Bio2 Technologies, Inc. Announces Receipt Of FDA 510(K) Clearance For CLM Bioactive Scaffold
Implants constructed from a novel porous resorbable biomaterial offer surgeons an attractive alternative to allograft
WOBURN, Mass., Dec. 19, 2014 /PRNewswire/ -- Bio2 Technologies, Inc. (a privately held development stage company) announced today that it 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 with a well-studied mechanism of action and a long track record of safe clinical use. Following four years of research and pre-clinical testing Bio2 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.
Paul Nichols, President and Chief Executive Officer of Bio2 Technologies, stated “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. 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.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/bio2-technologies-inc-announces-receipt-of-fda-510k-clearance-for-clm-bioactive-scaffold-300012308.html
SOURCE Bio2 Technologies, Inc.
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