SAN DIEGO, CA--(Marketwire - January 20, 2011) - Cytori Therapeutics (
In Dr. Duckers' presentation, ADRC therapy was associated with a significantly lower incidence of ventricular tachyarrhythmias. A total of three episodes of ventricular tachyarrhythmia were reported in the treated group as compared to 10 in the control group (p=0.018). On a per patient basis, the treated group experienced a mean of 0.3 episodes of ventricular tachyarrhythmias as compared to 2.5 in the control group (p=0.048). The analysis of Holter recordings also indicated lower incidence of premature ventricular contractions (PVC, a single abnormal beat) in patients treated with ADRCs. In ADRC-treated patients, 5 PVCs per patient, per day, were reported whereas in placebo-treated patients, the number of PVCs reported per patient, per day, was 72 (p=0.014).
Forty-eight hour Holter recordings were obtained weekly for the first month after discharge followed by 24-hour recordings at 2, 3, 4 and 6 months post-procedure. All Holter recordings were assessed by an independent, blinded Holter core laboratory. Post-hoc data analyses of Holter data were conducted independently by Thoraxcentre.
"Although not the primary study endpoint, the observed reduction in arrhythmias supports the safety of ADRCs in the treatment of patients with an acute heart attack," said Dr. Duckers. "Furthermore, the data presented are consistent with previously reported results from Cytori's preclinical studies."
Six month primary outcomes were reported from the APOLLO study in May 2010 at the 7th International Symposium on Stem Cell Therapy & Cardiovascular Innovation in Madrid, Spain.
About Cytori
Cytori is a leader in providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. The Celution® System family of medical devices and instruments are being sold into the European and Asian cosmetic, reconstructive surgery and wound markets. The Celution® System is not yet available in the United States. Our StemSource® product line is sold globally for cell banking and research applications. www.cytori.com
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends, business prospects and particularly the APOLLO clinical study results, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding improvements in patient outcomes, and other benefits that may to be attributable to the treatments discussed above, are all subject to risks and uncertainties that could cause the results of a more comprehensive clinical study to differ materially from those presented above. Some of these risks and uncertainties include, but are not limited to, risks related to the statistical power of the APOLLO study, the need for further clinical studies to confirm the above referenced outcomes, inherent risk and uncertainty in the costs and potential variability of outcomes of a pivotal heart attack study, regulatory uncertainties regarding the collection and results of clinical data, and 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 on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
Contact Information:
Contact:
Megan McCormick
858.875.5279
mmccormick@cytori.com