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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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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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68-0423298
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(State or other jurisdiction
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(I.R.S. Employer
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of incorporation or organization)
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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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NASDAQ Capital Market
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Large accelerated filer
¨
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Accelerated filer
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Non-accelerated filer
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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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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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30
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ITEM 2.
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Properties
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44
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ITEM 3.
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Legal Proceedings
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44
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ITEM 4.
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(Removed and Reserved)
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45 |
PART II
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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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45
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ITEM 6.
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Selected Financial Data
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46
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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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46
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ITEM 7A.
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Quantitative and Qualitative Disclosures About Market Risk
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53
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ITEM 8.
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Consolidated Financial Statements and Supplementary Data
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53
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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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84
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ITEM 9A.
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Controls and Procedures
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84
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ITEM 9B.
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Other Information
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85
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PART III
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ITEM 10.
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Directors, Executive Officers and Corporate Governance
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85
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ITEM 11.
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Executive Compensation
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85
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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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85
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ITEM 13.
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Certain Relationships and Related Transactions, and Director Independence
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86
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ITEM 14.
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Principal Accounting Fees and Services
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86
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PART IV
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ITEM 15.
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Exhibits, Financial Statement Schedules
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87
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Signatures
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94
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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 mechanical or surgical 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;
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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: and.
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7)
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As a hydrogel, for management and relief of burning, itching and pain experienced with various types of dermatoses including atopic dermatitis and radiation dermatitis.
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•
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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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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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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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antibiotics and antiseptics can kill bacteria and cure infection but do not independently accelerate wound healing;
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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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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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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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growth regulators, skin substitutes and vacuum-assisted closure accelerate wound healing but do not cure infection.
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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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Accelerates Wound Healing.
Based on numerous physician-based studies and usage feedback from doctors, we believe that Microcyn Technology may accelerate the wound healing process independently of the benefits of curing the infection.
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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)-cleared 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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Non-irritating.
Our 510(k) product labels states that our 510(k) product, which is based on 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 Microdacyn60 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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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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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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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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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)
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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
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Debridement of wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second burns, grafted and donor sites.
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510(k)
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2010
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Management of dermal irritation, sores, injuries and ulcers of dermal tissue including itch and pain relief
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510(k)
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2011
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Management and relief of the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis and radiation dermatitis.
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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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Mexico
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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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Product Registration
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2004
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Antiseptic treatment of wounds and infected areas.
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Canada
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Class II-Medical Device (Inactive)
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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
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2006
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Cleaning and debriding in wound management.
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China
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Medical Device
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2008
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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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Country
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Number
of
Patients
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Publication
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||||
David E. Allie, M.D.(1)
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U.S.
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40
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Allie D. Super-Oxidized Dermacyn in Lower-Extremity Wounds.
Wounds,
2006, 18 (Suppl), 3-6.
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Tom Wolvos, M.D.(2)
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U.S.
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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)
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U.S.
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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)
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Italy
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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
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Alberto Piagessi, M.D.(5)
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Italy
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33
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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.
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Ariel Miranda, M.D.(5)
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Mexico
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64
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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)
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Czech
Republic
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27
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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.
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Elia Ricci M.D.(6)
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Italy
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40
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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.
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Alfredo Barrera MD(5)
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Mexico
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40
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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.
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D Peterson MD
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U.S.
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5
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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.
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Steenvoorde, P.M.D, Van
Doorn, L.P., M.A.,
Jacobi, C.E, PhD &
Oskam, J., M.D., PhD.(3)
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Netherlands
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10
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An unexpected effect of Dermacyn on infected leg ulcers,
J Wound Care
2007, 16: 60-61.
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Fermin Martinez M.D.
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Mexico
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45
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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.
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|||
Hadi SF MD(3)
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Pakistan
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100
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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.
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BT Monaghan DPM(3)
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Ireland
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10
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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.
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Fernando Uribe MD(6)
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Mexico
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80
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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.
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|||
Ning Fanggang MD(3)
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China
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20
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Fanggang N, Guoan Z. The clinical efficacy of Dermacyn on deep partial thickness burn wounds.
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Amar Pal Suri DPM(6)
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India
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100
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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.
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Alberto Piaggesi M.D.(5)
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Italy
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40
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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 .
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|||
Robert G. Frykberg, DPM, MPH(6)
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U.S.
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23
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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.
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Matthew Regulski DPM(5)
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U.S.
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18
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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.
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Adam Landsman DPM PhD,(5)
Andres A Gutierrez MD PhD(1) &
Oculus Collaborative Group
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U.S.
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48
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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.
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Christopher Gauland, DPM(3)
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U.S.
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5
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Gauland C., Sickle Cell Disease, Symposium on Advanced Wound Care and Wound Healing Society, San Diego, CA, April 24-28, 2008.
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|||
Hadi, SF
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Pakistan
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100
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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.
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|||
Chittoria RV
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India
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20
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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.
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Anand A
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India
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50
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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.
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Dharap SB
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India
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30
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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.
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Dhusia H
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India
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41
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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.
