Healthcare Industry News: Cytori Therapeutics
News Release - May 1, 2008
Cytori Begins Breast Reconstruction Study in EuropeSAN DIEGO--(HSMN NewsFeed)--Cytori (NASDAQ:CYTX ) received approval to begin its European stem and regenerative cell-enhanced breast reconstruction study in breast cancer patients who have undergone partial mastectomy. This is a post-market study designated as RESTORE II. Currently, there is no generally accepted reconstructive technique for partial mastectomy patients despite the fact that breast conserving therapy is standard practice in the treatment of women with breast cancer worldwide.
In this study, tissue loss resulting from partial mastectomy will be reconstructed with the patients’ own fat tissue (adipose), which will be enhanced with their adipose-derived stem and regenerative cells. This procedure is referred to as cell-enhanced reconstruction. The cells in RESTORE II will be made available at the time of surgery using Cytori's Celution® 800 System.
The primary goal is to obtain European reimbursement for cell-enhanced reconstruction using the Celution® 800 System by measuring key quality of life improvements in breast cancer patients desiring reconstruction. Up to 70 women will be enrolled at six clinical centers in the U.K., Italy, Spain, and France. Primary endpoints will be patient and physician satisfaction with functional and cosmetic outcomes at six and 12 months after surgery. Cytori’s goal is to complete enrollment before the end of March 2009.
“RESTORE II is important for advancing reconstructive options for women with breast cancer,” said Professor Emmanuel Delay, the study’s principal investigator and Chief of Plastic and Reconstructive Surgery at The Leon Bérard Cancer Center in Lyon France. “A successful study should broaden availability of this therapy to partial mastectomy patients in Europe.”
“Unfortunately fewer options are available to women desperate for reconstructive surgery following partial mastectomy due to the effects of the adjuvant radiotherapy,” said Mrs. Eva Weiler-Mithoff, surgeon at the Glasgow Royal Infirmary, and lead investigator for the U.K. study site. “Adipose tissue enriched with stem and regenerative cells represents a new approach that we believe allows for predictable graft retention.”
“My ongoing clinical experience using Cytori’s Celution® 800 System in breast reconstruction has been very encouraging,” said Professor Claudio Calabrese, Associate Professor of Surgery and lead investigator at University of Florence Hospital. “The preliminary results warrant further investigation as part of the broader, post-market RESTORE II study.”
Secondary endpoints include six and 12-month assessments of breast volume and shape via magnetic resonance imaging (MRI) and improvement in skin pigmentation. The study will evaluate patients who have undergone their last breast treatment at least 12-months prior and are recurrence free.
“The Celution® 800 System is what makes this an effective, reproducible, bedside procedure,” said Dr. Marc H. Hedrick, president of Cytori. “Cytori has customized this system to provide a cell output specific to breast reconstruction, to be easy to use for doctors and hospitals, and to be affordable. We believe this mix of attributes combined with our goal of reimbursement could fill a tremendous patient and market need.”
Fat, known medically as adipose tissue, is the body's richest known source 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. These results have been confirmed in physician-initiated clinical studies.
Cytori’s (NASDAQ:CYTX ) goal is to be the global leader in regenerative medicine. The company is dedicated to providing patients with new options for reconstructive surgery, developing treatments for cardiovascular disease, and banking patients' adult stem and regenerative cells. The Celution® 800 System is being introduced in Europe into the reconstructive surgery market while the Celution® 900 System will be launched in Asia-Pacific for cryopreserving a patient's own stem and regenerative cells. Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs. www.cytoritx.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 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 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. 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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