Aclarion Advances CLARITY Trial Enrollment with Northwestern Medicine and Scripps Health Participation
核心洞察
Northwestern Medicine and Scripps Health have enrolled their first patients in Aclarion's pivotal CLARITY trial, bringing the total number of active enrollment sites to four out of seven approved centers.
The multi-site trial aims to evaluate whether Nociscan (搜索) technology can improve surgical outcomes beyond the current 54% industry benchmark for chronic low back pain (搜索) surgery patients.
The company targets enrolling 25% of the planned 300 patients by Q2 2026, with initial interim data readout expected in Q3 2026 after the first cohort completes 3-month follow-up visits.
Aclarion has announced significant progress in its pivotal CLARITY trial with Northwestern Medicine and Scripps Health enrolling their first patients, marking a critical milestone in the company's efforts to generate clinical evidence for its Nociscan (搜索) technology. The enrollment advancement brings the total number of sites actively enrolling patients to four, with seven leading U.S. spine centers having completed all regulatory and operational requirements.
Trial Design and Objectives
The CLARITY (Chronic Low bAck pain (搜索) Randomized Independent Trial studY) is a multi-site randomized trial designed to evaluate whether incorporating Nociscan (搜索) into standard surgical planning can improve outcomes that significantly exceed the current ~54% industry benchmarks for patients undergoing surgery for chronic low back pain. The study will enroll up to 300 patients, randomized between surgeons who are blinded-to-Nociscan results and unblinded-to-Nociscan results to guide surgical planning for Fusion/TDR.
The trial's primary endpoint focuses on patient-reported pain outcomes using the Visual Analog Scale (VAS), with comparisons to pre-surgical pain levels. This approach aims to provide objective measurements of treatment efficacy in a patient population that represents one of the most widespread health challenges globally.
Enrollment Timeline and Data Readout
Aclarion has established ambitious enrollment targets, aiming to enroll approximately 25% of patients by the end of Q2 2026. An initial readout on the results of this first cohort will be internally available 90 days later upon the last patient completing their 3-month follow-up visit, with the first interim data expected in Q3 2026.
The company targets full enrollment of 300 patients by mid-2027, though the trial design includes provisions for early termination if statistically significant improvements are observed in the Nociscan (搜索) group prior to reaching full enrollment. Additional patient data will be added to the initial readout on a rolling basis until enrollment is completed.
Clinical Site Network Expansion
The seven CLARITY sites that have completed regulatory approvals, contracting, training, and study setup include Texas Back Institute, University of Miami Health (搜索), Advocate Health, Northwestern Medicine, Scripps Health, Keck Medicine of USC, and Johns Hopkins University. To support enrollment acceleration, Aclarion recently hired Jason Brosniak as Commercial Director for the Eastern U.S. and Andy Murillo as Director of Market Access.
"The CLARITY trial is a foundational value-creation initiative for Aclarion, and we are encouraged by the pace of site activation, early enrollment, and completed surgeries," said Brent Ness, Chief Executive Officer of Aclarion. "Each patient enrolled and treated moves us one step closer to generating high-quality clinical evidence while reinforcing the commercial momentum we are building across the business."
Technology and Market Context
Nociscan (搜索) represents the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The technology leverages Magnetic Resonance Spectroscopy (MRS), proprietary signal processing techniques, and augmented intelligence algorithms to objectively quantify chemical biomarkers (搜索) demonstrated to be associated with disc pain.
The clinical need addressed by this technology is substantial, with an estimated 266 million people across the globe living with chronic low back pain (搜索), making it one of the most widespread health challenges. Through a cloud connection, Nociscan (搜索) receives MRS data from MRI machines for each lumbar disc being evaluated, with proprietary algorithms indicating if a disc may be a source of pain when used alongside other diagnostic tools.
Strategic Implications
The trial represents a key clinical and commercial catalyst for Aclarion and is intended to support future reimbursement discussions in the U.S. The company believes the continued expansion of high-quality clinical sites, combined with early surgical throughput, positions CLARITY to progress with increasing efficiency and predictability, supporting the strategy to generate Level 1 evidence and drive long-term shareholder value.
The CLARITY trial's design to potentially demonstrate improvements over current industry benchmarks could establish Nociscan (搜索) as a valuable tool in surgical planning for chronic low back pain (搜索), addressing a significant unmet medical need in spine care.