Neuros Medical has announced the completion of its QUEST pivotal trial’s 90-day primary endpoints, according to a company press release. QUEST outcomes will remain blinded through the 12-month follow-up period, per protocol, the release adds.
QUEST is a 180-subject, randomised, double-blinded, active sham-controlled clinical trial that is being conducted under an investigational device exemption (IDE).
It is designed to assess the safety and effectiveness of the company’s Altius bioelectric nerve block technology in treating intractable post-amputation pain—a “significant unmet medical need”, according to Neuros, as existing treatment options are limited, and consist primarily of opioids and gabapentinoids.
The company is also continuing plans for expansion of its facility and future headquarters in Aliso Viejo, USA. The 10,000-square-foot operation was recently certified by the designated European notified body, the British Standards Institution (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 premarket approval application after the QUEST study is unblinded in the fall of 2022,” said William Patterson, chief technology officer at Neuros.