SCOTTSDALE, Ariz., June 4, 2019 /PRNewswire/ --CyMedica Orthopedics®, the leading combined digital health and muscle strengthening therapy innovator, today announced the launch of a clinical trial to evaluate the effectiveness of their proven e-vive™ muscle strengthening device and patient engagement system in knee osteoarthritis patients. Researchers will combine the muscle strengthening e-vive™ data with the activity and health data collected by commercially available wearable smartwatch devices to determine the effect of this novel technology on improving patient osteoarthritis (OA) symptoms.
The randomized, prospective clinical trial will be conducted on 120 osteoarthritis patients in clinical collaboration with Northwell Health, New York's largest health system. The study is being led by researchers Matthew Stewart Hepinstall, MD (Primary Investigator) and Michael A. Mont, MD.
"The e-vive clinical trial for knee osteoarthritis marks a major advancement for CyMedica in the treatment landscape for managing osteoarthritis knee pain," said Rob Morocco, President and Chief Executive Officer. "It comes at a time when an overwhelming number of knee arthritis patients are in urgent need of non-narcotic, non-addictive and home-based wearable therapies to help the millions of Americans who suffer from this painful chronic condition."
Muscle weakness is considered one of the most common underlying clinical conditions associated with knee osteoarthritis and the rehabilitation challenges facing patients recovering from knee procedures. "The success of the e-vive™ quadriceps muscle-strengthening in post-surgical knee rehabilitation has been well documented," said Dr. Michael A. Mont, Vice President of Strategic Operations in Orthopedics at Northwell Health. "Through this clinical trial, CyMedica and Northwell Health have a unique opportunity to positively measure the effectiveness of e-vive™ muscle strengthening using a novel, app-based patient-engagement system and smartwatch technology, which patients are already wearing. In turn, patients are able to better manage their symptoms earlier in their knee osteoarthritis journey."
Struan Coleman, MD, PhD, Orthopedic surgeon at Hospital for Special Surgery and co-founder added: "OA knee pain presents a host of challenges for patients and clinicians alike, and as patients are diagnosed at younger ages with knee OA, physicians are seeking opioid-free, inventive therapies to help our patients proactively manage their symptoms and de-escalate the costs of health care."
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 therapy-based digital health combination 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-based muscle activation 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. Muscle weakness is considered one of the most common underlying clinical conditions associated with knee osteoarthritis and the rehabilitation challenges facing patients recovering from knee procedures.
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.