Myoscience said today it launched a clinical trial aiming to investigate its Iovera pain management system in treating post-surgical knee patients, with the 1st patient enrolled at Memphis, Tenn.’s Campbell Clinic.
The Fremont, Calif.-based company’s Iovera technology is a non-opioid and non-systemic treatment designed to block pain signals from the peripheral nerves.
Myoscience said the Iovera treatment uses the body’s natural response to cold to treat peripheral nerves, causing a sensory nerve to stop sending pain signals after receiving targeted cold therapy that is part of the treatment. The effect is transient, and provides pain relief until the nerve regenerates and its sensory function is restored.
“At Campbell Clinic, we carefully evaluate new technologies to solve challenging clinical issues, and to improve patient outcomes. I am very excited to begin enrolling patients in the Iovera study looking at reducing pain and narcotic use after total knee replacement. I look forward to seeing the data from this study, which I hope will confirm all our findings and experiences to date. We hope the Iovera technology will help us meet one of the significant needs today – reducing the reliance on opioid based pain medication after total knee replacement surgery,” principal investigator Dr. William Mihalko said in prepared remarks.
The trial is slated to enroll 120 patients who will receive either Iovera therapy three to seven days prior to the procedure or the current standard of care.
Six orthopedic surgeon practices will participate in the trial which aims to explore whether the Iovera therapy can reduce opioid consumption after total knee replacement procedures.
“I am very excited to see that we are able to conduct this study at a renowned institution like the Campbell Clinic. Data from this study will demonstrate and confirm that the Iovera technology can be a solution to help address the opioid epidemic in our nation today,” prez & CEO Cary Vance said in a press release.
In May, Myoscience won FDA 510(k) clearance for its Iovera device with indications for relieving pain and symptoms associated with knee osteoarthritis.