Myoscience scored FDA clearance for its device that uses the body’s natural reaction to cold to alleviate pain from osteoarthritis of the knee. The treatment targets specific nerves and does not involve drugs.
The Iovera device delivers “targeted cold” to a peripheral nerve, which blocks the nerve’s ability to relay pain signals. The cold causes the axon, the part of the nerve cell that conducts impulses, and the myelin sheath, which envelopes the axon, to degenerate. This temporarily interrupts the transmission of pain signals until the axon regenerates.
The clearance is based on a prospective, sham-controlled, randomized double-blind study (PDF) involving 180 patients, the company said in a statement. Patients who underwent Iovera treatment reported “statistically significant decreased knee pain” and improved symptoms compared to those who received the sham treatment.
“I anticipate this technology to become the non-narcotic and non-systemic solution of choice to manage knee pain,” said CEO Cary Vance in the statement.
Osteoarthritis, or "wear and tear" arthritis, affects more than 30 million adults in the U.S., according to the CDC. It is typically treated with some combination of physical activity, weight loss, surgery, support devices, physical therapy and drugs to relieve pain. While “cold therapy” tamps down on pain from knee osteoarthritis, it could also be a weapon against the rise of opioid use in the U.S.
“The iovera° technology has the potential to change the current paradigm of pain management for osteoarthritis,” said Dr. Vinod Dasa, who sits on Myoscience’s advisory board, in the statement. “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.”