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Khairulasri MG
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Malaysia
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178
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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.
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Christopher J. Gauland DPM (3)
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U.S.
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16
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Comparison of Microcyn and Amerigel in the Podiatric Clinical Setting
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Andres Tirado-Sanchez & RosaMaria Ponce-Olivera
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Mexico
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89
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Efficacy and tolerance of superoxidized solution in the treatment of mild to moderate inflammatory acne. A double-blinded, placebo-controlled, parallel-group, randomized, clinical trial.
Journal of Dermatological Treatment
. 2009; 20:289–292
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(1)
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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.
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(2)
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Indicates that the physician was a paid consultant, received expenses in connection with corporate development and licensing evaluations and is a warrant holder.
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(3)
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Indicates that the physician received Microcyn to complete the study.
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(4)
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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.
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(5)
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Indicates that the physician received payments, expense payments and Microcyn to complete the study.
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(6)
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Indicates that the physician received reimbursement of travel expenses and received Microcyn to complete the study.
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Researchers
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Country
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Publication
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||
Landa-Solis, González-Espinosa D.,
Guzman B, Snyder M, Reyes-Terán G.,
Torres K, and Gutiérrez AA(1)
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Mexico
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Microcyn™ a novel super-oxidized water with neutral pH and disinfectant activity.
J Hosp
Infect
(UK) 2005, 61: 291-299.
|
||
Gutiérrez, AA(1)
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U.S.
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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
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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)
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Mexico, U.S.
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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)
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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)
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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.
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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)
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U.S.
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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.
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(1)
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Dr. Gutierrez was our Director of Medical Affairs and conducted the study during his employment at our Company.
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(2)
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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.
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(3)
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Indicates that investigator received Microcyn to complete the study.
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(4)
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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.
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(5)
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Dr. Northey is our Director of Research and Development and conducted the study during his employment at our Company.
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•
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significantly greater name recognition;
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•
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established relationships with healthcare professionals, patients and third-party payors;
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•
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established distribution networks;
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•
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additional product lines and the ability to offer rebates or bundle products to offer discounts or incentives;
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•
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greater experience in conducting research and development, manufacturing, obtaining regulatory approval for products and marketing; and
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•
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greater financial and human resources for product development, sales and marketing and patient support.
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•
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fines, injunctions and civil penalties;
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•
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recall or seizure of products;
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•
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operating restrictions, partial suspension or total shutdown of production;
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•
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refusing requests for 510(k) clearance or pre-market approval of new products;
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•
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withdrawing 510(k) clearance or pre-market approval approvals already granted; and
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•
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criminal prosecution.
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•
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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.
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•
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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.
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•
|
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;
|
|
•
|
changes in the FDA requirements for approval, including requirements for testing efficacy and safety;
|
|
•
|
the FDA or other regulatory authority approval of a clinical trial protocol;
|
|
•
|
patients do not enrolling 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 not performing our clinical trials on our anticipated schedule or performance is not consistent with the clinical trial protocol and good clinical practices, or the third party organizations do not performing data collection and analysis in a timely or accurate manner; and
|
|
•
|
changes in governmental regulations or administrative actions.
|
|
•
|
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, 2011
|
||||||||||||||||
First
Quarter
|
Second
Quarter
|
Third
Quarter
|
Fourth
Quarter
|
|||||||||||||
Stock price-high
|
$
|
2.38
|
$
|
2.03
|
$
|
1.89
|
$
|
2.25
|
||||||||
Stock price-low
|
$
|
1.82
|
$
|
1.43
|
$
|
1.44
|
$
|
1.74
|
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,
|
||||||||||||||||
2011
|
2010
|
Increase
|
Increase
|
|||||||||||||
U.S.
|
$
|
2,784
|
$
|
1,196
|
$
|
1,588
|
133
|
%
|
||||||||
Europe and Rest of World
|
1,735
|
1,222
|
513
|
42
|
%
|
|||||||||||
Mexico
|
4,307
|
3,880
|
427
|
11
|
%
|
|||||||||||
Total
|
$
|
8,826
|
$
|
6,298
|
$
|
2,528
|
40
|
%
|
|
·
|
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
|
|
·
|
$4,317,000 received from the exercise of common stock purchase warrants and options during the years ended March 31, 2011 and 2010.
