Cytori Breast Reconstruction Cell Therapy Trial Results Published
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, competitive approaches are more costly with lengthy hospital stays, require repeat procedures and increase the overall burden on the healthcare system. Furthermore, because of these limitations, physicians are often reluctant to recommend reconstruction for patients with partial mastectomy defects and radiation-induced damage in the breast.
Each year, approximately 450,000 European women are diagnosed with breast cancer. Of the newly diagnosed breast cancer cases, 70-80% are eligible for breast conserving surgery, where only a portion of the breast is removed rather than the full breast. In the European G5, there are an estimated 1.25 million women who have undergone partial mastectomy. The majority of these patients are left with a sizeable volume defect, scarring and often radiation damage.
"Given that there is no widely accepted reconstructive option available today for partial mastectomy patients, this procedure could well address this substantial unmet need and help complete the overall cancer treatment," said Marc H. Hedrick, president of Cytori.
The European Journal of Surgical Oncology is the official journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology.
About the RESTORE Procedure
During the RESTORE Procedure, fat is taken from the patient's stomach, hips, thighs, or other areas by liposuction. Some of the tissue is processed in Cytori's Celution® system to extract the patient's own regenerative cells which occur naturally inside the tissue. The extracted cells are then combined with the remaining fat tissue, forming an ADRC-enriched fat graft that is injected into the breast to restore its natural look and feel. In addition to providing an entirely natural reconstruction, the procedure is minimally invasive with the potential to reduce scarring. The Celution® system is not commercially available in the United States.
About the RESTORE-2 Trial
RESTORE-2 is a 71 patient European post-marketing trial primarily intended to measure patient and physician satisfaction in reconstructing the breast utilizing the Celution® system. The trial took place at the following sites: Hospital General Universitario Gregorio Marañón in Madrid, Spain, Glasgow Royal Infirmary in Glasgow, Scotland, KU Leuven University Hospitals in Leuven, Belgium, Azienda Ospedaliero Universitaria Careggi in Florence, Italy, Instituto Valenciano Oncología in Valencia, Spain, Norfolk and Norwich University Hospital in Norwich, England, and Jules Bordet Institute of Cancer in Brussels, Belgium.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which could affect our future operating results and financial position, such as our expectation of increased hospital and patient availability, and our expectation of acceptance of the treatment for lumpectomy and radiation scarring. 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 regulatory uncertainties, the perceived quality of our clinical data, physician and patient acceptance of our technology, 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, 2011. 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 Therapeutics is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow. As a result, we believe these cells can be applied across multiple ischemic conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori's proprietary technologies and products, including the Celution® system product family. www.cytori.com