CyMedica completes early enrollment and launches rollover study of a clinical trial to evaluate the effectiveness of e-vive for reducing pain and improving function by increasing quadriceps strength in knee osteoarthritis patients.
SCOTTSDALE, Ariz., June 16, 2020 /PRNewswire/ — CyMedica Orthopedics®, the leading combined muscle strengthening therapy and digital health innovator, announced today that it completed early enrollment of 159 patients in the FDA-regulated clinical trial of their e-vive technology for pain relief in patients with knee osteoarthritis (OA), prior to the outbreak of COVID-19.
The effectiveness of CyMedica’s e-vive system is being studied in a randomized, prospective, double-blind, multi-site, pivotal trial in adults with symptomatic OA knee pain. The primary objective of the trial is to evaluate CyMedica’s patented CyMotion neuromuscular strengthening technology for reducing pain and increasing function in subjects with knee osteoarthritis as compared to a similar sham-controlled system. Due to the unique, home-based therapy design of the e-vive system with remote monitoring capabilities, study subjects have had the opportunity to continue treatment and participation in the trial while unable to attend in-office appointments following the restrictions caused by the global pandemic.
To account for any further unexpected impacts of COVID-19, a rollover study was activated to allow continuation of therapy for an additional 14 weeks of treatment to bolster the results of the parent trial. This rollover study will include subjects who had already been randomized into the original clinical trial and will be enrolled into the appropriate treatment group based upon the treatment received in the parent study. It is further hypothesized that the continued use of the CyMedica e-vive system may provide additional pain relief and improved knee function for an additional 14 weeks compared to the sham treatment group.
“At CyMedica, we recognize the significant unmet needs for patients living with painful knee osteoarthritis,” said Robert Morocco, President and CEO. “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.”
Vinod Dasa, MD, Associate Professor of Clinical Orthopaedics and Director of Research, LSU Health Sciences Center and one of the participating Principal Investigators of the CyMedica study commented, “knee osteoarthritis is generally diagnosed and defined as a loss of cartilage in the knee, but the muscle weakness associated with the disease is significant and may exacerbate the pain and stiffness. This muscle dysfunction may actually precede and further cartilage deterioration within the joint.4 Robust clinical studies like the CyMedica e-vive trial are essential to not only understanding the underlying pathophysiology but to also evaluate potentially clinically relevant treatments for our patients.”
Brian Cole, MD, MBA, Associate chairman and Professor, Department of Orthopedics, Rush University Medical Center added, “In the context of the opioid crisis, as surgeons, we are always looking for innovative solutions to help manage knee OA pain. Current clinical guidelines recommend exercise therapy and muscle strengthening as the first line of treatment for knee osteoarthritis paired with patient education and weight control. However, often times patients cannot exercise due to the pain, creating a significant decline in function and overall health. This clinical trial provides an opportunity to help patients overcome quadriceps strength deficits and thereby measure the effect strength improvement has on reducing pain and improving their management of symptoms.”
The original parent trial’s data collection was completed in May of 2020. The upcoming findings from this randomized, controlled clinical trial with rollover study will contribute to the growing body of high-level clinical data for CyMedica’s CyMotion portfolio, and highlight the important role evidence-based medicine continues to play in the company’s future indications and additional reimbursement opportunities.
About Osteoarthritis (OA) of the Knee
Symptomatic knee osteoarthritis (OA), also known as degenerative joint disease, affects more than 14 million Americans1 and accounts for more than $24 billion in annual expenditures2. More than half of all people with symptomatic knee osteoarthritis are younger than age 65 and will live for three decades or more after diagnosis1. The prevalence of OA is expected to continue to increase as a result of aging, obesity, and sports injuries. Coupled with increasing knee osteoarthritis prevalence, the rising costs of health care may inflict a tremendous societal economic burden in the future. There are currently no medical or surgical treatments that will improve this alarming trajectory3.
About CyMedica Orthopedics®, Inc.
CyMedica Orthopedics® has developed a home-based digital health therapy technology platform that engages patients and connects healthcare providers to actively treat muscles weakened by surgery or knee osteoarthritis. This award winning digital wearable technology, e-vive, is the only FDA cleared, app-controlled muscle strengthening and patient engagement system uniquely designed to deliver comfortable and individualized muscle stimulation therapy while remotely connecting patients and healthcare providers in real-time. The e-vive technology provides a platform to improve clinical outcomes while collecting critical data useful in measuring and promoting patient progress.
Deshpande BR, et al. Number of Persons with Symptomatic Knee Osteoarthritis in the U.S.: Impact of Race and Ethnicity, Age, Sex and Obesity. Arthritis Care & Research. 2016. 68(12):1743-1750.
Losina E, et al. Lifetime Medical Costs of Knee Osteoarthritis Management in the United States: Impact of Extending Indications for Total Knee Arthroplasty. Arthritis Care Res (Hoboken). 2015; 67: 203-215.
London NJ, et al. Clinical and Economic Consequences of the Treatment Gap in Knee Osteoarthritis Management. Med Hypotheses. 2011.
Alnahdi AH, Zeni JA, Snyder-Mackler L. Muscle impairments in patients with knee osteoarthritis. Sports Health. 2012;4(4):284-92.
SOURCE CyMedica Orthopedics