|
Payments Due by Period
|
||||||||||||||||
Less Than
|
1-3
|
After
|
||||||||||||||
Total
|
1 Year
|
Years
|
3 Years
|
|||||||||||||
Long-term debt
|
$ | 3,136 | $ | 1,144 | $ | 1,983 | $ | 9 | ||||||||
Operating leases
|
229 | 221 | 8 | — | ||||||||||||
Total
|
$ | 3,365 | $ | 1,365 | $ | 1,991 | $ | 9 |
Fiscal Year ended
|
Lease Payment
|
|||
3/31/2012
|
62,000 | |||
3/31/2013
|
125,000 | |||
3/31/2014
|
125,000 | |||
3/31/2015
|
62,000 | |||
374,000 |
|
•
|
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
|
54 | |
Consolidated Balance Sheets as of March 31, 2011 and 2010
|
55 | |
Consolidated Statements of Operations and Comprehensive Loss for the years ended March 31, 2011 and 2010
|
56 | |
Consolidated Statements of Changes in Stockholders’ Equity for the years ended March 31, 2011 and 2010
|
57 | |
Consolidated Statements of Cash Flows for the years ended March 31, 2011 and 2010
|
58 | |
Notes to Consolidated Financial Statements
|
59 |
March 31,
|
||||||||
2011
|
2010
|
|||||||
(In thousands, except share
and per share amounts)
|
||||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
4,371
|
$
|
6,258
|
||||
Accounts receivable, net
|
2,094
|
1,416
|
||||||
Inventory, net
|
733
|
565
|
||||||
Prepaid expenses and other current assets
|
611
|
811
|
||||||
Total current assets
|
7,809
|
9,050
|
||||||
Property and equipment, net
|
802
|
1,108
|
||||||
Other assets
|
53
|
60
|
||||||
Total assets
|
$
|
8,664
|
$
|
10,218
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
669
|
$
|
981
|
||||
Accrued expenses and other current liabilities
|
694
|
760
|
||||||
Deferred revenue
|
1,808
|
318
|
||||||
Current portion of long-term debt, net of debt discount of $237
|
907
|
204
|
||||||
Derivative liability
|
337
|
472
|
||||||
Total current liabilities
|
4,415
|
2,735
|
||||||
Deferred revenue
|
160
|
328
|
||||||
Long-term debt, less current portion, net of debt discount of $591
|
1,638
|
110
|
||||||
Put warrant liability
|
750
|
—
|
||||||
Total liabilities
|
6,963
|
3,173
|
||||||
Commitments and Contingencies
|
||||||||
Stockholders’ Equity
|
||||||||
Convertible preferred stock, $0.0001 par value; 5,000,000 shares authorized, none issued and outstanding at March 31, 2011 and 2010
|
—
|
—
|
||||||
Common stock, $0.0001 par value; 100,000,000 shares authorized, 26,576,302 and 26,161,428 shares issued and outstanding at March 31, 2011 and 2010, respectively
|
3
|
3
|
||||||
Additional paid-in capital
|
129,584
|
127,067
|
||||||
Accumulated other comprehensive loss
|
(2,901
|
)
|
(2,988
|
)
|
||||
Accumulated deficit
|
(124,985
|
)
|
(117,037
|
)
|
||||
Total stockholders’ equity
|
1,701
|
7,045
|
||||||
Total liabilities and stockholders’ equity
|
$
|
8,664
|
$
|
10,218
|
Year Ended March 31,
|
||||||||
2011
|
2010
|
|||||||
(In thousands, except per share amounts)
|
||||||||
Revenues
|
||||||||
Product
|
$
|
8,826
|
$
|
6,298
|
||||
Service
|
928
|
1,066
|
||||||
Total revenues
|
9,754
|
7,364
|
||||||
Cost of revenues
|
||||||||
Product
|
2,876
|
2,633
|
||||||
Service
|
737
|
853
|
||||||
Total cost of revenues
|
3,613
|
3,486
|
||||||
Gross profit
|
6,141
|
3,878
|
||||||
Operating expenses
|
||||||||
Research and development
|
2,046
|
1,996
|
||||||
Selling, general and administrative
|
11,600
|
9,898
|
||||||
Total operating expenses
|
13,646
|
11,894
|
||||||
Loss from operations
|
(7,505
|
)
|
(8,016
|
)
|
||||
Interest expense
|
(406
|
)
|
(9
|
)
|
||||
Interest income
|
3
|
2
|
||||||
Gain (loss) due to change in fair value of derivative instruments
|
135
|
(149
|
)
|
|||||
Other expense, net
|
(175
|
)
|
(60
|
)
|
||||
Net loss
|
$
|
(7,948
|
)
|
$
|
(8,232
|
)
|
||
Net loss per common share: basic and diluted
|
$
|
(0.30
|
)
|
$
|
(0.36
|
)
|
||
Weighted-average number of shares used in per common share calculations:
|
||||||||
Basic and diluted
|
26,374
|
22,993
|
||||||
Other comprehensive loss
|
||||||||
Net loss
|
$
|
(7,948
|
)
|
$
|
(8,232
|
)
|
||
Foreign currency translation adjustments
|
87
|
66
|
||||||
Comprehensive loss
|
$
|
(7,861
|
)
|
$
|
(8,166
|
)
|
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, 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
|
|||||||||||
