Reconstructive surgery
is one application
is one application
GE Healthcare to Back Cytori's Adipose Cell Tissue System
January 14, 2009
by Lynn Shapiro, Writer
Cytori Therapeutics said it is partnering with GE Healthcare to commercialize its Celution System in select European countries. The Celution System, approved in Europe, is a cell-processing device, which extracts and makes a dose of a patient's own adipose tissue-derived adult stem and regenerative cells.
Under the agreement, GE Healthcare will commercialize the Celution System in the areas of cosmetic and reconstructive surgery, translational medicine, and stem cell banking.
"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, underscores the growth potential of this system in regenerative medicine," she says.
The partnership provides GE Healthcare with exclusive commercialization rights to the tissue system 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 also granted a two-year right of first refusal to sales and distribution rights in the United States and all remaining European countries.
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, Cytori says.
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 breast reconstruction or augmentation procedure.
There is a significant unmet medical need for viable reconstructive alternatives for women who undergo partial mastectomy as part of their breast cancer treatment, Cytori officials note.
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.
Translational Medicine
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.
(In Japan, seven 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 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, Cytori says.
About Cytori
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.
Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs, the company says.
Under the agreement, GE Healthcare will commercialize the Celution System in the areas of cosmetic and reconstructive surgery, translational medicine, and stem cell banking.
"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, underscores the growth potential of this system in regenerative medicine," she says.
The partnership provides GE Healthcare with exclusive commercialization rights to the tissue system 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 also granted a two-year right of first refusal to sales and distribution rights in the United States and all remaining European countries.
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, Cytori says.
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 breast reconstruction or augmentation procedure.
There is a significant unmet medical need for viable reconstructive alternatives for women who undergo partial mastectomy as part of their breast cancer treatment, Cytori officials note.
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.
Translational Medicine
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.
(In Japan, seven 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 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, Cytori says.
About Cytori
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.
Clinical trials are ongoing in cardiovascular disease and planned for spinal disc degeneration, gastrointestinal disorders, and other unmet medical needs, the company says.