Sam Brusco, Associate Editor05.02.23
JOGO Health, a value-based virtual care firm that uses digital interventions for comprehensive rehabilitation for chronic pain and neuromuscular conditions, has earned U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its JOGO-CLBP chronic lower back pain product.
"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," Sanjai Murali, founder and CEO of JOGO Health told the press.
"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 co-founder of JOGO Health.
Since an FDA 510(k) exemption received during the COVID-19 pandemic, JOGO has treated over 15,000 patients worldwide for conditions including stroke, incontinence, and chronic constipation.
"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," Sanjai Murali, founder and CEO of JOGO Health told the press.
"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 co-founder of JOGO Health.
Since an FDA 510(k) exemption received during the COVID-19 pandemic, JOGO has treated over 15,000 patients worldwide for conditions including stroke, incontinence, and chronic constipation.