Enrollment complete in Cytori Therapeutics' international breast cancer reconstruction study

Cytori TherapeuticsNov 16 2009

Cytori Therapeutics (NASDAQ:CYTX) completed enrollment in a 70-patient, international breast cancer reconstruction study, RESTORE 2. 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 will be presented as a poster at the San Antonio Breast Cancer Symposium December 12, 2009 at 7 a.m. U.S. Central Time by Mrs. Eva Weiler-Mithoff, MD, lead investigator at the Glasgow Royal Infirmary.

The Cell-Enriched Breast Reconstruction procedure combines a patient’s own naturally occurring adipose-derived regenerative cells (ADRCs) with their fat tissue. This cell-enriched fat graft is then injected into and around the defect area. In the RESTORE 2 study, the ADRCs were extracted from adipose tissue using Cytori’s Celution®800 System. Currently, there is no generally accepted reconstructive method for partial mastectomy patients as the majority of these women are not implant candidates, leaving patients with limited options.

The RESTORE 2 study is a prospective, multi-center, post-marketing study in which all patients were treated with their own ADRCs and fat tissue. The study is designed to assess patient and physician satisfaction, improvement in overall breast deformity, imaging, quality of life, and safety among other measures. 70 patients were treated at seven centers in the European Union. The highest enrolling sites were Hospital Gregorio Marañón, Glasgow Royal Infirmary, and KU-Leuven University Hospital.

“Completion of the RESTORE 2 study is important because it lays the foundation for optimal reimbursement in Europe for Cell-Enriched Breast Reconstruction using the Celution®800 System,” said Alex Milstein, MD, vice president of clinical development at Cytori. “Together with existing evidence on the Celution®800 device, we believe the findings from RESTORE 2 will help physicians make the best possible treatment decisions for their patients. We would like to express our gratitude to all study participants, the investigators, and their teams for their dedication and support of RESTORE 2.”