The US Food and Drug Administration (FDA) has granted Neuros Medical investigational device exemption approval to initiate a pilot clinical trial to investigate its patented high-frequency electrical nerve-block technology, designed for the acute treatment of pain in the residual limbs of amputees.
The technology will eliminate chronic pain in a number of applications, such as amputation pain, chronic post-surgical pain, chronic migraine and trigeminal neuralgia.
The approval is supported by the first-in-man feasibility study, in which four out of five patients reported improvements in pain, reducing pain scores to zero.
Neuros Medical president and CEO Jon Snyder said the company will further commence the pilot study to provide long term safety and efficacy data of electrical nerve block technology in a larger set of patients.
