Orthofix Medical, a medical device company focused on spine and orthopaedics, has received the US Food and Drug Administration (FDA) pre-market approval for its bone healing therapy device AccelStim.

AccelStim is designed to provide a safe non-surgical treatment option for indicated fresh fractures and for fractures that have not healed (non-unions).

The device generates a low-intensity pulsed ultrasound (LIPUS) signal to stimulate the bone’s natural healing process to enable fracture healing.

According to the company, the LIPUS technology works to stimulate bone healing at the molecular, cellular and tissue level.

It has been proven to advance the fracture-healing recovery by 38% in indicated fresh fractures and a clinical success rate of 86% for non-union fractures.

Orthofix intends to commercialise the AccelStim device in the second quarter of this year, through a targeted and phased launch plan.

Orthofix global spine president Kevin Kenny said: “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.

“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.”

AccelStim is a lightweight, adjustable and portable device, worn externally in the region of the fracture, usually for 20 minutes a day.

The treatment duration may vary based on the fracture healing progress of the individuals and is determined by the prescribing physician.

The AccelStim system comes with a rechargeable battery to allow freedom of movement during treatment and includes a treatment calendar to engage patients in their recovery.

Orthofix said that the AccelStim device with LIPUS technology will complement its portfolio of PEMF bone growth stimulation devices, which includes CervicalStim, SpinalStim and PhysioStim systems.

In a separate development, Orthofix has expanded its partnership with MTF Biologics to extend its exclusive marketing rights to Trinity allograft line through 2032.

The extended partnership also includes the development of a demineralised bone matrix (DBM) that Orthofix would market under the Legacy brand name.