DS Healthcare Group, Inc. 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 Oct. 29, 2013 the company announced it had filed a patent with the US 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 toward designing and conducting clinical trials in the US 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.
DS Healthcare Group Inc. develops 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).