Abyrx,T Inc. Receives FDA 510(k) Clearance for New Absorbable Hemostatic Bone Putty (AHBPT)
Abyrx, Inc., a privately-held therapeutic device company, today announced that the United States Food and Drug Administration has cleared its new Absorbable Hemostatic Bone Putty (AHBP) for clinical use in the United States.
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, orthopedic, 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.
David J. Hart, Abyrx's Vice President of Business Operations, will be responsible for leading the market introduction of AHBP. Commenting on the Company's launch plans, he added, "Using the KAIRUKUT Platform, we have worked with our product representatives to develop a robust distribution channel. The introduction of AHBP in 2013 will significantly expand our market reach and improve the services we offer to our surgeon users and hospital partners." Additional development of Abyrx's biomaterial technology platforms is underway and the Company expects to introduce new products later this year and in 2014.
Founded in 2013, Abyrx develops, manufactures, and provides therapeutic devices for use during surgical procedures. The Company's portfolio of FDA-cleared products includes three putties that stop bone bleeding and two applicator devices. Its advanced technology platforms are being developed to create new products that support bone healing, enable re-approximation of bone surfaces, and deliver drugs to bone. Abyrx uses the KAIRUKU Platform (www.kairuku.com) to build and manage teams of product representatives across surgical specialties. The Company's products are protected by over 30 issued and pending patents. Abyrx occupies 8,000 square feet at its state-of-the-art facility in Irvington, New York. For more information, please visit www.abyrx.com.