Neuros Medical, a Cleveland-based medical device company, received an FDA investigational device exemption approval to begin a clinical study on its technology for intractable limb pain management for amputees. According to the company website, the Altius System High Frequency Nerve Block technology “consists of an electrode (also known as a lead) placed around a peripheral nerve and powered by a pacemaker-size generator.”
The pivotal clinical study will run through 2014 and most of 2015. The pivotal trial will test the technology with 130 patients in 15 U.S. institutions. If successful, the company plans to apply for premarket approval for the device in the second half of 2015, President and CEO Jon Snyder said in an e-mail.
The company recently completed a pilot trial on the product and announced successful results in June, the Altius System High Frequency Nerve Block technology, during which more than half the subjects quit their pain meds. (The company also received IDE approval to conduct that trial.)
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This milestone seems to be one on the path to success for the startup, which has seen funding from Boston Scientific (BSX), the U.S. Department of Defense, angels and venture capitalists for its technology.
According to the company’s website, the patented electrical nerve block technology also has potential applications in chronic post-surgical pain and chronic migraine.