0001552781-16-001433.txt : 20160324 0001552781-16-001433.hdr.sgml : 20160324 20160324073031 ACCESSION NUMBER: 0001552781-16-001433 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160324 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160324 DATE AS OF CHANGE: 20160324 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Xtant Medical Holdings, Inc. CENTRAL INDEX KEY: 0001453593 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 205313323 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34951 FILM NUMBER: 161525364 BUSINESS ADDRESS: STREET 1: 664 CRUISER LANE CITY: BELGRADE STATE: MT ZIP: 59714 BUSINESS PHONE: 406-388-0480 MAIL ADDRESS: STREET 1: 664 CRUISER LANE CITY: BELGRADE STATE: MT ZIP: 59714 FORMER COMPANY: FORMER CONFORMED NAME: Bacterin International Holdings, Inc. DATE OF NAME CHANGE: 20100615 FORMER COMPANY: FORMER CONFORMED NAME: K KITZ INC DATE OF NAME CHANGE: 20090108 8-K 1 e00170_xtnt-8k.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): March 24, 2016

 

Xtant Medical 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.)

 

664 Cruiser Lane  
Belgrade, Montana 59714
(Address of Principal Executive Offices) (Zip Code)

 

(406) 388-0480
(Registrant’s Telephone Number, Including Area Code)

 

Not applicable 

(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.

  

We are furnishing this Item 2.02 in connection with the disclosure of information, in the form of the textual information from a press release on March 24, 2016 entitled “Xtant Medical Announces Distribution Agreement with Vivex Biomedical Bringing OsteoVive™, a Cellular Allograft, to Market” and filed as Exhibit 99.1 hereto.

 

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 dated March 24, 2016 entitled “Xtant Medical Announces Distribution Agreement with Vivex Biomedical Bringing OsteoVive™, a Cellular Allograft, to Market”

 

 

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:  March 24, 2016  
  XTANT MEDICAL HOLDINGS, INC.
   
  By:  /s/ John Gandolfo
  Name:  John Gandolfo
  Title:  Chief Financial Officer

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
     
99.1   Press Release dated March 24, 2016 entitled “Xtant Medical Announces Distribution Agreement with Vivex Biomedical Bringing OsteoVive™, a Cellular Allograft, to Market”

 

EX-99.1 2 e00170_ex99-1.htm

 

 

 

Xtant Medical Announces Distribution Agreement with Vivex Biomedical Bringing OsteoVive™, a Cellular Allograft, to Market

 

 

 

BELGRADE, Mont., March 24, 2016 (GLOBE NEWSWIRE) -- Xtant Medical Holdings, Inc. (NYSE:XTNT), a leader in the development of regenerative medicine products and medical devices, is expanding its biologics portfolio through a distribution relationship with Vivex Biomedical, Inc., a leading processor of human tissue, synthetics, mimetic patterning technology, and biocellular products. Through this agreement, Xtant Medical will be entering the cellular bone graft market with a viable cell allograft, OsteoVive™.

 

Vivex Biomedical’s proprietary process preserves a cell population that includes marrow-isolated adult multilineage inducible (MIAMI) cells. These cells have been shown to support the patient’s innate bone healing process. Vivex will process the allograft for Xtant Medical, and Xtant Medical will provide national distribution, focused on spine and orthopedics, through its sales channels and extensive, national contract networks.

 

"Vivex is enthusiastic about teaming up with Xtant Medical, a leading distributor of biologics products," said Tracy Anderson, CEO of Vivex Biomedical. "Working closely with leading biologics distributors like Xtant Medical helps further our mission of enhancing patient care by expanding industry knowledge and capability."

 

This relationship allows Xtant Medical to immediately enter the cellular bone graft market with a differentiated product. According to BioMedGPS, it estimates the cellular allograft market was approximately $252MM in 2015, and is anticipated to be near $400MM in 2019, making it the fastest growing segment of the bone replacement market.

 

 

"We are pleased to be adding this distinguished viable cell allograft to our biologic portfolio," said Dan Goldberger, CEO of Xtant Medical. "The addition of OsteoVive will allow us to better meet the preferences of our surgeons, and will increase the value we are able to deliver to our customers."

 

About Xtant Medical Holdings, Inc.

Xtant Medical Holdings, Inc. (NYSE:XTNT) 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, 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.

 

About Vivex Biomedical, Inc.

Vivex Biomedical is a privately held company based out of Marietta, Georgia focused on cellular therapies that treat orthopaedic, spine, wound and soft tissue indications. Vivex and its wholly owned subsidiary, UMTB Biomedical, Inc., own and hold exclusive rights to proprietary technologies in the field of biomedicine, stem cells, and orthopaedic implant surface modification. The Vivex Biomedical technology includes marrow isolated adult multilineage inducible (MIAMI) cell identification and processing, as well as, mimetic patterning technologies (MIME) which can improve the efficiency and efficacy of a patient’s healing cascade and reduce the overall cost of healthcare.

 

About UMTB Biomedical, Inc.

Founded in 1970 through a partnership with the U.S. Naval Hospital in Bethesda, MD, the University of Miami Tissue Bank ("UMTB") is the oldest tissue bank in the United States. UMTB was acquired November of 2014 by UMTB Biomedical, Inc., a wholly owned subsidiary of Vivex Biomedical. UMTB has been led by H. Thomas Temple, M.D., a world renowned orthopaedic oncologist and surgeon.

 

 

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." You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. 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. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

 

 

Contact:

COCKRELL GROUP

877.889.1972

investorrelations@thecockrellgroup.com

cockrellgroup.com

 

 

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