SAN DIEGO, CA--(Marketwire - November 15, 2010) - Adipose (fat) tissue-derived regenerative cells (ADRCs) obtained using the Celution® System demonstrated a statistically significant improvement in cardiac functional capacity (MVO2) at 18 months in Cytori's (
The trial demonstrated the following outcomes in no-option chronic ischemic heart disease patients:
- The statistically significant improvement in MVO2 (maximum oxygen consumption) in the cell treated group compared to the control group, first demonstrated at six months, is sustained at 18 months;
- The statistically significant improvement in patients' ability to perform physical activity, as measured by metabolic equivalents (METS), in the cell treated group compared to the control group is sustained from 6 to 18 months; and
- The procedure, which includes withdrawing fat tissue, separating out the regenerative cells using Cytori's Celution® System, and re-injecting the cells into the patient's heart, has previously been found to be safe and feasible, with no safety concerns emerging during the 18-month observation period.
- ADRC treated patients had a lower cardiac mortality rate compared to the control. At an average follow up of 28 months, 2 of 6 placebo patients died of cardiac causes whereas 1 of 21 died in the cell treated group from cardiac causes. There were 2 patient deaths from non-cardiac causes in the cell treated group.
Based on this new information, Cytori will directly seek EU regulatory approval of this treatment for no-option chronic ischemia patients. The Company intends to file necessary submissions in early 2011.
Other highlights of the trial's 18-month interim outcomes are as follows:
| MVO2 (mL/kg/min) (matched pair analysis) | Baseline to 6 months | Baseline to 18 month | Conclusion |
| Cells | Improved +0.6 | Improved +0.3 | Persistent improvement in cardiac functional capacity |
| Placebo | Declined -2.8 | Declined -4.1 | Worsening cardiac functional capacity |
| Statistical Significance | p < 0.05 | p < 0.05 | Statistically significant difference |
| METS (matched pair analysis) |
Baseline to 6 months | Baseline to 18 month | Conclusion |
| Cells | Improved +0.18 | Improved +0.07 | Persistent improvement in exercise ability (activity level) |
| Placebo | Declined -0.81 | Declined -1.17 | Worsening in exercise ability (activity level) |
| Statistical Significance | p < 0.05 | p < 0.05 | Statistically significant difference |
| Safety: There were no liposuction or ADRC-related MACCE at either 6 or 18 months |
"These are the most excellent and clinically relevant long term trial results we have indicating that the use of stem cell therapy in chronic ischemia patients is beneficial," said Dr. Perin. "The documented improvements are important as these patients would otherwise be expected to show substantial decreases in MVO2 over time. MVO2 is a key measure for functional capacity and we are seeing a real signal that this treatment is impacting patients' lives in this randomized blinded study."
"Cell therapy is one of the most promising advances in the field of cardiovascular medicine today. Cytori's innovative technology is leading the way forward," said Principal Investigator Francisco Fernández-Avilés M.D., Ph.D., Professor of Medicine and Chief of Department of Cardiology at Hospital Universitario Gregorio Marañón in Madrid.
MVO2 (or VO2 max) is the maximum volume of oxygen that can be utilized by the heart in one minute during peak exercise. MVO2 is a clinically relevant prognostic factor for outcomes in heart disease, including mortality and transplant requirement and is commonly used as a contributing measure to stratify patients for heart transplant. METS (metabolic equivalent) is a related measure commonly used by doctors to assess how much energy a patient can exert during exercise.
The PRECISE trial is a multi-center, 27 patient, double-blind, placebo-controlled European study in patients with no-option chronic myocardial ischemia, a severe form of heart disease. As part of the procedure, a small amount of fat tissue was removed from each patient's abdomen. Using the Celution® System, stem and regenerative cells were separated from each patient's fat tissue and concentrated at the point-of-care. Immediately thereafter, using the NOGA™ System, made by Biologic Delivery Systems Group, a J&J company, a three dimensional image was created to guide the injection of cells into the ischemic (low blood flow) regions of the heart.
Heart disease is the leading killer in the U.S. and Europe. No-option chronic myocardial ischemia patients make up approximately 6% of coronary heart disease (CHD) patients worldwide and suffer from one of the most serious conditions among heart failure patients. In the United States, more than one million patients are in this class, with a 10 year mortality rate exceeding 20% and an annual healthcare cost of more than $10 billion.
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, and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding the significance of the perceived benefits of the PRECISE clinical trial results, such as improvements in patient outcomes with respect to maximum oxygen consumption and ability to perform physical activity, the significance of the improvements in the cell treated groups for cardiac functional capacity, and our ability to seek and obtain EU regulatory approval of this treatment for no-option chronic ischemia patients are all subject to risks and uncertainties that could cause the results of a more comprehensive clinical trial 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 PRECISE trial, 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 chronic heart disease trial, 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 Forms 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:
Investor Contact:
Tom Baker
tbaker@cytori.com
858.875.5258
Media Contact:
Sharon Nieuwenhuis
sharon@RLMpr.com
212.741.5106 ext. 237
