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.
http://www.bio2tech.com
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SOURCE Bio2 Technologies, Inc.