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 17, 2015
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 |
(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))
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| Item 7.01 | Regulation FD Disclosure. |
The Company has issued a press release entitled “Bacterin Announces 1000th Lot of OsteoSelect® DBM Putty” 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 February 17, 2015 entitled “Bacterin Announces 1000th Lot of OsteoSelect® DBM Putty” |
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 17, 2015 | BACTERIN INTERNATIONAL HOLDINGS, INC. |
| By: /s/ John Gandolfo | |
| Name: John Gandolfo | |
| Title: Chief Financial Officer |
EXHIBIT INDEX
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99.1
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Press Release of Bacterin International Holdings, Inc. dated February 17, 2015 entitled “Bacterin Announces 1000th Lot of OsteoSelect® DBM Putty” |
Exhibit 99.1
Bacterin Announces 1000th Lot of OsteoSelect® DBM Putty
BELGRADE, MT--(BUSINESS WIRE)— February 17, 2015 -- Bacterin International Holdings, Inc. (NYSE MKT: BONE), a leader in the development of bone graft material and coatings for medical applications, today announced that it has eclipsed an operational milestone processing over 1000 lots of OsteoSelect DBM Putty.
Every lot of OsteoSelect processed by Bacterin since inception has demonstrated an osteoinductive response (the ability to induce new bone formation) in an animal model. Although there are various methods for testing the bone forming potential of a bone graft substitute, the animal model is the most accurate test and is considered the ‘gold standard’. Demineralized bone matrices (DBM) are used during orthopedic surgery for the repair and replacement of bone loss resulting from trauma or related surgical procedures. The demineralized bone matrix market is expected to account for 25% of the total bone replacement market in the US, or $435MM annually, according to BioMedGPS, LLC.
"The succession of proven osteoinductive results for every lot of OsteoSelect processed by Bacterin over the past five years demonstrates the superiority of our patented and patent-pending demineralization technologies” said Gregory Juda, Bacterin’s Chief Scientific Officer. “The results speak to the quality and consistency of our operations and our commitment to exceeding the expectations of our customers. We look forward to implementing our demineralization processes in new product development as we continue to expand our product portfolio.”
OsteoSelect DBM Putty is processed human bone that has been combined with an absorbable carrier that makes it easier to handle during orthopedic surgical procedures. Bacterin’s OsteoSelect DBM Putty received its first 510k clearance in September of 2009.
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 promote bone growth, 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.
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 ability of the Company’s sales force to achieve expected results, the Company's ability to meet its existing and anticipated contractual obligations, including financial covenant and other obligations contained in the Company’s secured lending facility; the Company’s ability to manage cash flow; the Company’s ability to obtain shareholder approval of financing transactions; 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 customers to pay and the timeliness of such payments; 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 Company’s ability to successfully conclude government investigations; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; the Company’s ability to remain listed on the NYSE MKT; and other factors. Additional risk factors are listed in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q 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.
Investor Contact:
COCKRELL GROUP
Rich Cockrell
877-889-1972
investorrelations@thecockrellgroup.com
cockrellgroup.com