CryoLife (Kennesaw, Georgia), an implantable biological medical device and cardiovascular tissue processing company, has taken a significant step towards bringing its BioFoam Surgical Matrix to the U.S. market. The FDA has granted the company an investigational device exemption to conduct a human clinical trial for the product.

Based on the same protein hydrogel technology platform from which the company's BioGlue Surgical Adhesive was developed, CryoLife says the 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.

But before the trial can begin, CryoLife says it has to get approval from the U.S. Department of Defense. Such approval is standard operating procedure for any trial funded through DOD, David Fronk, VP of regulatory affairs and quality assurance at CryoLife, told Medical Device Daily.

The company reported receiving funds from the DOD, as part of its battlefield trauma program, for the development of protein hydrogel as a product to limit blood loss in soldiers injured in battle, about two years ago (Medical Device Daily, June 18, 2007). More recently, the company was awarded roughly $1.7 million under the DOD appropriations bill to continue development of the protein hydrogel technology (MDD, April 7, 2009).

While the original intent for BioFoam was for it to be useful on the battlefield, which is a "continued area of development," Fronk said, the company has found that the product has "less rigorous" clinical applications in liver surgery compared to the traumatic wounds incurred on the battlefield.

According to CryoLife, BioFoam is easily applied and can be used intraoperatively to control internal organ hemorrhage, limit blood loss and reduce the need for future reoperations in liver resections. The product received CE mark approval in July 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.

Scott Capps, VP of clinical research at CryoLife, told MDD that BioFoam is "very similar in the base technology to BioGlue," but that it contains an expansion agent that gives it a foaming characteristic." According to the company the foam creates a mechanical barrier to decrease blood flow and pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis.

"The anticipated degradation profile is faster than BioGlue because it is an open cell foam," Capps said.

Last month the company reported that the first clinical implant of BioFoam was used in a liver resection procedure following tumor removal as a supplement measure to promote hemostasis (a complex process that stops bleeding) by sealing vessels (MDD, Sept. 11, 2009).

CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the UK, 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 about $30 million and more than $100 million worldwide.

"We believe that BioFoam may hold tremendous promise for surgeons around the world and are excited by the early data published thus far," said Steven Anderson, CryoLife president/CEO.

The company said that once the feasibility study is complete it plans to conduct a follow-on prospective, multicenter, randomized, controlled pivotal study. That study is expected to enroll 164 patients, 82 in each treatment group across a maximum of 10 investigational sites, CryoLife said.

CryoLife said 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.

Amanda Pedersen, 229-471-4212;

amanda.pedersen@ahcmedia.com