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Cytori breast reconstruction cell therapy trial results published
Date:3/19/2012

Zug, Switzerland and San Diego, CA Cytori Therapeutics (NASDAQ: CYTX) announced today the publication of RESTORE-2 trial results in the peer-reviewed European Journal of Surgical Oncology.

RESTORE-2 is a 71 patient multi-center, prospective clinical trial using autologous adipose-derived regenerative cell (ADRC)-enriched fat grafting for reconstruction of the breast after cancer surgery. The majority of patients underwent radiation prior to the procedure, creating an unfavorable ischemic environment for which breast reconstruction with ADRC-enriched fat grafting appears to be ideally suited.

Key findings of the trial were:

  • High rates of investigator (85%) and patient (75%) satisfaction with the overall treatment results at 12 months;
  • High rates of investigator (87%) and patient (67%) satisfaction with overall breast deformity (based on functional and cosmetic outcomes) at 12 months;
  • Improved breast contour at both six and 12 months, demonstrated by blinded MRI assessment; and
  • No local cancer recurrences or serious adverse events related to the ADRC-enriched fat grafting procedure.

"Following cancer treatment, the patient's breast tissue can suffer from radiation injury, scarring and tight skin," said Consultant Plastic and Reconstructive Surgeon Mrs. Eva Weiler-Mithoff, co-principal investigator for RESTORE-2 at the NHS Glasgow Royal Infirmary Hospital. "This new technique is exciting because it may offer the opportunity to resolve some of the most difficult to treat conditions where other approaches, including fat alone, do not achieve satisfactory results."

ADRC-enriched partial mastectomy breast reconstruction is marketed in the EU as the RESTORE Procedure and represents an innovative treatment option with significant cost savings potential. The procedure can be performed on an outpatient basis. Satisfactory results can be achieved in a single procedure for the majority of patients. In contrast, com
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Contact: Megan McCormick
mmccormick@cytori.com
858-875-5279
Cytori Therapeutics
Source:Eurekalert

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