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news.CryoLife, an implantable biological medical device and tissue processing company, has received approximately $1.7 million under the Department of Defense appropriations bill to continue further development of the company's protein hydrogel technology.
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Preclinical studies of CryoLife’s BioFoam surgical matrix, a protein hydrogel product under development for organ sealing, are nearing completion. This grant will help fund upcoming clinical studies of BioFoam in the US.
In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the company’s BioFoam investigational device exemption submission for liver parenchyma sealing. Before beginning the feasibility study, the company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the same from the US Department of Defense. The Company is in the final review process with the Department of Defense.
The company has also filed a CE Mark submission for BioFoam’s use as an adjunct in the sealing of abdominal parenchymal tissues when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.
Steven Anderson, president and CEO of CryoLife, said: “Over the past four fiscal years the Department of Defense has allocated a total of approximately $5.4 million to CryoLife for the development of protein hydrogel products. We are excited about advancing this product through the clinical process.”