Bacterin International Holdings, Inc. (NYSE MKT: BONE), a leader in the
development of revolutionary bone graft material and coatings for
medical applications, is pleased to announce it has obtained 510(k)
approval to market OsteoSelect® DBM Putty for use in spinal fusion
procedures. OsteoSelect® is a moldable bone graft substitute designed to
withstand irrigation while exhibiting osteoinductive properties for
improved bone regeneration. The cohesive nature of the product provides
an advantage over other commercially available DBM putties which can
readily wash away after placement in wet, surgical environments.
As part of the regulatory approval process, Bacterin provided funding to
Hospital for Special Surgery in New York to perform a study evaluating
the efficacy of OsteoSelect® in a rabbit posterolateral lumbar spine
fusion model. Biomechanical, radiographic, and histological analysis
indicated that OsteoSelect® showed equivalence to a control of
autologous iliac crest bone graft which is widely considered to be the
gold standard for spinal fusion.
"We are proud to obtain another indication for use that will provide
Bacterin with additional marketing opportunities for the OsteoSelect®
DBM Putty product line," said Gregory Juda, PhD, Bacterin’s Chief
Scientific Officer. Dr. Juda continued to say, "In the 3 plus years of
OsteoSelect® being on the market, we have seen considerable adoption by
the orthopedic community across a variety of surgical specialties. Our
post market surveillance supports the efficacy of OsteoSelect® and the
results of the preclinical work validate the clinical findings."
OsteoSelect® DBM Putty is a malleable bone grafting material comprised
of demineralized bone matrix allograft combined with a polymer carrier
material. The product was engineered using feedback from key opinion
leaders in several orthopedic specialties, with a focus on providing
solutions to the shortcomings inherent to other commercially available
DBM products. The osteoinductive potential of every lot of OsteoSelect®
is confirmed after sterilization in an animal model thus providing
surgeons with a bone grafting solution that is both safe and
biologically active.
About Bacterin International Holdings
Bacterin International Holdings, Inc. (NYSE MKT: BONE) develops,
manufactures and markets biologics products to domestic and
international markets. Bacterin's proprietary methods optimize the
growth factors in human allografts to create the ideal stem cell
scaffold to promote bone, subchondral repair and dermal growth. These
products are used in a variety of applications including enhancing
fusion in spine surgery, relief of back pain, promotion of bone growth
in foot and ankle surgery, promotion of cranial healing following
neurosurgery and subchondral repair in knee and other joint surgeries.
Bacterin's Medical Device division develops, employs, and licenses
coatings for various medical device applications. For further
information, please visit www.bacterin.com.
Important Cautions Regarding Forward-looking Statements
This news release contains certain disclosures that may be deemed
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 that are subject to significant risks and
uncertainties. Forward-looking statements include statements that are
predictive in nature, that depend upon or refer to future events or
conditions, or that include words such as "continue," "efforts,"
"expects," "anticipates," "intends," "plans," "believes," "estimates,"
"projects," "forecasts," "strategy," "will," "goal," "target,"
"prospects," "potential," "optimistic," "confident," "likely,"
"probable" or similar expressions or the negative thereof. Statements of
historical fact also may be deemed to be forward-looking statements. We
caution that these statements by their nature involve risks and
uncertainties, and actual results may differ materially depending on a
variety of important factors, including, among others: our ability to
meet existing and anticipated contractual obligations, including
financial covenants and other obligations contained in our secured
lending facility; our ability to manage cash flow and achieve
profitability; our ability to regain compliance with the NYSE MKT
continued listing standards; our ability to develop, market, sell and
distribute desirable applications, products and services and to protect
our intellectual property and customer relationships; the ability of our
sales force to achieve expected results; the ability of our customers to
pay and the timeliness of such payments; our ability to obtain
additional equity or debt capital as and when needed; changes in
consumer demands and preferences; our ability to recruit a new CEO and
to attract and retain management and employees with appropriate skills
and expertise; our ability to successfully conclude certain pending
government investigations; the impact of changes in market, legal and
regulatory conditions and in the applicable business environment,
including actions of competitors; and other factors set forth in our SEC
filings from time to time. Additional risk factors are listed in our
Annual Report on Form 10-K and Quarterly Report on Form 10-Q under the
heading "Risk Factors." We undertake no obligation to release publicly
any revisions to any forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events, except as required by law.
Copyright Business Wire 2013