Neuros Medical, Inc., a medical device company developing an innovative, on-demand bioelectric nerve block therapy for patients with intractable post-amputation pain, announced today the completion of its QUEST Pivotal Trial 90-day primary endpoints. QUEST outcomes will remain blinded through the 12-month follow-up period, per protocol.
QUEST Pivotal Trial 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® Bioelectric Nerve Block Technology 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.
The Company continues its plans for expansion of its facility and future headquarters in Aliso Viejo, CA. The 10,000 square foot operation was recently certified by the designated European Notified Body, BSI, to International Standards Organization (ISO) 13485:2016.
“Expansion and ISO certification of our California headquarters will enable us to add additional personnel as we prepare to submit the Altius System Pre-Market Approval application after the QUEST study is unblinded in the Fall of 2022,” said William R. Patterson, PhD, Chief Technology Officer.
Neuros Medical, a bioelectric technology 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, On-Demand Bioelectric Nerve Block. Patients initiate a 30-minute Altius treatment session as needed for targeted pain relief.
Neuros’ technology delivers a bioelectric 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. Post-amputation pain represents a significant unmet medical need, as existing treatment options are limited and consist primarily of opioids and gabapentinoids.
For more information, please visit www.neurosmedical.com. Additional information regarding the QUEST IDE study can be found at https://clinicaltrials.gov/ct2/show/NCT02221934. The Altius is an investigational device that is not available for sale in the United States.