Orthofix Announces First Clinical Use of Virtuos Lyograft – a First-of-Its-Kind, Shelf-Stable and Complete Autograft Substitute for Spine and Orthopedic Procedures

Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the limited market release and first patient implant of the Virtuos^™ Lyograft, a first-of-its-kind, shelf-stable and complete autograft substitute for spine and orthopedic procedures. This allograft is prepared by MTF Biologics through a proprietary process that preserves all biologic components necessary for bone healing within the graft. Virtuos is provided in a room-temperature, ready-to-use, moldable form.

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Virtuos™ Lyograft is a first-of-its-kind, shelf-stable and complete autograft substitute for spine and orthopedic procedures in a room-temperature, ready-to-use, moldable form. (Photo: Business Wire)

“The Virtuos allograft is unique in the fact that it can be stored at room temperature and is ready to implant within two minutes of being hydrated,” said Dr. Tomas Ellis, a neurosurgeon at Baylor Scott and White Surgical Hospital in Fort Worth, Texas, who implanted the first patient. “This helps ensure we can always have an easy-to-use, moldable, complete bone graft on hand, and it streamlines the preparation and overall surgical procedure time.”

“The Virtuos Lyograft provided through our exclusive partnership with MTF Biologics is at the forefront of allograft technology,” said Orthofix President of Global Spine Kevin Kenny. “Processed through a proprietary preservation method, Virtuos provides the best of both worlds. It delivers a high-quality shelf-stable bone graft with the clinical performance and superior handling that clinicians desire, as well as streamlined logistics for storage and preparation for the hospital.”

Virtuos offers significant logistical and cost-savings advantages to the hospital with improved shipping, storage and operating room efficiency. The room temperature shipment and storage of Virtuos eliminates the use of large quantities of dry ice, Styrofoam shippers and freezer storage, enabling flexible shipping options and reduced packaging, with the aim of a reduced carbon footprint.

The Virtuos Lyograft is a complementary addition to the comprehensive line of biologics offered by Orthofix through its exclusive partnership with MTF Biologics including the Trinity Elite^™, Trinity Evolution^™, FiberFuse^™ Advanced and FiberFuse Strip allografts, AlloQuent structural allograft and the Legacy^™ DBM. In addition to MTF Biologic solutions, Orthofix proudly markets and distributes the Opus^™ BA bioactive bone graft, Opus^™ Mg Set bone void filler, Opus^™ osteoconductive matrix and the O-Genesis^™ graft delivery 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 Virtuos Lyograft; the risk that future patient studies or clinical experience and data may indicate that treatment with the Virtuos Lyograft does 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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