UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15(D) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of
report (Date of earliest event reported): February 16, 2011
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Bacterin International Holdings,
Inc.
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(Exact
Name of Registrant as Specified in Its Charter)
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Delaware
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(State
or Other Jurisdiction of
Incorporation)
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333-158426
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20-5313323
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(Commission
File Number)
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(IRS
Employer Identification No.)
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600
Cruiser Lane
Belgrade,
Montana
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59714
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(406)
388-0480
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(Registrant’s
Telephone Number, Including Area Code)
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(Former
Name or Former Address, if Changed Since Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see
General Instruction A.2. below):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
7.01 Regulation FD
Disclosure.
A copy of a press release entitled
“Bacterin International to Announce Launch of OsteoSponge®SC at American Academy of Orthopedic
Surgeons 2011 Annual Meeting February 15-19” is attached as Exhibit 99.1 and
incorporated herein. The information in this Item 7.01 and the
document attached as Exhibit 99.1 are being furnished and shall not be deemed
“filed” for purposes of Section 18 of the Securities and Exchange Act of 1934,
as amended (the “Exchange Act”), nor otherwise subject to the liabilities of
that section, nor incorporated by reference in any filing under the Securities
Act of 1933 or the Exchange Act, except as shall be expressly set forth by
specific reference in such a filing.
Item
9.01. Financial Statements and
Exhibits.
(d) Exhibits.
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Exhibit
No
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Description
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99.1
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Press
Release of Bacterin International Holdings, Inc., dated February 16, 2011
entitled “Bacterin International to Announce Launch of OsteoSponge®SC
at American Academy of Orthopedic Surgeons 2011 Annual Meeting February
15-19”
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| Dated: February 16, 2011 | BACTERIN INTERNATIONAL HOLDINGS, INC. | ||
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By:
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/s/ Guy S. Cook | |
| Name: | Guy S. Cook | ||
| Title: | President and Chief Executive Officer | ||
EXHIBIT
INDEX
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99.1
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Press
Release of Bacterin International Holdings, Inc., dated February 16, 2011
entitled “Bacterin International to Announce Launch of OsteoSponge®SC
at American Academy of Orthopedic Surgeons 2011 Annual Meeting February
15-19”
|
Bacterin
International to Announce Launch of OsteoSponge®SC at American Academy of
Orthopedic Surgeons 2011 Annual Meeting February 15-19
BELGRADE,
MT – February 16, 2011 – Bacterin International Holdings, Inc. (“Bacterin”)
(OTCBB: BIHI), a developer of revolutionary bone graft material, today announced
that it launched its OsteoSponge®SC product at the American Academy of
Orthopedic Surgeons (“AAOS”) 2011 Annual Meeting taking place February 15-19 in
San Diego, CA. Based on favorable preclinical data, Bacterin has
received permission from the Food and Drug Administration to market
OsteoSponge®SC as a subchondral bone void
filler. OsteoSponge®SC has demonstrated extraordinary
re-generative properties in both preclinical and clinical data and, as a result,
Bacterin will be presenting three separate case studies this week at
AAOS.
OsteoSponge®
SC is an acellular matrix scaffold made from donated human bone that is used to
replace a patient’s damaged subchondral bone. The OsteoSponge® SC
process is cost effective, minimally invasive with superior handling
characteristics, and enables surgeons more options in the treatment of
subchondral defects. Bacterin’s core technology revolves around the
designing and processing of human acellular biological scaffolds that can
incorporate the patient’s own stem cells or bioactive agents for accelerated
regeneration of tissue. To date, the Company has focused on bone
regeneration with the Osteo product line, including the cornerstone product
OsteoSponge®, OsteoSelect® DBM
Putty, OsteoLock® /
BacFast® HD,
and OsteoWrap®. In addition to OsteoSponge® SC, during first quarter
2011 Bacterin will begin marketing hMatrix™, a scaffold for dermal healing and
repair.
During
AAOS several surgeons will be at Bacterin’s booth number 1556 presenting their
data and sharing experiences using OsteoSponge®SC. Of particular
note, Friday, February 18, 2011, Dr. Wayne Gersoff, Founding partner of Advanced
Orthopedics in Denver, Colorado, will deliver his results using OsteoSponge®SC
on subchondral defects. Currently, there are over 30 patients who
have undergone foot, ankle and knee surgery utilizing OsteoSponge®SC, all
experiencing favorable outcomes. As of today, five surgeons have
already been trained to use OsteoSponge®SC at five separate medical
sites.
Commenting
on the results, Guy Cook, Bacterin’s chairman and CEO, said, “The current annual
market size addressing subchondral defects in the foot, ankle and knee is
approximately $1.7 billion annually. This market is large and growing
as more advanced repair technologies become
available. OsteoSponge® SC, a form of OsteoSponge® designed to
be used in subchondral repair surgery, has delivered favorable outcomes, which
could potentially and significantly change the standard of care in regeneration
of native tissues to avoid joint replacement.”
About Bacterin International
Holdings, Inc.
Bacterin
International Holdings, Inc. (“Bacterin”) 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 and promote bone and other tissue
growth. These products are used in a variety of applications
including enhancing fusion in spine surgery, relief of back pain by facet joint
stabilization, promotion of bone fusion in foot and ankle surgery, promotion of
cranial healing following neurosurgery and subchondral bone defect repair in
articulating joint surgeries.
Bacterin’s
Medical Device division develops anti-microbial coatings based upon proprietary
coating technologies. Bacterin 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.
Headquartered
in Belgrade, Montana, Bacterin operates a 32,000 square foot, state-of-the-art,
fully compliant and FDA registered facility, equipped with four "Class 100"
clean rooms. For further information please visit www.bacterin.com.
Contact:
Yvonne L.
Zappulla
Managing
Director
Grannus
Financial Advisors, Inc.
212-681-4108
or
Guy
Cook
Chairman
& CEO
Bacterin
International Holdings, Inc.
406-388-0480
gcook@bacterin.com
Certain statements in this news
release may constitute “forward-looking” statements within the meaning of
section 21E of the Securities and Exchange Act of 1934. Our
forward-looking statements include earnings guidance and other statements
regarding our expectations and beliefs. The Company believes that its
expectations, as expressed in these statements are based on reasonable
assumptions regarding the risks and uncertainties inherent in achieving those
expectations. These statements are not, however, guarantees of future
performance and actual results may differ materially. Risks and uncertainties
which may cause actual results to be different than expressed or implied in our
forward-looking statements include, but are not limited to, the risk factors
described under the heading “Risk Factors” in Amendment No. 5 to our Form S-1
filed February 9, 2011. The Company expressly disclaims any current
intention to update any forward-looking statements as a result of new
information or future events or developments.