Aclarion Provides Update on Strength of Company Positioning Following Q1 Strategic Initiatives

Rhea-AI Summary

Aclarion (NASDAQ: ACON) has strengthened its position following Q1 2025 strategic initiatives. The company raised over $20 million in Q1, maintaining nearly $15 million in cash with zero debt and no preferred equity. The company is now fully Nasdaq compliant, meeting both bid price and shareholder equity requirements.

The company's CLARITY trial for Nociscan, their AI-powered solution for identifying chronic low back pain locations, is fully funded with interim results expected in Q2 2026. Aclarion has secured additional payer approvals in England and expanded physician referral and commercial support in the U.S.

Nociscan is the first evidence-supported SaaS platform that noninvasively helps physicians distinguish between painful and nonpainful discs in the lumbar spine, demonstrating a 97% surgical success rate when all Nociscan-identified pain-positive discs are treated.

Positive

• Raised over $20M in Q1 2025 with $15M cash on hand
• Zero debt and clean capital structure with no preferred equity
• Achieved full Nasdaq compliance for bid price and shareholder equity
• CLARITY trial fully funded
• Secured new payer approvals in England
• 97% surgical success rate with Nociscan technology

Negative

• Initial interim results of CLARITY trial not expected until Q2 2026

Insights

Financial Analyst

Aclarion's Q1 update reveals a dramatic financial transformation that significantly strengthens the company's position. The $20M capital raise and $15M cash position are particularly notable given ACON's current market cap of just $7.66M – meaning the stock trades at a substantial discount to cash value alone. The absence of debt, preferred equity, or near-market warrants creates an exceptionally clean capital structure that eliminates near-term dilution concerns.

The successful resolution of Nasdaq compliance issues removes a significant regulatory overhang that often plagues microcap healthcare companies. Meeting both the bid price and shareholder equity requirements provides crucial stability for institutional investors who might otherwise avoid delisting risks.

From a cash runway perspective, while burn rate specifics aren't disclosed, the $15M position should provide substantial operational flexibility for a company of this size. Most critically, this funding fully supports the pivotal CLARITY trial through interim readouts expected in Q2 2026 – eliminating a major financing risk that could have necessitated dilutive capital raises during crucial clinical development stages.

The commercial progress in England demonstrates market expansion potential beyond the US, though no specific revenue metrics are provided to quantify current commercial traction. This financial transformation fundamentally changes the risk profile for Aclarion, providing the stability needed to execute on its clinical and commercial strategy without near-term funding pressures.

Medical Technology Specialist

Aclarion's Nociscan platform addresses a massive unmet need in chronic low back pain diagnosis – a condition affecting approximately 266 million people globally. The technology's key differentiator is its non-invasive approach to distinguishing between painful and non-painful discs through chemical biomarker quantification, potentially eliminating much of the guesswork in surgical decision-making.

The fully-funded CLARITY trial represents a pivotal validation opportunity. If successful, this study could position Nociscan to become standard of care in chronic low back pain evaluation. The claimed 97% surgical success rate when treating Nociscan-identified discs is remarkably high in a field where success rates typically hover between 60-75%.

The secured payer approvals in England represent a significant milestone, as reimbursement remains the critical gatekeeper for medical technology adoption. The company's dual-track approach of pursuing both imaging provider partnerships and MRI manufacturer agreements demonstrates a sophisticated commercialization strategy that could accelerate market penetration.

The continued focus on clinical evidence generation through multiple high-quality studies in 2025 shows appropriate recognition that physician adoption in this space requires robust data validation. If Nociscan can conclusively demonstrate improved surgical decision-making and outcomes, it could potentially transform the standard diagnostic workup for the hundreds of millions suffering from this debilitating condition, significantly reducing failed back surgeries and their associated costs.

Over $20M raised in Q1 with nearly $15M cash on hand

No debt, no preferred equity, and no warrants with strike prices near the current market

Nasdaq compliant: fully meets bid price and shareholder equity requirements

Pivotal CLARITY trial fully funded with initial interim results expected in Q2 2026

BROOMFIELD, Colo., March 31, 2025 (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 provided a corporate update on its strengthened positioning following the successful execution of strategic initiatives in Q1 2025.

“Aclarion significantly improved its financial and Nasdaq compliance positioning throughout Q1 such that we are now very well positioned to execute on our strategic plan of driving Nociscan to standard of care,” said Jeff Thramann, MD, Executive Chairman of Aclarion. “The team is rapidly enrolling sites for the CLARITY trial, and we look forward to demonstrating that the use of Nociscan data improves surgical decision making and outcomes. We believe this will be a game changing catalyst for Aclarion and for how chronic low back pain is evaluated and treated.”

Key Financial and Strategic Highlights:

• Over $20 million raised in Q1 with nearly $15 million in cash on hand
• Clean cap table, Zero debt, No preferred outstanding, No near-term warrant overhang.
• Fully Nasdaq compliant, meeting both bid price and shareholder equity requirements
• Clarity trial for Nociscan fully funded
• Secured additional payer approvals in England
• Expanded physician referral and commercial support for Nociscan in U.S.

“The Company is accelerating across all areas of execution,” said Brent Ness, CEO of Aclarion. “In addition to strong momentum enrolling CLARITY sites, we’ve made meaningful commercial progress. We’re also driving adoption in London, where we recently secured payer approvals and have built deep support among referring physicians and radiologists. Beyond London, we’re actively pursuing new commercial agreements with imaging providers and MRI manufacturers to expand access to Nociscan. Clinical evidence generation remains a key pillar of our strategy, and 2025 will see several high-quality studies and publications reinforcing our leadership in the category. With our financing and compliance initiatives now behind us, the team is energized and focused on value creation.”

Chronic low back pain (cLBP) 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-identified pain positive discs are treated.

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

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

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. 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, 2023, 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 Contact:
Jennie Kim
SPRIG Consulting
jennie@sprigconsulting.com

FAQ

What are the key financial achievements of Aclarion (ACON) in Q1 2025?

Aclarion raised over $20M, maintains $15M cash on hand, has zero debt, no preferred equity, and is fully Nasdaq compliant.

When are the interim results of Aclarion's CLARITY trial expected?

The interim results of the CLARITY trial are expected in Q2 2026.

What is the success rate of Aclarion's Nociscan technology for back pain treatment?

Nociscan demonstrates a 97% surgical success rate when all pain-positive discs identified by the technology are treated.

How has Aclarion expanded its market presence in Q1 2025?

Aclarion secured additional payer approvals in England and expanded physician referral and commercial support in the U.S.

What is the global market potential for Aclarion's Nociscan technology?

The technology addresses a market of approximately 266 million people worldwide suffering from degenerative spine disease and low back pain.