CryoLife Expands Distribution of Hemostase MPH(R) to France through Laboratoire Gamida
September 11 2008 - 5:00PM
PR Newswire (US)
Unique hemostatic powder is available in ready-to-use applicator
ATLANTA, Sept. 11 /PRNewswire-FirstCall/ -- CryoLife, Inc.
(NYSE:CRY), a biomaterials, medical device and tissue processing
company, announced today that it has begun distribution in France,
through Laboratoire Gamida, of Hemostase MPH for use in general,
cardiac and vascular surgery. CryoLife began distributing Hemostase
MPH in the U.S., the United Kingdom and Germany in the second
quarter of 2008. Distribution in other markets outside the U.S. is
planned for later in 2008 and in 2009. Hemostase MPH is developed
using Microporous Polysaccharide Hemospheres technology (MPH(R)),
which yields a plant-based powder engineered to rapidly dehydrate
blood, enhancing clotting on contact. When used as directed, this
hemostatic or antibleeding agent facilitates the formation of a
resilient, natural clot within just a few minutes. Hemostase MPH
received CE Mark approval in 2003 and FDA pre-market approval in
September 2006. Available in a convenient ready-to-use applicator,
Hemostase MPH, unlike many hemostatic agents, does not require
additional operating room preparation or special storage
conditions. In addition, pre-clinical evaluations have shown that
Hemostase MPH does not promote infection and absorbs within 24-48
hours of application at the wound site, compared to other surgical
hemostats which can take 3-8 weeks or more to fully break down. "As
a complement to CryoLife's BioGlue(R) product line, Hemostase MPH
gives surgeons the ability to quickly control active surgical
bleeding, and we are pleased to begin offering this product in
France," stated Steven G. Anderson, president and chief executive
officer. "We will showcase Hemostase MPH at the European
Association of Cardiothoracic Surgeons meeting in Lisbon, Portugal
later this week." 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 U.S. 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, Germany and France for
cardiac, vascular, and general surgery, subject to certain
exclusions. The Company also distributes the CryoLife-O'Brien(R)
Stentless Porcine Aortic Bioprosthesis, which is CE marked for
distribution within the European Community. 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 statements include those regarding the
ability of the Company to begin distributing the Hemostase MPH
product when expected and the anticipated benefits of Hemostase
MPH. 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. These risks and uncertainties
include that the Company may be unable to effectively leverage its
existing sales force to sell a new product, that surgeons may not
choose to utilize Hemostase MPH, that Hemostase MPH may not perform
in accordance with preliminary tests and results and that other
distributors may impede the Company's ability to sell to new or
existing customers. These risks and uncertainties also include the
risk factors detailed in CryoLife's Securities and Exchange
Commission filings, including CryoLife's Form 10-K filing for the
year ended December 31, 2007 and the Company's other SEC filings.
The Company does not undertake to update its forward-looking
statements. For additional information about the company, visit
CryoLife's Web site http://www.cryolife.com/ Media Contacts: D.
Ashley Lee Executive Vice President, Chief Financial Officer and
Chief Operating Officer Phone: 770-419-3355 Katie Brazel Fleishman
Hillard Phone: 404-739-0150 DATASOURCE: CryoLife, Inc. CONTACT: D.
Ashley Lee, Executive Vice President, Chief Financial Officer and
Chief Operating Officer, CryoLife, Inc., +1-770-419-3355; or Katie
Brazel of Fleishman Hillard for Cryolife, +1-404-739-0150 Web site:
http://www.cryolife.com/
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