07.28.15
Bimini Technologies LLC, which recently bought commercialization rights to Cytori Therapeutics Inc.’s Cytori Celution technology for alopecia, has received the go-ahead from the U.S. Food and Drug Administration (FDA) for a clinical trial for the technology. The investigational device exception (IDE) allows the trial to investigate studying the safety and feasibility of Cytori Celution 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, Ill. Style is a 70-patient controlled trial that is expected to begin enrollment in late 2015 at up to eight 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.
Under Bimini’s commercial agreement with Cytori, Bimini will be responsible for all key activities including clinical studies, regulatory approvals, and market development of the device. Bimini will acquire Cytori products at agreed upon transfer pricing and pay Cytori a perpetual royalty on sales.
Cytori Therapeutics and Bimini are both cell therapy companies developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Both companies are based in San Diego, Calif.
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, Ill. Style is a 70-patient controlled trial that is expected to begin enrollment in late 2015 at up to eight 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.
Under Bimini’s commercial agreement with Cytori, Bimini will be responsible for all key activities including clinical studies, regulatory approvals, and market development of the device. Bimini will acquire Cytori products at agreed upon transfer pricing and pay Cytori a perpetual royalty on sales.
Cytori Therapeutics and Bimini are both cell therapy companies developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Both companies are based in San Diego, Calif.