Full Press Release Details
Bacterin's OsteoSponge
Generates Positive Clinical Results
Clinical Results for Foot and Ankle Fusion
Published in "The Journal of Foot & Ankle Surgery."
BELGRADE, MT - January 22, 2013 - Bacterin
International Holdings, Inc. (NYSE MKT: BONE), a leader in the development of revolutionary bone graft material and antimicrobial
coatings for medical applications, announces that the first clinical results using the OsteoSponge product for
foot and ankle arthrodesis have been published in The Journal of Foot & Ankle Surgery. The article reports a
multi-center, retrospective analysis of 80 joint fusions in 47 subjects who had undergone foot and ankle fusion procedures utilizing
OsteoSponge bone graft. Overall, a fusion rate of 97.5% (78 of 80 joints) was determined by radiographic analysis.
The article, titled "A Retrospective
Analysis Evaluating Allogeneic Cancellous Bone Sponge for Foot and Ankle Arthrodesis," reported comparable or greater foot
and ankle fusion rates, as judged radiographically, to that reported in the biomedical literature. Additionally, at 12-month post-operative
assessment, the authors observed statistically significant improvements in function and pain alleviation at rates greater than
those previously reported in biomedical studies.
"The data published in The Journal
of Foot and Ankle Surgery serve as yet another testament to the efficacy of the OsteoSponge product," said Guy Cook,
Bacterin's CEO. "We believe these results will aid in our goal of expanding Bacterin's presence in the foot and
ankle bone grafting market and are consistent with Bacterin's mission of helping our surgeon users provide the best clinical
outcomes for their patients."
About Bacterin International Holdings
Bacterin International Holdings, Inc. (NYSE
Amex: 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 bioactive coatings for various medical device applications. Bacterin's strategic coating initiatives include
antimicrobial coatings designed to inhibit biofilm formation and microbial contamination. For further information, please visit
Important Cautions Regarding Forward-looking
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: the Company's ability to launch beta and full product releases, the Company's ability to obtain FDA concurrence
use for anti-microbial coatings in a timely manner; the Company's ability to meet its obligations under existing and anticipated
contractual obligations; the Company's ability to develop, market, sell and distribute desirable applications, products and services
and to protect its intellectual property; the ability of the Company's sales force to achieve expected results; the ability of
the Company's customers to pay and the timeliness of such payments, particularly during recessionary periods; the Company's ability
to obtain financing as and when needed; changes in consumer demands and preferences; the Company's ability to attract and retain
management and employees with appropriate skills and expertise; the impact of increased taxation, changes in market, legal and
regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. Additional
risk factors are listed in the Company's Annual Report on Form 10-K under the heading "Risk Factors." The Company undertakes
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.