ATLANTA and SAN MATEO, Calif., June 10 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), and BioForm Medical, Inc. (Nasdaq: BFRM) today announced that they have received a CE Mark for the use of CryoLife's BioGlue Surgical Adhesive for periosteal fixation following endoscopic browplasty or brow lift, a reconstructive plastic surgery procedure. The CE Mark approval allows the product to be marketed in the European Community (EU).
BioGlue will be distributed by CryoLife's partner BioForm Medical, for use in approved cosmetic and reconstructive plastic surgery in the EU, under the name "BioGlue Aesthetic(TM) Medical Adhesive." Under the terms of the agreement, CryoLife is the exclusive supplier of BioGlue to BioForm for all cosmetic and plastic surgery applications, and BioForm is responsible for all clinical trials and regulatory filings, and for sales and marketing of BioGlue in these applications in 12 EU countries.
"BioGlue has many potential applications in aesthetic surgery, and we are particularly excited about its promise in brow lift surgery. This is an important step in our overall development strategy to evaluate the use of BioGlue as a quick and easy-to-use fixation method in plastic surgery," said Steven Basta, chief executive officer, BioForm Medical, Inc. "The CE Mark will enable us to accelerate development and evaluation of BioGlue applications with European physicians."
"We will not commercially launch BioGlue in the EU until further clinical development is completed, but the product will be available in Europe on a limited basis to early users who will help us in the evaluation and development program," added Mr. Basta. "This program will complement the development program in the U.S., where we are advancing toward a planned U.S. pivotal study of BioGlue for use in browplasties."
"BioGlue has proven to be a safe and effective product and it has been used in over 400,000 procedures worldwide," said Steven G. Anderson, president and chief executive officer, CryoLife, Inc. "We are pleased that BioGlue is now available for use in browlift cosmetic and plastic surgery in the European Community. We look forward to continuing to expand BioGlue's applications and availability worldwide."
BioGlue 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. CryoLife's BioGlue Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is approved for soft tissue repair in the European Community, Canada and Australia.
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. The Company recently received FDA clearance for the CryoValve(R) SG pulmonary human heart valve, processed using CryoLife's proprietary SynerGraft(R) Technology. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. CryoLife distributes Hemostase MPH(R), a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in the United Kingdom and Germany for cardiac, vascular, and general surgery, subject to certain exclusions. The Company also distributes the CryoLife-O'Brien(R) stentless porcine heart valve, which is CE marked for distribution within the European Community. For additional information about CryoLife, please visit http://www.cryolife.com.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes 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 CryoLife's and BioForm Medical's business, are subject to various risks and uncertainties. Specifically, statements concerning the potential success of European commercialization efforts for BioGlue in cosmetic and reconstructive plastic surgery applications, as well as the timing and success of clinical efforts toward commencing a U.S. pivotal study of BioGlue for use in browplasties, are forward looking statements within the meaning of the Safe Harbor. There can be no guaranty that BioGlue Aesthetic Medical Adhesive will receive all necessary approvals and/or acceptance for use in plastic surgery applications in the U.S., the product may not perform as anticipated in these applications and surgeons may not accept it or otherwise choose to use it. Further information on potential risk factors that could affect CryoLife's business and its financial results is detailed in CryoLife's Securities and Exchange Commission filings, including CryoLife's Form 10-K filing for the year ended December 31, 2007, it's most recent Form 10-Q and the Company's other SEC filings. Further information on potential risk factors that could affect BioForm Medical's business and its financial results is detailed in its Form 10-Q for the quarter ended March 31, 2008 as filed with the Securities and Exchange Commission on May 9, 2008. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Neither CryoLife nor BioForm Medical undertake any obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.
CryoLife Media Contacts: BioForm Media Contact:
D. Ashley Lee Adam D. Gridley
Executive Vice President, Chief Operating Vice President, Corporate
Officer and Chief Financial Officer Development
CryoLife, Inc. BioForm Medical, Inc.
770-419-3355 650-286-4025
Katie Brazel
Fleishman-Hillard
404-739-0150