Orthofix Secures FDA and CE Mark Approvals for New PhysioStim Bone Growth Stimulators

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Orthofix International N.V., a global medical device company focused on musculoskeletal healing products and value added services, announced the U.S. Food and Drug Administration (FDA) and European CE Mark approvals for its next-generation PhysioStim bone growth stimulators.

The PhysioStim devices provide a non-surgical treatment option for patients who have a nonunion fracture to an extremity that has shown no visible signs of healing. These Class III medical devices use a pulsed electromagnetic field (PEMF) signal to induce a low-level electrical field at the fracture site which stimulates bone healing.

“We are proud to provide physicians with these next-generation devices that will enable them to redefine how patients with nonunion fractures are treated,” said Brad Niemann, President of the Orthofix BioStim strategic business unit. “These devices are built on our proprietary PEMF technology platform. Together with our spinal fusion stimulators, they are currently the No. 1 prescribed bone growth stimulators in the U.S.”

The PhysioStim devices will be accompanied by a new application for mobile devices, STIM onTrack. Designed for use with smartphones and other mobile devices, STIM onTrack is free and available in the U.S. through the iTunes App Store. The STIM onTrack mobile app includes a first-to-market feature that enables physicians to remotely view patient adherence to their prescription. Additionally, the app engages patients in their recovery process through treatment calendars, therapy reminders and educational resources.

“Bone growth stimulation therapy is a safe, effective and proven treatment for patients who have a fracture to an extremity that won’t heal,” said James Ryaby, Ph.D., Chief Scientific Officer at Orthofix. “When patients follow their prescription, their rate of successful healing is improved. The new mobile app is a great tool to foster better adherence to the prescribed treatment because it empowers the patient to take an active part in their recovery.”

The PhysioStim devices come in different models and are designed to anatomically fit the patient’s body. Specific applications are for treatment of nonunion fractures to the arm, hand, wrist, clavicle, shoulder, hip, thigh, lower leg, ankle or foot. The devices can be worn over clothing, casts or internal and external surgical fixation devices.

A leader in the bone growth stimulation market, Orthofix is dedicated to expanding indications for the use of PEMF devices. The Company is currently conducting three investigational device exemption (IDE) clinical trials to collect safety and effectiveness data of the Physio-Stim™ system for osteoarthritis of the knee, the RCStim system as an adjunctive treatment to surgical repair of full thickness rotator cuff tears and the Cervical-Stim system for treating odontoid fractures.

LEWISVILLE, Texas–(BUSINESS WIRE)–https://www.businesswire.com/news/home/20180307005078/en/Orthofix-Secures-FDA-CE-Mark-Approvals-New

For Further Information

More on the small bone and joint orthopedic devices market in the U.S. can be found in a series of reports published by iData entitled the U.S. Market Report Suite for Small Bone and Joint Orthopedic Devices. This report covers the following market segments: shoulder reconstruction devices, elbow repair devices, hand & wrist devices, foot & ankle devices, plate & screw devices, staple fixation devices and external fixation devices.

The iData series on the market for small bone and joint orthopedic devices covers the U.S., India, Japan, and China. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about small bone and joint orthopedic devices market data or procedure data, register online or email us at [email protected] for an U.S. Market Report Suite for Small Bone and Joint Orthopedic Devices brochure and synopsis.

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