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Bio2 Technologies Earns Clearance for Bioactive Scaffold

Release expected in early 2015.

Woburn, Mass.-based Bio2 Technologies Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CLM bioactive scaffold. CLM is constructed from bioactive glass, a resorbable implantable material.

Following four years of research and pre-clinical testing, the company claims it has successfully applied its proprietary CLM process technology to produce a rigid, osteoconductive material with an interconnected porous structure facilitating the ingrowth and remodeling of healthy bone.

“The receipt of FDA market clearance paves the way for U.S. commercialization of our first product line, resorbable bioactive wedges for use in reconstructive surgery of the extremities,” said Paul Nichols, president CEO of Bio2. “We believe the properties of CLM offer musculoskeletal surgeons an attractive alternative to allograft (cadaver bone) and ceramics such as beta-tricalcium phosphate.”

A limited product release is planned for the second quarter of 2015.

Bio2 is developing a pipeline of products constructed from CLM for use in reconstructive surgery of the extremities. The company has also initiated additional pre-clinical testing to support future FDA and European filings for the use of CLM in load bearing spine surgery applications, including interbody devices for cervical and lumbar fusion.

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