Abyrx,™ Inc. Receives FDA 510(k) Clearance for New Resorbable Hemostatic Bone Putty (Hemasorb Plus™)
, Sept. 4, 2013
/PRNewswire/ -- Abyrx, Inc., a privately-held therapeutic device company, today announced that the United States Food and Drug Administration has cleared its new resorbable hemostatic bone putty (Hemasorb Plus) for clinical use in the United States
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. With this new product, Abyrx is executing its strategy of providing to surgeons the most comprehensive bone hemostat product line available in the operating room.
David J. Hart, Abyrx's Chief Operating Officer, 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. The Company estimates that over 3.5 million patients undergoing surgical procedures each year could benefit from the intraoperative use of its products.
John J. Pacifico, Abyrx's President and Chief Executive Officer, commented, "Since 2006, our organization has been primarily focused on research and development. 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."
Hemasorb Plus is the second new product clearance Abyrx has announced since it was established in April of this year. Additional development of Abyrx's biomaterial technology platforms is underway and the Company expects to introduce new products 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. Abyrx's advanced technology platforms are being developed to create new products that have potential to support bone healing, enable approximation of bone surfaces, and deliver drugs to bone. The Company uses the KAIRUKU Platform (www.kairuku.com) to enable its product representatives to build and manage multiple point-of-care distribution channels across surgical specialties at each hospital. Abyrx's products are protected by over 40 issued and pending patents.
Abyrx is located in Irvington, New York. For more information, please visit www.abyrx.com and follow Abyrx on Twitter @abyrx.
SOURCE Abyrx, Inc.