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 25, 2015
Xtant Medical 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 | |
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(IRS Employer Identification No.)
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664 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 “Xtant Medical Announces FDA Approval of OsteoSelect® PLUS” 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 Xtant Medical Holdings, Inc. dated August 25, 2015 entitled “Xtant Medical Announces FDA Approval of OsteoSelect® PLUS” |
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: August 25, 2015 | XTANT MEDICAL HOLDINGS, INC. | ||
| By: | /s/ Daniel Goldberger | ||
Name: Daniel Goldberger Title: Chief Executive Officer | |||
EXHIBIT INDEX
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99.1
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Press Release of Xtant Medical Holdings, Inc. dated August 25, 2015 entitled “Xtant Medical Announces FDA Approval of OsteoSelect® PLUS” |
Exhibit 99.1
Xtant Medical Announces FDA Approval of OsteoSelect® PLUS
BELGRADE, Mont., Aug. 25, 2015 (GLOBE NEWSWIRE) -- Xtant Medical Holdings, Inc. (OTCQX:BONE), a leader in the development of regenerative medicine products and medical devices, today announced that its wholly owned subsidiary, Bacterin International, Inc., has received FDA 510(k) clearance of OsteoSelect PLUS Demineralized Bone Matrix (DBM) Putty.
OsteoSelect PLUS is a next-generation DBM putty, comprised of OsteoSelect Putty with the addition of demineralized cortical chips. Aligned with the Company’s commitment to patient safety, OsteoSelect PLUS will provide another Sterile grafting solution for customers. This new product will also eliminate the need to mix bone chips and DBM putty intra-operatively, saving time and reducing graft variability.
“We are very pleased with the FDA’s decision to approve OsteoSelect PLUS for marketing and distribution” said Dr. Gregory Juda, Bacterin’s Chief Scientific Officer. “We developed this next generation bone graft material in response to surgeon demand using design input from surgeon customers. Because of their involvement in the development process, we are confident that OsteoSelect PLUS will be successfully received in the market and will serve to make our comprehensive product portfolio even stronger.”
With this notice and clearance from the FDA, Xtant Medical is prepared to launch OsteoSelect PLUS to customers in Q4 2015. The Company will work with its primary GPO and IDN customers to add this product to current contracts, making it available immediately upon product launch. This is the first 510(k) approval for Bacterin International since becoming a subsidiary of Xtant Medical, and will be the first of many planned product releases, as management focuses on rounding out the combined product portfolio. This new product will help drive the Company’s growth and provides an opportunity for increased market share.
About Xtant Medical Holdings
Xtant Medical Holdings, Inc. (OTCQX:BONE) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.
Important Cautions Regarding Forward-looking Statements
This press 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 successfully integrate the acquisition of X-spine; 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 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 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 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.