Arizona medical device maker Regenesis Biomedical won new labeling for its Provant Therapy system, removing a contraindication discouraging doctors from using the system on patients with metallic implants in the area of treatment.
The company’s Provant system uses electromagnetic energy to help manage pain and edema in soft tissues following surgery, working by spurring the body’s own pain-relief mechanisms and regulating inflammation responses.
"The positive effects of using our non-thermal PEMT Therapy to treat patients with persistent post operative pain have been reported by both doctors and patients," Regenesis president & CEO Scott Brooks said in prepared remarks. "The FDA’s decision to approve the removal of this contraindication for the Provant System allows many more patients to benefit from Provant Therapy."
The FDA’s new ruling allows Regenesis to market the therapy in a wider range of treatments, including new indications in orthopedic care, podiatric care, primary care and rehabilitation.