverage;
|
|
|
•
|
failure
to meet analyst expectations regarding our operating
results;
|
|
|
•
|
additions
or departures of key
personnel; and
|
|
|
•
|
general
market conditions.
|
|
|
•
|
the
ability of our board of directors to issue and designate the rights of,
without stockholder approval, up to 5,000,000 shares of convertible
preferred stock, which rights could be senior to those of common
stock;
|
|
|
•
|
limitations
on persons authorized to call a special meeting of
stockholders; and
|
|
|
•
|
advance
notice procedures required for stockholders to make nominations of
candidates for election as directors or to bring matters before meetings
of stockholders.
|
|
Year Ended March 31, 2010
|
||||||||||||||||
|
First
Quarter
|
Second
Quarter
|
Third
Quarter
|
Fourth
Quarter
|
|||||||||||||
|
Stock
price-high
|
$ | 4.91 | $ | 3.45 | $ | 2.33 | $ | 2.69 | ||||||||
|
Stock
price-low
|
$ | 1.01 | $ | 3.02 | $ | 1.39 | $ | 1.75 | ||||||||
|
Year Ended March 31, 2009
|
||||||||||||||||
|
First
Quarter
|
Second
Quarter
|
Third
Quarter
|
Fourth
Quarter
|
|||||||||||||
|
Stock
price-high
|
$ | 5.18 | $ | 3.24 | $ | 1.74 | $ | 1.74 | ||||||||
|
Stock
price-low
|
$ | 2.41 | $ | 1.70 | $ | 0.40 | $ | 0.90 | ||||||||
|
Year
Ended March 31,
|
||||||||||||||||
|
2010
|
2009
|
Increase
|
Increase
|
|||||||||||||
|
U.S.
|
$ | 1,196,000 | $ | 298,000 | $ | 898,000 | 301 | % | ||||||||
|
Europe/Rest
of World
|
1,222,000 | 844,000 | 378,000 | 45 | % | |||||||||||
|
Mexico
|
3,880,000 | 3,273,000 | 607,000 | 19 | % | |||||||||||
|
Total
|
$ | 6,298,000 | $ | 4,415,000 | $ | 1,883,000 | 43 | % | ||||||||
|
|
·
|
net proceeds $21,936,000 raised
in our initial public offering on January 30,
2007;
|
|
|
·
|
net proceeds of $9,124,000 raised
in a private placement of common shares on August 13,
2007;
|
|
|
·
|
net proceeds of $12,613,000
raised through a registered direct placement from March 31, 2008 to
April 1, 2008;
|
|
|
·
|
net proceeds of $1,514,000 raised
through a private placement on February 6,
2009;
|
|
|
·
|
net proceeds of $948,000 from a
private placement on February 24,
2009;
|
|
|
·
|
net proceeds of $2,000,000 from a
private placement on June 1,
2009;
|
|
|
·
|
net proceeds of $5,411,000 from a
registered direct offering on July 30, 2009;
and
|
|
|
·
|
$4,223,000
received from the exercise of common stock purchase warrants and options
during the year ended March 31,
2010.
|
|
Payments Due by Period
|
||||||||||||||||
|
Total
|
Less Than
1 Year
|
1-3
Years
|
After
3 Years
|
|||||||||||||
|
Long-term
debt
|
$ | 314 | $ | 204 | $ | 95 | $ | 15 | ||||||||
|
Operating
leases
|
397 | 289 | 108 | — | ||||||||||||
|
Total
|
$ | 711 | $ | 493 | $ | 203 | $ | 15 | ||||||||
|
PaymentsDue by Period
|
||||||||||||
|
Total
|
Less Than
1 Year
|
1-3
Years
|
||||||||||
|
Long-term
debt
|
$ | 2,000 | $ | 358 | $ | 1,642 | ||||||
|
Operating
leases
|
211 | 22 | 189 | |||||||||
|
Total
|
$ | 2,211 | $ | 380 | $ | 1,831 | ||||||
|
|
•
|
the
scope, rate of progress and cost of our clinical trials and other research
and development activities;
|
|
|
•
|
future
clinical trial results;
|
|
|
•
|
the
terms and timing of any collaborative, licensing and other arrangements
that we may establish;
|
|
|
•
|
the
cost and timing of regulatory
approvals;
|
|
|
•
|
the
cost and delays in product development as a result of any changes in
regulatory oversight applicable to our
products;
|
|
|
•
|
the
cost and timing of establishing sales, marketing and distribution
capabilities;
|
|
|
•
|
the
effect of competing technological and market
developments;
|
|
|
•
|
the
cost of filing, prosecuting, defending and enforcing any patent claims and
other intellectual property
rights; and
|
|
|
•
|
the
extent to which we acquire or invest in businesses, products and
technologies.
