Healthcare Industry News: Cytori Therapeutics
News Release - November 6, 2007
Cytori's Celution(TM) System Under Evaluation for Breast Augmentation as Part of Investigator-Initiated StudySAN DIEGO--(HSMN NewsFeed)--A new study underway in Japan will examine the effect of adult stem and regenerative cells derived from adipose tissue in breast augmentation. In this investigational procedure, a patient’s breast is augmented with her own liposuctioned fat, which has been combined and enhanced with her own adipose-derived stem and regenerative cells. These cells are made available at the time of surgery using the Celution™ System - an investigational device developed by Cytori Therapeutics (NASDAQ:CYTX ) of San Diego, CA. This independent, investigator-initiated study is being sponsored by Tatsuro Kamakura, M.D., Chief Medical Officer of Cosmetic Surgery Seishin in Japan.
Fat, known medically as adipose tissue, is one of the body’s richest and most accessible sources of regenerative cells. Adipose-derived regenerative cells include adult stem cells in addition to other important cell types that have been shown pre-clinically to improve tissue retention compared to non ‘cell enhanced’ tissue transfers. For this reason, these cells potentially may improve and simplify traditionally complex fat transfer procedures as well as enable more predictable outcomes and graph retention when applied to cosmetic and reconstructive surgery.
“This study further demonstrates the breadth of potential applications for the Celution™ System,” said Marc H. Hedrick, M.D., president for Cytori Therapeutics. “A number of physicians like Dr. Kamakura are interested in exploring new applications for the Celution™ System through investigator-initiated studies. These studies will help accelerate and broaden the number of potential uses of the device and allow us in parallel to maintain our focus on the medical need of breast reconstruction in partial mastectomy patients.”
The study will enroll 20 patients, all of whom will undergo a standardized cell enhanced fat tissue transplantation procedure, whereby the cells are processed with Cytori’s Celution™ System. The primary endpoints will be cosmetic improvement volume retention at nine months. The study is being sponsored by Dr. Kamakura.
Clinical research is ongoing for breast reconstruction in partial mastectomy patients. The Celution™ System was evaluated in an 11-patient investigator-initiated safety and feasibility study, designated as RESTORE I, conducted in Japan. This study evaluated adipose-derived stem and regenerative cells extracted and processed with the Celution™ System to treat the complications of surgery and radiation damage following partial mastectomy. Results will be reported at the San Antonio Breast Cancer Symposium on December 15, 2007.
Based on preliminary findings and other data, Cytori is sponsoring two post-marketing studies, designated as the RESTORE II and VENUS studies, which will further evaluate the use of adipose-derived stem and regenerative cells for reconstruction of breast tissue following a partial mastectomy. RESTORE II will evaluate up to 70 patients at multiple European trial sites. VENUS will be a 20-patient single center adjunct to RESTORE II in patients with more severe damage and contour defects resulting from a partial mastectomy.
Cytori Therapeutics is a global leader in the development of regenerative medicine products. The company is developing therapeutic applications for its Celution™ System to enable real-time regenerative cell therapy in conjunction with breast reconstruction surgery, cardiovascular disease, and other large unmet medical needs. The Company’s StemSource™ Cell Bank, which is based on Cytori’s innovative Celution™ System, will be commercialized in Japan starting in 2008 to hospitals and clinics to enable regenerative cell banking. www.cytoritx.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and prospects of our business, 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 and uncertainties include our history of operating losses, the need for further financing, regulatory uncertainties, dependence on performance of third parties, and other risks and uncertainties described (under the heading "Risk Factors") in Cytori Therapeutics' Form 10-K annual report for the year ended December 31, 2006. 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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