Cytori Therapeutics, Inc. (NASDAQ: CYTX) today reported that stem and regenerative cells derived from adipose tissue (ADRCs) improved patient outcomes in two European clinical studies, one in acute heart attacks and the other in chronic heart disease. Both studies incorporated Cytori’s proprietary cell processing device, the Celution® System, as the means to separate, concentrate and prepare each patient’s own cells for re-injection in the same procedure.

- Both trials demonstrated that the Celution System-based procedure was safe and feasible

- Data from the 14 patient acute heart attack study, referred to as APOLLO, showed a substantial reduction in the size of injury to the heart, an improvement in the amount of blood supply to the heart muscle, and a corresponding functional improvement in the amount of blood the heart can pump. Infarct size in particular, based on emerging data by the medical community and literature, is what we believe to be the most important predictor of re-hospitalization for heart failure, subsequent infarct, and death

- Data from the 27 patient chronic heart disease study, referred to as PRECISE, showed a reduction in the extent of infarct size in the left ventricle and a statistically significant improvement in maximum oxygen consumption (MVO₂) and patients’ aerobic capacity measured as metabolic equivalents (METS)

Based on the biological, physiological and functional effects from the APOLLO heart attack study, Cytori is now planning to initiate a pivotal study for EU approval for the Celution® System in this indication.  Of the two indications, we believe we can bring acute heart attack to market in the shortest amount of time in Europe, where CE Mark regulatory approval for this indication would cover multiple countries and present a market opportunity of greater than 1.9 million patients per year. In parallel, we will begin making plans for a U.S. study, which we would look to fund through a co-development partnership.

Cytori is very encouraged by the data from the PRECISE chronic heart disease trial which is for a more complex disease state. For this reason, Cytori is awaiting data from 12 and 18 month follow up, which will help in the design of a pivotal study. Such a study would be funded by Cytori or a prospective partner.

The results from the two European safety and feasibility studies were reported at the 7th International Symposium on Stem Cell Therapy & Cardiovascular Innovation in Madrid Spain. More details on the outcomes of both studies may be found in the press releases posted in this webpage and in the accompanying videos and resources.

Cautionary Statement Regarding Forward-Looking Statements

This release includes forward-looking statements regarding events, trends, business prospects and particularly relating to the APOLLO and PRECISE 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, the significance of the improvements in the cell treated groups, other benefits believed to be imparted by the treatments discussed above, and our ability to design and implement a protocol in potential subsequent studies,are all subject to risks and uncertainties that could cause the results of more comprehensive clinical studies to differ materially from those presented above. Some of these risks and uncertainties include, but are not limited to, risks related to statistical power of the studies, the need for further clinical studies to confirm the above referenced outcomes, inherent risk and uncertainty in the costs and potential variability of outcomes in a pivotal acute heart attack or chronic heart disease 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.