|
|
Page
|
|
|
Report
of Independent Registered Public Accounting Firm
|
46
|
|
Consolidated
Balance Sheets as of March 31, 2010 and 2009
|
47
|
|
Consolidated
Statements of Operations and Comprehensive Loss for the years ended
March 31, 2010 and 2009
|
48
|
|
Consolidated
Statements of Stockholders’ Equity for the years ended March 31, 2010
and 2009
|
49
|
|
Consolidated
Statements of Cash Flows for the years ended March 31, 2010 and
2009
|
50
|
|
Notes
to Consolidated Financial Statements
|
51
|
|
March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
(In thousands, except share
and per share amounts)
|
||||||||
|
ASSETS
|
||||||||
|
Current
assets:
|
||||||||
|
Cash
and cash equivalents
|
$ | 6,258 | $ | 1,921 | ||||
|
Accounts
receivable, net
|
1,416 | 923 | ||||||
|
Inventory,
net
|
565 | 340 | ||||||
|
Prepaid
expenses and other current assets
|
811 | 758 | ||||||
|
Total
current assets
|
9,050 | 3,942 | ||||||
|
Property
and equipment, net
|
1,108 | 1,432 | ||||||
|
Other
assets
|
60 | 73 | ||||||
|
Total
assets
|
$ | 10,218 | $ | 5,447 | ||||
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$ | 981 | $ | 1,565 | ||||
|
Accrued
expenses and other current liabilities
|
1,078 | 853 | ||||||
|
Current
portion of long-term debt
|
204 | 255 | ||||||
|
Current
portion of capital lease obligations
|
— | 6 | ||||||
|
Derivative
liability
|
472 | — | ||||||
|
Total
current liabilities
|
2,735 | 2,679 | ||||||
|
Deferred
revenue
|
328 | 425 | ||||||
|
Long-term
debt, less current portion
|
110 | 74 | ||||||
|
Total
liabilities
|
3,173 | 3,178 | ||||||
|
Commitments
and Contingencies
|
||||||||
|
Stockholders’
Equity
|
||||||||
|
Convertible
preferred stock, $0.0001 par value; 5,000,000 shares authorized,
none issued and outstanding at March 31, 2010 and
2009
|
— | — | ||||||
|
Common
stock, $0.0001 par value; 100,000,000 shares authorized,
26,161,428 and 18,402,820 shares issued and outstanding at
March 31, 2010 and 2009, respectively
|
3 | 2 | ||||||
|
Additional
paid-in capital
|
127,067 | 113,803 | ||||||
|
Accumulated
other comprehensive loss
|
(2,988 | ) | (3,054 | ) | ||||
|
Accumulated
deficit
|
(117,037 | ) | (108,482 | ) | ||||
|
Total
stockholders’ equity
|
7,045 | 2,269 | ||||||
|
Total
liabilities and stockholders’ equity
|
$ | 10,218 | $ | 5,447 | ||||
|
Year Ended March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
(In thousands, except per share amounts)
|
||||||||
|
Revenues
|
||||||||
|
Product
|
$ | 6,298 | $ | 4,415 | ||||
|
Service
|
1,066 | 973 | ||||||
|
Total
revenues
|
7,364 | 5,388 | ||||||
|
Cost
of revenues
|
||||||||
|
Product
|
2,633 | 1,673 | ||||||
|
Service
|
853 | 913 | ||||||
|
Total
cost of revenues
|
3,486 | 2,586 | ||||||
|
Gross
profit
|
3,878 | 2,802 | ||||||
|
Operating
expenses
|
||||||||
|
Research
and development
|
1,996 | 6,252 | ||||||
|
Selling,
general and administrative
|
9,898 | 13,857 | ||||||
|
Total
operating expenses
|
11,894 | 20,109 | ||||||
|
Loss
from operations
|
(8,016 | ) | (17,307 | ) | ||||
|
Interest
expense
|
(9 | ) | (437 | ) | ||||
|
Interest
income
|
2 | 152 | ||||||
|
Loss
due to change in fair value of derivative instruments
|
(149 | ) | — | |||||
|
Other
income (expense), net
|
(60 | ) | (64 | ) | ||||
|
Net
loss
|
$ | (8,232 | ) | $ | (17,656 | ) | ||
|
Net
loss per common share: basic and diluted
|
$ | (0.36 | ) | $ | (1.09 | ) | ||
|
Weighted-average
number of shares used in per common share calculations:
|
||||||||
|
Basic
and diluted
|
22,993 | 16,221 | ||||||
|
Other
comprehensive loss, net of tax
|
||||||||
|
Net
loss
|
$ | (8,232 | ) | $ | (17,656 | ) | ||
|
Foreign
currency translation adjustments
|
66 | (279 | ) | |||||
|
Comprehensive
loss
|
$ | (8,166 | ) | $ | (17,935 | ) | ||
|
Accumulated
|
||||||||||||||||||||||||
|
Common Stock
|
Additional
|
Other
|
||||||||||||||||||||||
|
($0.0001 par Value)
|
Paid in
|
Comprehensive
|
Accumulated
|
|||||||||||||||||||||
|
Shares
|
Amount
|
Capital
|
(Loss)
|
Deficit
|
Total
|
|||||||||||||||||||
|
(In thousands, except share and per share amounts)
|
||||||||||||||||||||||||
|
Balance,
March 31, 2008
|
15,905,613 | $ | 2 | $ | 109,027 | $ | (2,775 | ) | $ | (90,826 | ) | $ | 15,428 | |||||||||||
|
Issuance
of common stock in connection with April 1, 2008 closing of offering,
net of commissions, expenses and other offering costs
|
18,095 | — | 36 | — | — | 36 | ||||||||||||||||||
|
Issuance
of common stock in connection with February 6, 2009 offering, net of
commissions, expenses and other offering costs
|
1,499,411 | — | 1,514 | — | — | 1,514 | ||||||||||||||||||
|
Issuance
of common stock in connection with February 24, 2009 offering, net of
commissions, expenses and other offering costs
|
854,701 | — | 948 | — | — | 948 | ||||||||||||||||||
|
Issuance
of common stock in connection with exercise of stock
options
|
105,000 | — | 15 | — | — | 15 | ||||||||||||||||||
|
Issuance
of common stock for services
|
20,000 | — | 21 | — | — | 21 | ||||||||||||||||||
|
Employee
stock-based compensation expense, net of forfeitures
|
— | — | 2,136 | — | — | 2,136 | ||||||||||||||||||
|
Fair
value of common stock purchase warrants issued to
non-employees
|
— | — | 106 | — | — | 106 | ||||||||||||||||||
|
Foreign
currency translation adjustment
|
— | — | — | (279 | ) | — | (279 | ) | ||||||||||||||||
|
Net
loss
|
— | — | — | — | (17,656 | ) | (17,656 | ) | ||||||||||||||||
