FDA Grants Orthofix PMA for its AccelStim Bone Growth Stimulation Device

Orthofix Medical Inc. has received U.S. Food and Drug Administration (FDA) pre-market approval for the AccelStim bone healing therapy Class III device.

The AccelStim device provides a safe, effective nonsurgical treatment for indicated fresh fractures and for fractures that have not healed (nonunions). The product generates a Low-Intensity Pulsed Ultrasound (LIPUS) signal to stimulate the bone’s natural healing process to promote fracture healing. The AccelStim will be commercially available in the second quarter.
 
“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,” said Orthofix President of Global Spine Kevin Kenny. “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.” 
 
The AccelStim device is worn externally in the region of the fracture, typically for 20 minutes daily. Treatment length may vary and is determined by the prescribing physician on an individual basis according to the fracture healing progress. The device is lightweight, adjustable and portable, and includes a rechargeable battery that allows freedom of movement during treatment. The AccelStim system includes a treatment calendar to engage patients in their recovery. The LIPUS technology stimulates bone healing at the molecular, cellular and tissue level and has been proven to accelerate fracture-healing recovery by 38 percent for indicated fresh fractures and an overall clinical success rate of 86 percent for nonunion fractures.
 
Since 1986, Orthofix Bone Growth Therapy has helped promote the natural bone-healing process in patients. The AccelStim device with LIPUS technology complements the Orthofix portfolio of PEMF bone growth stimulation devices which consists of the CervicalStim, SpinalStim, and PhysioStim systems. With the addition of the AccelStim device, Orthofix now provides the most treatment indications in the bone growth stimulation market.
 
Orthofix Medical Inc. is a global medical device company with a spine and orthopedics focus. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedics products are distributed in more than 60 countries.