Bacterin International Holdings, Inc. Announces ISO Certification
Bacterin International Holdings, Inc. (NYSE MKT: BONE), a leader in the
development of revolutionary bone graft material and coatings for
medical applications, today announced that it has achieved ISO
13485:2003 Certification. This certification is an internationally
recognized management system standard developed by the International
Organization for Standardization (ISO).
ISO 13485:2003 is a standard specific to medical device quality systems
that supplements the ISO 9001 standard and provides a comprehensive
quality management system for the design and manufacture of medical
devices. Some of the specific requirements included in the ISO
13485:2003 standard include inspection and traceability, process
documentation and validation, and verification of the effectiveness of
preventative or corrective actions.
“The addition of the ISO 13485:2003 Certification strengthens Bacterin’s
commitment to customer quality and service,” said Guy Cook, CEO of
Bacterin International. “Our company has been a leader in the
manufacturing and marketing of biologics. We look forward to leveraging
this certification to further enhance and expand our product portfolio
in regenerative medicine.”
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
bioactive coatings for various medical device applications. Bacterin's
strategic coating initiatives include coatings designed to inhibit
biofilm formation and microbial contamination. 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: 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.
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