Second FDA Clearance since April for Abyrx, Inc.

Although founded just five months ago, privately held Abyrx already has its second FDA clearance.

Abyrx, Inc., a privately-held therapeutic device company, reports that the United States Food and Drug Administration has cleared a new resorbable hemostatic bone putty, called Hemasorb Plus, for clinical use in the United States.

The firm’s release states that 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 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. “

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 the company was established in April of this year.