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Cytori Reports Publication of Cardiovascular Preclinical Study; Adipose Stem & Regenerative Cells Improve Function in Heart Attack Model
Thursday, May 28, 2009 7:16 AM


Cytori (NASDAQ: CYTX) announced publication of the first preclinical study to demonstrate adipose-derived stem and regenerative cells (ADRCs) significantly improved cardiac function after a heart attack. This preclinical cardiac cell therapy study was reported online ahead of print in the International Journal of Cardiology. The study was funded by Cytori Therapeutics and conducted at Tulane University.

“Treatment of cardiovascular disease, which places one of the greatest burdens on our healthcare system, could be revolutionized by cell therapy,” said Marc H. Hedrick, M.D., president of Cytori. “We observed a statistically significant improvement in heart function that contributed to our decision to proceed with our APOLLO study. Cardiovascular disease is the most advanced application in Cytori’s product pipeline and could eventually make a substantial contribution to our future commercial activities.”

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 are expected to be reported in early 2010. The APOLLO study is sponsored by Cytori and has incorporated the Company’s Celution® System to automate the processing of the patients’ cells at the point of care.

In Cytori's preclinical study, 17 large animals (pigs) were treated with their own uncultured adipose-derived stem and regenerative cells immediately following induction of a severe myocardial infarction. Uncultured cells include a multitude of heterogeneous cell types that Cytori believes facilitate several therapeutic mechanisms. Several functional measurements within the study indicated statistically significant improvement in both heart function and structure. The results are summarized in the table below.

Measurement   Cells   Control   Improvement   p
Perfusion Defect

% decrease

35 ± 9% 44 ± 5% 20% <0.05
Ejection Fraction

% increase

43 ± 7% 35 ± 3% 19% <0.05
Heart Wall Thickness

mm

11.2 ± 2.2 8.6 ± 1.6 23% <0.05
Capillary Density

per 0.1 mm2

41.6 ± 17.9 32.9 ± 12.6 21% <0.05

About Cytori

Cytori develops and globally commercializes regenerative medicine technologies, which provide real-time, point-of-care access to clinical grade regenerative cells. Our technology is incorporated into two product families. The Celution®-related products are sold throughout Europe and Asia primarily into the cosmetic and reconstructive surgery market and are under evaluation by the U.S. FDA. Our StemSource® products are sold globally for cell banking and research applications. We are also developing additional clinical uses of our technology for the treatment of multiple medical conditions, including cardiovascular disease, urinary tract disorders, and wound related conditions. To commercialize our technology, Cytori has partnered with global and regional leaders in healthcare such as Olympus Corporation, GE Healthcare, and Green Hospital Supply. www.cytoritx.com

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 statements, including, but not limited to, those regarding our preclinical research, clinical development, our ability to achieve or expand regulatory status or marketing approvals and executing on our commercialization activities, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection of intellectual property rights, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, as well as 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.

Cytori Therapeutics
Investor Contact:
Tom Baker
858.875.5258
tbaker@cytoritx.com

(Source: Business Wire )


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