Myoscience Receives 510k Clearance for its Nerve Stim Enabled Smart Tip

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Myoscience, Inc. announced today that it received 510k clearance from the US FDA for the Smart Tip with Nerve Stim, the latest innovative tip for Myoscience’s iovera° platform technology.

California-based Myoscience, Inc. announced today that it received 510k clearance from the US FDA for Smart Tip with Nerve Stim, the latest innovative tip for Myoscience’s iovera° platform technology.

With the FDA clearance for Smart Tip with Nerve Stim, physicians will be able to stimulate a nerve in advance of delivering iovera° cold therapy to the treatment area, reducing patient treatment times. Additionally, the use of Smart Tip with Nerve Stim enables physicians using iovera° to access nerves in the shoulder, hip, and knees (genicular).

Cary G. Vance, Myoscience’s President and CEO noted, “With 510k clearance for the Smart Tip with Nerve Stim, we can expand the use of iovera° technology in our existing call points. In addition to our continued commercial focus on reducing opioid use through the use of iovera° technology for treating perioperative pain due to total knee arthroplasties (TKA) and chronic pain, the Smart Tip with Nerve Stim will allow physicians to treat harder to reach areas and complete procedures more quickly and efficiently.”

Dr. Pieter Vreede, MD, of Riverview Health System in Noblesville, Indiana, commented on the addition of Smart Tip to the iovera° platform, “I’ve been using ioveraº technology for the last several months and am thrilled with the outcomes I’ve seen thus far. With this new tip I look forward to providing another non-opioid and non-systemic pain option for my patients suffering from shoulder pain and deep knee pain.”

Myoscience is the manufacturer of the ioveraº system, which is a non-opioid and non-systemic treatment for blocking pain signals from various peripheral nerves. The iovera° system includes a small, hand-held device that uses disposable tips to deliver focused cold to targeted nerves throughout the body. It has been proven to be safe and effective as a stand-alone, non-opioid modality for managing chronic, perioperative and acute pain. The iovera° treatment provides immediate, long-lasting pain relief by blocking the nerve’s ability to transmit pain signals without affecting the structure of the targeted nerve. The iovera° system is cleared by US FDA for the blocking of pain. It is also cleared for relieving pain and symptoms associated with osteoarthritis of the knee for up to 90 days.

For additional information, please visit http://www.iovera.com or email us directly at contact(at)myoscience(dot)com.

ABOUT MYOSCIENCE
Silicon Valley, California-based Myoscience is a privately-held medical device company committed to making its platform technology, the iovera° system, the standard of care for the treatment of peripheral nerves. The iovera° treatment is powered by the Focused Cold Therapy® delivery system, a patented miniaturization of traditional cryotherapy. The ioveraº system is 510k cleared in the U.S. for the blocking of pain, the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days and general surgical use. For more information, please visit http://www.iovera.com.    

© 2018 Myoscience. All rights reserved. iovera° and Focused Cold Therapy are trademarks of Myoscience. MKT-0486 REV B

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