CLEVELAND and ALISO VIEJO, Calif., June 29, 2021 /PRNewswire/ -- Neuros Medical, Inc., announced today that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel High-Frequency Nerve Block system as an aid in the management of chronic intractable pain of the lower limb of adult amputees.
The FDA Breakthrough Device Program is 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.
In the United States alone, there are nearly two million lower limb amputees, with 160,000 new amputations occurring annually. Chronic post-amputation pain is a significant unmet medical need, as existing treatment options are limited, and consist primarily of opioids and gabapentinoids. Chronic post-amputation pain is estimated to afflict approximately 30% to 80% of patients who undergo a major limb amputation.
Neuros anticipates completion of enrollment in its pivotal QUEST (High-FreQUEncy Nerve Block for PoST-Amputation Pain) study by the Fall of 2021. QUEST is a 180-subject, randomized, double blinded, active sham controlled clinical trial that is being conducted under an Investigational Device Exemption (IDE). QUEST is designed to assess the safety & effectiveness of the Company's Altius® High-Frequency Nerve Block system to treat intractable chronic post-amputation pain.
"The Altius System – as a designated Breakthrough Device – is the result of outstanding multi-disciplinary teamwork, and we look forward to completion of QUEST enrollment this Fall as another key milestone in our effort to develop this important therapy option for patients who suffer from chronic post-amputation pain," said William Patterson PhD, Chief Technology Officer.
About Neuros Medical, Inc.
Neuros Medical, a neuromodulation company, has developed the Altius® system for the treatment of chronic post-amputation pain (Phantom Limb Pain and Residual Limb Pain). Altius incorporates the Company's patented platform technology, High-Frequency Nerve Block.
Neuros Medical's technology, originally invented by Drs. Kevin Kilgore and Niloy Bhadra of Case Western Reserve University, 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 (IPG).