Cytori Therapeutics, Inc. (NASDAQ:CYTX) reports that surgeons from North Tees and Hartlepool NHS Foundation Trust have presented clinical outcomes using Adipose-Derived Regenerative Cell (ADRC) fat grafting in reconstructive breast surgery at the Association of Breast Surgery Conference in Manchester, UK, May 16-17, 2011. The procedure, referred to by Cytori as
, was separately investigated in Cytori’s own RESTORE 2 trial.
The presentation highlighted results from an independent, prospective study of 23 patients who received ADRC-enhanced fat grafting for the correction of breast contour defects following cancer treatment or benign conditions including implant complications, using the Celution® System. Patients were treated between September 2008 and November 2010 and followed up between 3 months and 2 years. Follow-up survey data was obtained to assess patient and investigator satisfaction with symmetry between the breast, size and shape of the breast, breast softness, and appearance of the scar at the donor and treated site.
The results showed 82% (19) of patients reported good to excellent results with a mean satisfaction score of 5.1. Satisfaction scores ranged from 1 (worst) to 6 (best).The results further showed a high level of investigator satisfaction with a mean satisfaction score of 4.3. Study findings demonstrated a low complication rate. Overall, the study results suggest the RESTORE procedure is a viable option for breast reconstruction with no safety concerns.
“The practical applications for the use of ADRC-enhanced fat grafting are expanding from simple volume replacements to use as an adjunct or alternative to traditional methods of breast reconstruction,” commented specialist surgeon Mr. Pud Bhaskar, lead investigator. “The procedure has low rates of fat resorption, is simple and safe to perform. We, and more importantly our patients, are highly satisfied with the operative outcome.”
Dr. Eric Daniels, Managing Director of Cytori GmbH, said: “We are extremely pleased by the data presented by Mr. Bhaskar and his collaborators at this year’s ABS conference for the RESTORE procedure. The study underlines how RESTORE is an innovative, minimally invasive approach to successfully treat patients with breast contour defects.”