Myoscience said today it won FDA 510(k) clearance for its Iovera device designed to relieve pain and symptoms associated with knee osteoarthritis.
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.
“The Iovera technology has the potential to change the current paradigm of pain management for osteoarthritis. The patients that I have treated with this technology have experienced immediate and long-lasting pain relief; and are grateful to have an option that is non-narcotic and non-systemic,” Dr. Vinod Dasa said in a press release.
FDA clearance was based on a prospective, multi-center, double-blind study of 180 subjects which showed that patients treated with Iovera reported statistically greater pain reduction and symptom improvements from those treated with a sham treatment. Pain reduction effects were noted to last up to 90 days, with reduced stiffness and improved physical function, the company said.
“The addition of osteoarthritis to the indications for the Iovera treatment will help in extending our innovative non-opioid therapy to more patients, especially in the growing baby-boomer population. I anticipate this technology to become the non-narcotic and non-systemic solution of choice to manage knee pain,” prez & CEO Cary Vance said in a prepared statement.