Cytori Receives Approval From FDA to Initiate U.S. Cardiac Cell Therapy Trial; Investigational Device Exemption (IDE) Approved for ATHENA

(PresseBox) ( San Diego,CA, )
Cytori Therapeutics (NASDAQ: CYTX) has received an Investigational Device Exemption (IDE) approval from the U.S. FDA to begin the ATHENA trial. ATHENA will investigate the use of the Celution® System, an innovative medical device to prepare adipose-derived stem and regenerative cells (ADRCs) to treat a form of coronary heart disease, chronic myocardial ischemia (CMI). The IDE application was originally submitted to the FDA in December 2011.

ATHENA is a multi-center, randomized, double blind, placebo controlled, pilot trial to investigate the use of autologous, clinical-grade ADRCs, processed at the point-of-care with Cytori's proprietary Celution® System. The trial will enroll up to 45 patients with no-option CMI who have limited therapeutic options. It will evaluate a variety of clinical and functional outcomes, including safety, peak oxygen consumption (mVO2), and clinical outcomes at 12-months.

"Following our pre-IDE meeting with the FDA, we received constructive guidance and implemented the Agency's recommendations, ultimately resulting in rapid approval to initiate the ATHENA trial," said Christopher J. Calhoun, chief executive officer for Cytori. "We look forward to working with the FDA on further defining our clinical strategy in the U.S."

Previously, Cytori reported six and 18-month trial data from PRECISE, a European clinical trial for this same indication showing improvement in mVO2. In Europe, Cytori has applied to expand its Celution® System CE Mark to include no-option CMI claims based on data from the PRECISE trial. Cytori is also enrolling ADVANCE, a European pivotal trial investigating the Celution® System for acute myocardial infarction (heart attacks).

In the U.S., it is estimated that 120,000 to 250,000 patients are diagnosed each year with chronic myocardial ischemia, a subset of the approximate 5.8 million patients who currently have some form of heart failure. CMI patients typically have undergone multiple revascularization procedures that have not improved their condition and are at a stage where they have few therapeutic options remaining.

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 as the successful initiation of a clinical trial of the Company's Celution® System for chronic myocardial ischemia, our efforts to expand our CE Mark. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical and regulatory uncertainties, such as those associated with the ATHENA clinical trial, including risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
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