|
Balance,
March 31, 2009
|
18,402,820 | $ | 2 | $ | 113,803 | $ | (3,054 | ) | $ | (108,482 | ) | $ | 2,269 | |||||||||||
|
Issuance
of common stock in connection with June 1, 2009 closing of offering,
net of commissions, expenses and other offering costs
|
1,709,402 | — | 2,000 | — | — | 2,000 | ||||||||||||||||||
|
Issuance
of common stock in connection with July 30, 2009 offering, net of
commissions, expenses and other offering costs
|
2,454,000 | 1 | 5,154 | — | — | 5,155 | ||||||||||||||||||
|
Issuance
of common stock in connection with exercise of stock purchase
warrants
|
2,193,959 | — | 3,975 | — | — | 3,975 | ||||||||||||||||||
|
Issuance
of common stock in connection with exercise of stock
options
|
663,592 | — | 248 | — | — | 248 | ||||||||||||||||||
|
Issuance
of common stock for accounts payable obligations
|
230,602 | — | 455 | — | — | 455 | ||||||||||||||||||
|
Issuance
of common stock for services
|
491,096 | — | 567 | — | — | 567 | ||||||||||||||||||
|
Issuance
of restricted stock units from the 2006 Stock Incentive
Plan
|
15,957 | — | 29 | — | — | 29 | ||||||||||||||||||
|
Employee
stock-based compensation expense, net of forfeitures
|
— | — | 836 | — | — | 836 | ||||||||||||||||||
|
Foreign
currency translation adjustment
|
— | — | — | 66 | — | 66 | ||||||||||||||||||
|
Cumulative
effect adjustment to retained earnings related to derivative
liabilities
|
— | — | — | — | (323 | ) | (323 | ) | ||||||||||||||||
|
Net
loss
|
— | — | — | — | (8,232 | ) | (8,232 | ) | ||||||||||||||||
|
Balance,
March 31, 2010
|
26,161,428 | $ | 3 | $ | 127,067 | $ | (2,988 | ) | $ | (117,037 | ) | $ | 7,045 | |||||||||||
|
Year Ended March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
(In thousands)
|
||||||||
|
Cash
flows from operating activities
|
||||||||
|
Net
loss
|
$ | (8,232 | ) | $ | (17,656 | ) | ||
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
|
Depreciation
and amortization
|
433 | 768 | ||||||
|
Provision
for doubtful accounts
|
61 | 29 | ||||||
|
Provision
for obsolete inventory
|
184 | 39 | ||||||
|
Stock-based
compensation
|
1,432 | 2,263 | ||||||
|
Change
in fair value of derivative liability
|
149 | — | ||||||
|
Non-cash
interest expense
|
— | 304 | ||||||
|
Foreign
currency transaction (gains) losses
|
(97 | ) | 64 | |||||
|
Loss
on disposal of assets
|
169 | 235 | ||||||
|
Changes
in operating assets and liabilities:
|
||||||||
|
Accounts
receivable
|
(453 | ) | (379 | ) | ||||
|
Inventories
|
(388 | ) | (177 | ) | ||||
|
Prepaid
expenses and other current assets
|
190 | 598 | ||||||
|
Accounts
payable
|
(163 | ) | (1,332 | ) | ||||
|
Accrued
expenses and other liabilities
|
76 | (1,588 | ) | |||||
|
Net
cash used in operating activities
|
(6,639 | ) | (16,832 | ) | ||||
|
Cash
flows from investing activities:
|
||||||||
|
Purchases
of property and equipment
|
(141 | ) | (393 | ) | ||||
|
Long-term
deposits
|
(43 | ) | (31 | ) | ||||
|
Net
cash used in investing activities
|
(184 | ) | (424 | ) | ||||
|
Cash
flows from financing activities:
|
||||||||
|
Proceeds
from issuance of common stock, net of offering costs
|
7,155 | 2,499 | ||||||
|
Proceeds
from issuance of common stock upon exercise of stock options and
warrants
|
4,223 | 15 | ||||||
|
Principal
payments on debt
|
(288 | ) | (2,119 | ) | ||||
|
Payments
on capital lease obligations
|
(6 | ) | (19 | ) | ||||
|
Net
cash provided by financing activities
|
11,084 | 376 | ||||||
|
Effect
of exchange rate on cash and cash equivalents
|
76 | (22 | ) | |||||
|
Net
increase (decrease) in cash and cash equivalents
|
4,337 | (16,902 | ) | |||||
|
Cash
and cash equivalents, beginning of year
|
1,921 | 18,823 | ||||||
|
Cash
and cash equivalents, end of year
|
$ | 6,258 | $ | 1,921 | ||||
|
Supplemental
disclosure of cash flow information:
|
||||||||
|
Cash
paid for interest
|
$ | 9 | $ | 154 | ||||
|
Obligations
settled with common stock
|
$ | 455 | $ |
—
|
||||
|
Non-cash
operating and financing activities:
|
||||||||
|
Insurance
premiums financed
|
$ | 184 | $ | 250 | ||||
|
Non-cash
investing and financing activities:
|
||||||||
|
Equipment
financed
|
$ | 157 | $ |
—
|
||||
|
Fair Value Measurements at March 31, 2010 Using
|
||||||||||||||||
|
March 31,
2010
|
Quoted
prices in
active
markets for
identical
assets
(Level 1)
|
Significant
other
observable
inputs
(Level 2)
|
Significant
other
unobservable
inputs
(Level 3)
|
|||||||||||||
|
Liabilities:
|
||||||||||||||||
|
Derivative
liability - warrants
|
$ | 472 | $ | — | $ | — | $ | 472 | ||||||||
|
Years
|
|||
|
Office
equipment
|
3
|
||
|
Manufacturing,
lab and other equipment
|
5
|
||
|
Furniture
and fixtures
|
7
|
|
|
•
|
a
significant decrease in the fair value of an
asset;
|
|
|
•
|
a
significant change in the extent or manner in which an asset is used or a
significant physical change in an
asset;
|
|
|
•
|
a
significant adverse change in legal factors or in the business climate
that affects the value of an asset;
|
|
|
•
|
an
adverse action or assessment by the U.S. Food and Drug Administration
or another regulator;
|
|
|
•
|
an
accumulation of costs significantly in excess of the amount originally
expected to acquire or construct an asset; and operating or cash flow
losses combined with a history of operating or cash flow losses or a
projection or forecast that demonstrates continuing losses associated with
an income-producing asset.
