CyMedica Orthopedics today said it completed early enrollment of 159 patients in an FDA-regulated clinical trial of its E-Vive pain relief technology.
The technology is designed for patients with knee osteoarthritis and is being studied in a randomized, prospective, double-blind, multisite, pivotal trial in adults. The trial will evaluate the company’s patented CyMotion neuromuscular strengthening technology for reducing pain and increasing function and subjects that have knee osteoarthritis compared to similar sham-controlled systems.
CyMedica’s technology is home-based therapy with remote monitoring capabilities. Study participants had the opportunity to continue treatment and participation in the trial while being unable to attend in-office appointments due to the COVID-19 pandemic.
“At CyMedica, we recognize the significant unmet needs for patients living with painful knee osteoarthritis,” president and CEO Robert Morocco said in a news release. “Our team remains focused on creating future-forward health technologies that simplify how people living with knee osteoarthritis manage their condition so they can live their best pain-free lives. The early enrollment completion of this study prior to COVID-19, along with the capability to continue treatment from home, are steps toward our strategic goal to provide patients and their healthcare providers with home-based, non-opioid, non-invasive products for chronic knee osteoarthritis pain.”
To account for other unexpected impacts of the pandemic, the company activated a rollover study to allow the continuation of therapy for an additional 14 weeks of treatment. The study will include subjects who had already been randomized into the original clinical trial and will be enrolled into the appropriate treatment group once treatment is received in the parent study.
The parent trial’s data was completed in May 2020. The findings of the upcoming clinical trial with the rollover study is planned to contribute to the growing body of high-level clinical data for the company’s CyMotion portfolio.