Orthofix Announces US and European Full Market Launch of OSCAR PRO System for Removal of Cement During Complex Joint Revision Surgeries

Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the U.S. and European full market launch of the OSCAR PRO^™ Ultrasonic Arthroplasty Revision System. Designed to reduce the challenges associated with revising failed cemented arthroplasties, the OSCAR PRO is an ultrasonic surgical system that aids in the removal of cement during complex joint revision surgeries.

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OSCAR PRO™ system for arthroplasty procedures and osteotomies. (Photo: Business Wire)

“The OSCAR PRO system is a fourth generation product from the OSCAR line that has been the gold standard in assisting with complex joint revision surgeries since 1990,” said Orthofix President of Global Orthopedics Paul Gonsalves. “The technology is well accepted and has been used successfully for decades in removing cement total joint arthroplasties and aiding cementless prosthesis removal. We are pleased to continue to bring new innovations to the market to assist surgeons in performing these often challenging procedures.”

This next generation product brings a technology platform to the market that extends functionalities beyond the original OSCAR system. The design includes an enhanced user interface to enable a more efficient surgical experience and new data collection capabilities.

About Joint Revision Surgery

Over time, joint replacements may fail and need surgical revision. Removing the implant can be challenging due to the need to efficiently remove the cement adhering the device to the bone. Traditional techniques for cement removal have included the use of drills, burrs, curettes and osteotomes. Mechanical removal through these methods can be difficult and time-consuming. The OSCAR PRO system uses ultrasonic vibrations to soften the cement holding the implant in place. The system also contains tools that enable the surgeon to remove the softened cement using specially designed probes.

About Orthofix

Orthofix Medical Inc. is a global medical device and biologics company with a spine and orthopedics focus. The Company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patient mobility. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic products are distributed in more than 70 countries via the Company's sales representatives and distributors. For more information, please visit www.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 OSCAR PRO system; the risk that future patient studies or clinical experience and data may indicate that treatment with the OSCAR PRO system 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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