Cytori Says Early Results of its Breast Reconstruction Treatment Are Promising
[Corrected 12/13/09, 9:45 am. See below] San Diego’s Cytori Therapeutics (NASDAQ: CYTX) is reporting encouraging interim results today concerning its breast reconstruction technology at the 32nd Annual San Antonio Breast Cancer Symposium.
Cytori has been developing its treatment for women whose partial mastectomy or lumpectomy has left a soft-tissue crater or deformity, as well as for women seeking breast enhancement or augmentation. The company’s approach combines regenerative medicine with a procedure increasingly used by plastic surgeons in which a patient’s own fat cells are used to rebuild an asymmetric breast. Cytori’s technique includes using its proprietary technology to process the patient’s fat cells to increase the concentration of (adipose) stem stem cells before they are implanted, a procedure Cytori calls a “cell-enriched” fat graft.
Cytori says 73 percent of the patients and 82 percent of their physicians expressed satisfaction with the overall outcome six months after the procedure, according to a follow-up study of the first 32 women who were treated.
[Corrects Tom Baker's title to director of investor relations] “It’s an interim look at the 71 patients who have been enrolled and treated,” says Tom Baker, Cytori’s director of investor relations. “The importance to Cytori is that this study is geared to getting [insurance] reimbursement in Europe for this treatment using our device.”
The company also is working to gain FDA approval of its technology in the United States. Cytori said in July that the FDA had determined that its Cellution stem cell concentration system should be regulated as a medical device. The determination clears the way for Cytori to seek FDA approval for use of the system “as a medical device in aesthetic body contouring and/or filling of soft tissue voids.”
Cytori’s Baker says breast cancer patients who have undergone surgery and radiation treatment represent a trickier challenge for cosmetic surgeons. While a simple “autologous fat graft” is possible in breast cancer patients, Baker says irradiated tissue is damaged, and therefore less receptive to a graft. Even with healthy patients who choose the procedure for breast augmentation (instead of breast implants), plastic surgeons report they often see a disappointingly high rate of complications—and the almost complete reabsorption of the grafted fat.
Cytori says its technology offers a higher success rate because because the stem cells used to enrich the fat graft promote the growth of blood vessels, which nourish the grafted fat cells, as well as supportive cellular scaffolding. Baker says Cytori recently established a website to explain its breast reconstruction technique.
“We’d like to show that we can perform this, and that it improves the chances of graft survival,” Baker says.