Cytori Therapeutics Announces Independent Clinical Study Results in Breast Reconstruction Presented at the Association of Breast Surgery Conference
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.
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. Visit www.restoreprocedure.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, such as statement regarding the viability and safety of the use of the RESTORE procedure for breast reconstruction, which could affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include our history of operating losses, the need for further financing, inherent risk and uncertainty in the protection of intellectual property rights, regulatory uncertainties regarding the collection and results of, clinical data, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, including its annual report on Form 10-K for the year ended December 31, 2010. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this press release.
Cytori Therapeutics, Inc.
Cytori is a leader in providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. The Celution® System family of medical devices and instruments is being sold into the European and Asian cosmetic and reconstructive surgery markets but is not yet available in the United States. Cytori's StemSource® product line is sold globally for cell banking and research applications. www.cytori.com
For more information about Cytori Exchange, and the Cell-Enriched Lipomodellling Course on 21 October visit www.cytoriexchange.com.