Cytori Forms Commercialization Partnership with GE Healthcare
"The addition of Cytori's Celution System to GE Healthcare's Cell Technologies portfolio demonstrates our commitment to the field," says Sarah Bork, Director for GE Healthcare's Cell Technologies Program. "Adipose tissue is emerging as one of the leading sources for adult stem and regenerative cells, and Cytori's Celution System can provide patients' own cells at the bedside. Its quality and ease-of-use, coupled with the demand from hospitals and surgeons for cells, underscore the growth potential of this system in regenerative medicine."
"GE Healthcare will immediately broaden our access to customers in Europe and should greatly expand our Celution System installed base," said Christopher J. Calhoun, chief executive officer for Cytori. "We will benefit from their existing hospital relationships and their established regenerative medicine sales infrastructure in countries where we currently do not commercialize the Celution System. Ultimately, our mutual goal is to broaden the relationship after we are able to better assess the market opportunities across several therapeutic indications and geographic regions."
The partnership provides GE Healthcare with exclusive commercialization rights for 18 months in the U.K., France, Germany, Norway, Finland, Denmark, Sweden, Austria, and Switzerland for the cosmetic and reconstructive surgery market, translational medicine, and stem cell banking. The same terms apply in Belgium, The Netherlands and Luxembourg for translational medicine and stem cell banking. GE Healthcare was granted a two year right of first refusal to sales and distribution rights in the United States and all remaining European countries.
Adipose-Derived Stem & Regenerative Cells
Adipose, also known as fatty tissue is one of the most studied sources of adult stem cells. In addition to stem cells, there lies within adipose tissue a defined population of cell types that are also major contributors to healing, referred to as 'regenerative cells.' Together, these stem and regenerative cells represent tremendous opportunities for treating cardiovascular disease, spine and orthopedic disorders, and vascular conditions, reconstructive surgery and several other areas of medicine. Compared to other cell sources like umbilical cord blood and bone marrow, adipose tissue offers several advantages, including relative ease of accessibility, a high concentration of cells, and its amenability to real-time processing and autologous use without cell culture.
Cosmetic and Reconstructive Surgery
The Celution 800 was introduced in February 2008 into the European and Asia Pacific cosmetic and reconstructive surgery market. In this market, surgeons combine the Celution output with a patient's own adipose tissue as a means to perform a cell-enhanced reconstruction or augmentation procedure. There is growing demand for the product among surgeons in Europe and Asia Pacific who are performing private-pay procedures. Additionally, several investigator-initiated studies and clinical cases are using the Celution System to perform small volume augmentations, breast implant salvage, and facial and dermal filler procedures.
There is a significant unmet medical need for viable reconstructive alternatives for women who undergo partial mastectomy as part of their breast cancer treatment. An estimated 375,000 patients in Europe are diagnosed each year with breast cancer, of which approximately 75% are eligible to undergo partial mastectomy. To pursue this market, Cytori is conducting a 70-patient, multi-center post-marketing study using the Celution System output for breast reconstruction in women who have undergone partial mastectomy.
The medical community is rapidly exploring the potential of adult stem cell-based therapies, as evidenced by the growing number of positive clinical outcomes being reported. The Celution System has the opportunity to serve as the technology of choice for accessing adult stem and regenerative cells, as it allows surgeons to work with their patient's own cells, eliminating the risk of rejection or disease transmission. In addition, the device enables the cells to be processed and re-implanted in the same surgical procedure.
Meeting the demand for cells for translational medicine represents a meaningful market on its own. In addition, data from any investigator-initiated studies may benefit Cytori in the future by establishing and broadening the utility for the Celution System platform. In Japan, seven new investigator-initiated clinical studies using adipose-derived stem and regenerative cells have been approved by local ethical committees to be performed at academic university hospitals. These studies include vocal cord paralysis, chronic liver insufficiency, cirrhosis, radiation injury, and urinary incontinence.
StemSource(R) Cell Bank
A StemSource Cell Bank will allow hospitals, stem cell storage companies, or tissue banking labs to process and cryopreserve a patient's own adipose-derived stem and regenerative cells when the cells are younger and more viable. StemSource cell banking services coupled with the real time Celution clinical cell therapy may ultimately allow hospitals to provide a broad array of regenerative medicine services to patients.
The foundation of the cell bank is Cytori's Celution 900-MB System, which automates the processing of stem and regenerative cells from adipose tissue. This function facilitates the preparation and storage of the cells, thereby creating economic and process efficiencies that would otherwise make cell banking too expensive or time consuming for many patients.
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
Cytori Therapeutics, Inc.
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(R) 800 System is being introduced in Europe into the reconstructive surgery market while the Celution(R) 900 System is being commercialized globally 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