Orthofix Expands Synthetic Bone Growth Offerings with Full Market Launch of Opus BA – a Bioactive Solution for Spine Procedures

Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the full market launch of Opus^™ BA, a synthetic bioactive bone graft solution for cervical and lumbar spine fusion procedures.

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Image of the Opus BA strip, a synthetic bioactive bone graft solution for cervical and lumbar spine fusion procedures. Also available in putty formulation. Image courtesy Orthofix Medical Inc.

Available in putty and strip formulations, Opus BA can be used to fill bone voids or gaps in the skeletal system that are not intrinsic to the stability of bony structure. Opus BA acts as a scaffold allowing bone growth across the surface that is reabsorbed and replaced with natural bone during the healing process. Easily hydrated with autogenous bone marrow or autograft with saline, Opus BA is moldable and ideal for versatile applications.

“Bioactive synthetics are a very large and growing market,” said President of Orthofix Global Spine Kevin Kenny. “We recognize that each bone substitute has its own unique advantages and surgeons have different preferences when evaluating the use of autologous, allogeneic or synthetic bone graft materials for their patients. The addition of Opus BA is another example of our commitment to providing surgeons with a wide range of solutions so they can select the best bone substitute for each patient.”

Opus BA’s osteoconductive matrix is made up of a carefully selected mix of components: carbonate apatite bone mineral, bioactive glass, and Type 1 Collagen carrier. These materials were selected for the ability to stimulate the growth, formation and resorption of bone. Opus BA undergoes a proprietary process to ensure the osteoconductive matrix has uniform distribution, mimicking the structure and porosity of cancellous bone.

Orthofix invites those attending the Congress of Neurological Surgeons Spine Summit 2022 Annual Meeting in Las Vegas, Nevada, February 24-25, 2022 to visit booth #212 to learn more about the Orthofix family of products. The latest data on Opus BA will be presented in a sponsored session entitled “The Clinical Value of Bioactive Synthetics in Spine Surgery” on February 25.

Orthofix recognizes the important role of a comprehensive offering of biologic solutions in spine and orthopedic surgical applications. The Company proudly markets and distributes the Trinity Elite^™ and Trinity Evolution^™ allografts with viable cells, FiberFuse^™ Advanced moldable allograft, FiberFuse Strip^™ preformed allograft, AlloQuent^™ structural allograft, VersaShield^™ amniotic membrane, Opus^™ Mg Set bone void filler, Collage^™ osteoconductive scaffold, 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 Orthofix.com.

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, 2020 (the “2020 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 Opus BA; the risk that future patient studies or clinical experience and data may indicate that treatment with the Opus BA does not improve patient outcomes as much as previously believed, or otherwise call into question the benefits of its use to patients, hospitals and surgeons; the risk that the product may not perform as intended and may therefore not 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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