Neurostimulation startup Neuros Medical has received regulatory approval to begin a pilot clinical trial of its device that blocks pain experienced by amputees.
Receiving Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration is an important next step for Cleveland-area Neuros. A successful pilot study could clear the way for a pivotal clinical trial aimed at securing the legal right to sell the device on the U.S. market.
The pilot study is expected to involve between 10 and 20 patients, and assess the pain-blocking effectiveness of the company’s device over about three months, Neuros CEO Jon Snyder said last month.
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Neuros is developing a device that uses a pacemaker-sized generator and an electrode to stimulate nerves to block pain from amputations — sometimes called stump pain — without the use of drugs. Last year, Neuros received a $1.2 million grant from the U.S. Department of Defense to further develop the device.
Earlier this year, the company completed the first successful in-man feasibility study of the device. Four of five patients in the study reported that Neuros’ device reduced their pain to “zero,” the company said at the time.
Neuros is looking to raise a $3.5 million round of investment to fund clinical studies. One of Neuros’ existing investors, Cleveland venture firm Glengary, will lead its next round of funding.
If all (or most) goes well for Neuros, the device could be on the market in about three years.
