Cytori Therapeutics (NASDAQ: CYTX) is a leading global innovator in the emerging field of regenerative medicine using adipose (fat) tissue as a rich source of adult stem cells capable of differentiating into a variety of cell types. The company develops and markets cell banking (StemSource), therapeutic, and cosmetic medicine applications for its Celution System, which enables real-time, point-of-care regenerative cell therapy applications by harvesting and processing a small amount of patient-derived fat tissue in about one hour to harvest the adipose-derived stem and regenerative cells (ADRCs) with key corporate partners that include GE Healthcare (NYSE: GE), Olympus Corp. [TYO: 7733] (OTCPK:OCPNY), and Green Hospital Supply [TYO: 3360].
RESTORE-2 is a European study designed to evaluate the transplantation of ADRC-enhanced fat tissue into and around breast deformities. The adipose-derived regenerative cells (ADRCs) are extracted from a patient’s own fat tissue using Cytori’s Celution 800/CRS System, which received a CE Mark in 2007 for use in Europe. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure. The study is evaluating the use of cell-enriched fat grafting to restore functional and cosmetic deformities in women who have undergone partial mastectomy for early breast cancer.
Interim data on the first 32 patients who have reached the six-month follow-up was presented at the San Antonio Breast Cancer Symposium today, demonstrating that cell-enriched breast reconstruction achieved a high rate of patient (73%) and physician (82%) satisfaction and improvements in overall breast deformity in lumpectomy patients after a single treatment. In addition, mean patient and physician satisfaction scores dramatically improved for breast symmetry, scarring and deformity measures from baseline to six month follow-up and qualitative analyses of imaging data confirmed clinical improvement in both breast defect and overall breast shape.
The final, 12-month data on all patients is expected during early 2011. Cytori also reported preclinical data that suggests an initial / temporary increase in several growth factors (while avoiding the potential safety concerns of a prolonged increase) within the fat grafts results in sustained regenerative / tissue re-growth effects. Beyond the breast reconstruction market, there is enormous commercial potential in the cosmetic medicine market for an all-natural ‘Celution’ to breast enhancement procedures.
Over the next 1-2 quarters, Cytori awaits several key regulatory and clinical catalysts in the form of expected data during 1H10 for two ongoing heart studies (PRECISE – chronic ishchemia – data expected during 1H10 and APOLLO – heart attacks – data possible by 1Q10) and the pending 510(k) FDA submission for initial marketing clearance of the Celution 700 System.
Disclosure: Author holds a long position in CYTX