FDA OKs CyMedica’s IntelliHab Knee Pain Management

CyMedica Orthopedics, a therapy-based digital health innovator, announced the U.S. Food and Drug Administration (FDA) has cleared the submission of its latest technology for the management of knee osteoarthritis pain, IntelliHab. With this clearance, IntelliHab is the only neuromodulation strengthening therapy indicated to treat pain associated with the debilitating osteoarthritis disease.
 
The IntelliHab System, a home-based therapeutic and digital health ecosystem, introduces a non-opioid, non-invasive treatment for patients seeking pain relief from knee osteoarthritis, while remotely connecting providers to progress data in real-time. IntelliHab is strongly supported by a recent randomized, sham-controlled, double-blind, multicenter study designed to evaluate the efficacy and safety of IntelliHab in knee osteoarthritis patients. FDA 510(k) clearance was based on the highly positive data from this rigorous level one clinical trial, including significant pain reduction and improved mobility.
 
“CyMedica recognizes the current standard of care for managing knee osteoarthritis pain presents a significant gap in available treatment options,” said Rob Morocco, president and CEO at CyMedica. “With the regulatory clearance of IntelliHab, we can provide a bridge between conservative management to more invasive treatment options, allowing patients to treat their pain comfortably at home while reducing opioid exposure.”
 
Vinod Dasa,  MD, Professor of Clinical Orthopaedics and Director of Research, LSU Health Sciences Center and one of the participating Principal Investigators of the CyMedica study added, “our goal as physicians is to provide patients with a menu of modalities to break the cycle of pain and stiffness caused by knee osteoarthritis. IntelliHab’s clinical evidence demonstrates the ability to strengthen the quadriceps muscles resulting in decreased pain and improved function. The product regulatory clearance offers an advanced tool for early and late stage treatment of this complex disease.”
 
This advancement is the company’s first approved solution to treat pain associated with knee arthritis. The regulatory clearance of IntelliHab, on the heels of the successful clinical trial, further drives CyMedica’s focus on evidence-based medicine and the dedication to helping patients manage OA symptoms to live their best, active lives.
 
CyMedica Orthopedics, Inc. received 510(k) clearance from the Food and Drug Administration (FDA) for the IntelliHab System in June of 2021. The product will be commercially available in the United States in the fall of 2021.