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): January 22, 2013
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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| 001-34951 | 20-5313323 |
| (Commission File Number) |
(IRS Employer Identification No.)
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600 Cruiser Lane Belgrade, Montana |
59714 |
| (Address of Principal Executive Offices) |
(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): |
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01 Regulation FD Disclosure.
The Company has issued a press release entitled “Bacterin’s OsteoSponge® Product Generates Positive Clinical Results” which 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.
| Exhibit No | Description | |
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99.1
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Press Release of Bacterin International Holdings, Inc. dated January 22, 2013 entitled “Bacterin’s OsteoSponge® Product Generates Positive Clinical Results” | |
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: January 22, 2013 | BACTERIN INTERNATIONAL HOLDINGS, INC. | |
| By: /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 January 22, 2013 entitled “Bacterin’s OsteoSponge® Product Generates Positive Clinical Results” |
Bacterin’s OsteoSponge®
Product
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.”
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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 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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Investor Contact:
COCKRELL GROUP
Rich Cockrell,
NY 212.521.4138
ATL 404.942.3369
investorrelations@thecockrellgroup.com
cockrellgroup.com
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