CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)

/PRNewswire/ -- CryoLife, Inc., (NYSE:CRY) , an implantable biological medical device and cardiovascular tissue processing company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.

The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group. CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial.

"Following our July 2009 CE Mark approval to distribute BioFoam in the EU, we now have approval to begin a clinical trial, a critical step forward in the process to gain FDA approval of BioFoam in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. He added, "We believe that BioFoam may hold tremendous promise for surgeons around the world and are excited by the early data published thus far."

CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Based on the number of liver and spleen procedures performed annually in the European Community, CryoLife estimates the annual European market opportunity for BioFoam to be approximately $30 million and more than $100 million worldwide.

Upon successful completion of the feasibility study, and subsequent FDA and DoD approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study will be conducted. It is currently anticipated that the pivotal investigation will enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites.

The primary objective of the pivotal investigation will be to demonstrate a decrease in the time to achieve intraoperative hemostasis (a complex process that causes bleeding to stop) following open liver resection surgery in subjects receiving an application of BioFoam compared to a standard topical hemostatic agent. The secondary objectives of this investigation will be to compare time to hemostasis and the achievement of immediate hemostasis between the BioFoam group and the control group (a standard topical hemostatic agent) to demonstrate that BioFoam is at least equivalent in performance to the control group.

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FDA Clears New Immune Response Claim for the CryoValve(R) SG Pulmonary Human Heart Valve

/PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE:CRY) , a biomaterials, medical device and tissue processing company, announced today that the U.S. Food and Drug Administration (FDA) has cleared a new claim for the CryoValve(R) SG pulmonary human heart valve. The new labeling claim relates to reducing a component of the immune response in recipients of the CryoValve SG.

CryoValve SG pulmonary human heart valve is processed with the Company's proprietary SynerGraft(R) technology, which is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix.

The new claim relates to the fact that data from three company-sponsored clinical studies and a comprehensive review of the scientific literature on allograft heart valves shows that implantation of the CryoValve SG reduces the risk of inducing HLA class I and class II alloantibodies, based on Panel Reactive Antibody (PRA) measured at up to one year, compared to the standard- processed pulmonary human heart valve. The effect of reduced alloantibodies, however, on the long-term durability, or long-term resistance to rejection by the patient, of the CryoValve SG has not yet been clinically proven. The company has documented the implantation of more than 1,800 CryoValve SG pulmonary human heart valves.

The CryoValve SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary valves. The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures (RVOT), commonly performed in children with congenital heart defects. In addition, the valve can be used for pulmonary valve replacement during the Ross Procedure, an operation in which a patient's defective aortic valve is removed and replaced with his or her own pulmonary valve. The CryoValve SG is then surgically implanted in place of the removed native pulmonary valve.

A PRA screen is used to identify allosensitized patients prior to organ transplantation. An elevated PRA level, indicating pretransplant alloantibodies, increases the risk of organ transplant rejection and patient mortality. In addition, high and prolonged PRA levels may prevent or delay transplantation until a suitable crossmatch-compatible donor is identified.

"A major objective of our research and development is to reduce and ultimately eliminate the risk of an immune response for patients, and we are making great strides toward achieving that goal," said Steven G. Anderson, president and chief executive officer of CryoLife. "This new claim is important because a subset of patients receiving an allograft heart valve is likely to eventually require an organ transplant. Demonstration of reduced alloantibody levels with the CryoValve SG can be a key consideration for cardiac surgeons when replacing the pulmonary valve. Working with the FDA, we will monitor the long-term clinical outcomes over the coming years to assess what impact the SynerGraft process has on valve durability."

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