CryoLife, Inc. announced that it has received European approval for its BioFoam Surgical Matrix (BioFoam). The company can commercially distribute BioFoam 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 in the European Community. BioFoam is based on protein hydrogel technology platform. It is the second product of the company to receive a CE mark approval.
The company is planning for a controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy to support its initial marketing efforts.
We are excited about securing our first approval for the use of BioFoam in organ resection surgery and look forward to continuing our development efforts to bring BioFoam into the US market, said Steven G. Anderson, CryoLife president and chief executive officer. Over the past four fiscal years, the US Department of Defense has allocated approximately $5.4 million to CryoLife for the development of products containing a protein hydrogel, which is the primary component of BioFoam.
The company received conditional approval from the FDA to conduct the feasibility phase of the BioFoam IDE submission for liver parenchymal sealing in December 2008. The feasibility phase will enroll 20 subjects at two investigational sites in the US. The company before beginning this phase must receive final approval of the study protocol and related documents from the FDA and an additional approval of the study from the US Department of Defense. CryoLife is in the final stages of this approval process.