Cytori Therapeutics Inc (NASDAQ:CYTX) 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. (Original Source)
Shares of Cytori Therapeutics closed yesterday at $0.4001. CYTX has a 1-year high of $2.21 and a 1-year low of $0.36. The stock’s 50-day moving average is $0.56 and its 200-day moving average is $0.77.
On the ratings front, Cytori has been the subject of a number of recent research reports. In a report issued on June 15, Roth Capital analyst Joseph Pantginis maintained a Buy rating on CYTX, with a price target of $6, which represents a potential upside of 1399.6% from where the stock is currently trading. Separately, on the same day, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $7.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Jason Kolbert have a total average return of 4.6% and -4.7% respectively. Pantginis has a success rate of 45.2% and is ranked #677 out of 3717 analysts, while Kolbert has a success rate of 33.3% and is ranked #3644.
Cytori Therapeutics Inc is engaged in the development of novel treatments for cardiovascular disease and soft tissue injuries and burns.