|
|
Year Ended March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
(In thousands)
|
||||||||
|
Anti-dilutive
securities excluded from the computation of basic and diluted net loss per
share are as follows:
|
||||||||
|
Options
to purchase common stock
|
3,987 | 3,964 | ||||||
|
Restricted
stock units
|
— | 30 | ||||||
|
Warrants
to purchase common stock
|
9,144 | 7,056 | ||||||
| 13,131 | 11,050 | |||||||
|
March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
Accounts
receivable
|
$ | 1,512 | $ | 974 | ||||
|
Less:
allowance for doubtful accounts
|
(96 | ) | (51 | ) | ||||
| $ | 1,416 | $ | 923 | |||||
|
Year Ended March 31
|
Balance at
Beginning
of Year
|
Additions
Charged to
Operations
|
Deductions
Write-Offs
|
Balance at
End of Year
|
||||||||||||
|
2009
|
$ | 31 | $ | 29 | $ | (9 | ) | $ | 51 | |||||||
|
2010
|
$ | 51 | $ | 61 | $ | (16 | ) | $ | 96 | |||||||
|
March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
Raw
materials
|
$ | 406 | $ | 277 | ||||
|
Finished
goods
|
302 | 134 | ||||||
| 708 | 411 | |||||||
|
Less:
inventory allowances
|
(143 | ) | (71 | ) | ||||
| $ | 565 | $ | 340 | |||||
|
Year Ended March 31
|
Balance at
Beginning
of Year
|
Additions
Charged to
Cost of
Product
Revenues
|
Deductions
Write-Offs
|
Balance at
End of Year
|
||||||||||||
|
2009
|
$ | 208 | $ | 39 | $ | (176 | ) | $ | 71 | |||||||
|
2010
|
$ | 71 | $ | 184 | $ | (112 | ) | $ | 143 | |||||||
|
March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
Prepaid
expenses
|
$ | 590 | $ | 657 | ||||
|
Value
Added Tax receivable
|
31 | 23 | ||||||
|
Other
current assets
|
190 | 78 | ||||||
| $ | 811 | $ | 758 | |||||
|
March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
Manufacturing,
lab, and other equipment
|
$ | 2,470 | $ | 3,067 | ||||
|
Office
equipment
|
388 | 421 | ||||||
|
Furniture
and fixtures
|
52 | 60 | ||||||
|
Leasehold
improvements
|
275 | 252 | ||||||
| 3,185 | 3,800 | |||||||
|
Less:
accumulated depreciation and amortization
|
(2,077 | ) | (2,368 | ) | ||||
| $ | 1,108 | $ | 1,432 | |||||
|
March 31
|
||||||||
|
2010
|
2009
|
|||||||
|
Salaries
and related costs
|
$ | 467 | $ | 394 | ||||
|
Professional
fees
|
143 | 90 | ||||||
|
Value
Added Tax payable
|
140 | 90 | ||||||
|
Deferred
revenue
|
318 | 272 | ||||||
|
Other
|
10 | 7 | ||||||
| $ | 1,078 | $ | 853 | |||||
|
For Years Ending March 3
1,
|
||||
|
2011
|
$ | 204 | ||
|
2012
|
31 | |||
|
2013
|
31 | |||
|
2014
|
33 | |||
|
2015
|
15 | |||
|
Total
principal payments
|
314 | |||
|
Less:
current portion
|
(204 | ) | ||
|
Long-term
portion
|
$ | 110 | ||
|
March 31,
|
April 1,
|
|||||||
|
2010
|
2009
|
|||||||
|
Expected
Term
|
2.37
yrs
|
3.37
yrs
|
||||||
|
Risk-free
interest rate
|
1.02 | % | 1.15 | % | ||||
|
Dividend
yield
|
0.00 | % | 0.00 | % | ||||
|
Volatility
|
84.0 | % | 84.0 | % | ||||
|
Warrants
outstanding
|
724,188 | 953,752 | ||||||
|
Fair
value of warrants
|
$ | 472,000 | $ | 323,000 | ||||
|
For Years Ending March 31,
|
||||
|
2011
|
$ | 289 | ||
|
2012
|
108 | |||
|
Total
minimum lease payments
|
$ | 397 | ||
|
Plan
|
Number of
Options
|
Total
Number of
Options and
Restricted
Stock Units
Outstanding
in Plan
|
||||||
|
1999
Plan
|
6 | 6 | ||||||
|
2000
Plan
|
40 | 40 | ||||||
|
2003
Plan
|
162 | 162 | ||||||
|
2004
Plan
|
543 | 543 | ||||||
|
2006
Plan
|
3,236 | 3,236 | ||||||
| 3,987 | 3,987 | |||||||
|
Number of
Shares
|
Weighted-Average
Exercise Price
|
Weighted-Average
Contractual Term
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding
at March 31, 2008
|
2,624 | $ | 5.67 | |||||||||||||
|
Options
granted
|
2,035 | 0.97 | ||||||||||||||
|
Options
exercised
|
(105 | ) | 0.14 | |||||||||||||
|
Options
forfeited or expired
|
(590 | ) | 6.45 | |||||||||||||
|
Outstanding
at March 31, 2009
|
3,964 | 3.28 | ||||||||||||||
|
Options
granted
|
1,140 | 1.89 | ||||||||||||||
|
Options
exercised
|
(664 | ) | 0.37 | |||||||||||||
|
Options
forfeited or expired
|
(453 | ) | 6.93 | |||||||||||||
|
Outstanding
at March 31, 2010
|
3,987 | $ | 2.96 | 7.72 | $ | 2,376 | ||||||||||
|
Exercisable
at March 31, 2010
|
1,677 | $ | 4.55 | 5.76 | $ | 695 | ||||||||||
|
Options
available for grant as of March 31, 2010
|
1,080 | |||||||||||||||
|
Employee
Stock-based
Compensation
for the Year Ended
March 31,
2010
|
Employee
Stock-based
Compensation
for the Year Ended
March 31,
2009
|
|||||||
|
Cost of revenues service
|
$ | 22 | $ | 18 | ||||
|
Research
and development
|
97 | 82 | ||||||
|
Selling,
general and administrative
|
746 | 1,935 | ||||||
|
Total
stock-based compensation
|
$ | 865 | $ | 2,035 | ||||
|
Year Ended March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
Fair
value of common stock
|
$ | 1.89 | $ | 3.42 | ||||
|
Expected
Term
|
5.90
yrs
|
5.97
yrs
|
||||||
|
Risk-free
interest rate
|
2.45 | % | 1.89 | % | ||||
|
Dividend
yield
|
0.00 | % | 0.00 | % | ||||
|
Volatility
|
84.2 | % | 83.0 | % | ||||
|
March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
Deferred
tax assets:
|
||||||||
|
Net
operating loss carryforwards
|
$ | 33,477 | $ | 31,205 | ||||
|
Research
and development tax credit carryforwards
|
1,335 | 1,262 | ||||||
|
Stock-based
compensation
|
2,713 | 2,419 | ||||||
|
Reserves
and accruals
|
2,267 | 1,553 | ||||||
|
Other
deferred tax assets
|
19 | 18 | ||||||
|
Total
deferred tax assets
|
$ | 39,811 | $ | 36,457 | ||||
|
Deferred
tax liabilities:
|
||||||||
|
Basis
difference in assets
|
(35 | ) | (26 | ) | ||||
|
Net
deferred tax asset
|
39,776 | 36,431 | ||||||
|
Valuation
allowance
|
(39,776 | ) | (36,431 | ) | ||||
|
Net
deferred tax asset
|
$ | — | $ | — | ||||
|
Years Ended March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
Income
tax benefit
|
$ | 3,345 | $ | 5,164 | ||||
|
Change
in valuation allowance
|
(3,345 | ) | (5,164 | ) | ||||
|
Net
income tax benefit
|
$ | — | $ | — | ||||
|
Years Ended March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
Expected
federal statutory rate
|
(34.0 | )% | (34.0 | )% | ||||
|
State
income taxes, net of federal benefit
|
(5.8 | )% | (5.8 | )% | ||||
|
Research
and development credit
|
(0.8 | )% | (1.9 | )% | ||||
|
Foreign
earnings taxed at different rates
|
0.9 | % | 0.8 | % | ||||
|
Recognition
of change in estimate of state and foreign NOL carryforward
benefits
|
(2.5 | )% | 9.6 | % | ||||
|
Effect
of permanent differences
|
1.5 | % | 2.2 | % | ||||
| (40.7 | )% | (29.1 | )% | |||||
|
Change
in valuation allowance
|
40.7 | % | 29.1 | % | ||||
|
Totals
|
0.0 | % | 0.0 | % | ||||
|
March 31,
|
||||||||
|
2010
|
2009
|
|||||||
|
U.S.
