Orthofix and MTF Biologics Expand Partnership Agreement

Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the renewal and expansion of its partnership agreement with MTF Biologics – a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients and advancing science. The collaboration extends Orthofix’s exclusive marketing rights to the Trinity^™ allograft line through 2032 and includes an expansion agreement for the development of a demineralized bone matrix (DBM) that Orthofix will market under the Legacy^™ brand name.

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The Legacy™ demineralized bone matrix expands and complements the Orthofix line of biologic solutions for spine and orthopedic surgical applications. (Photo: Business Wire)

“Together Orthofix and MTF Biologics have a long history of bringing advanced biologic solutions to the market, with more than 350,000 patients receiving their Trinity allografts,” said Orthofix President of Global Spine Kevin Kenny. “This agreement solidifies our partnership with MTF Biologics as the sole provider of MTF allograft offerings. The addition of the Legacy demineralized bone line will expand our biologic portfolio, increasing the options available and offering a value solution for our customers and their patients.”

“MTF Biologics is pleased to strengthen our exclusive partnership with Orthofix to continue our joint investments in innovative solutions, and the provision of Trinity Elite^™ and Trinity Evolution^™ allografts,” said Joe Yaccarino, President and CEO MTF Biologics. “This agreement aligns with MTF Biologics’ mission of honoring donor families by serving patients who are in need of grafts and innovative allograft solutions to aid them on their road to recovery.”

The Legacy DBM will be a complementary addition to the Orthofix demineralized bone line which consists of FiberFuse^™ Advanced and FiberFuse Strip, both also provided by MTF Biologics. A demineralized cortical bone powder with a sodium hyaluronate carrier, the Legacy DBM will be applicable in spine and orthopedic procedures. The Parties expect to make the Legacy DBM available to customers starting in the third quarter of 2022.

Orthofix recognizes the important role of biologic solutions in spine and orthopedic surgical applications. In addition to the MTF Biologics allograft solutions, Orthofix proudly markets and distributes the Opus^™ Mg Set bone void filler, Opus BA bioactive bone graft, Collage^™ osteoconductive scaffold, and the O-Genesis^™ graft deliver system. This broad portfolio gives surgeons the ability to select the best option to meet their procedural and patient needs.

About Orthofix

Orthofix Medical Inc. is a global medical device company with a spine and orthopedics focus. The Company’s mission is to deliver innovative, quality-driven solutions while partnering with health care professionals to improve patient mobility. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedics products are distributed in more than 60 countries via the Company's sales representatives and distributors. For more information, please visit www.Orthofix.com.

About MTF Biologics

MTF Biologics is a global nonprofit organization that saves and heals lives by honoring donated gifts, serving patients and advancing science. They provide unmatched service, resources, and expertise to donors and their loved ones who give the gift of donation, people who depend on tissue and organ transplants, healthcare providers, and clinicians and scientists.

The International Institute for the Advancement of Medicine (IIAM), a Division of MTF Biologics, honors donors of non-transplantable organs by providing their gifts to the medical research community to combat and cure diseases. Statline, also a Division of MTF Biologics, provides specialized communications and technology expertise to organ, tissue, and eye procurement organizations, as well as the hospitals and patients that they serve. Its sister organization, Deutsches Institute for Zell-und Gewebeersatz – DIZG (The German Institute for Cell and Tissue Transplantation), expands its reach to patients across the globe. For more information, visit www.mtfbiologics.org.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict, including the risks described in Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 Form 10-K”). In addition to the risks described there, factors that could cause or contribute to such differences may include, but are not limited to: the risk that surgeons may be slow to adopt the Legacy DBM; the risk that future patient studies or clinical experience and data may indicate that treatment with the Trinity allografts or the Legacy DBM do not improve patient outcomes as much as previously believed, or otherwise call into question the benefits of the use of these products to patients, hospitals and surgeons; the risk that the products may not perform as intended and may therefore not continue or achieve commercial success; the risk that competitors may develop superior products or may have a greater market position enabling more successful commercialization; the risk that insurance payers may decline to reimburse healthcare providers for the use of our products.

This list of risks, uncertainties and other factors is not complete. We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the SEC, which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise.

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