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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): April 10, 2026

XTANT
MEDICAL HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-34951 |
|
20-5313323 |
(State
or other jurisdiction
of
incorporation) |
|
(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:
| ☐ |
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)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common
stock, par value $0.000001 per share |
|
XTNT |
|
NYSE
American LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item
7.01 | Regulation
FD Disclosure. |
On
April 13, 2026, Xtant Medical Holdings, Inc. (“Xtant”) announced that it has entered into a Distribution Agreement (the “Distribution
Agreement”) with Dilon Technologies, Inc. (“Dilon”) pursuant to which Xtant has obtained the exclusive rights to import,
market, distribute and sell the HEMOBLAST® Bellows product in the United States. The HEMOBLAST® Bellows
product is an FDA-approved powder-based, topical, surgical hemostatic agent used to control bleeding during surgical procedures. The
full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form
8-K.
Xtant
is furnishing the information contained in Exhibit 99.1 pursuant to Regulation FD and Item 7.01 of Form 8-K promulgated by the Securities
and Exchange Commission (“SEC”). This information shall not be deemed to be “filed” with the SEC for the purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, nor shall it be deemed to be incorporated by reference into any registration statement or other document filed under
the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Xtant
entered into the Distribution Agreement with Dilon on April 10, 2026, and in connection therewith, hired approximately 20 Dilon sales
personnel to assist in the sale of the HEMOBLAST® Bellows product in the United States. Under the terms of the Distribution
Agreement, Dilon will continue to manufacture the Product from its current manufacturing location in France and will supply and sell
the Product to Xtant at a specified transfer price as provided in the Distribution Agreement, which price is subject to change under
the terms of the Distribution Agreement. The Distribution Agreement does not contain any minimum purchase requirements on behalf of Xtant.
Under the terms of the Distribution Agreement, Xtant paid Dilon a $5.0 million exclusivity fee, which fee is subject to repayment by
Dilon under certain circumstances, including upon a termination of the Distribution Agreement, which agreement can be terminated by either
party upon certain specified events. In connection with entering into the Distribution Agreement, Dilon has also agreed to cooperate
with Xtant to transition the existing United States customer base for the Product to Xtant and assign all existing contracts with customers
for the Product for sales in the United States to Xtant, subject to Xtant’s review and approval of such agreements. The Distribution
Agreement also contains other terms and conditions that are customary for an agreement of this nature.
| Item
9.01 | Financial
Statements and Exhibits. |
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Joint Press Release of Xtant Medical Holdings, Inc. and Dilon Technologies, Inc. dated April 13, 2026 entitled “Xtant Medical and Dilon Technologies Announce Exclusive U.S. Distribution Agreement for Dilon’s HEMOBLAST® Bellows Product” (furnished herewith) |
| |
|
|
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
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.
| |
XTANT
MEDICAL HOLDINGS, INC. |
| |
|
|
| |
By:
|
/s/
Sean E. Browne |
| |
|
Sean
E. Browne |
| |
|
President
and Chief Executive Officer |
Date:
April 13, 2026
Exhibit
99.1
Xtant
Medical and Dilon Technologies Announce Exclusive U.S. Distribution Agreement for Dilon’s HEMOBLAST® Bellows Product
Xtant
has hired Dilon’s U.S. sales team to assist in selling the HEMOBLAST® Bellows product and penetrating the estimated
$2.0 billion global addressable market for hemostatic products
BELGRADE,
Mont., and NEWPORT NEWS, VA., April 13, 2026 — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a medical technology company
focused on surgical solutions for spinal and other orthopedic conditions, and Dilon Technologies, Inc., a medical device manufacturer,
today announced that the companies have entered into an agreement whereby Xtant has acquired exclusive U.S. distribution rights to Dilon’s
HEMOBLAST® Bellows for high-performance hemostasis following certain surgical procedures.
Sean
Browne, President and CEO of Xtant Medical, stated, “We are excited to partner with Dilon Technologies to bring HEMOBLAST, a highly
complementary hemostatic technology, to a broader group of surgeons. This agreement expands our portfolio with a unique and versatile
hemostatic solution while also significantly bolstering our own commercial capabilities with the integration of Dilon’s approximately
20-person U.S. sales team into our organization. With our broadened product offering and enhanced reach and sales capabilities, we believe
we can better address the comprehensive needs of surgeons and patients alike while meaningfully expanding our addressable market.”
George
Makhoul, CEO of Dilon Technologies, stated, “HEMOBLAST is highly differentiated in the surgical hemostat market with its unique
composition as the only collagen/thrombin formulation that provides applicability across minimal, mild, and moderate bleeding types,
and we are very pleased to entrust its future growth to Xtant. As a recognized leader in the manufacture and distribution of novel biologics
solutions for a range of surgical applications, we believe Xtant is the ideal partner to extend the U.S. commercial reach of HEMOBLAST
and achieve its full market potential.”