|
$ | 1,196 | $ | 298 | ||||
|
Mexico
|
3,880 | 3,273 | ||||||
|
Europe
and other
|
1,222 | 844 | ||||||
| $ | 6,298 | $ | 4,415 | |||||
|
·
|
150,000
options to Hoji Alimi. 75,000 of the options vest immediately
and 75,000 of the options vest monthly in equal amounts over the 48 months
following the grant date.
|
|
·
|
187,500
options to Robert Miller. 100,000 of the options vest
immediately and 87,500 of the options vest monthly in equal amounts over
the 48 months following the grant
date.
|
|
·
|
62,500
options to Jim Schutz. All of the options vest
immediately.
|
|
Exhibit
Number
|
Description
|
|
|
3.1(i)
|
Restated
Certificate of Incorporation of Registrant (incorporated by reference to
the exhibit of the same number filed with the Company’s Annual Report on
Form 10-K for the year ended March 31, 2007).
|
|
|
3.1(ii)
|
Amended
and Restated Bylaws of Registrant, as amended effective on June 11,
2008 (incorporated by reference to the exhibit of the same number filed
with the Company’s Annual Report on Form 10-K for the year ended
March 31, 2008).
|
|
|
4.1
|
Specimen
Common Stock Certificate (incorporated by reference to the exhibit of the
same number filed with Registration Statement on Form S-1 (File
No. 333-135584), as amended, declared effective on January 24,
2007).
|
|
|
4.2
|
Warrant
to Purchase Series A Preferred Stock of Registrant by and between
Registrant and Venture Lending & Leasing III, Inc., dated
April 21, 2004 (incorporated by reference to the exhibit of the same
number filed with Registration Statement on Form S-1 (File
No. 333-135584), as amended, declared effective on January 24,
2007).
|
|
|
4.3
|
Warrant
to Purchase Series B Preferred Stock of Registrant by and between
Registrant and Venture Lending & Leasing IV, Inc., dated
June 14, 2006 (incorporated by reference to the exhibit of the same
number filed with Registration Statement on Form S-1 (File
No. 333-135584), as amended, declared effective on January 24,
2007).
|
|
|
4.4
|
Form
of Warrant to Purchase Common Stock of Registrant (incorporated by
reference to the exhibit of the same number filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
4.5
|
Form
of Warrant to Purchase Common Stock of Registrant (incorporated by
reference to the exhibit of the same number filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
4.6
|
Amended
and Restated Investors Rights Agreement, effective as of
September 14, 2006 (incorporated by reference to the exhibit of the
same number filed with Registration Statement on Form S-1 (File
No. 333-135584), as amended, declared effective on January 24,
2007).
|
|
|
4.7
|
Form
of Promissory Note issued to Venture Lending & Leasing III, Inc.
(incorporated by reference to the exhibit of the same number filed with
Registration Statement on Form S-1 (File No. 333-135584), as
amended, declared effective on January 24, 2007).
|
|
|
4.8
|
Form
of Promissory Note (Equipment and Soft Cost Loans) issued to Venture
Lending & Leasing IV, Inc. (incorporated by reference to the
exhibit of the same number filed with Registration Statement on
Form S-1 (File No. 333-135584), as amended, declared effective
on January 24, 2007).
|
|
|
4.9
|
Form
of Promissory Note (Growth Capital Loans) issued to Venture
Lending & Leasing IV, Inc. (incorporated by reference to the
exhibit of the same number filed with Registration Statement on
Form S-1 (File No. 333-135584), as amended, declared effective
on January 24,
2007).
|
|
4.10
|
Form
of Promissory Note (Working Capital Loans) issued to Venture
Lending & Leasing IV, Inc. (incorporated by reference to the
exhibit of the same number filed with Registration Statement on
Form S-1 (File No. 333-135584), as amended, declared effective
on January 24, 2007).
|
|
|
4.11
|
Form
of Warrant to Purchase Common Stock of Registrant (incorporated by
reference to the exhibit of the same number filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
4.12
|
Form
of Warrant to Purchase Common Stock of Registrant (incorporated by
reference to the exhibit of the same number filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
4.13
|
Form
of Warrant to Purchase Common Stock of Registrant (incorporated by
reference to exhibit 10.3 to the Company’s Current Report on
Form 8-K filed August 13, 2007).
|
|
|
4.14
|
Form
of Warrant to Purchase Common Stock of Registrant (incorporated by
reference to exhibit 4.1 to the Company’s Current Report on
Form 8-K filed March 28, 2008).
|
|
|
4.15
|
Form
of Common Stock Purchase Warrant for April 2009 offering (incorporated by
reference to exhibit 4.15 to the Company’s Registration Statement on
Form S-1 (File No. 333-158539) declared effective on July 24,
2009, and incorporated herein by reference).
|
|
|
4.16*
|
Warrant
issued to Dayl Crow, dated March 4, 2009 (included as Exhibit 4.16 to
the Form 10-K filed on June 11, 2009 and incorporated herein by
reference).
|
|
|
4.17*
|
Form
of Common Stock Purchase Warrant for July 2009 offering, (included as
Exhibit 4.15 to the Registration Statement on Form S-1 (File No.
