Abyrx receives FDA clearance for new resorbable hemostatic bone putty
Sep 19, 2013 (MarketLine via COMTEX) --
Abyrx, Inc., a therapeutic device company providing new biosurgical products, has received FDA clearance for its new resorbable hemostatic bone putty, or Hemasorb Plus, for clinical use in the US.
Hemasorb Plus is provided ready-to-use and achieves hemostasis by mechanical tamponade. Its proprietary formulation is comprised of granular hydroxyapatite/beta-tricalcium phosphate and water soluble components that are fully synthetic and absorbable. Abyrx will offer Hemasorb Plus in a single-package configuration and in several sizes to accommodate hospital procurement requirements and improve efficiency in a variety of surgical procedures across surgical specialties in which the product will be used.
Hemasorb Plus complements Abyrx's existing surgical hemostat product offerings which currently include AHBP, a synthetic hemostatic bone putty that absorbs within days following surgery, and Hemasorb, a synthetic resorbable hemostatic bone putty that is available with a custom spatula or in a syringe-like applicator.
David J. Hart, Abyrx's COO, is leading Abyrx's market introduction of Hemasorb Plus. He stated, "The bone hemostasis market is undergoing a significant transformation as surgeons seek improved solutions to address bone bleeding. We will launch Hemasorb Plus using the KAIRUKU Platform and leverage the distribution channels we've built with Hemasorb to achieve widespread availability to surgeons across specialties."
Abyrx's surgical hemostat products are used by cardiothoracic, craniomaxillofacial, spine, orthopedic, neurological, and trauma surgeons.
John J. Pacifico, Abyrx's President and CEO, commented, "Since 2006, our organization has been primarily focused on R&D. With the addition of Hemasorb Plus to our product portfolio, we will increase efforts toward expanding the availability of our products to surgeons and hospitals throughout the world. As part of this process, we will evaluate opportunities to further enhance our commercial infrastructure and manage the growth of our distribution channels."
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