StockNews.AI

Aclarion Announces First Patient Enrollments at Two Additional CLARITY Trial Sites and Provides Guidance on Expected Availability of Initial Data

StockNews.AI • 3 days

ACON
High Materiality8/10

Information

Northwestern and Scripps Health join two previously announced sites in achieving this critical patie...

Original source

AI Summary

Aclarion Inc. (ACON) advances its CLARITY trial for chronic low back pain, enrolling patients across seven sites. The company's innovative Nociscan technology aims to improve surgical outcomes, with important data expected by Q3 2026. New leadership hires emphasize their commitment to enhancing market access and enrollment speed.

Trading Thesis

Given the trial's progress and potential improvements in surgical outcomes, consider investing in ACON.

Market-Moving

  • The enrollment of patients accelerates ACON's potential clinical relevance.
  • Positive trial data could stall or reverse ACON's previous downward trends.
  • Hiring new leadership positions ACON for greater operational effectiveness.
  • Regulatory progress across multiple sites enhances long-term growth prospects.
  • Patient outcomes from the CLARITY trial could significantly sway reimbursement discussions.

Key Facts

  • ACON's Nociscan targets chronic low back pain, affecting 266 million globally.
  • Seven spine centers are now active in the CLARITY trial.
  • The trial aims to enroll 300 patients by mid-2027.
  • Initial results from the first cohort are due 90 days post follow-up.
  • The company emphasizes generating Level 1 clinical evidence through trial outcomes.

Companies Mentioned

  • Northwestern Medicine (N/A): Part of the clinical trial, enhancing ACON's visibility.
  • Scripps Health (N/A): Joining trial sites contributes to ACON's enrollment goals.
  • Texas Back Institute (N/A): One of the sites contributing significant data for ACON's trial.
  • University of Miami Health (N/A): Another contributor improving ACON's clinical data collection.

Research Analysis

The healthcare technology sector is seeing a surge in innovative solutions for chronic pain management, where ACON's Nociscan represents a significant advancement in clinical practice, potentially transforming surgical planning and patient outcomes.

FAQ

Why Bullish?

Historically, similar clinical trials that generated positive data led to substantial price increases for biotech companies, particularly in areas addressing significant health challenges like chronic pain.

How important is it?

The ongoing trial and early patient enrollment are critical indicators of Acon's future growth and market penetration, making this news highly relevant to investor sentiment.

Why Long Term?

The long-term potential is driven by ACON's trial results and expected product adoption, impacting its market position as data accumulates over time.

Related Companies

ACON

Aclarion Reports Progress in CLARITY Trial with New Patient Enrollments

BROOMFIELD, Colo., Jan. 6, 2026 (GLOBE NEWSWIRE) — Aclarion, Inc. (Nasdaq: ACON), a leading healthcare technology company, has announced significant advancements in its pivotal CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The company confirmed that Northwestern Medicine and Scripps Health have successfully enrolled their first patients. This marks a critical milestone as Aclarion aims to enhance treatment options for chronic low back pain, a prevalent health issue affecting millions worldwide.

Enrollment Update and Trial Sites

The CLARITY trial has gained momentum with a total of four clinical sites now actively enrolling participants. In addition to Northwestern Medicine and Scripps Health, sites include:

  • Texas Back Institute
  • University of Miami Health
  • Advocate Health
  • Keck Medicine of USC
  • Johns Hopkins University

Seven leading U.S. spine centers have completed the necessary regulatory and operational requirements to begin screening and enrolling patients. This trial is seen as a vital clinical and commercial catalyst for Aclarion as it seeks to support future reimbursement discussions in the United States.

Clinical Trial Objectives and Expected Outcomes

The CLARITY trial will evaluate the effectiveness of incorporating Aclarion’s Nociscan technology into standard surgical planning for patients with chronic low back pain. The study aims to exceed the current industry benchmarks of approximately 54% for surgical outcomes. A total of 300 patients are expected to be enrolled, with the company targeting approximately 25% enrollment by the end of Q2 2026.

Initial results from the first cohort will be available internally 90 days after the last patient completes their three-month follow-up visit, with additional data rolling in until enrollment concludes. Notably, should statistically significant improvements emerge in the Nociscan group, the trial could conclude before reaching full enrollment.

Statement from Aclarion's Leadership

Brent Ness, CEO of Aclarion, remarked, “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. 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.”

Aclarion's Innovative Nociscan Technology

An estimated 266 million individuals globally suffer from chronic low back pain, making it one of the most significant health challenges today. Aclarion’s Nociscan is the first evidence-supported SaaS platform designed to help physicians noninvasively distinguish between painful and non-painful discs in the lumbar spine. By quantifying chemical biomarkers associated with disc pain, Nociscan aims to enhance surgical outcomes for patients with degenerative spine disease.

For More Information

To learn more about the CLARITY trial, visit the CLARITY official page. To locate a Nociscan center, please refer to our site map. For inquiries about Nociscan, reach out via email at info@aclarion.com.

About Aclarion, Inc.

Aclarion, Inc. is dedicated to leveraging Magnetic Resonance Spectroscopy (MRS), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to enhance clinical treatments for chronic low back pain. For more information about the company's innovations, visit www.aclarion.com.

Related News