Issuance of common stock in connection with exercise of stock options
|
126,120
|
—
|
94
|
—
|
—
|
94
|
||||||||||||||||||
Issuance of common stock for accounts payable obligations
|
35,000
|
—
|
57
|
—
|
—
|
57
|
||||||||||||||||||
Issuance of common stock for services
|
253,754
|
—
|
482
|
—
|
—
|
482
|
||||||||||||||||||
Employee stock-based compensation expense, net of forfeitures
|
—
|
—
|
1,884
|
—
|
—
|
1,884
|
||||||||||||||||||
Foreign currency translation adjustment
|
—
|
—
|
—
|
87
|
—
|
87
|
||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(7,948
|
)
|
(7,948
|
)
|
||||||||||||||||
Balance, March 31, 2011
|
26,576,302
|
$
|
3
|
$
|
129,584
|
$
|
(2,901
|
)
|
$
|
(124,985
|
)
|
$
|
1,701
|
Year Ended March 31,
|
||||||||
2011
|
2010
|
|||||||
(In thousands)
|
||||||||
Cash flows from operating activities
|
||||||||
Net loss
|
$
|
(7,948
|
)
|
$
|
(8,232
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
395
|
433
|
||||||
Provision for doubtful accounts
|
17
|
61
|
||||||
Provision for obsolete inventory
|
98
|
184
|
||||||
Stock-based compensation
|
2,366
|
1,432
|
||||||
Change in fair value of derivative liability
|
(135
|
)
|
149
|
|||||
Non-cash interest expense
|
159
|
—
|
||||||
Foreign currency transaction (gains) losses
|
(2
|
)
|
(97
|
)
|
||||
Loss on disposal of assets
|
157
|
169
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
(626
|
)
|
(453
|
)
|
||||
Inventories
|
(245
|
)
|
(388
|
)
|
||||
Prepaid expenses and other current assets
|
375
|
190
|
||||||
Accounts payable
|
(266
|
)
|
(163
|
)
|
||||
Accrued expenses and other liabilities
|
1,226
|
76
|
||||||
Net cash used in operating activities
|
(4,429
|
)
|
(6,639
|
)
|
||||
Cash flows from investing activities:
|
||||||||
Purchases of property and equipment
|
(174
|
)
|
(141
|
)
|
||||
Long-term deposits
|
10
|
(43
|
)
|
|||||
Net cash used in investing activities
|
(164
|
)
|
(184
|
)
|
||||
Cash flows from financing activities:
|
||||||||
Proceeds from issuance of common stock, net of offering costs
|
—
|
7,155
|
||||||
Proceeds from issuance of common stock upon exercise of stock options and warrants
|
94
|
4,223
|
||||||
Proceeds from issuance of long-term debt
|
3,000
|
—
|
||||||
Principal payments on long-term debt
|
(410
|
)
|
(288
|
)
|
||||
Payments on capital lease obligations
|
—
|
(6
|
)
|
|||||
Net cash provided by financing activities
|
2,684
|
11,084
|
||||||
Effect of exchange rate on cash and cash equivalents
|
22
|
76
|
||||||
Net (decrease) increase in cash and cash equivalents
|
(1,887
|
)
|
4,337
|
|||||
Cash and cash equivalents, beginning of year
|
6,258
|
1,921
|
||||||
Cash and cash equivalents, end of year
|
$
|
4,371
|
$
|
6,258
|
||||
Supplemental disclosure of cash flow information:
|
||||||||
Cash paid for interest
|
$
|
247
|
$
|
9
|
||||
Issuance of common stock for accounts payable obligations
|
$
|
57
|
$
|
455
|
||||
Non-cash operating and financing activities:
|
||||||||
Insurance premiums financed
|
$
|
165
|
$
|
184
|
||||
Non-cash investing and financing activities:
|
||||||||
Equipment financed
|
$
|
68
|
$
|
157
|
||||
Debt discount in connection with long-term debt | $ | 750,000 | $ |
—
|
Fair Value Measurements at March 31, 2011 Using
|
||||||||||||||||
Total
March 31,
2011
|
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
|
$
|
337
|
$
|
—
|
$
|
—
|
$
|
337
|
Fair Value Measurements at March 31, 2010 Using
|
||||||||||||||||
Total
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
|
|
•
|
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,
|
||||||||
2011
|
2010
|
|||||||
(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
|
4,396
|
3,987
|
||||||
Warrants to purchase common stock
|
9,366
|
9,144
|
||||||
13,762
|
13,131
|
March 31,
|
||||||||
2011
|
2010
|
|||||||
Accounts receivable
|
$
|
2,156
|
$
|
1,512
|
||||
Less: allowance for doubtful accounts
|
(62
|
)
|
(96
|
)
|
||||
$
|
2,094
|
$
|
1,416
|
Year Ended March 31
|
Balance at
Beginning
of Year
|
Additions
Charged to
Operations
|
Deductions
Write-Offs
|
Balance at
End of Year
|
||||||||||||
2010
|
$
|
51
|
$
|
61
|
$
|
(16
|
)
|
$
|
96
|
|||||||
2011
|
$
|
96
|
$
|
17
|
$
|
(51
|
)
|
$
|
62
|
March 31,
|
