SOURCE: Cytori Therapeutics, Inc.

Cytori Therapeutics, Inc.

March 02, 2011 06:00 ET

New Breast Reconstruction Procedure Demonstrates Long Term Success in European Trial; Data Reported From Cytori's RESTORE-2 Study of the Celution® System

ZUG, SWITZERLAND and SAN DIEGO, CA--(Marketwire - March 2, 2011) - Results from a European breast reconstruction trial using a new minimally invasive procedure to repair lumpectomy defects resulted in a sustained and substantial rate of physician and patient satisfaction at 12 months. The study, sponsored by Cytori Therapeutics (NASDAQ: CYTX), utilized the regenerative cells in the patient's own fat tissue, extracted at the time of the procedure using the Celution® 800/CRS System. The cells were then mixed back with a portion of the patient's own body fat, and this mixture of fat and cells was injected into the breast defect.

The trial, referred to as RESTORE-2, was a 71 patient prospective long-term breast reconstruction study. Specifically, 12 month physician satisfaction was 85% and patient satisfaction 75%, which is consistent with reported six month results. Physician and patient satisfaction criteria encompassed functional and cosmetic outcomes, namely breast deformity, breast symmetry, appearance of scarring, and skin pigmentation. With no generally accepted standard of care, there was no defined control for this trial. The comprehensive data are being prepared for peer-review and are expected to be publicly available later this year. 

These important findings, along with the recent July 2010 European approval (CE Mark) on the Celution® System for breast reconstruction, are expected to increase availability to both hospitals and patients. Marketed in Europe as the RESTORE procedure, this novel approach is today funded at the local hospital level in an increasing number of European countries. This new data will further the Company's effort in securing specific national level payment in a number of key geographies. Patients and physicians in Europe can learn more about the RESTORE procedure at www.cellreconstruct.eu.

"We believe cancer treatment is incomplete without reconstruction," said Marc H. Hedrick, M.D., president of Cytori Therapeutics. "The RESTORE procedure has the potential to become the gold standard for lumpectomy defect repair, even in the context of radiation scarring, for which there is no accepted standard-of-care. The data from the study strengthens the long-term safety profile of this treatment and soundly shows efficacy in breast cancer patients." 

Each year, approximately 450,000 European women are diagnosed with breast cancer. About 70% of these patients are eligible for breast conserving surgery, where only a portion of the breast is removed rather than the full breast. In these instances, patients are often left with a sizeable volume defect, scarring, and radiation damage. Because there is currently no widely accepted reconstruction procedure, offering a new option can address a major unmet medical need.

The Celution® System offers hospitals and clinics the only device that is approved in Europe for the extraction and re-implantation of regenerative cells from adipose tissue and it can do so in a cost-effective manner, without the need for cell-culture or time-consuming manual processing.

About the RESTORE Procedure

During the RESTORE procedure, fat is taken from the patient's stomach, hips, thighs, or other areas, by liposuction. Some of the tissue is used to extract the patient's own stem and regenerative cells which occur naturally inside the tissue, using Cytori's Celution® 800/CRS System. The extracted cells are then combined with some of the patient's own fat tissue, which forms a cell-enriched fat graft that is injected into the breast to restore its natural look and feel. In addition to providing an entirely natural option, the impact of post-operative scarring is greatly reduced due to the minimally invasive nature of this procedure.

About the RESTORE-2 Trial

RESTORE-2 is a post-marketing trial primarily intended to measure patient and physician satisfaction in reconstructing the breast utilizing the Celution® 800/CRS System. The trial took place at the following sites: Hospital General Universitario Gregorio Marañón in Madrid, Spain, Glasgow Royal Infirmary in Glasgow, Scotland, KU Leuven University Hospitals in Leuven, Belgium, Azienda Ospedaliero Universitaria Careggi in Florence, Italy, Instituto Valenciano Oncología in Valencia, Spain, Norfolk and Norwich University Hospital in Norwich, UK, and Jules Bordet Institute of Cancer in Brussels, Belgium.

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 is being sold into the European and Asian cosmetic and reconstructive surgery markets but 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 could affect our future operating results and financial position, such as our expectation of increased hospital and patient availability, and our expectation of acceptance of the treatment for lumpectomy and radiation scarring. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, inherent risk and uncertainty in the protection of intellectual property rights, regulatory uncertainties regarding the collection and results of, the perceived quality of our clinical data, the effectiveness of our marketing programs, physician and patient acceptance of our technology, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, including its annual report on Form 10-K for the year ended December 31, 2009. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.

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