The device is designed as a non-surgical treatment option for patients with a nonunion fracture in an extremity with no visible signs of healing, using pulsed electromagnetic field signals to induce a low-level electrical field at the fracture site that the Lewisville, Texas-based company claims stimulates bone healing.
“We are proud to provide physicians with these next-generation devices that will enable them to redefine how patients with nonunion fractures are treated. These devices are built on our proprietary PEMF technology platform. Together with our spinal fusion stimulators, they are currently the No. 1 prescribed bone growth stimulators in the U.S.,” Orthofix BioStim biz unit prez Brad Niemann said in a press release.
The newly cleared PhysioStim devices include an associated smartphone application designed to allow physicians to remotely view patient adherence to prescribed use and to allow patietns to track their recovery process, Orthofix said.
“Bone growth stimulation therapy is a safe, effective and proven treatment for patients who have a fracture to an extremity that won’t heal. When patients follow their prescription, their rate of successful healing is improved. The new mobile app is a great tool to foster better adherence to the prescribed treatment because it empowers the patient to take an active part in their recovery,” Orthofix chief scientific officer James Ryaby said in a prepared statement.
Last month, Orthofix put black ink in the ledger for the fourth quarter and beat the consensus forecast as it considered moving its corporate registration from Curacao to the U.S.