Orthofix Announces FDA Approval of STIM onTrack 2.1 Mobile App for Bone Growth Stimulators

App designed to facilitate patient compliance and improve outcomes now captures Patient Reported Outcome Measures

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal products and therapies, today announced the U.S. Food and Drug Administration (FDA) approval of the STIM onTrack mobile app version 2.1 for use with the Company’s bone growth stimulators.

The STIM onTrack technology works with the Orthofix Bone Growth Therapy devices. The mobile device app is an accessory designed to help patients adhere to their prescriptions and improve their clinical outcomes. The new version of the app hosts Patient Reported Outcome Measure (PROM) questionnaires which enable patients to remotely share the status of their quality of life and functional well-being with their physician. This is in addition to the daily treatment reminders and device usage calendar that allows physicians to remotely view patient data to monitor treatment.

“The new STIM onTrack mobile app version 2.1 is designed to augment treatment with the CervicalStim, SpinalStim and PhysioStim bone growth stimulators by allowing patients to remotely share PROM data, in addition to device usage data, with their treating physician,” said Kevin Kenny, President of Global Orthofix Spine. “We are proud to be the first in the bone growth stimulation market to be able to deliver tools to support physician remote patient monitoring endeavors to aid in a joint vision of improving patient outcomes.”

“We know that patients who take an active role in their follow-up care have an overall better recovery experience and outcomes,” said Dr. Peter Whang, Associate Professor, Department of Orthopaedics and Rehabilitation, Yale University School of Medicine. “The STIM onTrack mobile app version 2.1 is very beneficial for tracking adherence to their treatment plan, and the addition of the PROM questionnaire feature provides us with even more insights on how the patient is responding in their home setting, not just when they visit our office.”

Prescribing providers have access to their patients’ PROM submissions via the proprietary Orthofix physician portal. Remote patient monitoring CPT codes are potentially available to prescribing practitioners if they meet the requirements for reimbursement. The STIM onTrack mobile app version 2.1 is an upgrade of the original STIM onTrack mobile app that was first introduced in 2017. The app is free and supported by iOS and Android devices.

About Bone Growth Stimulators

Orthofix bone growth stimulators are approved by the FDA and provide patients with a safe and effective non-surgical treatment to improve nonunion fractures and spinal fusion healing. These devices use a pulsed electromagnetic field (PEMF) to introduce a low-level electrical field at the nonunion fracture or spinal fusion site which stimulates bone healing. To learn more about Orthofix Bone Growth Therapy devices, visit www.BoneGrowthTherapy.com.

About Orthofix

Orthofix Medical Inc. is a global medical device company focused on musculoskeletal products and therapies. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic extremities 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 certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the estimates, projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on Orthofix management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.

The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to: practices of health insurance companies and other third-party payors with respect to reimbursement for our PEMF devices and other risks described in the “Risk Factors” section of our 2018 Annual Report on Form 10-K, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Mark Quick

Investor Relations

Tel 214 937 2924

[email protected]

Denise Landry

Media Relations

Tel 214 937 2529

[email protected]

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