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CyMedica Orthopedics® Announces Successful Clinical Trial Utilizing e-vive(TM)
SCOTTSDALE, Ariz., March 12, 2019 /PRNewswire/ -- CyMedica Orthopedics®, the leading combined digital health and muscle strengthening therapy developer, today announced statistically significant, positive results from a randomized, controlled trial which will be presented at the 2019 American Academy of Orthopedic Surgeons meeting. This clinical trial evaluated the effectiveness of the company's patented e-vive™ neuromuscular electrical stimulation and patient engagement system for the enhanced rehabilitation of patients undergoing total knee replacement.
The clinical trial results measuring 66 total knee replacement patients released today demonstrate an earlier return to function and increase in quadriceps strength in patients treated with e-vive™ neuromuscular electrical stimulation (NMES) versus the standard of care, according to researchers at Cleveland Clinic. Statistically significant improvements were shown with these patients, including a clinically significant 12.9% increase in quadriceps strength at the 3 week post-operative point (a critical period of time where patients commonly experience a substantial loss of quadriceps strength, 29% loss for the standard of care patients in this trial), and increased TUG (Timed Up and Go) test times at both the 6 and 12 week postoperative points, further supporting previous publications representing NMES as an effective method for quadriceps strengthening for knee osteoarthritis and surgical rehabilitation.
"We are incredibly pleased to share the results of this clinical trial which reaffirm the effectiveness of the e-vive™ solution for TKA patients," said Rob Morocco, President and CEO, CyMedica Orthopedics. "At CyMedica, we are focused on empowering patients throughout their entire journey of knee osteoarthritis, from the early onset of disease to post-surgical rehabilitation. This is accomplished by providing advanced muscle stimulation solutions that foster patient engagement and improve outcomes."
"The results of this trial demonstrate that pre- and post-surgical muscle strengthening and neuromuscular electrical stimulation therapy was shown to be a significant component for patient rehabilitation to achieve quadriceps strength and an earlier return to activity. Combined with the digital health patient engagement features of the device, patients were able to actively participate in more productive rehabilitation following total knee replacement surgery," said Carlos Higuera-Rueda, MD, Orthopaedic Surgeon at Cleveland Clinic and Primary Investigator.
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. e-vive™ 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.
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SOURCE CyMedica Orthopedics