Healthcare Industry News: Cytori Therapeutics
News Release - June 17, 2010
Breast Cancer Reconstruction Using Cell-Enriched Fat Grafts Shows Continued High Rates of Physician and Patient Satisfaction at 12 MonthsInterim Data Presented at British Oncoplastic Surgery Meeting; Complete 12-Month Results Expected in Early 2011
SAN DIEGO--(HSMN NewsFeed)--Interim results from a breast reconstruction trial show stem and regenerative cell-enriched fat grafting resulted in a high sustained rate of physician and patient satisfaction and persistent improvements in overall outcomes of the procedure at six and 12 months.
Improvements in outcomes previously reported in 30 patients at six months were confirmed in a larger sample of 51 patients at six months. These improvements were sustained for the first 30 patients to reach the 12-month evaluation period.
The European trial, referred to as RESTORE 2, is sponsored by Cytori Therapeutics (NASDAQ: CYTX ) and enrolled a total of 71 patients. The fat grafts in the study were enriched with stem and regenerative cells using Cytori’s European-approved Celution® 800 System. The interim data reported today was presented at the Fifth Winchester-Jersey Masterclass in Oncoplastic Breast Surgery at the Royal Hampshire County Hospital.
Interim results from the RESTORE 2 trial demonstrated a high rate of physician and patient satisfaction at six and 12 months:
- Overall physician satisfaction with treatment results was 84% at six months in 51 patients
- Overall physician satisfaction with treatment results (90%) persisted in the first 30 patients at 12 months
- Overall patient satisfaction with treatment results was 73% in 51 patients measured at six months
- Overall patient satisfaction with treatment results (70%) persisted in the 30 patients at 12 months
“A woman is not cured until she is reconstructed. Unfortunately for most patients, few options are available and there is currently no accepted standard-of-care for breast reconstruction,” added Dr. Rosa Pérez Cano, co-principal investigator for RESTORE 2 and Chief of Plastic Surgery Services at Hospital Universitario Gregorio Marañón, Madrid, Spain. “These interim results are encouraging as we see consistent improvements in breast deformity, breast symmetry and tissue elasticity.”
Cell-enriched breast reconstruction is a new procedure that addresses the unmet need created by partial mastectomy. This approach uses a woman’s own fat tissue combined with her own naturally available adipose-derived stem and regenerative cells to form a ‘cell-enriched’ fat graft, which is used to reconstruct the affected breast.
In RESTORE 2, the cell-enriched graft was prepared by first extracting each patient’s own stem and regenerative cells from their fat tissue using Cytori’s Celution® 800/CRS System and then combining these cells with the fat graft, all in the same surgical procedure. More information on cell-enriched breast reconstruction and other reconstructive surgery options for breast cancer is available at www.cellreconstruct.eu.
RESTORE 2 is a post-marketing study primarily intended to measure physician and patient satisfaction in reconstructing the breast utilizing the Celution 800/CRS System. The study endpoints have been designed, among other things, to address hospital and physician reimbursement and adoption of the Celution® 800/CRS System throughout Europe. The outcomes of the study will be assessed at 12 months, per study design.
For more information, log on to www.cytori.com.
1 “Effect of Esthetic Outcome After Breast-Conserving Surgery on Psychosocial Functioning and Quality of Life” Journ. Of Clin. Oncology Vol 26 No. Jul 2008
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 communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical and regulatory uncertainties, including risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, and 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.
Source: Cytori Therapeutics
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