ATLANTA, Jan. 11 CryoLife, Inc. (NYSE: CRY), abiomaterials, medical device and tissue processing company, announced todaythat it has been notified that a lawsuit will be filed against it in theSuperior Court of Cobb County, Georgia relating to a meniscal allograft.
The lawsuit concerns an individual who contracted an infection following atransplant of a meniscal allograft in December 2006. Meniscal transplants arecommonly used for patients with significant damage to the knee, who havealready undergone several previous knee operations. A meniscal transplant isoften recommended as the last resort before total knee replacement surgery.When a meniscal transplant is contemplated, it is routine medical procedurefor the patient to be informed of the risks of transplant surgery, includingthe risk of infection from the transplanted tissue.
After receiving notice of the individual's infection, CryoLife conductedan immediate and thorough investigation of the manner in which thetransplanted tissue was recovered and handled. As a result of thisinvestigation, CryoLife believes that it handled the tissue in accordance withits procedures and in accordance with all applicable industry standards andregulatory requirements. Shortly after the infection was discovered, CryoLifenotified the FDA of the incident, as it was required to do.
"We regret that this recipient experienced a problem following implant ofour aseptically-processed tissue. We wish him the best; however, it is ourunderstanding that his knee function was severely compromised prior to hismeniscal transplant. Regrettably, the lawyers representing this individualhave chosen to make untrue public statements against our company and ourtissue processing services in an effort to force us into a monetary settlementof the case," stated Ashley Lee, executive vice president, chief operatingofficer and chief financial officer of CryoLife. "We feel it is important thatwe address these statements."
"We are confident that we followed industry standard and FDA practices andpolicies fully in processing this tissue and in notifying the properauthorities after learning of the infection. We intend to vigorously defendagainst this lawsuit and believe that we have adequate insurance coverage forthis particular case."
About CryoLife, Inc.
Founded in 1984, CryoLife, Inc. is a leader in the processing anddistribution of implantable living human tissues for use in cardiac andvascular surgeries throughout the United States and Canada. The Company'sBioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures andstaples 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 andAustralia for use in soft tissue repair. The Company also distributes theCryoLife-O'Brien(R) stentless porcine heart valve, which is CE marked fordistribution within the European Community. For additional information aboutCryoLife please visit http://www.cryolife.com.
Statements made in this press release that look forward in time or thatexpress management's beliefs, expectations or hopes are forward-lookingstatements within the meaning of the Private Securities Litigation Reform Actof 1995. These statements include those regarding the potential outcome ofthe litigation described above. These future events may not occur as and whenexpected, if at all, and, together with the Company's business, are subject tovarious risks and uncertainties. These risks and uncertainties include theuncertainties surrounding the trial of any litigation, the expenses associatedwith that litigation and the risk of an adverse judgment at trial, as well asrisk factors detailed in CryoLife's Securities and Exchange Commissionfilings, including CryoLife's Form 10-K filing for the year ended December 31,2006, its most recent Form 10-Q, and