Preparation and implantation of autologous cell-enriched fat grafts for cell-enriched breast reconstruction, the first approval for a regenerative technology for this application, as well as for other soft tissue defects; Preparation and implantation of autologous cell-enriched fat grafts for elective procedures, such as breast and buttocks augmentation and facial applications; The delivery of the Celution?® System cellular output to facilitate healing of rectal and vaginal fistulas (wounds) resulting from Crohn's disease, the first stem cell-based approval in Europe for this condition.

"The expanded indications improve our ability to provide the Celution?® System to European hospitals in addition to the private-pay plastic and cosmetic surgery clinics," said Marc H. Hedrick, M.D., president of Cytori. "These claims, coupled with our expanded focus on reimbursement, will make this technology more broadly available, not just for a wider range of procedures but to a greater population of patients."

More than 370,000 women are diagnosed with breast cancer in Europe every year, the majority of whom are eligible to undergo a partial mastectomy, conserving as much of the unaffected breast as possible. Although the goal is to protect as much of the patient's own tissue, the procedure can create a deformity that can be extremely difficult to repair, and most patients have limited reconstructive options. While there are several reconstructive options for women that have a full mastectomy, there is no uniformly accepted standard-of-care for partial mastectomy patients adopted by any country or medical society.

Interim results from Cytori's RESTORE 2 trial show stem and regenerative cell-enriched fat grafting using the Celution?®800 System resulted in a high sustained rate of physician (84% and 90%) and patient (73% and 70%) satisfaction and persistent improvements in overall outcomes of the procedure at six and 12 months respectively. The Celution?® System is the only device approved under the European medical directive for separation and re-implantation of stem and regenerative cells residing in adipose tissue.

Source : Cytori Therapeutics