Orthofix (NSDQ:OFIX) said today it won both FDA and European Union-based CE Mark approval for its next-gen CervicalStim and SpinalStim bone growth stimulators.
The Lewisville, Texas-based company said the devices use a low-level pulsed electromagnetic field to “activate and augment” the body’s natural healing process to promote post-operative spinal fusion.
Orthofis said it is launching the Stim onTrack smartphone mobile application along with the systems, designed to aid patients in staying up to date with treatments and prescriptions as well as communicating real-time data to managing physicians.
“With the launch of these new devices, our goal is to redefine the recovery experience of patients using bone growth stimulation devices post-operatively for lumbar and cervical fusion surgical procedures. We are proud to offer the addition of Stim onTrack to our CervicalStim and SpinalStim devices as we continue to find ways to partner with physicians in achieving improved clinical outcomes,” BioStim biz unit president Brad Niemann said in a prepared statement.
“Patient recovery is often dependent on how well they follow the prescription for the device. Equipping patients with a mobile app to help them adhere to their prescription is an excellent addition to this system while simultaneously enhancing post-surgical care by giving physicians additional data to help personalize follow-up protocols,” chief scientific officer James Ryab said in a press release.
Last September, Orthofix said it enrolled the 1st patient in a study exploring the use of its Physio-Stim pulsed electromagnetic field system for treating osteoarthritis of the knee.
The company said the study aims to explore the efficacy and safety of its Physio-Stim system in reducing inflammation and restoring homeostasis of the extracellular matrix to potentially provide symptomatic relief of osteoarthritis pain and stimulate new cartilage formation.
The 1st patient in the study was enrolled by Dr. Roy Aaron, Professor at Brown University in Providence, RI.