CRYOLIFE'S BIOGLUE(R) SURGICAL ADHESIVE RECEIVES EUROPEAN APPROVAL FOR USE IN BROWLIFT COSMETIC AND RECONSTRUCTIVE PLASTIC SURGERY
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
"We will not commercially launch BioGlue in the EU until further clinical
development is completed, but the product will be available in
"BioGlue has proven to be a safe and effective product and it has been
used in over 400,000 procedures worldwide," said
About BioGlue
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,
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
About BioForm Medical, Inc.
BioForm Medical, Inc. is a medical aesthetics company headquartered in
Forward Looking Statement:
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
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
SOURCE CryoLife, Inc.
