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): November 28, 2011
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
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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.
The Company has issued a press release entitled “Bacterin Signs Agreement with Jeil for ‘LeForte Craniomaxillofacial System’” 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.
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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 November 28, 2011 entitled “Bacterin Signs Agreement with Jeil for ‘LeForte Craniomaxillofacial System’”
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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: November 28, 2011 | BACTERIN INTERNATIONAL HOLDINGS, INC | ||
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By:
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/s/ Guy S. Cook | |
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Guy S. Cook
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| 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 November 28, 2011 entitled “Bacterin Signs Agreement with Jeil for ‘LeForte Craniomaxillofacial System’”
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Bacterin Signs Distribution Agreement with Jeil for ‘LeFórte Craniomaxillofacial System’
Company Complements Core Technology with Craniomaxillofacial Trauma Set;
Bacterin Appoints Nick Navarro as Executive Vice President of Medical Devices
BELGRADE, MT, – November 28, 2011 – Bacterin International Holdings, Inc. (NYSE Amex: BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, signed an exclusive agreement with Jeil Medical Corporation for distribution in the U.S. and Canada of Jeil’s LeFórte System.
The LeFórte System is composed of orthopedic implants used in craniomaxillofacial procedures, including trauma and reconstruction, and complements Bacterin’s existing expertise and product offerings in the tissue grafting arena. Bacterin is planning a beta-launch of the LeFórte System next month followed by a full product release during the second quarter of 2012.
The introduction of these products will expand Bacterin’s capabilities to include surgical procedures in the facial area, such as cranial and maxillofacial trauma, orthognathic surgery of the mid-face and mandible, mandibular reconstruction, reconstruction of the chin, and fracture fixation. Bacterin intends to develop a 2nd generation of the LeFórte System to include its proprietary antimicrobial coating technology.
To support Bacterin’s expanding product portfolio, the company has promoted Nick Navarro to executive vice president of medical devices. Navarro has been with Bacterin more than two years, starting as a sales representative with rapid advancement to a regional vice president.
Navarro began his career with Johnson and Johnson focusing on wound closure. He was then recruited by Wright Medical, a global orthopaedic medical device company, where he became an extremity/foot and ankle specialist. It was in this role where his true passion for promoting hardware to surgeons was developed. Navarro looks forward to bringing his medical device expertise and detailed training style to the sales force and overseeing the launch of the Bacterin LeFórte System.
About Jeil Medical Corporation
Founded in 1990, Jeil Medical Corporation manufactures medical equipment, including Orthodontics Screw and Oral Maxilla Facial Fixation System. The company operates in Korea as one of the largest independent distributors of Dental Implant System and Instrument. For more information about Jeil Medical Corporation, visit www.jeilmed.co.kr/.
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 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.
Company Contact:
Guy Cook
President & CEO
Bacterin International Holdings, Inc.
Tel 406-388-0480
gcook@bacterin.com
Investor Relations:
Liolios Group, Inc.
Scott Liolios or Ron Both
Tel 949-574-3860
info@liolios.com