SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that Kerastem Technologies, a wholly owned subsidiary of Bimini Technologies, received U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to conduct a clinical trial studying the safety and feasibility of its technology for the treatment of female and early male pattern baldness (androgenic alopecia).
The phase II study, known as the STYLE trial, follows initial clinical work in Europe and Japan. This clinical experience served as a basis for the FDA IDE submission. The data will be presented in September at the 2015 International Society of Hair Restoration Surgery meeting in Chicago. STYLE is a 70 patient controlled trial that is expected to begin enrollment in late 2015 at up to eight (8) centers within the United States. The primary endpoint is safety and tolerability of the treatment and secondary endpoints include change in hair growth and density.
In 2013, Bimini, a private medical technology company, acquired global and exclusive rights to commercialize Cytori Celution® Technology for alopecia and hair related indications. Under the commercial agreement, Bimini will be responsible for all key activities including clinical studies, regulatory approvals, and market development. Bimini will acquire Cytori products at agreed upon transfer pricing and pay Cytori a perpetual royalty on sales.
For more information on the STYLE trial, visit www.kerastem.com or https://clinicaltrials.gov/ct2/show/NCT02503852?term=Kerastem&rank=1
About Cytori Therapeutics, Inc.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, those regarding presentation of clinical data and conduct of clinical trials, as well discharge of product, royalty payment and other obligations, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori’s Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
