PETALUMA, Calif., Dec. 12, 2013 (GLOBE NEWSWIRE) -- Oculus Innovative Sciences, Inc. (Nasdaq:OCLS) a global healthcare company that designs, manufactures and markets prescription and non-prescription products 27 countries, today announced a regulatory approval in Mexico for the company's new Microcyn®-based scar management hydrogel, under the brand name Epicyn™.
Bruce Thornton, executive vice president of Oculus said: "From a corporate perspective, this is just the first of many opportunities for our new scar management hydrogel formulation outside the United States. In addition to the approval by the Mexican Ministry of Health, our Latin American partner, More Pharma, in parallel with the introduction of the new Epicyn™ Scar Hydrogel in the Mexican dermatology market, intends to move forward to secure regulatory approvals, and subsequent product launches, in additional Latin American countries as well. We are exceedingly proud of our teams in both Mexico and the United States for working in tandem to secure respective regulatory approvals." Oculus announced FDA 510(k) regulatory clearance for the Microcyn® Scar Management HydroGel this past week.
The medical device approval by the Mexican Ministry of Health is for the care of keloid and hypertrophic scars. In preparation for a commercial launch in the summer of 2014, More Pharma, in concert with Oculus, plans to conduct an additional clinical study in the first half of 2014, similar to one conducted for the FDA in the United States. This clinical study will evaluate the safety and efficacy profile of Epicyn™ relative to the current standard of scar management in Mexico, thus providing key opinion leaders the clinical data to support adoption of the new Microcyn-based technology.
Guillermo Ibarra, More Pharma's CEO said, "Since we acquired the license to the Microcyn-based products in 2012, our customers have come to recognize the Microcyn Technology as a highly efficacious product in both advanced wound care and dermatology. This new scar management hydrogel will simply build upon this established legacy of safety and success in Mexico. We look forward to bringing doctors and patients in Mexico, Central America, Caribbean and other Latin American countries a genuine advance in the management of scars."
About Oculus Innovative Sciences
Oculus Innovative Science is a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 27 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.
About More Pharma
Founded in 2007, More Pharma is a pharmaceutical company with strong growth performance and a team of more than 300 people. The company has a talented sales and marketing team with significant prior experience with large international pharmaceutical companies. They have ample funding and support by their renowned financial sponsors, Southern Cross Group and Evercore, both of which manage more than $1 billion of venture funds. The company is dedicated to finding solutions to healthcare challenges via product development, in-licensing and product acquisitions. With headquarters in Mexico City, More Pharma has a presence in Mexico, Latin America and the Caribbean. More information can be found at www.morepharmacorp.com/eng/compania.php
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 "growth," "expansion" and "build," 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.
CONTACT: Media and Investor Contact: Oculus Innovative Sciences, Inc. Dan McFadden VP of Public and Investor Relations (425) 753-2105Source:Oculus Innovative Sciences, Inc.