BioForm Medical Enrolls First Patient in Clinical Trial of CryoLife's BioGlue(R) Surgical Adhesive for Use in Cosmetic and Plastic Surgery
ATLANTA, Ga. and SAN MATEO, Calif., June 26 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY) and BioForm Medical, Inc. announced that the first patient has been enrolled in a clinical study evaluating BioGlue(R) Surgical Adhesive as a method of fixation in brow lifts. BioForm recently received permission from Food and Drug Administration (FDA), under an Investigational Device Exemption (IDE), to initiate enrollment in a feasibility study to evaluate the safety and effectiveness of BioGlue as a method for tissue fixation in patients undergoing browplasty procedures (sometimes described as brow lifts).
"This is the first clinical trial of a surgical adhesive as a fixation methodology for browplasty," said Steven L. Basta, chief executive officer, BioForm Medical, Inc. "If shown to be safe and effective in clinical studies, the use of BioGlue may represent an attractive and less invasive alternative for physicians and patients compared to traditional methods of fixation. Surgical adhesive fixation with BioGlue may enable physicians to avoid the surgical time, risk and patient discomfort associated with procedures that require drilling into the skull for tissue fixation."
"We are excited that the first clinical study of BioGlue for use in cosmetic surgery is now underway," said Steven G. Anderson, president and chief executive officer, CryoLife, Inc. "CryoLife is committed to pursuing additional potential uses for BioGlue, and we are pleased that our partnership with BioForm has resulted in clinical evaluation of our products in the fast- growing, minimally-invasive cosmetic surgery industry."
BioForm, a privately-held medical aesthetics company, and CryoLife, a biomaterials, medical device, and tissue processing company, entered into a licensing and distribution partnership in October 2006 for the development and commercialization of CryoLife's proprietary BioGlue Surgical Adhesive for its potential use in cosmetic and plastic surgery indications. BioForm is responsible for all clinical trials and regulatory filings for cosmetic and plastic surgery applications, and will be responsible for sales and marketing of BioGlue in these applications. CryoLife will remain the exclusive manufacturer of BioGlue.
BioGlue Surgical Adhesive is a two-component adhesive that creates a flexible, mechanical seal, independent of the body's clotting mechanism, within 20 to 30 seconds, and reaches its maximum bonding strength in two to three minutes.
BioGlue is FDA-approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is CE-marked in the European Community and approved in Canada and Australia for use in cardiac, vascular, pulmonary, and other soft tissue repair.
About CryoLife, Inc.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the United States and Canada. In addition to BioGlue, the Company also distributes the CryoLife-O'Brien(R) stentless porcine heart valve and the SG Model 100 vascular graft, which are CE-marked for distribution within the European Community. For additional information about CryoLife, please visit http://www.cryolife.com.
About BioForm Medical, Inc.
BioForm Medical, Inc. is a privately-held medical aesthetics company headquartered in San Mateo, California. BioForm is dedicated to bringing doctors and their patients safe and effective products for use in the dermatology, plastic surgery and ENT markets. BioForm's products include Radiesse, a long-lasting filler for use in facial aesthetics and vocal fold insufficiency and Coaptite(R) for treating female stress urinary incontinence ("SUI") which is marketed through a partnership with Boston Scientific Corporation. BioGlue, a new surgical adhesive product for plastic surgery applications, is being developed in a partnership with CryoLife, Inc. For more information about BioForm, please visit http://www.bioformmedical.com
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes, including statements regarding the potential application of BioGlue in plastic and cosmetic surgery, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These future events may not occur as and when expected, if at all, and, together with the Company's business, are subject to various risks and uncertainties, including the risks that the clinical studies will not show BioGlue to be safe and effective in plastic and cosmetic surgery, that the FDA or other regulatory agencies will not approve BioGlue for this use in the near future or at all, that the costs of obtaining this approval may substantially offset any resulting benefits or that even if such approval is obtained, the use of BioGlue in this arena, as marketed by BioForm, will not materially increase CryoLife's revenues or earnings.
CryoLife Media Contacts:
D. Ashley Lee
Executive Vice President, Chief Operating Officer
and Chief Financial Officer
BioForm Media Contact:
Adam D. Gridley
Vice President, Corporate Development
BioForm Medical, Inc.
SOURCE CryoLife, Inc.
Web site: http://www.cryolife.com