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): November 15, 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.
The Company has issued a press release on November 15, 2016, entitled “Xtant Medical Receives FDA Clearance to Use Allografts in the Stand-Alone Irix-C™ Cervical Cage,” which is attached as Exhibit 99.1 and incorporated herein.
The Company has also issued a press release on November 15, 2016, entitled “Xtant Medical Announces Expiration of Rights Offering and Estimated Gross Proceeds of $3.8 Million,” which is attached as Exhibit 99.2 and incorporated herein.
The information in this Item 7.01 and the documents attached as Exhibits 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 filings.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 |
Press Release of Xtant Medical Holdings, Inc. dated November 15, 2016 entitled “Xtant Medical Receives FDA Clearance to Use Allografts in the Stand-Alone Irix-C™ Cervical Cage.”
| |
| 99.2 | Press Release of Xtant Medical Holdings, Inc. dated November 15, 2016 entitled “Xtant Medical Announces Expiration of Rights Offering and Estimated Gross Proceeds of $3.8 Million.” |
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 15, 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 of Xtant Medical Holdings, Inc. dated November 15, 2016 entitled “Xtant Medical Receives FDA Clearance to Use Allografts in the Stand-Alone Irix-C™ Cervical Cage.”
| |
| 99.2 | Press Release of Xtant Medical Holdings, Inc. dated November 15, 2016 entitled “Xtant Medical Announces Expiration of Rights Offering and Estimated Gross Proceeds of $3.8 Million.” |
Xtant Medical Receives FDA Clearance to Use Allografts in the Stand-Alone Irix-C™ Cervical Cage
BELGRADE, Mont., Nov. 15, 2016 (GLOBE NEWSWIRE) -- Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Irix-C cervical cage for use with autograft and/or allograft and the expansion of the range of levels allowable from C3-T1 to C2-T1. Previously the device was cleared only for use with autogenous bone graft. This furthers Xtant Medical's goal of being a comprehensive supplier of products to spine surgeons.
Xtant Medical’s 3Demin and patented OsteoSponge technology are excellent allografts to use with Irix-C due to their ability to compress, fill and expand in the device’s graft chamber, allowing for ideal bone contact and fusion. OsteoVive, a cellular allograft, can also be used in conjunction with Irix-C. This new clearance is indicative of common surgical practices of using allografts in cervical cages to promote fusion.
Dr. Gregory Juda, Chief Scientific Officer of Xtant Medical states, "This new FDA clearance allows Xtant Medical to leverage the clinical effectiveness of our established allograft product offerings for use with our stand-alone interbody devices in cervical discectomy and fusion procedures. We expect that the use of these products as a combined spinal fusion solution will result in positive patient outcomes."
The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients for treatment of degenerative disc disease.
Xtant Medical estimates the worldwide market for cervical fusion devices at $1.3B and growing. The worldwide market for Demineralized Bone Matrix (DBM) is estimated at $485M. Irix-C, 3Demin, OsteoSponge, and OsteoVive are currently widely available.
About Xtant Medical Holdings
Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical 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 Medical 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: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third- party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; 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.
Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
xtant@cg.capital
Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com
Xtant Medical Announces Expiration of Rights Offering and Estimated Gross Proceeds of $3.8 Million
BELGRADE, Mont., Nov. 15, 2016 (GLOBE NEWSWIRE) -- Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development, manufacturing and marketing of orthopedic products for domestic and international markets, announced today that the subscription period for its previously announced rights offering (the "Offering") of units at a subscription price of $0.75 per unit expired on November 14, 2016, and these rights are no longer exercisable.
Based on the review of results provided by the Company’s subscription agent, Corporate Stock Transfer, Inc., Xtant Medical estimates that it will receive aggregate gross proceeds from the offering of approximately $3.8 million. The results of the Offering and Xtant Medical’s estimates regarding the aggregate gross proceeds of the Offering to be received by the Company are preliminary and subject to finalization and verification by its subscription agent.
Xtant Medical anticipates that closing of the Offering will occur on or about Thursday, November 17, 2016, subject to satisfaction or waiver of all conditions to closing. Upon the closing, the subscription agent will distribute, by way of direct registration in book-entry form or through the facilities of the Depositary Trust Company, as applicable, the common stock and warrants to holders of rights who validly exercised their rights and paid the subscription price in full. No physical stock or warrant certificates will be issued to stockholders.
Maxim Group LLC acted as sole dealer manager for the Offering.
If you have questions about the offering, please contact:
Maxim Group LLC
405 Lexington Avenue
New York, NY 10174
Attention: Syndicate Department
Email: syndicate@maximgrp.com
Telephone: 212-895-3745.
This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Xtant Medical’s registration statement on Form S-1 was declared effective by the U.S. Securities and Exchange Commission (SEC) on October 31, 2016. The prospectus, the prospectus supplement no. 1 thereto dated November 9, 2016, and all of Xtant Medical’s SEC filings may be found on the SEC's website at http://www.sec.gov.
About Xtant Medical Holdings
Xtant Medical Holdings, Inc. (NYSE MKT: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, 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: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; 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.
Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
xtant@cg.capital
Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com