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Abyrx receives FDA 510(k) approval for resorbable hemostatic bone putty

Therapeutic devices developer Abyrx has received 510(k) approval from the US Food and Drug Administration (FDA) for its new resorbable hemostatic bone putty called Hemasorb Plus that achieves hemostasis by mechanical tamponade.

Hemasorb Plus, which will be launched using the company’s KAIRUKU platform, will comprise of granular hydroxyapatite/beta-tricalcium phosphate and water soluble components.

Abyrx will offer Hemasorb Plus in a single-package configuration and in different sizes to accommodate hospital procurement requirements and improve efficiency in a variety of surgical procedures.

Abyrx COO David Hart said that the bone hemostasis market is undergoing a significant transformation as surgeons seek improved solutions to address bone bleeding.

Abyrx president and CEO John Pacifico said, "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."

Abyrx is planning to introduce new biomaterial technology platforms in 2014.