CryoLife's BioGlue(R) Surgical Adhesive Receives European Approval for use in Browlift Cosmetic and Reconstructive Plastic Surge
June 10 2008 - 8:30AM
PR Newswire (US)
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." 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, Canada
and Australia. 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. 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/. About BioForm Medical, Inc. BioForm
Medical, Inc. is a medical aesthetics company headquartered in San
Mateo, California, developing products that enhance aesthetic
procedures performed in dermatology and plastic surgery practices.
BioForm Medical's lead product is Radiesse(R) dermal filler, a
long-lasting filler for use in facial aesthetics. BioForm Medical
is developing several future aesthetics products including a nerve
ablation device for frown lines, a sclerotherapy treatment for
spider veins, and a surgical adhesive for brow lifts. For more
information about BioForm, please visit http://www.bioform.com/.
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 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
DATASOURCE: CryoLife, Inc. CONTACT: CryoLife Media Contacts: D.
Ashley Lee, Executive Vice President, Chief Operating Officer and
Chief Financial Officer, +1-770-419-3355, or Katie Brazel,
Fleishman-Hillard, +1-404-739-0150; BioForm Media Contact: Adam D.
Gridley, Vice President, Corporate Development, +1-650-286-4025 Web
site: http://www.cryolife.com/ http://www.bioform.com/
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