MissionIR News - Cytori Therapeutics Gets Green Light from FDA to Initiate Cardiac Cell Therapy Trial

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Investigational Device Exemption allows for investigation of Celution® System in U.S.

MissionIR would like to highlight Cytori Therapeutics, Inc., a publicly traded company that provides patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. These technologies enable the research and practice of regenerative medicine in a way that, until now, has not been possible.

In the company’s news yesterday,

Cytori Therapeutics announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration to begin the ATHENA trial to investigate the use of the company’s Celution® System.

Cytori develops medical technologies to realize the potential of adult regenerative cells from fatty (adipose) tissue. The Celution® System is an innovative medical device to prepare adipose-derived stem and regenerative cells (ADRCs) to treat chronic myocardial ischemia (CMI), a form of coronary heart disease. The company sells its Celution® System family of medical devices in the European and Asian cosmetic and reconstructive surgery markets. Per today’s news, the device is available in the U.S. as an investigational advice.

“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,” Christopher J. Calhoun, CEO for Cytori stated in the press release. “We look forward to working with the FDA on further defining our clinical strategy in the U.S.”

The ATHENA trial will enroll up to 45 patients to evaluate several clinical and functional outcomes, including safety, peak oxygen consumption (mVO2), and clinical outcomes at 12 months.

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Forward-Looking Statement:
This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.


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