ATLANTA, June 30 /PRNewswire-FirstCall/ -- CryoLife,
Inc. (NYSE: CRY), an implantable biological medical device and
cardiovascular tissue processing company, announced today that
Medafor, Inc. is in the process of shipping approximately
$2.1 million in HemoStase in
accordance with the terms of the parties exclusive distribution
agreement ("EDA").
On June 28, 2010 Medafor and
CryoLife participated in a hearing with the District Court for the
Northern District of Georgia,
Atlanta Division, regarding CryoLife's preliminary injunction
motion against Medafor, Inc. CryoLife had filed a motion for
preliminary injunction contending that Medafor had improperly
terminated the EDA between the parties and requesting that the
Court enjoin Medafor from proceeding with the termination.
Based on the proceedings, CryoLife expects Medafor to
continue to fill valid purchase orders from CryoLife substantially
in accordance with the terms of the EDA until the Court rules on
the preliminary injunction motion or a motion for partial summary
judgment related to the same issue that may be filed by CryoLife.
Previously, Medafor had rejected three purchase orders from
CryoLife in the March to April time frame totaling approximately
$1.8 million. CryoLife
submitted a new purchase order in the amount of approximately
$2.5 million on June 25, 2010, and Medafor commenced shipping
$2.1 million of the ordered product
on June 29, 2010.
About CryoLife
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's CryoValve® SG
pulmonary heart valve, processed using CryoLife's proprietary
SynerGraft® technology, has FDA 510(k) clearance for the
replacement of diseased, damaged, malformed, or malfunctioning
native or prosthetic pulmonary valves. The Company's
CryoPatch® SG pulmonary cardiac patch has FDA 510(k) clearance for
the repair or reconstruction of the right ventricular outflow tract
(RVOT), which is a surgery commonly performed in children with
congenital heart defects, such as Tetralogy of Fallot, Truncus
Arteriosus, and Pulmonary Atresia. CryoPatch SG is
distributed in three anatomic configurations: pulmonary
hemi-artery, pulmonary trunk, and pulmonary branch. The
Company'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 also CE marked in the
European Community and approved in Canada and Australia for use in soft tissue repair.
The Company's BioFoam™ Surgical Matrix is CE marked in the
European Community for use as an adjunct in the sealing of
abdominal parenchymal tissues (liver and spleen) when cessation of
bleeding by ligature or other conventional methods is ineffective
or impractical. BIOGLUE Aesthetic® Medical Adhesive is
CE marked in the European Community for periosteal fixation
following endoscopic browplasty (brow lift) in reconstructive
plastic surgery and is distributed by a third party for this
indication. CryoLife currently distributes HemoStase®, a
hemostatic agent, in much of the U.S. for use in cardiac and
vascular surgery and in many international markets for cardiac,
vascular, and general surgery, subject to certain exclusions.
Except for the historical information contained in this press
release, the statements made by CryoLife are forward-looking
statements that involve risks and uncertainties. All such
statements are subject to the safe harbor created by the Private
Securities Litigation Reform Act of 1995. These statements include
those regarding CryoLife's expectations that Medafor will continue
to fill valid purchase orders from CryoLife in accordance with the
terms of the EDA. These future events may not occur as and
when expected, if at all, and, together with our business, these
statements are subject to a number of risks and uncertainties that
are outside CryoLife's control. Medafor has repeatedly
attempted to terminate the EDA on various grounds, and Medafor may
again seek to terminate the EDA, cease shipments of HemoStase to
CryoLife or otherwise refuse to meet its obligations under the EDA.
CryoLife's business is also subject to a number of risks and
uncertainties, including those risk factors detailed in our
Securities and Exchange Commission filings, including our Form 10-K
filing for the year ended December 31,
2009 and Form 10-Q for the quarter ended March 31, 2010. 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:
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D. Ashley
Lee
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Executive Vice
President, Chief Financial Officer and
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Chief Operating
Officer
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Phone:
770-419-3355
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Nina
Devlin
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Edelman
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Phone:
212-704-8145
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SOURCE CryoLife, Inc.