The US Food & Drug Administration (FDA) has approved new indication for Myoscience's iovera° device to relieve pain and symptoms associated with osteoarthritis of the knee.
The iovera° technology is a non-opioid and non-systemic treatment, which can block pain signals from peripheral nerves.
Myoscience’s iovera° treatment is supported by the Focused Cold TherapyÂ delivery system, a patented miniaturization of traditional cryotherapy.
The approval was based on a prospective, multi-center, sham-controlled, randomized and double-blind study, which included 180 patients.
Study population comprised of male or female aged between 35 and 75 with chronic knee pain related to knee osteoarthritis.
The company said pain reduction effects were noted to last up to 90 days, with reduced stiffness and enhanced physical function.
According to the company, the study showed patients treated with the iovera° device reported statistically significant reduction in pain and improvement in symptoms when compared to patients who received the sham treatment.
The iovera° treatment is said to use the body’s natural response to cold to treat peripheral nerves. A sensory nerve will block carrying pain signals immediately after receiving targeted cold therapy through the iovera° treatment.
Myoscience president and CEO Cary Vance 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.”
Image: Myoscience’s iovera° device has received FDA clearance to treat pain and symptoms associated with osteoarthritis of the knee. Photo: courtesy of Myoscience, Inc.