The new home-based therapeutic and digital health ecosystem will help treat pain associated with the debilitating osteoarthritis disease
The FDA has approved CyMedica Orthopedics’ IntelliHab system to treat knee osteoarthritis pain. (Credit: naturwohl-gesundheit from Pixabay)
CyMedica Orthopedics has secured approval from the US Food and Drug Administration (FDA) for its neuromodulation strengthening therapy called IntelliHab to manage knee osteoarthritis pain.
The new home-based therapeutic and digital health ecosystem is designated to treat pain associated with the debilitating osteoarthritis disease.
Symptomatic knee osteoarthritis (OA), which is also called degenerative joint disease, is said to affect over 14 million Americans, said the company citing a research study.
CyMedica has designed the therapy-based and pain management digital health platform to deliver at-home pain relief for patients experiencing knee osteoarthritis.
IntelliHab ecosystem is claimed to be the only FDA-cleared pain management and patient engagement technology that offers comfortable and individualised muscle stimulation to minimise muscle weakness.
CyMedica’s system provides a non-opioid and non-invasive treatment for patients seeking pain relief from knee osteoarthritis, in addition to remotely connecting providers to progress data in real-time.
The approval is based on a recent randomised, sham-controlled, double-blind and multi-centre study, which assessed the efficacy and safety of IntelliHab in knee osteoarthritis patients.
According to the company, the clinical trial has demonstrated significant pain reduction and improved mobility.
CyMedica president and CEO Rob Morocco said: “CyMedica recognizes 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 company is planning to commercialise the IntelliHab system in the US this fall.