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Baxter Launches HEMOPATCH, An Innovative Sealing Hemostat, In European Union

Baxter International Inc. (NYSE:BAX) today announced the launch of HEMOPATCH Sealing Hemostat, a novel collagen-based hemostatic device, following CE mark approval in Europe. HEMOPATCH is a resorbable hemostatic device used for surgical procedures when control of bleeding by pressure, ligature or conventional procedures is either ineffective or impractical. The development of HEMOPATCH combined Baxter’s expertise in collagen, internal coagulation processes, and PEG (polyethylene glycol) technology platforms.

''HEMOPATCH is a valuable addition to the tools in the surgical suite, as it provides fast hemostasis and strong tissue adherence. Surgeons will appreciate that the product works quickly and effectively, does not require preparation time, and can be used in a range of surgical settings,'' said Frank Ulrich, M.D., head of surgical oncology at Goethe University in Frankfurt, Germany.

HEMOPATCH is a soft, thin and flexible collagen pad that is designed to allow surgeons control during application to gain hemostasis and firm adherence of the hemostatic pad to the bleeding tissue surface. In preclinical tests, HEMOPATCH achieved fast and effective hemostasis, reaching 97.5 percent success by fully controlling bleeding at two minutes.

The pad consists of a specifically-formulated porous collagen matrix, coated on one side with a thin protein bonding layer (known as NHS-PEG). This gives the pad a dual-method mechanism of action, in which two components interact to achieve hemostasis by sealing off the bleeding surface and initiating the body’s own clotting mechanisms. Significant preclinical testing was conducted to confirm its hemostatic performance, biocompatibility, and safety profile.

''HEMOPATCH is a significant innovation in the field of surgical hemostasis and is a valuable enhancement to the portfolio of biosurgical products offered by Baxter,'' said Russell Holscher, vice president of research and development in Baxter’s BioSurgery business. ''Importantly, the robust development process, including evaluation of more than 400 prototypes with feedback from more than 200 surgeons, exemplifies the company’s commitment to customer-centric innovation. This hemostat will offer surgeons a valuable new tool. We plan to support the registration and launch of HEMOPATCH in additional countries in the coming years.''

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