Oculus Innovative Sciences Files for Patent Protection on Breakthrough Wound Care Device to Accelerate Wound Healing
PETALUMA, Calif.--(BUSINESS WIRE)--
Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), a biopharmaceutical company that develops, manufactures and markets a family of products based upon the Microcyn(R) Technology platform, announced today that it has filed a patent application with the U.S. Patent and Trademark Office in which it seeks patent protection for a breakthrough wound care device.
The patent application describes a device that delivers a Microcyn-based solution to a chronic or acute wound site and transports organic load away from the wound bed via a vacuum process. The device will have the capability to monitor the wound environment and deliver additional Microcyn solution to the wound when required. The device's innovative sponge-free dressing avoids contact with the wound, thereby eliminating the common practice of repeatedly debriding otherwise healthy fibroblast as dressings are changed. Unnecessary trauma to the wound bed can hamper or delay wound healing.
Hoji Alimi, founder and CEO of Oculus, said, "While there have been some modest advances in wound care over the past few decades with the advent of new dressings and negative-pressure vacuum devices, a significant number of hard-to-heal wounds remain a challenge. As a result, there are more than 100,000 amputations in the U.S. alone. This device provides a novel approach to wound care by delivering the Microcyn-based solution to the wound while eliminating the practice of frequent dressing changes as is standard today. This device is designed with a focus on preserving healthy fibroblast growth within the wound bed."
In the United States, a 510k clearance is typically a quicker regulatory process and may provide Oculus with a significant new market in which the Microcyn Technology can play an increased role in the management of wounds. Meanwhile, the company continues to advance its U.S. clinical program for drug approval of the Microcyn Technology in the treatment of mildly infected diabetic foot ulcers with the recent submission of a request for an End-of-Phase II meeting with the FDA.
Alimi continued, "We see great value in securing the drug approval for the Microcyn Technology to reduce the amount of antibiotics used in the treatment of infected diabetic ulcers. At the same time, based upon substantial U.S. wound care market feedback on physician use of our FDA 510k cleared Dermacyn Wound Care, we believe that this new device, in combination with Dermacyn, will make us commercially competitive in a number of additional markets."
U.S. Wound Care Market
In 2005, chronic and acute wound care represented an aggregate of $9.6 billion in global product sales, of which $3.3 billion was spent for the treatment of skin ulcers, $1.6 billion to treat burns and $4.7 billion for the treatment of surgical and trauma wounds, according to Kalorama Information, a life sciences market research firm. According to Medtech Insight, a Division of Windhover Information, over 51 million wound incidents were reported in the United States during 2004, of which over six million were chronic wounds and approximately 46 million were acute wounds.
About Oculus
Oculus Innovative Sciences is a biopharmaceutical company that develops, manufactures and markets a family of products based upon the Microcyn(R) Technology platform. The Microcyn Technology platform is a biocompatible, shelf-stable solution containing active oxychlorine compounds that is currently commercialized outside the United States (Europe, India and Mexico) for the treatment of a wide variety of wound types.
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.
Forward-Looking Statements
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, including statements about our plans to move forward in our clinical program, our intent to secure a new drug approval or our ability to secure a patent for this wound delivery system. These forward-looking statements are identified by the use of words such as "seeks," "provides," "eliminating," "may provide," and "will make," 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, Inc.
Released June 4, 2008