Neuros Medical Announces Key Milestones in the QUEST Pivotal Clinical Study for Chronic Post-Amputation Pain
CLEVELAND and ALISO VIEJO, Calif., Jan. 7, 2021 /PRNewswire/ -- Neuros Medical, Inc. Inc., a medical device company developing innovative high-frequency nerve block technology for patients with intractable post-amputation pain, announced today the achievement of two milestones in its pivotal QUEST (High-FreQUEncy Nerve Block for PoST-Amputation Pain) study. 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 post-amputation pain. Post-amputation pain is a significant unmet medical need, as existing treatment options are limited, and consist primarily of opioids and gabapentinoids.
In December 2020, an independent Data Monitoring Committee successfully completed the final planned interim safety and futility analysis of 80 subjects at the 90-day primary endpoints. In addition, despite the ongoing COVID-19 pandemic, QUEST enrollment now exceeds 100 subjects, and the study is on track for completion of enrollment by the Fall of 2021.
"I wish to thank the QUEST investigators and their clinical research teams for a remarkable collective effort during this extremely challenging year," said Leonardo Kapural MD PhD, Carolinas Pain Institute and National Principal Investigator of the QUEST study. "I believe that the Altius therapy, with its unique mechanism of action achieved with High-Frequency Nerve Block (HFNB), has great potential to become an important treatment option for post-amputation phantom and stump pain."
"We join Dr. Kapural in expressing gratitude to the QUEST site clinical research teams for their commitment to both the study as well as to the amputee subjects whom they enrolled," said David Veino, Neuros Chief Operating Officer. "We look forward to completing enrollment this year, a key milestone in our efforts to develop a promising treatment option for this significant unmet medical need."
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).
Chronic pain is characterized as pain lasting more than 3 months in duration. Post-amputation pain includes both phantom limb and residual limb (or "stump") pain, and impacts nearly one million Americans. There are nearly two million amputees in the U.S. with 185,000 new amputations occurring every year.
About Amputees and Post-Amputation Pain
Additional information regarding amputees, including post-amputation pain, can be found at the Amputee Coalition (https://www.amputee-coalition.org).
Caution – Investigational Device. Limited by Federal (or United States) law to investigational use.
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SOURCE Neuros Medical