HEMOBLAST
Bellows is a pre-loaded hemostatic powder indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild,
and moderate bleeding by conventional procedures is ineffective or impractical, except in ophthalmic and urological procedures. HEMOBLAST
is the only hemostat containing collagen (mechanical hemostat), human derived thrombin (which converts fibrinogen to fibrin, a basic
element required for blood clotting), and bovine-derived chondroitin sulfate (which provides cohesion between the wound and surrounding
tissue). Delivered via a pre-loaded bellows applicator, HEMOBLAST requires no prep prior to use.
Xtant
plans to update its full-year 2026 financial guidance in light of the new distribution arrangement in connection with the release of
its first quarter 2026 financial results.
About
Dilon Technologies® Inc.
Dilon
Technologies Inc., a medical device manufacturer based in Newport News, Virginia, strives to improve the quality of care by providing
a wide range of innovative medical device technology that benefits patients around the world. Dilon has a strong medical device portfolio
which includes HEMOBLAST Bellows, the only combination powdered surgical hemostat that contains collagen, thrombin and chondroitin sulfate,
MarginProbe, a groundbreaking technology for accurate margin assessment in breast cancer surgery, the Navigator System, a surgical gamma
probe system for radio-guided lymphatic mapping and tumor localization, TrueView Pro 100, a specimen radiography system (SRS) that uses
advanced radiography and automated software to precisely identify tumor lesions in resected or biopsied breast tissue, and the CoPilot,
an innovative, portable, and easy to use video laryngoscope.
About
Xtant Medical Holdings, Inc.
Xtant
Medical’s mission of honoring the gift of donation so that our patients can live as full and complete a life as possible, is the
driving force behind our company. Xtant Medical Holdings, Inc. (www.xtantmedical.com) is a global medical technology company focused
on the design, development, and commercialization of a comprehensive portfolio of orthobiologics serving the chronic and surgical wound
care and sports medicine markets, as well as spinal implant systems. Xtant people are dedicated and talented, operating with the highest
integrity to serve our customers.
The
symbols ™ and ® denote trademarks and registered trademarks of Xtant Medical Holdings, Inc. or its affiliates, registered as
indicated in the United States, and in other countries. All other trademarks and trade names referred to in this release are the property
of their respective owners.
Cautionary
Statement Regarding Forward-Looking Statements
This
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 “intends,” ‘‘expects,’’ ‘‘anticipates,’’ ‘‘plans,’’
‘‘believes,’’ ‘‘estimates,’’ “continue,” “future,” ‘‘will,’’
“potential,” similar expressions or the negative thereof, and the use of future dates. Forward-looking statements in this
release include Xtant’s expectations regarding the exclusive distribution arrangement and its ability to better address the comprehensive
needs of surgeons and patients. Xtant cautions that its forward-looking 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 success of the distribution
arrangement and the HEMOBLAST® Bellows product, including future U.S. sales and the additional U.S. sales personnel and
their impact on Xtant’s business and operating results; the possibility that the distribution agreement may be terminated by either
party; the effect of the distribution agreement on Xtant’s business, including its relationships with other distributors, independent
sales representatives and personnel, and its business and operating results; Xtant’s future operating and financial performance
and its ability to increase or maintain revenue; the success of Xtant’s expanded field sales force to improve Xtant’s reach
and leverage its outstanding contract portfolio and independent agent network; its ability to become operationally self-sustaining and
less reliant on third-party manufacturers and suppliers; risks associated with acquisitions and dispositions; its ability to implement
successfully its future growth initiatives and risks associated therewith; possible future impairment charges to long-lived assets and
goodwill and write-downs of excess and obsolete inventory; its ability to continue to innovate, develop and introduce new products and
the success of those products; its ability to remain competitive; its ability to engage and retain new and existing independent distributors
and agents and qualified sales and other personnel and its dependence on key independent agents for a significant portion of its revenue;
the effect of inflation, elevated interest rates and other recessionary factors and supply chain disruptions; the effect of product sales
mix changes on its financial results; its ability to service its debt, comply with debt covenants, and access additional indebtedness
or financing on favorable terms or at all, if and when needed, and other risk factors contained in Xtant’s Annual Report on Form
10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (SEC) on March 31, 2026 and subsequent SEC
filings by Xtant. Investors are encouraged to read Xtant’s filings with the SEC, available at www.sec.gov, for a discussion of
these and other risks and uncertainties. Xtant 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 Xtant or persons acting on its behalf are expressly qualified in their entirety by
this cautionary statement.
Investor
Relations Contact:
For
Xtant Medical:
Kevin
Gardner
LifeSci
Advisors
kgardner@lifesciadvisors.com
-OR-
Rob
Windsor
LifeSci
Advisors
rwindsor@lifescipartners.com
For
Dilon Technologies:
George
Makhoul
CEO,
Dilon Technologies
(877)
463-4566
info@dilon.com