Healthcare Industry News: diabetic foot ulcers
News Release - April 23, 2008
Oculus Innovative Sciences Appoints Michelle Carpenter, JD, RAC, as Vice President of Regulatory Affairs and QualityPETALUMA, Calif.--(HSMN NewsFeed)--Oculus Innovative Sciences, Inc. (Nasdaq:OCLS ) today announced the appointment of Michelle Carpenter, JD, RAC, to the position of vice president of regulatory affairs and quality. Ms. Carpenter will lead and manage the company’s regulatory and quality personnel and activities including key negotiations with the FDA regarding clinical development initiatives. Her experience further strengthens Oculus’ management team in preparation for the upcoming End-of-Phase II meeting discussions with the FDA.
Ms. Carpenter joins Oculus as a pharmaceutical industry professional with 15 years of diversified experience in the areas of regulatory affairs, project management and compliance. Previously, she served as vice president of regulatory/medical affairs and chief compliance officer at DEY, L.P., a pharmaceutical drug delivery company where she developed and implemented clinical and regulatory strategies. She has been responsible for several successful IND, NDA and MAA regulatory filings during her career.
Michael Wokasch, COO of Oculus, commented, “We are pleased to welcome Ms. Carpenter to our management team. She is a talented and experienced individual who will be our primary liaison with the FDA. Her experience will be especially helpful given the critical stage we are at in our development of Microcyn Technology for patients with diabetic foot infections.”
Ms. Carpenter started her career at Oclassen Pharmaceuticals before moving into regulatory affairs at Insite Vision and then at Santen, where she served as global vice president of regulatory and project management. Ms. Carpenter received her doctor of jurisprudence from Golden Gate University school of law with an emphasis on health law. She earned an undergraduate degree in sociology with the majority of her coursework in pre-medicine at the University of California at Santa Barbara.
Ms. Carpenter stated, “Oculus has a compelling platform technology, sound business model, and strong global presence through various commercial partners. I believe that Microcyn has excellent potential as a treatment for both acute and chronic wounds, and I am very excited about the recently announced positive data from the U.S. Phase II clinical trial. I look forward to working with the rest of the management team in fulfilling both near-term and future clinical and regulatory goals to expand Microcyn’s market opportunities.”
Oculus Innovative Sciences is a biopharmaceutical company that develops, manufactures and markets a family of products based upon the Microcyn® Technology platform, which is intended to help prevent and treat infections in chronic and acute wounds. The Microcyn Technology platform is a biocompatible, shelf-stable solution containing active oxychlorine compounds that is currently commercialized outside the United States for the treatment of infected wounds. The solutions derived from the Microcyn Technology platform have demonstrated, in a variety of research and investigational studies, the ability to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE), viruses, fungi and spores.
The technology has also demonstrated wound healing in chronic and acute wounds in clinical investigational studies. A recently completed U.S. Phase II clinical trial of Microcyn Technology met the primary endpoints of safety and efficacy for the treatment of mildly infected diabetic foot ulcers.
Oculus' principal operations are in Petaluma, California, and it conducts operations in Europe, Latin America and Japan through its wholly owned subsidiaries, Oculus Innovative Sciences Netherlands B.V., Oculus Technologies of Mexico, S.A. de C.V. and Oculus Japan K.K. Oculus' website is www.oculusis.com.
Except for historical information herein, some 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. These forward-looking statements are identified by the use of words such as "upcoming," "will be,” “potential,” and "to expand," 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 risks inherent in the development and commercialization of potential products, the risk that regulatory clinical and guideline developments may change, the risk that scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, the risk that clinical results may not be replicated in actual patient settings, the risk that protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, the risk that present trends will continue and that the available market for our products will not be as large as expected, the risk that our products will not be able to penetrate one or more targeted markets, the risk that revenues will not be sufficient to fund further development and clinical studies, the Company's future capital needs, and its ability to obtain additional funding and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including the quarterly report on Form 10-Q for the quarter ended December 31, 2007. Oculus Innovative Sciences disclaims any obligation to update these forward-looking statements.
Oculus and Microcyn are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners.
Source: Oculus Innovative Sciences
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