Bone-Healing AccelStim System From Orthofix Granted FDA Clearance

Orthofix Medical’s AccelStim system, a nonsurgical treatment meant to help in repairing fresh bone breaks, has earned clearance from the FDA. The 20-minute-per-day system is particularly useful for breaks and fractures that would otherwise have trouble healing on their own. Orthofix powers its AccelStim via low-intensity pulsed ultrasound treatment, known as LIPUS, which stimulates tissue by delivering waves of pressure. Studies have shown that this technology can help to heal fractures 38% faster, and an 86% success rate was achieved with unhealed previous fractures.

With AccelStim, Orthofix is adding to its existing stable of healing devices leveraging pulsed electromagnetic fields, or PEMFs. Cellular formation is stimulated by the generation of weak electric currents through an individual’s bones. The company’s other wearables, which include the spine-centric CervicalStim and SpinalStim systems, contain FDA-approved technology that dates back to 1986. Its PhysioStim is more similar to AccelStim in that it is designed for the acceleration of bone healing.

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“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,” said the company’s President, Kevin Kenny. “We believe that expanding access to patients should help grow the existing $100 million market for fresh-fracture LIPUS solutions.” Orthofix proudly reports that more than 1 million people have benefited from treatment with devices from its PEMF portfolio, and the LIPUS-equipped AccelStim is due to be commercially available around June via a carefully phased launch campaign.