||||||||
2011
|
2010
|
|||||||
Raw materials
|
$
|
482
|
$
|
406
|
||||
Finished goods
|
409
|
302
|
||||||
891
|
708
|
|||||||
Less: inventory allowances
|
(158
|
)
|
(143
|
)
|
||||
$
|
733
|
$
|
565
|
Year Ended March 31
|
Balance at
Beginning
of Year
|
Additions
Charged to
Cost of
Product
Revenues
|
Deductions
Write-Offs
|
Balance at
End of Year
|
||||||||||||
2010
|
$
|
71
|
$
|
184
|
$
|
(112
|
)
|
$
|
143
|
|||||||
2011
|
$
|
143
|
$
|
98
|
$
|
(83
|
)
|
$
|
158
|
March 31,
|
||||||||
2011
|
2010
|
|||||||
Prepaid expenses
|
$
|
403
|
$
|
590
|
||||
Value Added Tax receivable
|
24
|
31
|
||||||
Other current assets
|
184
|
190
|
||||||
$
|
611
|
$
|
811
|
March 31,
|
||||||||
2011
|
2010
|
|||||||
Manufacturing, lab, and other equipment
|
$
|
2,375
|
$
|
2,470
|
||||
Office equipment
|
333
|
388
|
||||||
Furniture and fixtures
|
53
|
52
|
||||||
Leasehold improvements
|
284
|
275
|
||||||
3,045
|
3,185
|
|||||||
Less: accumulated depreciation and amortization
|
(2,243
|
)
|
(2,077
|
)
|
||||
$
|
802
|
$
|
1,108
|
March 31,
|
||||||||
2011
|
2010
|
|||||||
Salaries and related costs
|
$
|
472
|
$
|
467
|
||||
Professional fees
|
36
|
143
|
||||||
Value Added Tax payable
|
143
|
140
|
||||||
Other
|
43
|
10
|
||||||
$
|
694
|
$
|
760
|
For Years Ending March 31,
|
||||
2012
|
$
|
1,144
|
||
2013
|
1,214
|
|||
2014
|
739
|
|||
2015
|
30
|
|||
2016
|
9
|
|||
Total principal payments
|
3,136
|
|||
Less: current portion
|
(1,144
|
)
|
||
Long-term portion
|
$
|
1,992
|
March 31,
|
March 31,
|
|||||||
2011
|
2010
|
|||||||
Expected Term
|
1.87 yrs
|
2.37 yrs
|
||||||
Risk-free interest rate
|
0.61
|
%
|
1.02
|
%
|
||||
Dividend yield
|
0.00
|
%
|
0.00
|
%
|
||||
Volatility
|
83.0
|
%
|
84.0
|
%
|
||||
Warrants outstanding
|
725,866
|
724,188
|
||||||
Fair value of warrants
|
$
|
337,000
|
$
|
472,000
|
Years Ended March 31,
|
||||||||
2011
|
2010
|
|||||||
Beginning balance
|
$ | (472 | ) | $ | (323 | ) | ||
Net unrealized gain (loss)
|
135 | (149 | ) | |||||
Ending balance
|
$ | (337 | ) | $ | (472 | ) |
For Years Ending March 31,
|
||||
2012
|
$
|
221
|
||
2013
|
8
|
|||
Total minimum lease payments
|
$
|
229
|
Plan
|
Total
Number of
Options and
Restricted
Stock Units
Outstanding
in Plan
|
|||
1999 Plan
|
4 | |||
2000 Plan
|
— | |||
2003 Plan
|
162 | |||
2004 Plan
|
536 | |||
2006 Plan
|
3,694 | |||
4,396 |
Number of
Shares
|
Weighted-
Average
Exercise Price
|
Weighted-
Average
Contractual Term
|
Aggregate
Intrinsic
Value
|
|||||||||||||
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 |
|
|||||||||||||
Options granted
|
750 | 1.95 |
|
|||||||||||||
Options exercised
|
(126 | ) | 0.74 |
|
||||||||||||
Options forfeited or expired
|
(215 | ) | 4.79 |
|
||||||||||||
Outstanding at March 31, 2011
|
4,396 | $ | 2.76 | 7.41 | $ | 1,903 | ||||||||||
Exercisable at March 31, 2011
|
2,947 | $ | 3.25 | 6.87 | $ | 1,200 | ||||||||||
Options available for grant as of March 31, 2011
|
1,805 |
Employee
Stock-based
Compensation
for the Year Ended
March 31,
2011
|
Employee
Stock-based
Compensation
for the Year Ended
March 31,
2010
|
|||||||
Cost of revenues service
|
$ | 58 | $ | 22 | ||||
Research and development
|
206 | 97 | ||||||
Selling, general and administrative
|
1,620 | 746 | ||||||
Total stock-based compensation
|
$ | 1,884 | $ | 865 |
Year Ended March 31,
|
||||||||
2011
|
2010
|
|||||||
Fair value of common stock
|
$ | 1.95 | $ | 1.89 | ||||
Expected Term
|
5.60 yrs
|
5.90 yrs
|
||||||
Risk-free interest rate
|
2.03 | % | 2.45 | % | ||||
Dividend yield
|
0.00 | % | 0.00 | % | ||||
Volatility
|
83.5 | % | 84.2 | % |
March 31,
|
||||||||
2011
|
2010
|
|||||||
Deferred tax assets:
|
||||||||
Net operating loss carryforwards
|
$
|
34,532
|
$
|
33,477
|
||||
Research and development tax credit carryforwards
|
1,187
|
1,335
|
||||||
Stock-based compensation
|
2,451
|
2,713
|
||||||
Reserves and accruals
|
2,044
|
2,267
|
||||||
Other deferred tax assets
|
23
|
19
|
||||||
Total deferred tax assets
|
$
|
40,237
|
$
|
39,811
|
||||
Deferred tax liabilities:
|
||||||||
Basis difference in assets
|
(19
|
)
|
(35
|
)
|
||||
Net deferred tax asset
|
40,218
|
39,776
|
||||||
Valuation allowance
|
(40,218
|
)
|
(39,776
|
)
|
||||