333-158539), as amended, declared effective on July 24,
2009)
|
|
|
10.1
|
Form
of Indemnification Agreement between Registrant and its officers and
directors (incorporated by reference to the exhibit of the same number
filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.2
|
1999
Stock Plan and related form stock option plan agreements (incorporated by
reference to the exhibit of the same number filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
10.3
|
2000
Stock Plan and related form stock option plan agreements (incorporated by
reference to the exhibit of the same number filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
10.4
|
2003
Stock Plan and related form stock option plan agreements (incorporated by
reference to the exhibit of the same number filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
10.5
|
2004
Stock Plan and related form stock option plan agreements (incorporated by
reference to the exhibit of the same number filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
10.6
|
Form
of 2006 Stock Incentive Plan and related form stock option plan agreements
(incorporated by reference to the exhibit of the same number filed with
Registration Statement on Form S-1 (File No. 333-135584),
as amended, declared effective on January 24,
2007).
|
|
|
10.7
|
2006
Stock Incentive Plan Notice of Stock Unit Award and Stock and Stock Unit
Agreement issued to Robert Miller (incorporated by reference to the
exhibit of the same number filed with the Company’s Annual Report on
Form 10-K for the year ended March 31, 2007).
|
|
|
10.8
|
Office
Lease Agreement, dated October 26, 1999, between Registrant and RNM
Lakeville, L.P. (incorporated by reference to exhibit 10.7 filed with
Registration Statement on Form S-1 (File No. 333-135584),
as amended, declared effective on January 24,
2007).
|
|
|
10.9
|
Amendment
to Office Lease No. 1, dated September 15, 2000, between
Registrant and RNM Lakeville L.P. (incorporated by reference to
exhibit 10.8 filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.10
|
Amendment
to Office Lease No. 2, dated July 29, 2005, between Registrant
and RNM Lakeville L.P. (incorporated by reference to exhibit 10.9
filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
10.11
|
Amendment
No. 3 to Lease, dated August 23, 2006, between Registrant and
RNM Lakeville L.P. (incorporated by reference to exhibit 10.23 filed
with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.12
|
Office
Lease Agreement, dated May 15, 2005, between Oculus Technologies of
Mexico, S.A. de C.V. and Antonio Sergio Arturo Fernandez Valenzuela
(translated from Spanish) (incorporated by reference to exhibit 10.10
filed with Registration Statement on Form S-1 (File
No. 333-135584), as amended, declared effective on January 24,
2007).
|
|
|
10.13
|
Office
Lease Agreement, dated July 2003, between Oculus Innovative Sciences, B.V.
and Artikona Holding B.V. (translated from Dutch) (incorporated by
reference to exhibit 10.11 filed with Registration Statement on
Form S-1 (File No. 333-135584), as amended, declared effective
on January 24, 2007).
|
|
|
10.14
|
Loan
and Security Agreement, dated March 25, 2004, between Registrant and
Venture Lending & Leasing III, Inc. (incorporated by reference to
exhibit 10.12 filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.15
|
Loan
and Security Agreement, dated June 14, 2006, between Registrant and
Venture Lending & Leasing IV, Inc. (incorporated by reference to
exhibit 10.13 filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.16
|
Amendment
No. 1 to Supplement to Loan and Security Agreement, dated
March 29, 2007, between Registrant and Venture Lending &
Leasing IV, Inc. (incorporated by reference to the exhibit of the same
number filed with the Company’s Annual Report on Form 10-K for the
year ended March 31, 2007).
|
|
|
10.17
|
Employment
Agreement, dated January 1, 2004, between Registrant and Hojabr Alimi
(incorporated by reference to exhibit 10.14 filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
10.18
|
Employment
Agreement, dated January 1, 2004, between Registrant and Jim Schutz
(incorporated by reference to exhibit 10.15 filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
10.19
|
Employment
Agreement, dated June 1, 2004, between Registrant and Robert Miller
(incorporated by reference to exhibit 10.16 filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
10.20
|
Employment
Agreement, dated June 1, 2005, between Registrant and Bruce Thornton
(incorporated by reference to exhibit 10.17 filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
10.21
|
Employment
Agreement, dated June 10, 2006, between Registrant and Mike Wokasch
(incorporated by reference to exhibit 10.19 filed with Registration
Statement on Form S-1 (File No. 333-135584), as amended,
declared effective on January 24, 2007).
|
|
|
10.22
|
Form
of Director Agreement (incorporated by reference to exhibit 10.20
filed with Registration Statement on Form S-1 (File
No. 333-135584), as amended, declared effective on January 24,
2007).
|
|
|
10.23
|
Consultant
Agreement, dated October 1, 2005, by and between Registrant and White
Moon Medical (incorporated by reference to exhibit 10.21 filed with
Registration Statement on Form S-1 (File No. 333-135584),
as amended, declared effective on January 24,
2007).
|
|
|
10.24
|
Leasing
Agreement, dated May 5, 2006, by and between Mr. Jose Alfonzo I.
