Aclarion's CLARITY Trial for Nociscan: A Breakthrough in Chronic Low Back Pain Diagnosis

Aclarion Secures Full Funding for CLARITY Trial

Aclarion, Inc. (NASDAQ: ACON, ACONW), a healthcare technology company, has announced that it has secured full funding for its pivotal CLARITY trial. The company has raised nearly $20 million in gross proceeds since January 1, 2025, ensuring complete funding for the study designed to demonstrate Nociscan's clinical and economic value in spine surgery 1

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CLARITY Trial Overview

The CLARITY trial is a prospective, randomized, multicenter study that aims to validate Nociscan's ability to improve surgical outcomes for chronic low back pain patients. Led by Dr. Nicholas Theodore of Johns Hopkins as the principal investigator, the trial will enroll 300 patients across multiple high-volume sites in the United States 1

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Key aspects of the CLARITY trial include:

1. Randomization: Patients will be randomized at a 1:1 ratio of surgeons blinded-to-Nociscan and unblinded-to-Nociscan to guide surgical treatment (Fusion / TDR) 1

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2. Primary Endpoint: Change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline 1

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3. Participation: Northwestern Medicine has been announced as the initial site for the trial, with Dr. Alpesh Patel, Professor and Co-Director of the Northwestern Center for Spine Health, leading the efforts 1

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Nociscan Technology

Nociscan is Aclarion's flagship product, described as the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The technology leverages:

1. Magnetic Resonance Spectroscopy (MRS)
2. Proprietary signal processing techniques
3. Biomarkers
4. Augmented Intelligence (AI) algorithms 1

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Nociscan objectively quantifies chemical biomarkers associated with disc pain, providing critical insights into the location of a patient's low back pain. When used with other diagnostic tools, it has demonstrated a 97% surgical success rate at one-year follow-up when all Nociscan-identified pain-positive discs are treated 2

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Market Potential and Impact

Chronic low back pain is a global healthcare problem affecting approximately 266 million people worldwide 1

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. Aclarion aims to position Nociscan as the new gold standard in identifying sources of discogenic pain, potentially redefining chronic low back pain treatment 3

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Future Prospects

Aclarion's Chief Strategy Officer, Ryan Bond, stated that the full funding of the CLARITY trial could potentially unlock broad payer coverage for Nociscan 2

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. The company is also showcasing the technology at conferences, with Dr. Sigurd Berven presenting Nociscan's capabilities at the Selby Spine Conference 3

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As Aclarion continues to develop and validate its technology, the healthcare industry watches closely to see if Nociscan will indeed become the new standard in chronic low back pain diagnosis and treatment optimization.