Tuesday, July 2, 2013

US FDA clears Abyrx's absorbable haemostatic bone putty for clinical use

Abyrx, Inc., a privately-held therapeutic device company, has received the United States Food and Drug Administration (FDA) clearance for its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use in the state.

AHBP is provided ready-to-use (without requiring mixing or warming) and achieves hemostasis by mechanical tamponade. Its proprietary formulation is comprised of water soluble and dispersible components that are fully synthetic and substantially absorb within days following surgery. Abyrx will offer AHBP in a multi-package configuration and in several sizes to accommodate hospital procurement requirements and to improve efficiency in a variety of surgical procedures across surgical specialties in which the product will be used.

AHBP complements Abyrx’s existing surgical hemostat product offerings which currently include Hemasorb and Hemasorb Apply. With this new product, Abyrx is executing its strategy of vertically integrating within the surgical hemostasis marketplace.

Commenting on Abyrx’s portfolio approach to the marketplace, John J Pacifico, the Company’s president and chief executive officer, stated, “Our team is committed to providing the most comprehensive bone hemostat product line in the operating room. AHBP and other products under development complement our Hemasorb products and will provide surgeons with more options to treat their patients and help enable hospitals to reduce costs.”

Richard Kronenthal, Ph.D., Abyrx’s chief scientific officer, offered his thoughts about the developmental challenge and the potential of the AHBP technology platform, “Our technical team evaluated dozens of subtle chemical and processing variables to specifically meet the surgical performance requirements of AHBP. Indeed, we continue to enjoy the challenge of further innovation by drawing on this new technology platform and our knowledge of the surgeon’s important needs.”

Abyrx’s surgical hemostat products are used by cardiothoracic, craniomaxillofacial, spine, orthopaedic, neurological, and trauma surgeons. The Company estimates that over 3.5 million patients undergoing surgical procedures each year could benefit from the intraoperative use of its products.

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