Aclarion Adds Tenth Nociscan Study Site

Aclarion Inc. has added the University of Arizona College of Medicine – Phoenix as a new site in its CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial, which aims to demonstrate Nociscan’s clinical and economic value in spine surgery.

The University of Arizona College of Medicine – Phoenix is home to a nationally recognized neurosurgery and orthopedic spine program with expertise in complex and minimally invasive spine surgery, advanced neuromodulation, and translational research. The program’s integration of clinical care, research and education makes it a natural fit for the CLARITY trial network, according to the company.

“Chronic low back pain remains one of the most challenging problems in spine surgery, not because we lack the ability to treat it, but because identifying the precise disc responsible for a patient’s pain has historically been imprecise. When I agreed to serve as principal investigator for the CLARITY trial, it was because I believed Nociscan represented a meaningful advance in our ability to objectively measure the chemical biomarkers associated with disc pain,” said Nicholas Theodore, M.D., chairman of Neurosurgery, University of Arizona College of Medicine – Phoenix at Banner – University Medical Center Phoenix, and CLARITY trial principal investigator. “Having the University of Arizona College of Medicine – Phoenix participate as a trial site allows my team to contribute directly to generating the evidence needed to establish Nociscan as a standard of care for surgical decision making in chronic low back pain.”

The University of Arizona College of Medicine – Phoenix joins a growing network of high-volume CLARITY trial sites including Johns Hopkins University, Northwestern Medicine, Advocate Aurora Research Institute, Texas Back Institute, Keck Medicine at USC, UHealth — University of Miami Health System, Scripps Health, Lanman Spinal Neurosurgery, and Texas Spine Care Center.

The CLARITY trial is a 300-patient, prospective, randomized, multi-center study evaluating Nociscan in patients undergoing surgical treatment (fusion/TDR) for discogenic low back pain. The primary endpoint is a change in back pain as measured on a 100mm VAS at 12 months compared to baseline, with several secondary endpoints collected. The company expects to disclose early interim results (with initial data) next quarter.

“Having Dr. Theodore’s institution as an active CLARITY trial site adds another dimension to his leadership as principal investigator,” Aclarion Chief Strategy Officer Ryan Bond stated. “The University of Arizona College of Medicine – Phoenix brings exceptional clinical and research capabilities to the trial, and we are proud to have Dr. Theodore and his team contributing directly to the evidence we are building for Nociscan.”

Chronic low back pain is a global healthcare problem with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain. Aclarion’s Nociscan solution is the first evidence-supported software-as-a-solution (SaaS) platform to noninvasively help physicians distinguish between painful and non-painful lumbar spine discs. Nociscan objectively quantifies chemical biomarkers associated with disc pain. When used with other diagnostic tools, Nociscan provides critical insights into low back pain location and demonstrates a 97% surgical success rate when all Nociscan-positive discs are treated.

Aclarion is a healthcare technology company that leverages magnetic resonance spectroscopy (MRS), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to optimize clinical treatments. The company is first addressing the chronic low back pain market with Nociscan, the first, evidence-supported, SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Through a cloud connection, Nociscan receives MRS data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to indicate whether a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into low back pain location, giving physicians clarity to optimize treatment strategies.