FDA Grants PMA for the AccelStim Bone Growth Stimulation Device — Expanding Orthofix’s Portfolio of Market-Leading Bone Healing Therapy Solutions

Might 4, 2022

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a worldwide medical machine firm with a backbone and orthopedics focus, at the moment introduced the U.S. Food and Drug Administration (FDA) pre-market approval for the AccelStim^™ bone therapeutic remedy Class III machine. The AccelStim machine offers a protected and efficient nonsurgical therapy for indicated contemporary fractures and for fractures that haven’t healed (nonunions). The machine generates a Low-Depth Pulsed Ultrasound (LIPUS) sign to stimulate the bone’s pure therapeutic course of to advertise fracture therapeutic. Business availability of the AccelStim machine is anticipated to happen within the second quarter of this yr via a focused and phased launch plan.

“Because the market chief in bone progress stimulation gadgets, greater than 1,000,000 sufferers have been handled with our Pulsed Electromagnetic Subject Stimulation (PEMF) programs,” stated Orthofix President of World Backbone Kevin Kenny. “With the addition of the AccelStim machine, Orthofix is now the primary and solely firm to supply each PEMF and LIPUS bone progress stimulation gadgets, and one in every of solely two corporations within the U.S. with a contemporary fracture indication. We imagine that increasing entry to sufferers ought to assist develop the prevailing $100M marketplace for contemporary fracture LIPUS options. This funding and approval additional demonstrates our management in and dedication to the bone progress stimulation market.”

The AccelStim machine is worn externally within the area of the fracture, usually for 20 minutes every day. Remedy size might differ and is set by the prescribing doctor on a person foundation in response to the fracture therapeutic progress. The machine is light-weight, adjustable and moveable, and features a rechargeable battery that enables freedom of motion throughout therapy. The AccelStim system features a therapy calendar to interact sufferers of their restoration. The LIPUS know-how stimulates bone therapeutic on the molecular, mobile and tissue degree and has been confirmed to speed up fracture-healing restoration by 38 % for indicated contemporary fractures and an total scientific success price of 86 % for nonunion fractures.

Since 1986, Orthofix Bone Progress Remedy has helped promote the pure bone-healing course of in sufferers. The AccelStim machine with LIPUS know-how enhances the Orthofix portfolio of PEMF bone progress stimulation gadgets which consists of the CervicalStim^™, SpinalStim^™ and PhysioStim^™ programs. With the addition of the AccelStim machine, Orthofix now offers probably the most therapy indications within the bone progress stimulation market.

About Orthofix

Orthofix Medical Inc. is a worldwide medical machine firm with a backbone and orthopedics focus. The Firm’s mission is to ship progressive, quality-driven options whereas partnering with well being care professionals to enhance affected person mobility. Headquartered in Lewisville, Texas, Orthofix’s backbone and orthopedics merchandise are distributed in additional than 60 international locations through the Firm’s gross sales representatives and distributors. For extra data, please go to Orthofix.com.

Ahead-Wanting Statements

This communication comprises forward-looking statements inside the which means of Part 21E of the Securities Trade Act of 1934, as amended, and Part 27A of the Securities Act of 1933, as amended, referring to our enterprise and monetary outlook, that are primarily based on our present beliefs, assumptions, expectations, estimates, forecasts and projections. In some circumstances, you possibly can establish forward-looking statements by terminology reminiscent of “might,” “will,” “ought to,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “initiatives,” “intends,” “predicts,” “potential,” or “proceed” or different comparable terminology. These forward-looking statements will not be ensures of our future efficiency and contain dangers, uncertainties, estimates and assumptions which can be troublesome to foretell, together with the dangers described in Half I, Merchandise 1A beneath the heading Threat Components in our Annual Report on Kind 10-Ok for the yr ended December 31, 2021 (the “2021 Kind 10-Ok”). Along with the dangers described there, elements that might trigger or contribute to such variations might embody, however will not be restricted to: the chance that surgeons could also be sluggish to undertake the AccelStim machine; the chance that future affected person research or scientific expertise and information might point out that therapy with the AccelStim machine doesn’t enhance affected person outcomes as a lot as beforehand believed, or in any other case name into query the advantages of its use to sufferers, hospitals and surgeons; the chance that the product might not carry out as meant and will subsequently not obtain business success; the chance that rivals might develop superior merchandise or might have a larger market place enabling extra profitable commercialization; the chance that insurance coverage payers might decline to reimburse healthcare suppliers for the usage of our merchandise.

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