Net deferred tax asset
|
$
|
—
|
$
|
—
|
Years Ended March 31,
|
||||||||
2011
|
2010
|
|||||||
Income tax benefit
|
$ | (442 | ) | $ | (3,345 | ) | ||
Change in valuation allowance
|
442 | 3,345 | ||||||
Net income tax benefit
|
$ | — | $ | — |
Years Ended March 31,
|
||||||||
2011
|
2010
|
|||||||
Expected federal statutory rate
|
(34.0 | )% | (34.0 | )% | ||||
State income taxes, net of federal benefit
|
(2.8 | )% | (5.8 | )% | ||||
Research and development credit
|
(1.1 | )% | (0.8 | ) % | ||||
Foreign earnings taxed at different rates
|
1.7 | % | 0.9 | % | ||||
Recognition of change in estimate of state and foreign NOL carryforward benefits
|
|
% | (2.5 | ) % | ||||
Effect of permanent differences
|
13.2 | % | 1.5 | % | ||||
Impact of change in foreign rate on deferred and true-ups
|
9.0 | % | ||||||
Cancellation of stock options
|
8.4 | % | ||||||
(5.6 | )% | (40.7 | ) % | |||||
Change in valuation allowance
|
5.6 | % | 40.7 | % | ||||
Totals
|
0.0 | % | 0.0 | % |
March 31,
|
||||||||
2011
|
2010
|
|||||||
U.S.
|
$ | 2,784 | $ | 1,196 | ||||
Mexico
|
4,307 | 3,880 | ||||||
Europe and other
|
1,735 | 1,222 | ||||||
$ | 8,826 | $ | 6,298 |
For the year
ending
March 31,
|
||||
2012
|
$ | 62,000 | ||
2013
|
125,000 | |||
2014
|
125,000 | |||
2015
|
62,000 | |||
Total minimum payments | $ | 374,000 |
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).
|
|
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 Company’s Annual Report on Form 10-K filed 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 (included as Exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
|
10.2
|
Form of 2006 Stock Incentive Plan and related form stock option plan agreements (included as Exhibit 10.6 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
10.3
|
Amended and Restated Investors Rights Agreement, effective as of September 14, 2006 (included as Exhibit 4.6 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
|
10.4
|
Form of Promissory Note issued to Venture Lending & Leasing III, Inc. (included as Exhibit 4.7 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
|
10.5
|
Form of Promissory Note (Equipment and Soft Cost Loans) issued to Venture Lending & Leasing IV, Inc. (included as Exhibit 4.8 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
|
10.6
|
Form of Promissory Note (Growth Capital Loans) issued to Venture Lending & Leasing IV, Inc. (included as Exhibit 4.9 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
10.7
|
Form of Promissory Note (Working Capital Loans) issued to Venture Lending & Leasing IV, Inc. (included as Exhibit 4.10 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
|
10.8
|
Office Lease Agreement, dated October 26, 1999, between Registrant and RNM Lakeville, L.P. (included as Exhibit 10.7 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
|
10.9
|
Amendment to Office Lease No. 1, dated September 15, 2000, between Registrant and RNM Lakeville L.P. (included as Exhibit 10.8 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
|
10.10
|
Amendment to Office Lease No. 2, dated July 29, 2005, between Registrant and RNM Lakeville L.P. (included as Exhibit 10.9 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
10.11
|
Amendment No. 3 to Lease, dated August 23, 2006, between Registrant and RNM Lakeville L.P. (included as Exhibit 10.23 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
|
10.12
|
Amendment No. 4 to Lease, dated September 13, 2007, by and between Registrant and RNM Lakeville L.P. (included as Exhibit 10.43 to the Company’s Annual Report on Form 10-K filed June 13, 2008, and incorporated herein by reference).
|
|
10.13
|
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) (included as Exhibit 10.10 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
|
10.14
|
Office Lease Agreement, dated July 2003, between Oculus Innovative Sciences, B.V. and Artikona Holding B.V. (translated from Dutch) (included as Exhibit 10.11 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
|
10.15
|
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) (included as Exhibit 10.44 to the Company’s Annual Report on Form 10-K filed June 13, 2008, and incorporated herein by reference).
