Breaking News

FDA Clears Myoscience's iovera System to Relieve Knee Osteoarthritis Pain

By Myoscience Inc. | May 17, 2017

The iovera technology is a non-opioid and non-systemic treatment for blocking pain signals from peripheral nerves.

California-based Myoscience Inc. announced that the U.S. Food & Drug Administration (FDA) has cleared its iovera device for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera technology is a non-opioid and non-systemic treatment for blocking pain signals from peripheral nerves.
Osteoarthritis compromises the quality of life of more than 27 million Americans, with approximately 25 percent of knee osteoarthritis sufferers complaining of pain while performing daily activities (walking, climbing stairs, kneeling, etc.)1. The effect of this disease on the United States economy is estimated to be $60 billion per year2. Also, Center for Disease Control and Prevention (CDC) states that the US is in the throes of an opioid epidemic, and that the total number of opioid-related deaths may be underestimated.
“The iovera technology has the potential to change the current paradigm of pain management for osteoarthritis,” said Dr. Vinod Dasa. “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.”
The FDA clearance was based on a recent prospective, multi-center, sham-controlled, randomized, double-blind study of 180 subjects. The study concluded that patients treated with the iovera device reported statistically significant greater reduction in pain and improvement in symptoms (p=0.001) when compared to patients who received the sham treatment3. Also, patients who received the iovera treatment reported pain relief lasting up to 90 days, accompanied by reduced stiffness and improved physical function.
Cary Vance, president and CEO of Myoscience, stated that “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.”
The iovera treatment uses the body’s natural response to cold to treat peripheral nerves. A sensory nerve will stop sending pain signals immediately after receiving targeted cold therapy via the iovera treatment. The effect on the nerve is transient, providing pain relief until the nerve regenerates and its sensory function is fully restored. This pain relief is achieved without the use of habit-forming drugs such as opioids.
*Dr. Vinod Dasa, MD, is a member of Myoscience’s Medical Advisory Board 
1Source: A National Public Health Agenda for Osteoarthritis. CDC. February 4, 2010. 
2Buckwalter, JA, et al. The Impact of Osteoarthritis. Clin Orthop Related Res. Oct 2004. 427(427 Suppl):S6-S15. 
3Radnovich R, et al., Cryoneurolysis to Treat the Pain and Symptoms of Knee Osteoarthritis: A Multicenter, 
Randomized, Double-Blind, Sham-Controlled Trial, Osteoarthritis and Cartilage (2017), 

Find more information on the study here.

Related Markets:

  • Loading Orthopedic Devices with Biologics and Pharmaceuticals

    Loading Orthopedic Devices with Biologics and Pharmaceuticals

    Dr. Kevin Nelson, Founder and CSO, TissueGen Inc.||May 19, 2017
    Fiber technology enables the delivery of the therapeutic components via a biodegradable platform that can be implanted.

  • Looking Beneath the Surface

    Looking Beneath the Surface

    Sam Brusco, Associate Editor||May 19, 2017
    Surface treatments seek to improve orthopedic device usability, longevity, and bone integration.

  • Going to Extremes

    Going to Extremes

    Michael Barbella, Managing Editor||May 19, 2017
    The innovation and market value found in extremity solutions is prompting a change of heart among major orthopedic firms.