UHealth – University of Miami Welcomes First Participants in Aclarion's Key CLARITY Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 25 2025
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Should l Buy ACON?
Source: Newsfilter
Enrollment and Study Overview: Aclarion, Inc. has initiated the CLARITY trial at the University of Miami Health System, enrolling its first two patients to evaluate the effectiveness of Nociscan in improving surgical outcomes for chronic low back pain.
Nociscan Technology: Nociscan utilizes MR Spectroscopy and AI to help identify sources of low back pain, aiming to become the gold standard in the field by distinguishing between painful and nonpainful discs in the lumbar spine.
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About ACON
Aclarion, Inc. is a healthcare technology company. The Company leverages magnetic resonance spectroscopy (MRS) and proprietary biomarkers to optimize clinical treatments. The Company has developed a software application called NOCISCAN. The product uses the existing MRS capabilities of many commercially available scanners to non-invasively analyze the chemical makeup of intervertebral discs in the spine. The software post-processes the MRS exam data and detects the presence of chemical biomarkers that Aclarion, in conjunction with spine researchers at University of California San Francisco (UCSF), have demonstrated to be associated with degenerative pain and structural integrity of the lumbar discs. After processing the MRS exam data, the Company sends the ordering clinician a report that details how to interpret the results of the MRS exam. The platform used to conduct a NOCISCAN involves a diagnostic report called a Nocigram that identifies discs as painful or not.
About the author

Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
- Repurchase Program Initiation: Aclarion has announced a share repurchase program of up to $2.5 million over the next 12 months, reflecting the company's confidence in its stock value and aiming to enhance shareholder returns.
- Clear Funding Source: The company intends to fund the repurchase using approximately $19.0 million in cash and cash equivalents as of March 31, 2026, ensuring sufficient liquidity and financial stability.
- Positive Market Reaction: Following the announcement, Aclarion's stock price rose by 4.81% in premarket trading, indicating investor optimism regarding the company's future performance.
- Strategic Implications: This repurchase program not only aims to boost earnings per share but may also increase demand for Aclarion's stock in a competitive market, thereby enhancing the company's overall valuation.
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- Repurchase Program Initiated: Aclarion, Inc.'s board has authorized a share repurchase program of up to $2.5 million, expected to be executed over the next 12 months, aimed at enhancing shareholder value and boosting market confidence.
- Flexible Value Tool: CEO Brent Ness stated that the program is viewed as a flexible and opportunistic tool to leverage the attractiveness of current share prices while continuing to invest in the clinical adoption and expansion of Nociscan.
- Clear Funding Source: Aclarion intends to fund this repurchase program using existing cash and cash equivalents, ensuring financial stability without compromising other investments.
- Market Reaction Anticipated: The implementation of this repurchase program is expected to enhance investor confidence in Aclarion, potentially having a positive impact on the stock price and further driving the company's growth in the healthcare technology sector.
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- Strengthened Financial Position: Aclarion's recent financings provide a cash runway into 2028, ensuring that the company can complete its 300-patient CLARITY trial and achieve initial data readout without raising additional capital, thereby boosting shareholder confidence.
- Clinical Trial Progress: The company anticipates an initial internal readout of the CLARITY trial by the end of Q3 2026, with public disclosure of early interim results expected in Q4, which will provide critical data support for its technology in the chronic low back pain market.
- Optimized Capital Structure: Aclarion has terminated its ATM and allowed its ELOC to expire at the end of 2025, indicating that the company will not pursue new capital raises in the near term, further solidifying its clean capital structure.
- Software-Driven Innovation: As a new generation of software-native MedTech innovator, Aclarion's Nociscan platform delivers solutions entirely through the cloud, enabling rapid scalability and continuous algorithmic improvements, which are expected to significantly enhance its competitive position in the market.
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- Market Opportunity Analysis: CEO Brent Ness highlighted that approximately 266 million people globally suffer from chronic low back pain, with Aclarion's market opportunity spanning spinal fusion surgeries, non-fusion procedures, and pain management, which are expected to increase scan volumes over time, driving revenue growth.
- Early Revenue Sources: Aclarion is generating revenue from Nociscan scans in the UK, cash-pay usage, and clinical trials, particularly in London where insurance coverage reduces financial friction for physicians and patients, thereby supporting higher scan utilization and growth.
- Clinical Trials and Reimbursement Pathway: Aclarion's Clarity trial aims to enroll 300 patients and features an early-stop design to accelerate discussions with insurers, with findings indicating that Nociscan reduces costs by about $1,700 per patient, strengthening the case for payer adoption.
- Comparison with HeartFlow: Ness compared Aclarion's strategy to HeartFlow, which saw quarterly revenue grow from $26.8 million to $46.3 million in 2025, illustrating the challenges Aclarion faces in regaining investor confidence and improving market performance.
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- Market Expansion Strategy: Aclarion has established an agreement with Source Healthcare in Los Angeles to introduce Nociscan, aiming to fill a critical gap in chronic low back pain treatment, thereby enhancing the company's market share in this sector.
- Clinical Validation Advantage: Nociscan, as a non-invasive alternative, objectively measures pain and structural integrity biomarkers in spinal discs through an MRI-like experience, providing clinical validation compared to anesthetic discography, further solidifying its application potential in pain management.
- Data Asset Development: By collaborating with a high-volume clinical practice, Aclarion will strengthen the evidence base for Nociscan, supporting its adoption in the broader pain management market, which is expected to drive payer and provider acceptance.
- Improved Success Rates: Research indicates that Nociscan has improved outcomes and reduced costs in the spinal fusion market, with a 97% surgical success rate, highlighting its potential value among chronic low back pain patients and further advancing the company's strategic position in the healthcare technology field.
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