|
10.16
|
Form of Director Agreement (included as Exhibit 10.20 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
|
10.17
|
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. (included as Exhibit 10.22 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
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10.18
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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 (included as Exhibit 10.24 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
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10.19
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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. (included as Exhibit 10.25 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
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10.20
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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 (included as Exhibit 10.26 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
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10.21
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Partnership Interest Purchase Option Agreement, dated June 16, 2005, by and between Registrant and Javier Orozco Gutierrez (included as Exhibit 10.27 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
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10.22
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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) (included as Exhibit 10.28 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
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10.23
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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) (included as Exhibit 10.29 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
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10.24
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Director Agreement, dated November 8, 2006, by and between Registrant and Robert Burlingame (included as Exhibit 10.34 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
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10.25†
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Exclusive Marketing Agreement, dated December 5, 2005, by and between Registrant and Alkem Laboratories Ltd (included as Exhibit 10.35 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
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10.26
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Securities Purchase Agreement, dated August 7, 2007, by and between Registrant and certain purchasers identified on the signatures pages thereto (originally filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed August 13, 2007, and refiled as Exhibit 10.26 to the Company’s Quarterly Report on Form 10-Q filed November 4, 2010 to add signature pages of investors).
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10.27
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Registration Rights Agreement, dated August 7, 2007, by and between Registrant and certain purchasers identified on signatures pages thereto (originally filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed August 13, 2007, and refiled as Exhibit 10.27 to the Company’s Quarterly Report on Form 10-Q filed November 4, 2010 to add signature pages of investors).
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10.28
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Form of Securities Purchase Agreement, dated March 27, 2008, by and between Registrant and each investor signatory thereto (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 28, 2008, and incorporated herein by reference).
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10.29
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Purchase Agreement by and between Registrant and Robert Burlingame, dated January 26, 2009 (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed January 29, 2009 and incorporated herein by reference).
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10.30
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Purchase Agreement by and between Registrant and Non-Affiliated Investors, dated January 26, 2009 (included as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed January 29, 2009 and incorporated herein by reference).
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10.31
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Revenue Sharing Distribution Agreement by and between Registrant and VetCure, Inc., dated January 26, 2009 (included as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed January 29, 2009 and incorporated herein by reference).
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10.32
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Purchase Agreement by and between Registrant and certain accredited investors, dated February 6, 2009 (originally filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 9, 2009, and refiled as Exhibit 10.32 to the Company’s Quarterly Report on Form 10-Q filed November 4, 2010 to add investor lists and signature pages of investors).
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10.33
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Purchase Agreement by and between Registrant, Robert Burlingame and Seamus Burlingame, dated February 24, 2009 (incuded as Exhibit 10.4 to the Company’s Current Report on Form 8-K filed February 27, 2009 and incorporated herein by reference).
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10.34
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Amendment to Revenue Sharing Distribution Agreement by and between Registrant and Vetericyn, Inc., dated February 24, 2009 (included as Exhibit 10.5 to the Company’s Current Report on Form 8-K filed February 27, 2009 and incorporated herein by reference).
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10.35
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Agreement by and between Registrant and Robert C. Burlingame, dated April 1, 2009 (included as Exhibit 10.52 to the Company’s Annual Report on Form 10-K filed June 11, 2009 and incorporated herein by reference).
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10.36
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Microcyn U.S. Commercial Launch Agreement, by and between Registrant and Advocos, dated April 24, 2009 (included as Exhibit 10.53 to the Company’s Current Report on Form 10-K filed June 11, 2009 and incorporated herein by reference).
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10.37
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Amendment No. 5 to Lease by and between Registrant and RNM Lakeville, LLC, dated May 18, 2009 (included as Exhibit 10.54 to the Company’s Current Report on Form 10-K filed June 11, 2009 and incorporated herein by reference).
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10.38
|
Engagement Agreement by and between Registrant and Dawson James Securities, Inc., dated April 10, 2009, (included as Exhibit 10.55 to the Company’s Registration Statement on Form S-1 (File No. 333-158539), as amended, declared effective on July 24, 2009, and incorporated herein by reference).
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10.39
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Letter Agreement by and between Registrant and Dawson James Securities, Inc., dated July 2, 2009, (included as Exhibit 10.56 to the Company’s Registration Statement on Form S-1 (File No. 333-158539), as amended, declared effective on July 24, 2009, and incorporated herein by reference).
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10.40
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Letter Agreement by and between Registrant and Dawson James Securities, Inc., dated July 10, 2009, (included as Exhibit 10.57 to the Company’s Registration Statement on Form S-1 (File No. 333-158539), as amended, declared effective on July 24, 2009, and incorporated herein by reference).
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10.41
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Warrant Purchase Agreement by and between Registrant and Dawson James Securities, Inc., dated July 13, 2009, (included as Exhibit 10.58 to the Company’s Registration Statement on Form S-1 (File No. 333-158539), as amended, declared effective on July 24, 2009, and incorporated herein by reference).
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10.42
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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 Company’s Current Report on Form 8-K filed on May 6, 2010, and incorporated herein by reference).
