Neuros Medical receives Breakthrough Device Designation from FDA

Neuros Medical Inc., a neuromodulation-focused medical device company in Willoughby Hills, said it has received Breakthrough Device Designation from the U.S. Food and Drug Administration for the use of its high-frequency nerve block technology for patients with intractable post-amputation pain.

The FDA Breakthrough Device Program is important, Neuros said in a news release announcing the designation, because it’s “intended to help patients and health care providers receive timely access to medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.”

Neuros said it expects to complete enrollment in its QUEST (High-FreQUEncy Nerve Block for PoST-Amputation Pain) study by this fall. It described QUEST as “a 180-subject, randomized, double-blinded, active sham-controlled clinical trial” that is being conducted under an Investigational Device Exemption. It’s designed to assess the safety and effectiveness of the company’s Altius high-frequency nerve block system.

The Breakthrough Device Designation is another important step forward for Neuros.

In January, Neuros announced it had closed a financing round totaling $38.5 million that was co-led by new investors Amzak Health and Sectoral Asset Management.

Neuros’ technology was invented by Drs. Kevin Kilgore and Niloy Bhadra of Case Western Reserve University. The company says it “delivers a high-frequency electrical signal to sensory nerves in the peripheral nervous system to block the pain signal.” The system consists of a nerve cuff electrode (also known as a lead) placed around a peripheral nerve and an implantable pulse generator, or IPG.

This article originally appeared in Crain’s Cleveland Business on June 29, 2021.

Click here to read the full story