ATLANTA, June 30 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.
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(TM) 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: D. Ashley Lee Executive Vice President, Chief Financial Officer and Chief Operating Officer Phone: 770-419-3355 Nina Devlin Edelman Phone: 212-704-8145
SOURCE CryoLife, Inc.