CryoLife awarded patent for BioFoam

CryoLife has announced that it has been awarded a patent by the U.S. Patent Office for BioFoam, a protein hydrogel foam for rapidly filling and sealing open wounds.

Scientists at CryoLife invented and developed this product as a hemostatic agent and tissue and organ sealant. CryoLife is continuing to develop BioFoam as an organ and tissue sealant. Other applications the company may explore include vascular sealing and tissue augmentation.

Additionally, CryoLife has received funds from the U.S. Department of Defense (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.

"When we began developing BioFoam, we quickly realized the many potential life-saving uses this product could have," said Steven G. Anderson, CryoLife president and chief executive officer. "The granting of the patent validates our technology leadership, reflects our history of innovation and protects our intellectual property."

BioFoam contains an expansion agent, and rapidly fills wounds when dispensed. It is easily applied and could potentially be used intraoperatively to control internal organ hemorrhage, limit blood loss, reduce the need for future operations, as well as to seal open wounds to improve outcomes in penetrating abdominal and chest injury. BioFoam is based on the same technology platform as the BioGlue(R) Surgical Adhesive, a CryoLife product approved by the U.S. Food and Drug Administration to control bleeding as an adjunct to sutures and staples in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair, which includes vascular and pulmonary sealing and repair.

CryoLife's U.S. patent (#7226615 B2) for expandable foam-like biomaterials and methods, describes BioFoam's unique properties. This patent includes the following:

• A kit for forming a solid cellular foam comprised of a proteinaceous biopolymeric material.
• Liquid, injectable, aqueous solutions are transformed at the site into an expandable foam-like, space-filling, adherent biomaterial.
• Preferably, the foam-like biomaterial is produced in reaction to a two-part liquid system.
• The liquid system is generally comprised of a protein solution and a cross linker solution, which can be premixed and then applied, or simultaneously mixed and delivered through an in-line mixing/dispensing tip directly to the site.
• In especially preferred embodiments, an expandable foam-like biomaterial includes the reaction product of human or animal-derived protein materials and a di- or polyaldehyde in the presence of a bicarbonate and an acidic titrant in amounts sufficient to impart a cellular foam structure to the material. About CryoLife, Inc.