Orozco Perez and Oculus Technologies of Mexico, S.A. de C.V. (incorporated
by reference to exhibit 10.22 filed with Registration Statement on
Form S-1 (File No. 333-135584), as amended, declared effective
on January 24, 2007).
|
|
|
10.25
|
Stock
Purchase Agreement, dated June 16, 2005, by and between Registrant,
Quimica Pasteur, S de R.L., Francisco Javier Orozco Gutierrez and Jorge
Paulino Hermosillo Martin (incorporated by reference to exhibit 10.24
filed with Registration Statement on Form S-1 (File
No. 333-135584), as amended, declared effective on January 24,
2007).
|
|
|
10.26
|
Framework
Agreement, dated June 16, 2005, by and among Javier Orozco Gutierrez,
Quimica Pasteur, S de R.L., Jorge Paulino Hermosillo Martin, Registrant
and Oculus Technologies de Mexico, S.A. de C.V. (incorporated by reference
to exhibit 10.25 filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
10.27
|
Mercantile
Consignment Agreement, dated June 16, 2005, between Oculus
Technologies de Mexico, S.A. de C.V., Quimica Pasteur, S de R.L. and
Francisco Javier Orozco Gutierrez (incorporated by reference to
exhibit 10.26 filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.28
|
Partnership
Interest Purchase Option Agreement, dated June 16, 2005, by and
between Registrant and Javier Orozco Gutierrez (incorporated by reference
to exhibit 10.27 filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.29
|
Termination
of Registrant and Oculus Technologies de Mexico, S.A. de C.V. Agreements
with Quimica Pasteur, S de R.L. by Jorge Paulino Hermosillo Martin
(translated from Spanish) (incorporated by reference to exhibit 10.28
filed with Registration Statement on Form S-1 (File
No. 333-135584), as amended, declared effective on January 24,
2007).
|
|
|
10.30
|
Termination
of Registrant and Oculus Technologies de Mexico, S.A. de C.V. Agreements
with Quimica Pasteur, S de R.L. by Francisco Javier Orozco Gutierrez
(translated from Spanish) (incorporated by reference to exhibit 10.29
filed with Registration Statement on Form S-1 (File
No. 333-135584), as amended, declared effective on January 24,
2007).
|
|
|
10.31
|
Loan
and Security Agreement, dated November 7, 2006, by and between
Registrant and Robert Burlingame (incorporated by reference to
exhibit 10.30 filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.32
|
Non-Negotiable
Secured Promissory Note, dated November 10, 2006, by and between
Registrant and Robert Burlingame (incorporated by reference to
exhibit 10.31 filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.33
|
Amendment
No. 1 to Non-Negotiable Secured Promissory Note, dated March 29,
2007, by and between Registrant and Robert Burlingame (incorporated by
reference to the exhibit of the same number filed with the Company’s
Annual Report on Form 10-K for the year ended March 31,
2007).
|
|
|
10.34
|
Subordination
Agreement, dated November 7, 2006, by and among Registrant, Robert
Burlingame, Venture Lending & Leasing III, LLC, and Venture
Lending & Leasing IV, LLC (incorporated by reference to
exhibit 10.32 filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.35
|
Amendment
No. 1 to Subordination Agreement, dated March 29, 2007, by and
among Registrant, Robert Burlingame, Venture Lending & Leasing
III, LLC, and Venture Lending & Leasing IV, LLC. (incorporated by
reference to the exhibit of the same number filed with the Company’s
Annual Report on Form 10-K for the year ended March 31,
2007).
|
|
|
10.36
|
Consulting
Agreement, effective November 9, 2006, by and between Registrant and
Robert Burlingame (incorporated by reference to exhibit 10.33 filed
with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.37
|
Director
Agreement, dated November 8, 2006, by and between Registrant and
Robert Burlingame (incorporated by reference to exhibit 10.34 filed
with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.38†
|
Exclusive
Marketing Agreement, dated December 5, 2005, by and between
Registrant and Alkem Laboratories Ltd (incorporated by reference to
exhibit 10.35 filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.39
|
Settlement
Agreement, effective September 21, 2006, by and among Registrant and
Messrs. Jorge Ahumada Ayala and Fernando Ahumada Ayala (incorporated
by reference to exhibit 10.36 filed with Registration Statement on
Form S-1 (File No. 333-135584), as amended, declared effective
on January 24, 2007).
|
|
|
10.40
|
Settlement
Agreement, dated October 25, 2006, by and between Registrant and
Mr. Kim Kelderman (incorporated by reference to exhibit 10.37
filed with Registration Statement on Form S-1
(File No. 333-135584), as amended, declared effective on
January 24, 2007).
|
|
|
10.41
|
Securities
Purchase Agreement, dated August 7, 2007, by and between Registrant
and purchasers identified on the signatures pages thereto (incorporated by
reference to exhibit 10.1 to the Company’s Current Report on
Form 8-K filed August 13, 2007).
|
|
|
10.42
|
Registration
Rights Agreement, dated August 7, 2007, by and between Registrant and
purchasers identified on signatures pages thereto (incorporated by
reference to exhibit 10.2 to the Company’s Current Report on
Form 8-K filed August 13,
2007).
|
|
10.43
|
Amendment
No. 4 to Lease, dated September 13, 2007, by and between
Registrant and RNM Lakeville L.P. (incorporated by reference to the
exhibit of the same number filed with the Company’s Annual Report on
Form 10-K for the year ended March 31, 2008).
|
|
|
10.44
|
Amendment
to Office Lease Agreement, effective February 15, 2008, by and
between Oculus Innovative Sciences Netherlands B.V. and Artikona Holding
B.V. (translated from Dutch) (incorporated by reference to the exhibit of
the same number filed with the Company’s Annual Report on Form 10-K
for the year ended March 31, 2007).
|
|
|
10.45
|
Form
of Securities Purchase Agreement, dated March 27, 2008, by and
between Registrant and each investor signatory thereto (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on
Form 8-K filed March 28, 2008).
|
|
|
10.46
|
Purchase
Agreement by and between Registrant and Robert Burlingame, dated
January 26, 2009 (included as Exhibit 10.1 to the Form 8-K
filed January 29, 2009 and incorporated herein by
reference).
|
|
|
10.47
|
Purchase
Agreement by and between Registrant and Non-Affiliated Investors, dated
January 26, 2009 (included as Exhibit 10.2 to the Form 8-K
filed January 29, 2009 and incorporated herein by
reference).
|
|
|
10.48
|
Revenue
Sharing Distribution Agreement by and between Registrant and VetCure,
Inc., dated January 26, 2009 (included as Exhibit 10.3 to the
Form 8-K filed January 29, 2009 and incorporated herein by
reference).
|
|
|
10.49
|
Purchase
Agreement by and between Registrant and accredited investors, dated
February 6, 2009 (included as Exhibit 10.1 to the Form 8-K
filed February 9, 2009 and incorporated herein by
reference).
