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Orthofix wins FDA PMA for bone growth stimulation device

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Orthofix AccelStim
[Image from Orthofix]
Orthofix (Nasdaq:OFIX) announced today that it received FDA premarket approval (PMA) for its AccelStim bone healing therapy device.

Lewisville, Texas-based Orthofix designed the AccelStim device to provide a safe and effective nonsurgical treatment for indicated fresh fractures and for fractures that have not healed (nonunions).

According to a news release, the device generates a low-intensity pulsed ultrasound (LIPUS) signal to stimulate the bone’s natural healing process to promote fracture healing. The device, worn externally in the region of the fracture for about 20 minutes daily (treatment length varies on an individual basis), was designed to be lightweight, adjustable and portable with a rechargeable battery that allows freedom of movement during treatment. The system also includes a treatment calendar to engage patients in their recovery.

LIPUS technology stimulates bone healing at the molecular, cellular and tissue level. Orthofix said it has been proven to accelerate fracture healing by 38% for indicated fresh fractures and has an overall clinical success rate of 86% for nonunion fractures.

Orthofix expects to make AccelStim commercially available in the second quarter of this year through a targeted and phased launch plan.

“As the market leader in bone growth stimulation devices, more than a million patients have been treated with our Pulsed Electromagnetic Field Stimulation (PEMF) systems,” Orthofix President of Global Spine Kevin Kenny said in the release. “With the addition of the AccelStim device, Orthofix is now the first and only company to offer both PEMF and LIPUS bone growth stimulation devices, and one of only two companies in the U.S. with a fresh fracture indication.

“We believe that expanding access to patients should help grow the existing $100M market for fresh fracture LIPUS solutions. This investment and approval further demonstrates our leadership in and commitment to the bone growth stimulation market.”

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