Global Home EUROPE
Austria Austria

 

Innovative Sciences, Disruptive Technologies

 

OCULUS INNOVATIVE SCIENCES ANNOUNCES COMPANY’S FIRST U.S. CLINICAL TRIAL ON HUMANS

Results will support new drug application for Microcyn® Technology to be used as an anti-microbial preoperative and pre-injection skin preparation.

PETALUMA, CA-- (June 17, 2005)— Theresa Mitchell, vice president of regulatory and clinical affairs for Oculus Innovative Sciences, today announced that the company has initiated its first United States clinical trial on humans to gain approval for the Microcyn® Technology to be marketed as an anti-microbial preoperative and pre-injection skin preparation. The company anticipates the technology to demonstrate both safety and efficacy, while remaining non-irritating and non-toxic.

According to Mitchell, “This is a major step towards Oculus’ eventual pursuit of FDA review for a new drug application that may allow for claims of anti-microbial characteristics on open wounds and skin ulcers, such as those experienced by burn or diabetic foot ulcer victims.”

This Phase I study includes 290 volunteers and is being conducted at BioSciences Laboratories in Bozeman, Montana. Ms. Mitchell indicates the company expects significant clinical data from this study by fall of this year.

The company will also be initiating other clinical studies in Europe and the U.S. that it intends to announce this summer. These studies are expected to provide supporting data for the technology’s anti-microbial claims as they relate to treatment of open wounds and will be submitted to the U.S. Food and Drug Administration. This is a critical step in improving upon the “standard of care” in healthcare institutions as a result of integrating the Microcyn® Technology into traditional wound care regimens.

Microcyn® Technology is a super-oxidized, pH-neutral solution that is ready for use with no dilution or mixing, and requires no special handling or disposal. It is manufactured using a sophisticated, multi-chamber electrolysis process in which ionic species are selectively produced and isolated. This process allows for the production of a pH-neutral solution while minimizing the level of chlorine in the final product.

The company received its first two FDA 510K clearances last month to market Dermacyn™ Wound Care, formulated with the Microcyn® Technology, in the United States as a medical device to lubricate, moisten, cleanse and debride wounds and burns. The company also received CE approval according to the European Medical Devices Directive (93/42/EEC) for Dermacyn™ Wound Care in April. It was certified as a Class IIb medical device for treating acute and chronic wounds (e.g. diabetic foot ulcers and burns) as part of a comprehensive wound care regimen.

The Microcyn® Technology received approval as a disinfectant, antiseptic and sterilant from the Mexican Ministry of Health in 2003 where the product is now widely commercialized and in use for the treatment of myriad wounds and burns. Dermacyn™ Wound Care, with the Microcyn® Technology, also received regulatory approval this past November from the Therapeutic Product Directorate, the Canadian federal authority that regulates pharmaceutical drugs and medical devices, as a dermal wound irrigant that facilitates removal of wound debris as it cleanses and debrides.

 

About Oculus
Oculus Innovative Sciences, headquartered in Petaluma, California, is an innovator in the development of “landscape-altering” medical devices and pharmaceutical products.

The company’s first proprietary technology platform, Microcyn® super-oxidized water, is a non-toxic, shelf-stable anti-microbial with the potential to revolutionize the wound treatment market. It has proven effective in safely and quickly killing bacteria (including antibiotic-resistant strains such as MRSA and VRE in vitro), viruses, spores, and fungi. The company also has a promising oncology compound under development that will be entered into clinical trials for the treatment of cervical dysplasia, a pre-cancerous condition.

Oculus has employees and operations in Mexico, Europe and the U.S. and includes two wholly owned subsidiaries, Oculus Technologies of Mexico, S.A. de C.V., and Oculus Innovative Sciences Netherlands B.V. Please visit us at www.oculusis.com.

 

Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. These forward-looking statements relate to, among other things, plans and timing for the introduction of our products, statements about future market conditions, supply and demand conditions, revenues, gross margins, operating expenses, profits and other expectations, intentions and plans contained in this press release that are not historical fact. Our expectations as expressed in this press release depend upon our ability to develop, manufacture and supply products that meet defined specifications. When used in this press release, the words “plan,” “expect,” “believe,” and similar expressions generally identify forward-looking statements. These statements reflect our current expectations. They are subject to a number of risks and uncertainties, including, but not limited to, changes in technology and changes in the health sciences market. In light of the many risks and uncertainties surrounding this market, you should understand that we cannot assure you that the forward-looking statements contained in this press release will be realized.

 

(Download PDF: 115 KB)