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Aclarion Announces Addition of First Private Practice Site in Los Angeles into CLARITY Trial to Further Accelerate Enrollment

(Moderate)
(Positive)
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Aclarion (Nasdaq: ACON, ACONW) added Lanman Spinal Neurosurgery in Beverly Hills as the first private-practice site for its 300-patient CLARITY randomized trial of Nociscan for discogenic chronic low back pain. The trial's primary endpoint is 12-month change in 100mm VAS Back; early interim results are expected to be publicly disclosed in Q4 2026.

Nociscan is described as a SaaS MR spectroscopy solution that quantifies chemical biomarkers and is reported to show a 97% surgical success rate when all Nociscan-positive discs are treated.

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Positive

  • 300-patient randomized CLARITY trial underway
  • Primary endpoint: 12-month change in 100mm VAS Back
  • First private-practice site added in Beverly Hills
  • Expected public interim results in Q4 2026
  • Company-reported 97% surgical success rate when all Nociscan-positive discs treated

Negative

  • Public readout is only an expected early interim disclosure (timing not guaranteed)
  • Single private-practice site addition is limited to one center so far

News Market Reaction – ACON

-3.66%
-3.66% Session close to close

In the May 7 session, ACON declined 3.66%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement advances Aclarion’s CLARITY trial by adding a high-volume private practice site in...
Analysis

This announcement advances Aclarion’s CLARITY trial by adding a high-volume private practice site in Los Angeles, supporting enrollment toward the planned 300 patients and a 12‑month primary endpoint on a 100mm VAS Back scale. It reinforces prior evidence claims, including a 97% surgical success rate when all Nociscan‑positive discs are treated. Investors may watch for the planned interim readout in Q4 2026 and how expanding into private practices supports broader adoption.

Key Figures

CLARITY trial size: 300 patients VAS scale length: 100 mm Primary endpoint timing: 12 months +3 more
6 metrics
CLARITY trial size 300 patients Prospective randomized multi-center CLARITY trial
VAS scale length 100 mm Primary endpoint uses 100mm VAS Back pain scale at 12 months
Primary endpoint timing 12 months Back pain change at 12 months vs baseline in CLARITY
Interim results timing Q4 2026 Expected public disclosure of early interim CLARITY results
Global patient population 266 million people Worldwide degenerative spine disease and low back pain
Surgical success rate 97% When all Nociscan-positive discs are treated

Historical Context

5 past events · Latest: May 05 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
May 05 Commercial agreement Positive -3.3% Second commercial Nociscan agreement with Weill Cornell in randomized trial.
Apr 30 Earnings update Positive +1.8% Strong Q1 with 196% scan growth and solid cash supporting adoption.
Apr 28 Management hire Positive +0.0% New Commercial Director for Western U.S. to drive Nociscan adoption.
Apr 22 Stock buyback Positive +10.8% Authorization of $2.5M repurchase plan funded from existing cash.
Apr 16 Patent issuance Positive +3.8% New U.S. patent for AI-driven MRS analysis within Nociscan platform.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent positive corporate and clinical updates often saw favorable but inconsistent price reactions, with some news selling off despite constructive fundamentals.

Recent Company History

Over recent months, Aclarion has focused on strengthening Nociscan’s clinical and commercial footing. A U.S. patent and a $2.5M buyback in April 2026 were followed by strong Q1 results with 196% YoY scan growth and ample cash. Additional commercial and trial-related agreements, including Weill Cornell, reinforced the evidence-building strategy. Today’s CLARITY site expansion in Los Angeles continues this trajectory of scaling trials and real-world use, extending the same theme of adoption and data generation highlighted in prior releases.

Key Terms

mr spectroscopy, biomarkers, saas
3 terms
mr spectroscopy medical
"Nociscan introduces a new layer of clarity by leveraging MR Spectroscopy to identify"
MR spectroscopy is a scientific technique that uses magnetic fields and radio waves to analyze the chemical composition of materials, including biological tissues. It helps researchers identify and measure the presence of different molecules, providing insights into health, disease, or material properties. For investors, understanding MR spectroscopy can be important when evaluating innovations in medical technology or pharmaceutical developments that may impact healthcare markets.
biomarkers medical
"leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians"
Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.
saas technical
"Nociscan solution is the first evidence-supported SaaS platform to noninvasively help"
SaaS, or Software as a Service, is a way of delivering computer programs over the internet, allowing users to access and use them through a web browser without needing to install or maintain the software themselves. For investors, it highlights a business model where companies generate recurring revenue by providing ongoing access to their software, often leading to predictable income and growth potential.

