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Press Release

May 04, 2022
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Orthofix receives FDA pre-market approval for bone healing therapy device

Source:

Press Release

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Orthofix Medical Inc. announced it received FDA pre-market approval for the AccelStim bone healing therapy class III device, which provides nonsurgical treatment for indicated fresh fractures and nonunions.

According to a company press release, the AccelStim device generates a low-intensity pulsed ultrasound (LIPUS) signal to stimulate the natural healing process to promote fracture healing. Worn externally in the region of the fracture, typically for 20 minutes daily, the AccelStim device is lightweight, adjustable and portable. According to the release, it includes a rechargeable battery that allows freedom of movement during treatment. Treatment length may vary and is determined by the prescribing physician on an individual basis according to the fracture healing process.

FDA approval
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Orthofix anticipates the AccelStim device to be commercially available in the second quarter of this year through a targeted and phased launch plan, according to the release.

“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,” Kevin Kenny, president of global spine of Orthofix, 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 stimulations 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 $100 million market for fresh fracture LIPUS solutions. This investment and approval further demonstrates our leadership in and commitment to the bone growth stimulation market.”