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): August 23, 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)
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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 International to Present at Rodman & Renshaw Annual Global Investment Conference on September 12, 2011" attached as Exhibit 99.1 and incorporated herein, and the Company sent a letter to its customers and distribution partners which is attached as Exhibit 99.2 and incorporated herein. The information in this Item 7.01 and the documents attached as 99.1 and 99.2 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 Holidngs, Inc. dated August 23, 2011 entitled "Bacterin International to Present at Rodman & Renshaw Annual Global Investment Conference on September 12, 2011"
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| 99.2 |
Letter from Bacterin’s CEO dated August 23, 2011
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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.
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Dated: August 23, 2011
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BACTERIN INTERNATIONAL HOLDINGS, INC.
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By: /s/ Guy S. Cook
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Name: Guy S. Cook
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Title: President and Chief Executive Officer
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Bacterin International to Present at Rodman & Renshaw Annual Global Investment Conference on September 12, 2011
BELGRADE, MT, – August 23, 2011 – Bacterin International Holdings, Inc. (NYSE Amex: BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, has been invited to present at the Rodman & Renshaw Annual Global Investment Conference. The conference will be held at The Waldorf Astoria Hotel in New York City on September 11-13, 2011.
Bacterin’s chairman and CEO, Guy Cook, and CFO, John Gandolfo, are scheduled to present on Monday, September 12, 2011 at 1:35 p.m. Eastern time, with one-on-one meetings held throughout the day. Management will discuss the company’s business plan and objectives for the remainder of 2011.
The presentation will be available via webcast at www.wsw.com/webcast/rrshq20/bone. A replay link will also be available for 90 days following the live presentation on the company’s website at www.bacterin.com.
Bacterin recently reported record revenue for the second quarter 2011 of $7.5 million, up 25% sequentially and 135% year-over-year. The company also reported its first positive EBITDA quarter of $33,000.
For more information about the conference or to schedule a one-on-one meeting with Bacterin management, contact your Rodman & Renshaw representative or the conference desk at 212-920-3595.
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.
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
August 23, 2011
Dear valued customers and partners,
This letter is to inform you of a voluntary quarantine action Bacterin is taking to ensure we maintain the highest possible quality and ethical standards in our stewardship of the precious gift of tissue donation.
We initiated this action because of a deficiency discovered in how New Life Generation (NLG), a tissue recovery partner of Bacterin, had administered the standard medical/social history questionnaire for some of its donors.
During a routine FDA audit of NLG, the FDA determined two screeners were not asking the next of kin all of the required questions related to the medical/social inquiry for 50 donors. NLG had previously represented to Bacterin that the questions were asked, but it was later determined after listening to recorded screenings that NLG was deficient in this regard. NLG has since initiated a voluntary recall, and Bacterin’s actions have been made in response.
It is important to note that although there was a deficiency associated with the administration of the medical/social questionnaire, all 50 donors passed the required blood and microbiological testing, their donor consent records are in order, and their medical records were reviewed and approved by Bacterin’s medical director - a licensed physician - before they were released.
Since the FDA inspection, NLG has re-contacted the next of kin using new donor screeners for 47 of the 50 donors, and all 47 were subsequently redeemed eligible for donation. The remaining three donor families are expected to be contacted shortly, with the delay due to donor families relocating or a change in their contact information.
Bacterin and NLG will continue to work closely with the FDA to resolve any unanswered questions on the remaining three medical/social histories, and on any additional steps needed in regard to any tissue already implanted.
Bacterin’s action at this time involves quarantining the tissue from ALL 50 donors that have been released until the disposition of these tissues is resolved satisfactorily with the FDA. We have also reviewed our donor acceptance criteria for our recovery agencies and have enhanced the reporting criteria for all of our donor procurement partners to include this contingency moving forward.
We have multiple recovery partners and the vast majority of our products are unaffected. The tissues derived from these 50 donors are less than 1% of our current inventory, and we have ample product to meet our current and future demands. We do not believe this action will materially affect Bacterin’s operations.
If you have any additional questions, please feel free to contact me or your local Bacterin representative.
Sincerely,
Guy Cook
CEO
Bacterin International Holdings Inc.