SAN DIEGO, CA--(Marketwire - January 24, 2011) - Published clinical experience in over 2,000 patients who received autologous fat grafts showed no evidence of increased risk of development, metastasis or recurrence of breast cancer in contrast to laboratory data. The newly published review entitled "Oncologic Risks of Autologous Fat Grafting to the Breast" in the January issue of the American Society of Aesthetic Plastic Surgery's Aesthetic Surgery Journal discusses the data disparity between the clinical and certain laboratory-based scientific literature regarding fat grafting procedures to the breast. This includes procedures in which the graft has been enriched with adipose-derived stem and regenerative cells (ADRCs).
The article, authored by John Fraser, Ph.D. and Marc Hedrick, M.D. of Cytori Therapeutics (
Through the comprehensive review of published reports, the article explores potential issues and concludes that the apparent data discrepancy between the laboratory and the clinic are the result of the application of artificial conditions used in certain laboratory studies that do not arise in a clinical setting. This analysis is consistent with Cytori preclinical studies, demonstrating that cell-enriched fat grafting did not increase the risk of breast cancer development or metastasis, and in some situations, actually decreased cancer growth.
"Patient safety is paramount in the development of PureGraft™ and Celution® products," said Christopher Calhoun, CEO of Cytori Therapeutics. "There is increased patient and physician demand for our technologies and this careful review supports our view that our recommended fat grafting techniques are safe in the breast. We will continue to conduct our own safety research and analyze data from sources external to Cytori, as part of the regulatory progress and the ultimate commercial adoption of our products."
The January issue of the Aesthetic Surgery Journal is currently available online at http://aes.sagepub.com/content/current.
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, including the reporting of data that potentially supports the safety of our products. 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 limited experience in evaluating the safety of our products in the clinical setting, our history of operating losses, the potential need for further financing, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, 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, 2008. 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.