|
|
|
10.50
|
Purchase
Agreement by and between Registrant, Robert Burlingame and Seamus
Burlingame, dated February 24, 2009 (included as Exhibit 10.4 to
the Form 8-K filed February 27, 2009 and incorporated herein by
reference).
|
|
|
10.51
|
Amendment
to Revenue Sharing Distribution Agreement by and between Registrant and
Vetericyn, Inc., dated February 24, 2009 (included as
Exhibit 10.5 to the Form 8-K filed February 27, 2009 and
incorporated herein by reference).
|
|
|
10.52*
|
Agreement
by and between Registrant and Robert C. Burlingame, dated April 1,
2009 (included as Exhibit 10.52 to the Form 10-K filed on June 11, 2009
and incorporated herein by reference).
|
|
|
10.53*
|
Microcyn
U.S. Commercial Launch Agreement, by and between Registrant and Advocos,
dated April 24, 2009 (included as Exhibit 10.53 to the Form 10-K
filed on June 11, 2009 and incorporated herein by
reference).
|
|
|
10.54*
|
Amendment
No. 5 to Lease by and between Registrant and RNM Lakeville, LLC,
dated May 18, 2009 (included as Exhibit 10.54 to the Form 10-K filed
on June 11, 2009 and incorporated herein by reference).
|
|
|
10.55
|
Engagement
Agreement by and between Registrant and Dawson James Securities, Inc.,
dated April 10, 2009, (included as Exhibit 10.55 to the Registration
Statement on Form S-1 (File No. 333-158539), as amended, declared
effective on July 24, 2009)
|
|
|
10.56
|
Letter
Agreement by and between Registrant and Dawson James Securities, Inc.,
dated July 2, 2009, (included as Exhibit 10.56 to the Registration
Statement on Form S-1 (File No. 333-158539), as amended, declared
effective on July 24, 2009)
|
|
|
10.57
|
Letter
Agreement by and between Registrant and Dawson James Securities, Inc.,
dated July 10, 2009, (included as Exhibit 10.57 to the Registration
Statement on Form S-1 (File No. 333-158539), as amended, declared
effective on July 24, 2009)
|
|
|
10.58
|
Warrant
Purchase Agreement by and between Registrant and Dawson James Securities,
Inc., dated July 13, 2009, (included as Exhibit 10.58 to the Registration
Statement on Form S-1 (File No. 333-158539), as amended, declared
effective on July 24, 2009)
|
|
|
10.59
|
Loan
and Security Agreement, dated May 1, 2010 between Oculus Innovative
Sciences, Inc. and Venture Lending & Leasing V., Inc., (Included as
Exhibit 10.1 to the Form 8-K filed on May 6, 2010, and incorporated herein
by reference.)
|
|
|
10.60
|
Supplement
to the Loan and Security Agreement, dated as of May 1, 2010 between Oculus
Innovative Sciences, Inc., and Venture Lending & Leasing V, Inc.,
(Included as Exhibit 10.2 to the Form 8-K filed on May 6, 2010, and
incorporated herein by reference.)
|
|
|
10.61
|
Warrant
to Purchase Shares of Common Stock of Oculus Innovative Sciences, Inc.,
(Included as Exhibit 10.3 to the Form 8-K filed on May 6, 2010, and
incorporated herein by reference.)
|
|
|
21.1
|
List
of Subsidiaries (incorporated by reference to the exhibit of the same
number filed with the Company’s Annual Report on Form 10-K (File
No. 001-3216) for the year ended March 31,
2007).
|
|
|
23.1*
|
Consent
of Marcum LLP, independent registered public accounting
firm.
|
|
|
31.1*
|
Certification
of Chief Executive Officer pursuant to Securities Exchange Act
Rule 13a — 14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of
2002.
|
|
31.2*
|
Certification
of Chief Financial Officer pursuant to Securities Exchange Act
Rule 13a — 14(a), as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
|
32.1**
|
|
Certification
of Officers pursuant to 18 U.S.C. Section 1250, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
*
|
Filed
herewith.
|
|
**
|
In
accordance with Item 60(b)(32)(ii) of Regulation S-K and SEC
Release Nos. 33-8238 and 34-47986, Final Rule: Management’s Reports on
Internal Control Over Financial Reporting and Certification of Disclosure
in Exchange Act Periodic Reports, the certifications furnished in
Exhibits 32.1 and 32.2 hereto are deemed to accompany this
Form 10-K and will not be deemed “filed” for purposes of
Section 18 of the Exchange Act. Such certifications will not be
deemed to be incorporated by reference into any filing under the
Securities Act or the Exchange Act, except to the extent that the Company
specifically incorporates it by
reference.
|
|
†
|
Confidential
treatment has been granted with respect to certain portions of this
agreement.
|
|
OCULUS
INNOVATIVE SCIENCES, INC.
|
|||
|
By:
|
/s/ Hojabr Alimi
|
||
|
Hojabr
Alimi
|
|||
|
President,
Chief Executive Officer and
|
|||
|
Chairman
of the Board
|
|||
|
(Principal
Executive Officer)
|
|||
|
Signature
|
Title
|
Date
|
||
|
/s/ Hojabr Alimi
|
President,
Chief Executive Officer and
|
June
8, 2010
|
||
|
Hojabr
Alimi
|
Chairman
of the Board
|
|||
|
(Principal
Executive Officer)
|
||||
|
/s/ Robert E.
Miller
|
Chief
Financial Officer
|
June
8, 2010
|
||
|
Robert
E. Miller
|
(Principal
Financial Officer and
|
|||
|
Principal
Accounting Officer)
|
||||
|
/s/ Gregg Alton
|
Director
|
June
8, 2010
|
||
|
Gregg
Alton
|
||||
|
/s/ Jay Edward
Birnbaum
|
Director
|
June
8, 2010
|
||
|
Jay
Edward Birnbaum
|
||||
|
/s/ Robert
Burlingame
|
Director
|
June
8, 2010
|
||
|
Robert
Burlingame
|
||||
|
/s/ Richard
Conley
|
Director
|
June
8, 2010
|
||
|
Richard
Conley
|
||||
|
/s/ Gregory M.
French
|
Director
|
June
8, 2010
|
||
|
Gregory
M. French
|
||||
|
/s/ James Schutz
|
Director
|
June
8, 2010
|
||
|
James
Schutz
|
|
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|