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“Matching the right procedure to the right patient is what moves the field forward”

  • Lanman Spinal Neurosurgery is a leading spine-focused private practice recognized for its expertise in complex spinal procedures, early adoption of innovative technologies and high surgical volume
  • The CLARITY randomized clinical trial is designed to demonstrate Nociscan’s ability to improve surgical outcomes for chronic low back pain

BROOMFIELD, Colo., May 07, 2026 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, today announced the addition of Lanman Spinal Neurosurgery as a clinical site in its CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial.

Based in Beverly Hills, Lanman Spinal Neurosurgery is a leading spine-focused private practice known for its expertise in complex spinal procedures, early adoption of advanced technologies aimed at improving patient outcomes and high surgical volume. The inclusion of a premier private practice site reflects the growing interest in integrating Nociscan into real-world clinical workflows beyond academic medical centers.

“I have spent more than 25 years practicing spinal surgery in Beverly Hills, and my perspective is shaped not only by that experience, but also by having undergone multiple spine surgeries myself,” said Todd Lanman, MD, Neurosurgeon and Founder of Lanman Spinal Neurosurgery. “We have made significant progress in moving beyond one-size-fits-all solutions for low back pain, driven by advances in technology and technique. Nociscan introduces a new layer of clarity by leveraging MR Spectroscopy to identify pain-generating discs in ways that standard MRI cannot. The CLARITY trial is particularly important because it is designed to evaluate how this technology can enhance clinical decision-making by more precisely identifying pain-generating discs. This ability to match the right procedure to the right patient is what moves the field forward.”

The addition of Lanman Spinal Neurosurgery marks an important milestone in the continued expansion of the 300-patient CLARITY trial, a prospective, randomized, multi-center study evaluating Nociscan in patients undergoing surgical treatment (Fusion / TDR) for discogenic low back pain. The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline, with several secondary endpoints collected. The company anticipates having an initial internal data readout and an expected public disclosure of early interim results in Q4 2026.

“Private practice spine surgeons play a critical role in treating the majority of patients suffering from chronic low back pain, and the inclusion of Lanman Spinal Neurosurgery reflects the growing demand for more precise, data-driven tools in everyday clinical practice,” said Ryan Bond, Chief Strategy Officer of Aclarion. “Dr. Lanman is widely recognized for his commitment to innovation and patient-centered care, and we are excited to partner with his team as we continue to expand CLARITY and generate the high-quality evidence needed to advance 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 SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain and demonstrates a 97% surgical success rate when all Nociscan-positive discs are treated.

For more information about CLARITY, please visit: CLARITY Trial

To find a Nociscan center, view our site map here.

For more information on Nociscan, please email: info@aclarion.com

All organizations cited and/or quotes from individuals not part of Aclarion have reviewed and approved the contents herein.

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.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company’s current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the Company’s current plans and expectations, as well as future results of operations and financial condition.  Forward-looking statements in this release include, among others, statements regarding the enrollment of patients in our ongoing clinical trial, the growing interest in integrating Nociscan into real-world clinical workflows, having an initial internal data readout and the expected public disclosure of early interim results in Q4 2026 and, the continued expansion of the CLARITY trial to generate the high-quality evidence needed to advance Nociscan. These and other risks and uncertainties are discussed more fully in our filings with the Securities and Exchange Commission. Readers are encouraged to review the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as well as other disclosures contained in the Prospectus and subsequent filings made with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contacts:

Kirin M. Smith
PCG Advisory, Inc.
ksmith@pcgadvisory.com

Media Contacts:

Jennie Kim
SPRIG Consulting
jennie@sprigconsulting.com


FAQ

What is Aclarion announcing about the CLARITY trial and ACON on May 7, 2026?

Aclarion added Lanman Spinal Neurosurgery as a private-practice site to CLARITY, expanding enrollment efforts. According to the company, CLARITY is a 300-patient randomized study evaluating Nociscan in surgical treatment for discogenic low back pain.

What is the CLARITY trial primary endpoint and expected timeline for ACON?

The primary endpoint is 12-month change in back pain on a 100mm VAS Back scale. According to the company, an initial internal data readout and expected public interim results are planned for Q4 2026.

How does Nociscan aim to help surgeons treating chronic low back pain (ACON)?

Nociscan uses MR spectroscopy to quantify chemical biomarkers and identify painful discs noninvasively. According to the company, it is intended to provide data-driven localization to guide surgical decision-making alongside standard diagnostics.

What evidence does Aclarion cite about Nociscan surgical outcomes for ACON investors?

The company reports a 97% surgical success rate when all Nociscan-positive discs are treated. According to the company, that metric reflects outcomes observed when Nociscan findings guided disc-directed treatment.

How does adding a private-practice site affect CLARITY enrollment for ACON shareholders?

Adding a high-volume private-practice site aims to accelerate real-world enrollment beyond academic centers. According to the company, the inclusion reflects growing clinical interest and may broaden patient access to the trial.