Ohio's Neuros Medical has received an IDE approval from the FDA to start a pilot study of its high-frequency Electrical Nerve Block technology for use in treatment of acute pain in the residual limb of amputees.
In results from a first-in-man study reported this year, four of 5 patients reported that their pain was reduced to zero, the company said in a statement. One patient was able to sleep pain-free through the night for the first time in years, while another could work in his woodworking shop for hours.
"We are very pleased with the IDE approval and look forward to commencing the pilot study to provide longer term safety and efficacy data of our Electrical Nerve Block technology in a larger set of patients," Jon Snyder, Neuros president and CEO, said in a statement.
Last month, Snyder said Neuros' pilot study would assess its technology in about 10 to 20 patients over a three-month period. Neuros hopes that the study paves the pay for a roughly 100-patient trial to gain FDA clearance, according to MedCity News.
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