DS Healthcare Group Prepares to File Investigational New Drug Application with FDA for Prescription Hair Loss Treatment

Move follows recent patent application for topical prescription-grade treatment


Pompano Beach, Jan. 9, 2014 (GLOBE NEWSWIRE) --  DS Healthcare Group, Inc.(NASDAQ:DSKX), a leading developer of personal care products, today announced it is preparing to submit to the United States Food and Drug Administration (FDA) an Investigational New Drug Application (IND) for its proprietary topical hair loss treatment. On October 29, 2013 the Company had announced it filed a patent with the United States Patent and Trademark Office for the invention. An IND is a request for the FDA's authorization to administer an investigational drug to humans and is the first step towards designing and conducting clinical trials in the U.S. DS Healthcare is currently in late stage discussions with various clinical research organizations (CROs) to design and conduct clinical trials for its breakthrough hair loss treatment.

"The highly lucrative prescription market for hair loss treatments currently does not serve the needs of many patients. Regulatory approval, plus our patent-pending technology would expand our leadership position in hair loss therapies," stated DS Healthcare President and CEO Daniel Khesin.

"We believe our proprietary treatment offers unique benefits that may result in greater efficacy without the undesirable side effects of other prescription hair loss drugs on the market today. Currently there are only two applications approved by the FDA for hair loss. One is an oral tablet and the other is a topical treatment," Khesin added.  

About DS Healthcare Group

DS Healthcare Group Inc. leads in the development of biotechnology for topical, and nutritional therapies. It markets through online and specialty retailers, distributors, cosmetics wholesalers, and salons. Its brands include DS Laboratories (www.DSLaboratories.com), Sigma Skin (www.SigmaSkin.com), Polaris Research Laboratories (www.PolarisReserachLabs.com) and The Pure Guild (www.ThePureGuild.com).

Forward-looking statements

Except for statements of historical fact, the matters discussed in this press release are forward-looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies, and are generally preceded by words such as "future," "plan" or "planned," "expects," or "projected." These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing and marketing products, intense competition, and additional risks factors as discussed in reports filed by the company with the Securities and Exchange Commission, which are available at http://www.sec.gov.



            

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