/PRNewswire/ -- CryoLife, Inc., (NYSE: CRY), a leading tissue processing and medical device Company focused on cardiac and vascular surgery, today announced that it has enrolled the first patient in its U.S. Investigational Device Exemption (IDE) clinical trial for its BioFoam Surgical Matrix protein hydrogel technology. In connection with the trial, BioFoam will be used as an adjunct to conservative measures of achieving hemostasis on newly resected liver parenchyma.
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 up to three investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group.
"We are pleased to begin enrolling patients in our IDE study, which is a milestone in our efforts to obtain BioFoam approval for distribution in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. "We have worked with FDA on two recent protocol amendments which we think should help speed enrollment into the pilot study. Once it is completed, assuming that the data is positive, we will begin planning for a larger pivotal study to support a PMA application for BioFoam with the FDA. We believe that BioFoam may hold promise for surgeons around the world and are encouraged by the early clinical experience in Europe."
Upon successful completion of the feasibility study in the U.S., and subsequent FDA and Department of Defense approvals, a follow-on prospective, multicenter, randomized, controlled pivotal study is planned. It is currently anticipated that the pivotal investigation would enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites. This data would then be used to support a U.S. Premarket Approval application to allow commercialization of BioFoam in the U.S.
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 control group (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 control group to demonstrate that BioFoam is at least equivalent in performance.
In Europe, CryoLife has completed a 55-patient prospective, multicenter, single-arm study of BioFoam at three centers in the United Kingdom, Germany, and France. The results from this study were presented at the Association of Surgeons of Great Britain and Ireland (ASGBI) Congress in May 2011. The efficacy results show that the time to obtain hemostasis after an application of BioFoam compares favorably to results reported for related products. Analysis of the safety endpoints defined for this study and the collection of adverse events were also consistent with data reported within historical literature. 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 USD and more than $100 million USD worldwide.
For additional information, visit www.cryolife.com.