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): July 16, 2013
Bacterin International Holdings, Inc.
|
(Exact Name of Registrant as Specified in Its Charter) |
| Delaware |
|
(State or Other Jurisdiction of Incorporation) |
| 001-34951 | 20-5313323 |
| (Commission File Number) |
(IRS Employer Identification No.)
|
|
600 Cruiser Lane Belgrade, Montana |
59714 |
| (Address of Principal Executive Offices) |
(Zip Code) |
(406) 388-0480
(Registrant’s Telephone Number, Including Area Code)
(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 OsteoSelect® DBM Putty Approved for Spinal Fusion Applications” 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 | |
|
99.1
|
Press Release of Bacterin International Holdings, Inc. dated July 16, 2013 entitled “Bacterin’s OsteoSelect® DBM Putty Approved for Spinal Fusion Applications” |
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: July 16, 2013 | BACTERIN INTERNATIONAL HOLDINGS, INC. | |
| By: /s/ John Gandolfo | ||
| Name: | John Gandolfo | |
| Title: | CFO and Interim Co-CEO | |
EXHIBIT INDEX
|
99.1 |
Press Release of Bacterin International Holdings, Inc. dated July 16, 2013 entitled “Bacterin’s OsteoSelect® DBM Putty Approved for Spinal Fusion Applications” |
Bacterin’s OsteoSelect® DBM Putty Approved for Spinal Fusion Applications
BELGRADE, Mont., July 16, 2013 /PRNewswire/ -- Bacterin International Holdings, Inc. (NYSE MKT: BONE), a leader in the development of revolutionary bone graft material and coatings for medical applications, is pleased to announce it has obtained 510(k) approval to market OsteoSelect® DBM Putty for use in spinal fusion procedures. OsteoSelect® is a moldable bone graft substitute designed to withstand irrigation while exhibiting osteoinductive properties for improved bone regeneration. The cohesive nature of the product provides an advantage over other commercially available DBM putties which can readily wash away after placement in wet, surgical environments.
As part of the regulatory approval process, Bacterin provided funding to Hospital for Special Surgery in New York to perform a study evaluating the efficacy of OsteoSelect® in a rabbit posterolateral lumbar spine fusion model. Biomechanical, radiographic, and histological analysis indicated that OsteoSelect® showed equivalence to a control of autologous iliac crest bone graft which is widely considered to be the gold standard for spinal fusion.
"We are proud to obtain another indication for use that will provide Bacterin with additional marketing opportunities for the OsteoSelect® DBM Putty product line," said Gregory Juda, PhD, Bacterin’s Chief Scientific Officer. Dr. Juda continued to say, "In the 3 plus years of OsteoSelect® being on the market, we have seen considerable adoption by the orthopedic community across a variety of surgical specialties. Our post market surveillance supports the efficacy of OsteoSelect® and the results of the preclinical work validate the clinical findings."
OsteoSelect® DBM Putty is a malleable bone grafting material comprised of demineralized bone matrix allograft combined with a polymer carrier material. The product was engineered using feedback from key opinion leaders in several orthopedic specialties, with a focus on providing solutions to the shortcomings inherent to other commercially available DBM products. The osteoinductive potential of every lot of OsteoSelect® is confirmed after sterilization in an animal model thus providing surgeons with a bone grafting solution that is both safe and biologically active.
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 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 coatings for various medical device applications. 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: our ability to meet existing and anticipated contractual obligations, including financial covenants and other obligations contained in our secured lending facility; our ability to manage cash flow and achieve profitability; our ability to regain compliance with the NYSE MKT continued listing standards; our ability to develop, market, sell and distribute desirable applications, products and services and to protect our intellectual property and customer relationships; the ability of our sales force to achieve expected results; the ability of our customers to pay and the timeliness of such payments; our ability to obtain additional equity or debt capital as and when needed; changes in consumer demands and preferences; our ability to recruit a new CEO and to attract and retain management and employees with appropriate skills and expertise; our ability to successfully conclude certain pending government investigations; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors set forth in our SEC filings from time to time. Additional risk factors are listed in our Annual Report on Form 10-K and Quarterly Report on Form 10-Q under the heading "Risk Factors." We undertake 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.
Rich Cockrell
Rich.Cockrell@thecockrellgroup.com
NY 212.521.4138
ATL 404.942.3369
MBL 404.394.5304
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