Aclarion Enrolls First Patient In CLARITY Trial Evaluating Nociscan In Spine Surgery

(RTTNews) - Aclarion, Inc. (ACON), a healthcare technology firm, has announced the enrollment of the first patient in its CLARITY trial.

The study aims to evaluate the clinical and economic value of its Nociscan platform in spine surgeries, with the Texas Back Institute enrolling the inaugural participant.

Dr. Alexander Satin, orthopedic spine surgeon and principal investigator at the Texas Back Institute, expressed optimism about the study, noting the trial's potential to correlate Nociscan's biomarker data with surgical outcomes in patients suffering from chronic low back pain.

The CLARITY trial is a prospective, randomized, multi-center study involving 300 patients scheduled for surgery due to 1- or 2-level discogenic low back pain. Patients will be randomized into two groups—one with surgeons blinded to Nociscan data and another with access to it to guide treatment (fusion or total disc replacement). The primary outcome is pain reduction on the 100mm VAS scale at 12 months post-surgery. The trial is led by Dr. Nicholas Theodore of Johns Hopkins Medicine, with additional sites including Northwestern Medicine, Advocate Aurora, Keck Medicine of USC, and UHealth/University of Miami.

With around 266 million people globally affected by degenerative spine disease, Aclarion's Nociscan is the first SaaS platform backed by clinical evidence to noninvasively differentiate between painful and nonpainful spinal discs. It uses chemical biomarkers to help physicians make more precise surgical decisions and potentially improve patient outcomes.

Wednesday, ACON closed at $7.08, or 4.16% higher on the NasdaqCM.