Cytori (NASDAQ: CYTX): FDA 510(k) Celution Clearance, Heart Data Pending Print E-mail
Friday, 08 January 2010 09:05

On 1/7/10, the FDA granted marketing clearance to Cytori Therapeutics (NASDAQ: CYTX) for the PureGraft System, which will be launched as the first and only device in the US cleared for aesthetic body contouring using autologous (patient-derived) fat (including both small / large volumes, ranging from 50 to 250mL) and allows a patient's own fat tissue to rapidly be prepared in about 15 minutes for re-injection and aesthetic contouring.

Cytori expects to launch PureGraft in the US during 1Q10 with a formal launch at the American Society of Aesthetic Plastic Surgeons in May 2010. Marketing approval (CE Mark) is pending in Europe and expected during 1H10.

On 5/27/09, Cytori announced that it completed enrollment in the first study to investigate adipose derived stem and regenerative cells in chronic heart disease. The trial, which has been named the PRECISE study, was carried out at leading cardiology centers in Europe. It specifically enrolled patients suffering from an advanced form of chronic heart disease, known as chronic myocardial ischemia, for which there is no generally accepted treatment. The trial enrolled 27 patients and was designed as a double-blind, randomized, placebo controlled, dose escalation study. The primary objectives of the study were to assess safety and feasibility of Cytori's Celution System as part of a novel procedure for chronic heart disease.

The Company believes it will be able to fully assess these primary objectives with the data obtained from 27 patients (the protocol allowed for up to 36 patients). Further, the independent data safety and monitoring board had not identified any safety concerns relating to the Celution output or the procedure. Six month results are expected during 1H10. On 5/28/09, Cytori announced the publication of the first preclinical study to demonstrate ADRCs significantly improved cardiac function after a heart attack. The APOLLO study is the first clinical trial to investigate uncultured adipose-derived stem and regenerative cells in heart attacks in human patients. Enrollment was recently completed in APOLLO, a double blind, placebo controlled, safety and feasibility trial. Data from this study is expected to be reported during 1Q10.

The ProActive News Room website for Cytori contains a link to a product demo video for PureGraft, in addition to other report downloads, video interviews, market data, medical / scientific presentations, and more.

Disclosure: Long CYTX

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