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.
