CryoLife to Distribute FDA-approved Hemostatic Agent Under Private Label

ATLANTA, April 17 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY), a
biomaterials, medical device and tissue processing company, announced today
that it has signed an exclusive three-year agreement with Minneapolis-based
Medafor, Inc. Under terms of the agreement CryoLife will distribute Medafor's
microporous polysaccharide hemostatic agent for use in cardiac and vascular
surgery in the U.S. and for cardiac, vascular and general surgery, other than
orthopaedic and ear, nose and throat surgery, outside the U.S. (excluding
Japan and China).
CryoLife expects to begin distributing Hemostase MPH in the U.S. in the
second quarter of 2008, except to approximately 41 hospitals for which Medafor
will retain distribution rights until no later than December 31, 2008.
Outside of the U.S., CryoLife expects to begin distributing Hemostase MPH in
Canada, United Kingdom and Germany in the second quarter of 2008, with
distribution in other markets beginning in 2009. Department of Defense
hospitals are excluded from CryoLife's territory under the distribution
agreement, but Veterans' Administration Hospitals are included.
The unique, absorbable powder hemostat, which received CE Mark approval in
2003 and FDA pre-market approval in September 2006, will be distributed by
CryoLife under the private label name Hemostase MPH.
Hemostase MPH is developed using Medafor's exclusive, licensed Microporous
Polysaccharide Hemospheres technology (MPH(R)), which yields a plant-based,
flowable powder engineered to rapidly dehydrate blood, enhancing clotting on
contact. When used as directed, this highly effective hemostatic agent
facilitates the formation of a resilient, natural clot within just a few
minutes.
Available in a convenient ready-to-use applicator, Hemostase MPH, unlike
many hemostatic agents, does not require additional preparation steps in the
operating room or special storage conditions thereby saving valuable operating
room time and resources. 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.
"Hemostase MPH gives surgeons the ability to quickly control active
surgical bleeding, making it the perfect complement to CryoLife's BioGlue(R)
product line, which is much stronger and provides both tissue reinforcement
and sealant capabilities," stated Steven G. Anderson, president and chief
executive officer. "Hemostase MPH also allows us to compete in the surgical
hemostat market, which we believe totaled approximately $380 million in the
U.S. in 2007."
Gary Shope, Medafor's chief executive, said, "We are pleased to be working
with CryoLife as a major distribution partner. CryoLife is a world leader in
its chosen areas, and its strength in sales, marketing and distribution in the
cardio and vascular fields should provide great impetus to Medafor's market
penetration."
The agreement allows for a three-year extension at the option of CryoLife
if certain minimum purchases are met.
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 its 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. The Company also
distributes the CryoLife-O'Brien(R) stentless porcine heart valve, which is CE
marked for distribution within the European Community.
About Medafor Inc.
Medafor is a privately held Minneapolis based medical device company that
has commercialized a naturally absorbent starch based hemostatic powder
engineered to rapidly dehydrate blood and enhance clotting. This powder,
which is Medafor's microporous polysaccharide hemostatic agent, has been
commercialized for use in both intra-operative surgical procedures as well as
numerous topical applications worldwide. This agent has a number of cost and
safety features important to both surgeons and patients. The Company received
FDA approval for surgical use of this product in September 2006 and has had CE
Mark approval since 2003.
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, the ability of
the Company to compete in the surgical hemostat market, and expectations
regarding the market penetration 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, and that Hemostase MPH may not perform as expected
or provide all expected benefits. In addition, the Company's business is
subject to the following risks: the Company's strategic directives may not
generate anticipated revenue and earnings growth, that the Company is
dependent on revenues from BioGlue, competitive pressures and tissue
availability may adversely affect the Company's ability to grow revenues, the
Company's efforts to develop and introduce new products outside the U.S. may
be unsuccessful, the Company's efforts to improve procurement and tissue
processing yields may not continue to prove effective, the possibility that
the FDA or foreign regulatory bodies could impose restrictions on the
Company's operations, require a recall, or prevent the Company from processing
and distributing tissues or manufacturing and distributing other products, FDA
and other approvals for products in development may not be obtained, and if
obtained, may be costly and require lengthy review periods, products and
services under development may not be commercially feasible, CryoValve SG may
not perform as well as expected or provide all the benefits anticipated,
demand for CryoValve SG may not reach anticipated levels, and accordingly, the
Company may choose not to process the majority of its pulmonary valves with
the Company's SynerGraft technology, the SynerGraft post-clearance study
requested by the FDA may not provide the expected positive results, that the
Company's products and the tissues the Company processes allegedly have caused
and may in the future cause injury to patients and the Company has been and
may be exposed to product liability claims and additional regulatory scrutiny
as a result, that uncertainties related to patents and protection of
proprietary technology may affect the availability, amount and timing of the
Company's revenues, that pending or future litigation cannot be settled on
terms acceptable to the Company, that the Company may not have sufficient
resources to pay punitive damages (which are not covered by insurance) or
other liabilities in excess of its available insurance, that the Company may
not have sufficient borrowing or other capital availability to fund its
business, that the Company may be unable to obtain sufficient financing to
fully pursue its strategic plan and future healthcare policies, healthcare
reimbursement methods and healthcare reimbursement policies may affect the
availability, amount and timing of the Company's revenues. These risks and
uncertainties 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 Katie Brazel
Executive Vice President, Chief Financial Officer Fleishman Hillard
and Chief Operating Officer Phone: 404-739-0150
Phone: 770-419-3355

SOURCE CryoLife, Inc.

D. Ashley Lee, Executive Vice President, Chief Financial Officer and Chief
Operating Officer of CryoLife, Inc., +1-770-419-3355; or Katie Brazel of
Fleishman Hillard, +1-404-739-0150