CryoLife's BioFoam, a protein hydrogel, received FDA approval today to begin an IDE for sealing of liver parenchymal tissue when conventional methods (e.g., ligature) prove ineffective.
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. CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial.
"Following our July 2009 CE Mark approval to distribute BioFoam in the EU, we now have approval to begin a clinical trial, a critical step forward in the process to gain FDA approval of BioFoam in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. He added, "We believe that BioFoam may hold tremendous promise for surgeons around the world and are excited by the early data published thus far."
See link .
The use of hemostatic and sealing agents in liver surgery represents a significant opportunity for developers of biologically based sealants and glues. CryoLife has a good start, having received approval earlier this year to market BioFoam in the EU.
See report #S715 for the worldwide analysis of surgical sealants, glues and wound closure products.