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September 4, 2013

Abyrx secures USFDA 510(k) clearance for new resorbable hemostatic bone putty

Abyrx, a therapeutic device company, has obtained US Food and Drug Administration clearance for its Hemasorb Plus, a new resorbable hemostatic bone putty designed for clinical use in the US.

By admin-demo

Abyrx, a therapeutic device company, has obtained US Food and Drug Administration clearance for its Hemasorb Plus, a new resorbable hemostatic bone putty designed for clinical use in the US.

Hemasorb Plus is an easy-to-use synthetic resorbable hemostatic bone putty that achieves hemostasis by mechanical tamponade.

The proprietary formulation of Hemasorb Plus comprises granular hydroxyapatite/beta-tricalcium phosphate and water soluble components that are fully synthetic and absorbable in nature.

The Hemasorb Plus is available in a single-package configuration and several sizes to facilitate hospital procurement requirements and improve efficiency in a variety of surgical procedures.

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

"As part of this process, we will evaluate opportunities to further enhance our commercial infrastructure and manage the growth of our distribution channels."

"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," Hart added.

Abyrx president and CEO John J Pacifico said with the addition of Hemasorb Plus to company’s product portfolio, it would increase efforts toward expanding the availability its 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," Pacifico said.

Hemasorb Plus is the second new product clearance Abyrx has received since it was established in April 2013.

The company’s portfolio of FDA-cleared products includes three putties that stop bone bleeding and two applicator devices.

Abyrx expects to launch new products, which are currently under development, in 2014.

According to GlobalData estimates, orthobiologics market in the US, which was valued at $2.78bn in 2012, is expected to grow at a CAGR of 3.8% to reach $3.61bn by 2019.

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