-
First International Consensus Guidelines published in December 2013 issue of Journal of Plastic and Reconstructive Surgery
- Microcyn® Solution Only One of Two Irrigation Products Available in the United States Receiving "Strong Consensus" from Panel of Medical Experts
PETALUMA, Calif., April 9, 2014 (GLOBE NEWSWIRE) -- Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 33 countries, today announced that the company's Microcyn® Negative-Pressure Wound Therapy Solution™ received a "strong consensus" rating for use with Kinetic Concepts Inc.'s (KCI) Negative Pressure Wound Therapy with Instillation (NPWTi) as identified in the First International Consensus Guidelines.
The guidelines were published in the December 2013 issue of Journal of Plastic and Reconstructive Surgery. In addition to Microcyn, only one other irrigation solution available in the United States also received strong consensus (greater than 80% agreement of the panel) for use with NPWTi. That product is a broad-spectrum, polynexanide-based antimicrobial solution.
Other solutions reviewed, including acetic acid, sodium hypochlorite, silver nitrate and saline, did not achieve the panel support necessary for a "strong consensus" rating from the group.
The international consensus panel, convened by MedStar Georgetown University Hospital (through an unrestricted educational grant from KCI), provides the first authoritative guidance on the appropriate use of NPWTi. The guidelines include nine major consensus statements that provide clinical guidance in the following areas:
- Appropriate wound types that would benefit from instillation therapy
- Importance of debridement for acutely infected, chronically infected, or contaminated wounds
- Appropriate instillation solutions, volume of solution and soak time
- Appropriate pressure settings and modes
- Optimal duration of NPWTi
"We're honored that Microcyn's safety and efficacy in a negative pressure wound therapy setting has generated such overwhelming support from a truly premiere slate of healthcare professionals," said Dr. Robery Northey, Oculus' vice president of research and development. "Our research and development team continues to work diligently to create a variety of Microcyn-based solutions that are safe and compatible in a broad array of indications and devices, including negative pressure instillation."
"Negative-Pressure Wound Therapy with Instillation: International Consensus Guidelines" is available in print or by visiting www.PRSJournal.com. The guidelines represent the collective opinions, derived from literature and practice support, of medical experts in the field, including panel experts Paul J. Kim, D.P.M., M.S., Christopher E. Attinger, M.D., John S. Steinberg, D.P.M., Karen K. Evans, M.D., Burkhard Lehner, M.D., Christian Willy, M.D., Ph.D., Larry Lavery, D.P.M., M.P.H., Tom Wolvos, M.D., M.S., Dennis Orgill, M.D., Ph.D., William Ennis, D.O., M.B.A., John Lantis, M.D., Allen Gabriel, M.D. and Gregory Schultz, Ph.D.
About Negative Pressure Wound Therapy
Traditional negative pressure wound therapy (NPWT), as noted by Tom Wolvos, MD, in the recent publication of Surgical Technology International XXIV, revolutionized the treatment of complex wounds since it became commercially available in 1995. It is a system that typically consists of open-cell reticulated polyurethane foam cut to size and placed into a wound. The foam is covered by a semi-permeable clear drape. Suction tubing is placed over a hole cut in the drape. The other end of the tubing is then attached to a pump that delivers negative pressure to the wound in a continuous, or intermittent fashion, and is controlled by a computerized microprocessor. NPWT had been shown to cause macrodeformation by contracting the foam and thus exaggerating wound contraction, and microdermation of the cells in the wound as they are drawn into the interstices of the foam, stimulating cellular division to help fill in and accelerate healing of the wound.
A modification in 2003 of the NPWT system added automated intermittent instillation of topical wound irrigation solutions to traditional NPWT. The modified system is indicated for wounds that would benefit from the combination of negative pressure wound therapy combined with intermittent instillation of topical wound solutions and suspensions.
About Oculus Innovative Sciences
Oculus Innovative Science is a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 33 countries. The company's products are used to treat patients in surgical/advanced wound management, dermatology, women's health and animal health; addressing the unmet medical needs of these markets—while raising the standard of patient care and lowering overall healthcare costs. The company's headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. More information can be found at www.oculusis.com.
Forward-Looking Statements
Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the Company's commercial and technology progress and future financial performance. These forward-looking statements are identified by the use of words such as "create" and "generated," among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital needs, and its ability to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including the annual report on Form 10-K for the year ended March 31, 2013. Oculus Innovative Sciences disclaims any obligation to update these forward-looking statements except as required by law.
Oculus® and Microcyn® Technology are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners.