Myoscience, a medtech company based in California, has developed the iovera° cryoanalgesia device. The device was FDA cleared in 2013, with an additional clearance in 2017 for knee pain, and uses cryotherapy to freeze peripheral nerves to reduce pain without affecting nearby tissues. The company claims that the device is a useful alternative to opioid therapy for chronic pain.
The iovera° is handheld, and can deliver precise, controlled doses of cryotherapy to specific sensory nerves through a series of needles. The needles create a cold zone around the nerve which is −20°C (-4° F). This causes the myelin sheath and axon of the targeted sensory nerve to degrade, meaning that the nerve can no longer transmit signals to the brain.
This nerve block is reversible however, and the nerve eventually regains function allowing for sensory innervation. This temporary disruption of nerve function can help to reduce pain in the treated area, and also avoids many of the serious issues that accompany the use of opioid analgesics, such as addiction and overdose.
The company claims that the effects of the treatment can last as long as 90 days and in certain conditions relief for up to 150 days has been reported. In a recent clinical trial in patients who had undergone knee replacement surgery, the device allowed for a significant reduction in the required amount of opioids and resulted in significantly reduced pain.
See a video about the system below:
Medgadget had the opportunity to ask Tim Still, Myoscience CEO, some questions about the technology.
Conn Hastings, Medgadget: Please give us an overview of currently used analgesics and the problems they can create.
Tim Still, Myoscience: Commonly used analgesics to help relieve pain for people undergoing total knee arthroplasty surgery, also known as total knee replacement, include opioids such as morphine, oxycodone and codeine to help relieve chronic pain after the painful procedure. More than 10 million people in the U.S. suffer from moderate or severe osteoarthritis in the knee, and nearly 1 million of them have knee replacement surgeries each year. Among those who have the surgery, 16.7% become persistent opioid users through six months after surgery. In 2017 alone, there were more than 46,000 deaths across the U.S. related to opioid overdoses.
Medgadget: Is the current opioid crisis a wake-up call in terms of the need to find alternative analgesic solutions?
Tim Still: Yes, absolutely. Current approaches to treating knee pain leave many patients addicted to opioids and continuing to experience chronic pain, and patients who have a total knee replacement are at a very high risk. iovera° provides clinically proven, long-lasting pain relief without the use of drugs or opioids.
Most recently, positive clinical data was presented at AAOS 2019 supporting iovera° as an effective alternative to opioids. In the prospective and randomized study, there was statistically significant reduced use of opioids, and pain, after total knee replacement.
Medgadget: Please give us an overview of the iovera° cryoanalgesia device and how it works.
Tim Still: The iovera° system treats the nerves in the knee through cryoneurolysis and provides immediate pain relief that can last up to 90 days in patients recovering from total knee replacement surgery, and in those suffering from chronic knee pain. iovera° therapy uses the body’s natural response to cold to immediately block a sensory nerve from sending pain signals. Using a small probe, a precise cold zone is formed under the skin – cold enough to temporarily stop the nerve from signaling, providing pain relief until the nerve regenerates. No fluid, chemical or drug is injected into the body during the procedure.
Medgadget: What types of pain can the device help to alleviate?
Tim Still: iovera° is FDA-cleared for use to relieve pain anywhere in the body, with an additional indication for knee pain that we received in 2017 – so it can be used for other common pain areas such as the shoulder, lower back, hip, ankle and foot.
Medgadget: What can patients expect when they are treated using the device?
Tim Still: The iovera° system is a non-systemic, localized approach that provides fast and immediate pain relief while protecting surrounding tissue. It’s a simple, minimally invasive outpatient procedure that typically takes between 10–20 minutes, with results that can be felt immediately after treatment. When individual nerve branches are treated, there is an immediate reduction in pain – so patients can walk out of their physician’s office with less pain than they had when they walked in.
Medgadget: Please give us an overview of the recent clinical trial of the device in knee replacement patients.
Tim Still: In the 125-patient study presented at AAOS, patients’ daily morphine equivalents – the measure of prescribed opioids based on the pill count – were significantly lower in the iovera° treatment group at 72 hours, six weeks and 12 weeks after the surgery, with an overall reduction in DME by 35% at the 12-week mark.
There were three times more patients taking opioids at six weeks after surgery in the control group than in the iovera° treatment group – 46% verses only 16%. Additionally, the iovera° treatment group demonstrated significant reduction in pain scores from the baseline at 72 hours and at 12 weeks.
Total knee replacement is known to be among the most painful surgeries. This new data provides additional validation for iovera° and shows that the therapy is a compelling alternative for doctors to offer safe and effective pain relief to their patients without the opioids.
Product page: iovera°…