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10.43
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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 Company’s Current Report on Form 8-K filed on May 6, 2010, and incorporated herein by reference).
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10.44†
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Amendment No. 2 to Revenue Sharing, Partnership and Distribution Agreement between the Registrant and Vetericyn, Inc., dated July 24, 2009 (refiled as Exhibit 10.44 to the Company’s Quarterly Report on Form 10-Q/A for the quarter ended September 30, 2010 filed April 29, 2011, and incorporated herein by reference).
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10.45†
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Amendment No. 3 to Revenue Sharing, Partnership and Distribution Agreement between the Registrant and Vetericyn, Inc. dated June 1, 2010 (refiled as Exhibit 10.44 to the Company’s Quarterly Report on Form 10-Q/A for the quarter ended June 30, 2010 filed April 29, 2011 and incorporated herein by reference).
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10.46†
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Amendment No. 1 to Exhibit A to the Revenue Sharing Distribution Agreement and to the Revenue Sharing, Partnership and Distribution Agreement as Revised and Amended, June 1, 2010, dated September 1, 2010 (included as Exhibit 10.46 to the Company’s Quarterly Report on Form 10-Q filed November 4, 2010 and incorporated herein by reference).
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10.47
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Continuous Offering Program Agreement, dated September 3, 2010 between Oculus Innovative Sciences, Inc. and Rodman & Renshaw, LLC (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed September 17, 2010, and incorporated herein by reference).
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10.48†
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Distribution Agreement between Oculus Innovative Sciences, Inc. and Tianjian Ascent Import and Export Company, Ltd dated January 28, 2011 (included as Exhibit 10.47 to the Company’s Quarterly Report on Form 10-Q filed February 4, 2011, and incorporated herein by reference).
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10.49†
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Exclusive Sales and Distribution Agreement between Oculus Innovative Sciences, Inc. and Quinnova Pharmaceuticals, Inc., dated February 14, 2011 (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 18, 2011, and incorporated herein by reference).
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10.50†
|
Exclusive Co-Promotion Agreement between Oculus Innovative Sciences, Inc. and Quinnova Pharmaceuticals, Inc., dated February 14, 2011 (included as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed February 18, 2011, and incorporated herein by reference).
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10.51
|
Product Option Agreement between Oculus Innovative Sciences, Inc. and AmDerma Pharmaceuticals, LLC, dated February 14, 2011 (included as Exhibit 10.3 to the Company's Current Report on Form 8-K filed February 18, 2011, and incorporated herein by reference).
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10.52*
|
Amendment No. 6 to Lease by and between Registrant and RNM Lakeville, L.P., dated May 31, 2011. | |
21.1
|
List of Subsidiaries (included as Exhibit 21.1 to the Company’s Quarterly Report on Form 10-Q filed November 4, 2010, and incorporated herein by reference).
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23.1*
|
Consent of Marcum LLP, independent registered public accounting firm.
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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.
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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.
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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.
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*
|
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.
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†
|
Confidential treatment has been granted with respect to certain portions of this agreement.
|
OCULUS INNOVATIVE SCIENCES, INC.
|
||
By:
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/s/ Hojabr Alimi
|
|
Hojabr Alimi
|
||
President and Chief Executive Officer
|
||
(Principal Executive Officer)
|
||
Signature
|
Title
|
Date
|
||
/s/ Hojabr Alimi
|
President, Chief Executive Officer and
|
June 3, 2011
|
||
Hojabr Alimi
|
Chairman of the Board
|
|||
(Principal Executive Officer)
|
||||
/s/ Robert E. Miller
|
Chief Financial Officer
|
June 3, 2011
|
||
Robert E. Miller
|
(Principal Financial Officer and
|
|||
Principal Accounting Officer)
|
||||
/s/ Gregg Alton
|
Director
|
June 3, 2011
|
||
Gregg Alton
|
||||
/s/ Jay Edward Birnbaum
|
Director
|
June 3, 2011
|
||
Jay Edward Birnbaum
|
||||
/s/ Richard Conley
|
Director
|
June 3, 2011
|
||
Richard Conley
|
||||
/s/ Gregory M. French
|
Director
|
June 3, 2011
|
||
Gregory M. French
|
||||
/s/ James Schutz
|
Director
|
June 3, 2011
|
||
James Schutz
|
|
|
By:
|
/s/ Hojabr Alimi
|
|
Hojabr Alimi
|
||
Chief Executive Officer
(Principal Executive Officer)
|
Date: June 3, 2011
|
By:
|
/s/ Robert E. Miller
|
Robert E. Miller
|
||
Chief Financial Officer
(Principal Financial Officer and Principal Accounting
Officer)
|
/s/ Hojabr Alimi
|
|
Hojabr Alimi
|
|
Chief Executive Officer and Principal Executive Officer
|
|
/s/ Robert E. Miller
|
|
Robert E. Miller
|
|
Chief Financial Officer, Principal Financial Officer and
|
|
Principal Accounting Officer
|