Cytori Therapeutics Announces Independent Clinical Study Results In Breast Reconstruction Presented At The Association Of Breast Surgery Conference

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 RESTORE, 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."


As part of its Cytori Exchange educational program, Cytori is announcing that the UK's first ADRC-enriched fat grafting live surgery seminar and workshop will be held on October 21st 2011 at University Hospital of North Tees in collaboration with Mr. Pud Bhaskar.




For more information about Cytori Exchange, and the Cell-Enriched Lipomodellling Course on 21 October visit here.


Notes



About ADRCs


Adipose-derived stem and regenerative cells encompass a group of cells, including adult stem cells, endothelial progenitor cells, tissue resident macrophages, microvascular cells, and vascular smooth muscle cells. The cells can be readily extracted from fat tissue and are believed to increase survival rate for fat transplantation from one part of the body to another by bringing the necessary oxygen and nutrients to the transplant area. This helps the body to heal, rather than scar.



About the RESTORE procedure


Cell-enriched breast reconstruction utilises the body's own fat, enriched with stem and regenerative cells, to rebuild the breast's contour following breast cancer surgery. Cell-enriched reconstruction can be performed alone as a standalone reconstructive technique or in combination with synthetic implants. Fat is withdrawn via liposuction from the stomach, hips, thighs, or other area determined to provide the necessary tissue. A portion of this tissue is processed to extract stem and regenerative cells which naturally reside within the tissue. The cells are then combined with another sample of fat, forming a cell-enriched fat graft which is used to re-sculpt the breast.


Source:

Cytori Therapeutics, Inc.