Oct 15, 2025 (PRISM News via COMTEX) --
AI-driven Nociscan platform posts 89% scan growth year-over-year; pivotal CLARITY trial advancing toward early 2026 data readout.
A commercial-stage healthcare technology company using AI-powered biomarkers to pinpoint the source of chronic low back pain Aclarion, Inc. (NASDAQ: ACON), provided a corporate update detailing its expanding global footprint, strong financial position, and steady progress in its pivotal CLARITY clinical trial.
Accelerating Adoption of Nociscan
Aclarion reported an 89% year-over-year increase in scan volumes for its Nociscan(R) platform during the third quarter of 2025, marking the third consecutive quarter of record utilization across the U.S., U.K., and European Union.
The platform, which uses MR spectroscopy and biochemical imaging to identify discogenic pain biomarkers, continues to gain traction among physicians and spine centers as a noninvasive decision-support tool for surgical planning.
Nociscan's biomarker technology was recently featured at the International Society of Pain and Neuroscience (ISPN) meeting in London, underscoring the growing recognition of disc chemistry as a biomarker for chronic back pain. The company was also named a finalist for Rising Star - Clinical Diagnostic Device at the 2025 Digital Health Awards (HLTH), reinforcing its visibility within the digital health and diagnostics sector.
"We are executing on our key milestones--expanding adoption, accelerating Nociscan growth, and advancing the CLARITY trial on time," said Brent Ness, CEO of Aclarion. "With a debt-free balance sheet, expanding data pipeline, and growing commercial traction, Aclarion is positioned to create meaningful long-term value for patients and shareholders alike."
CLARITY Pivotal Trial Progressing Toward Data Catalyst
The company's CLARITY pivotal trial, designed to validate Nociscan's AI algorithms and quantify the clinical impact of integrating chemical biomarker data into surgical planning, remains on schedule.
Enrollment is underway at seven major research centers, including the University of Miami Health System, Texas Back Institute, Advocate Health, Northwestern Medicine, Scripps Health, Keck Medicine of USC, and Johns Hopkins University.
The study aims to demonstrate surgical outcomes significantly exceeding the industry benchmark of approximately 54% success in identifying the pain-generating disc.
Aclarion expects early three-month interim data in Q2 2026, followed by full enrollment by the end of 2026, representing a key clinical and valuation catalyst for the company.
If successful, the CLARITY trial could further establish Nociscan as the first AI-enabled diagnostic platform to objectively identify disc pain biomarkers and improve spine surgery precision.
Financial Position and Leadership Strength
Aclarion also emphasized its debt-free balance sheet and $13.3M in cash as of October 14, 2025, equivalent to $15.11 per share fully diluted, providing the company with flexibility to fund both clinical development and commercial expansion.
The company's cash position includes net proceeds from a recent $2.5M registered direct offering, conducted at market price under Nasdaq regulations.
In September, Aclarion appointed Greg Gould as Chief Financial Officer, adding extensive experience in public markets and operational scaling. The company reaffirmed its focus on disciplined capital allocation, operational leverage, and expanding partnerships to support long-term revenue growth.
Next Catalyst: LD Micro Main Event Presentation
Aclarion will present at the 19th Annual LD Micro Main Event on October 20, 2025, at the Hotel del Coronado in San Diego, California, where CEO Brent Ness will provide an update on clinical milestones and commercial progress.
Investors can register for the webcast at ldmicrocasts.com/#register.
About Aclarion, Inc.
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 magnetic resonance spectroscopy (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 if a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient's low back pain, giving physicians clarity to optimize treatment strategies. For more information, please visit www.aclarion.com .
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The post Aclarion Highlights Market Expansion and Strong Balance Sheet as CLARITY Trial Nears Key Milestone appeared first on PRISM MarketView.
COMTEX_469539863/2927/2025-10-15T10:31:04
