Thursday, April 9, 2020

Thursday, April 9, 2020

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


STIM onTrack 2.1 Mobile App for Bone Growth Stimulator  

Orthofix Medical Inc. issued the following announcement on Feb. 13.

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.

Original source can be found here.

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