JOGO Health Receives FDA's Breakthrough Device Designation For Its Non-invasive Digital Therapy For Chronic Lower Back Pain
Wednesday, May 03, 2023
JOGO Health, a value-based virtual care company that leverages proprietary digital interventions to provide comprehensive rehabilitation for chronic pain and neuromuscular conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its chronic lower back pain product, JOGO-CLBP. During the COVID-19 pandemic, the FDA granted 510(k) exemption for JOGO's foundational platform, JOGO-Gx.
"Receiving Breakthrough Device Designation isn't easy. It requires a solid clinical foundation and bold thinking. JOGO-CLBP addresses the root cause of chronic low back pain (CLBP) through a proprietary protocol. JOGO Health is fully committed to the journey of providing people with new therapeutic options for the treatment of chronic pain," said Sanjai Murali, Founder and CEO of JOGO Health Inc.
"Electromyography biofeedback has been studied since the 1970s to treat chronic pain and other neuromuscular conditions. But, due to technological limitations in delivering the treatment virtually and lack of awareness and training, the modality is not in practice. JOGO's twenty-first century technology and modern telemedicine-based approach will make EMG biofeedback widely available to patients. This Breakthrough Device Designation by the FDA will accelerate this." said Gary Krasilovsky, PT, Ph.D., and Chief Scientific Officer of JOGO Health.
"Low back pain has a major economic impact in the United States, with total costs related to this condition exceeding $100 billion per year. The majority of the cost is due to invasive procedures and unlimited physical therapy. Our studies show adding JOGO could significantly reduce patients needing surgery or other invasive procedures like nerve blocks, epidural steroid injections, opioids, and surgery," said Siva Nadarajah, President and Cofounder of JOGO Health.
Since receiving FDA 510(k) exemption during the COVID-19 pandemic, JOGO has treated more than 15,000 patients worldwide across a wide variety of conditions, including stroke, incontinence, and chronic constipation.