CyMedica Orthopedics has secured approval from the US Food and Drug Administration (FDA) for its Intellihab system, a non-invasive modality to treat knee osteoarthritis pain.
The home-based therapeutic and digital health ecosystem has been designed to treat pain that is associated with the debilitating osteoarthritis disease.
The FDA 510(k) clearance is based on positive data from a randomised, sham-controlled, double-blind and multi-center clinical trial.
This study evaluated the safety and efficacy of IntelliHab for knee osteoarthritis patients, and the positive results included significant pain reduction and improved mobility.
With this regulatory clearance, CyMedica will be able to further focus on evidence-based medicine and its dedication to helping patients manage symptoms related to osteoarthritis.
CyMedica Orthopedics president and CEO Rob Morocco said: “CyMedica recognises the current standard of care for managing knee osteoarthritis pain presents a significant gap in available treatment options.
“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.”
The system is claimed to be the first FDA approved neuromodulation strengthening therapy for patients seeking pain relief from knee osteoarthritis.
It provides individualised muscle stimulation to reduce muscle weakness and keeps patients proactive during the therapy by using an intuitive, app-driven interface.
Through the IntelliHab app, patients can also connect to healthcare providers and communicate critical data to a secure portal.
Additionally, it allows providers to remotely monitor usage and motivate patients in real-time.
CyMedica plans to make the IntelliHab system commercially available as a treatment for osteoarthritis of the knee in the US this fall.