Aclarion is betting that its Nociscan technology can reshape how spine surgeons identify pain-generating discs. The company’s pivotal Clarity trial is designed to provide the evidence to make that shift possible, Brent Ness, CEO, told Becker’s.
“We acknowledge we needed to take that great evidence [from the single-site Gornet trial] and perform a multi-center, multi-surgeon, true randomized control trial,” Mr. Ness told Becker’s. “This is the kind of evidence that can drive reimbursement and move Nociscan toward standard of care.”
In the Gornet trial, when surgical treatment aligned with Nociscan’s findings, 97% of patients reported significant improvements in pain and function, compared with 54% when treatment did not match. Those results, Mr. Ness noted, stand in stark contrast to average lumbar fusion success rates of about 50% to 55%.
The Clarity trial builds on that foundation. It is a 300-patient, multi-center randomized study evaluating whether Nociscan can improve outcomes for patients with chronic low back pain, with interim results expected in 2026.
Beyond outcomes, economics are central to the case for adoption.
“In this country, $2.2 billion is spent every year on revision spine surgeries,” Mr. Ness said. “Our noninvasive test costs $1,450 — a small amount in the context of a $70,000 procedure if it helps confirm which levels are truly causing the pain.”
Still, Mr. Ness said adoption will take more than one trial.
“First off, it starts with [key opinion leader] advocacy,” he said. “It’s not enough for surgeons to say, ‘I like this tool.’ They need to back that up with evidence that demonstrates real value for patients, payers and providers across the care pathway.”
Looking ahead, Aclarion is advancing its platform alongside the trial.
“We’ve actually launched through the stage gate process the 3.0 version of Nociscan,” Mr. Ness said. “By training a new algorithm with outcomes data from Clarity, we’ll be able to make much stronger claims about how the test improves surgical planning and patient results.”
He added that the company is financially prepared to reach its next milestone.
“We have cash on hand that gets us through the preliminary results of the Clarity trial. We have no debt and we’re really in a great position to execute on the catalysts,” he said.
Mr. Ness pointed to early reimbursement traction in the U.K., where three of the top four private payers already cover Nociscan. He also highlighted Aclarion’s broader ambitions.
“Our 40 patents can be applied to the breast, brain and prostate,” he said. “Spine is first, but we see a broad platform opportunity.”
