Aclarion Provides 2025 Update and 2026 Corporate Outlook
MWN-AI** Summary
Aclarion, Inc., a healthcare technology company focused on chronic low back pain diagnosis, released its financial and strategic update on January 8, 2026, highlighting significant growth and operational advancements for 2025. The company reported a remarkable 114% year-over-year increase in Nociscan scan volumes in Q4 2025, contributing to a substantial 69% annual growth in scan volumes. This success underscores Aclarion's commitment to enhancing its proprietary Nociscan platform, which utilizes augmented intelligence and biomarkers to aid in precise diagnostics.
As of December 31, 2025, Aclarion boasts a debt-free balance sheet with $12 million in cash, enhancing its operational flexibility and extending its runway into 2027. The company aims to enroll around 25% of patients in its pivotal CLARITY trial by the end of Q2 2026, with the first interim data expected in Q3 2026. Efforts to expand its market presence included the addition of nine new imaging centers and 22 new physician users during 2025, alongside key leadership hires in the U.S. and UK.
Aclarion's advancements extend to strengthening its clinical evidence base, evidenced by publications showing the economic benefits of Nociscan compared to traditional methods. The company continues to cultivate relationships with healthcare providers and payers to improve adoption and reimbursement. In 2026, Aclarion plans to accelerate enrollment in its clinical trial, expand partnerships, enhance clinician education, and refine its workflow integration.
Overall, CEO Brent Ness expressed optimism about the company’s trajectory, emphasizing its growth in scan volumes and investor confidence as pivotal elements in its strategy for long-term value creation for stakeholders.
MWN-AI** Analysis
Aclarion, Inc. (Nasdaq: ACON, ACONW) is presenting a promising investment case following its significant operational and financial updates for 2025, which reflect its robust growth momentum in the healthcare technology space. The company's proprietary Nociscan platform for chronic low back pain diagnosis has shown a striking 114% increase in Q4 2025 scan volumes year-over-year, contributing to an impressive 69% growth for the entire year. These figures not only highlight market acceptance but also underscore the expanding clinical utility of Aclarion's technology.
With a debt-free balance sheet and $12 million in cash reserves, Aclarion is well-positioned to pursue strategic growth opportunities and extend its operational runway into 2027. The company's ability to raise over $22 million in equity financing in 2025 further strengthens its financial foundation, allowing it to invest in technology advancement and market penetration initiatives. The goal to enroll 25% of patients in the ongoing CLARITY trial by Q2 2026 and the anticipated interim data readout in Q3 represent key milestones that could catalyze further interest from investors.
Moreover, Aclarion's commitment to expanding its commercial footprint, particularly through strategic partnerships and enhanced reimbursement pathways, suggests a broader adoption of its Nociscan technology. The anticipated completion of various investigator-initiated trials and the ongoing efforts to refine clinical workflows are likely to reinforce the company's market positioning.
Overall, Aclarion's growth metrics, solid financials, and strategic initiatives indicate a favorable outlook. Investors may find opportunities in Aclarion as it navigates the next phases of clinical validation and commercial expansion. However, they should remain cognizant of the inherent risks associated with early-stage companies in the healthcare sector. Thus, potential stakeholders should consider a balanced approach, weighing the growth prospects against market volatility and execution risks.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Quarterly Nociscan scan volumes increased 114% year-over-year in Q4 2025
- Annual Nociscan scan volumes increased 69% year-over-year in 2025
- Debt-free balance sheet with $12.0 million in cash as of December 31, 2025, extending cash runway into 2027 and providing strategic flexibility for continued commercial growth
- Company aims to enroll approximately 25% of patients in CLARITY trial by the end of Q2 2026, with the first internal readout on interim data anticipated in Q3 2026
BROOMFIELD, Colo., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a commercial-stage 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 comprehensive corporate update, including financial results and strategic progress as the Company enters 2026 advancing its proprietary Nociscan platform.
Market Adoption & Growth Momentum
During 2025, Aclarion continued to build on its mission to transform the diagnosis of chronic low back pain achieving 69% year-over-year scan volume growth.
- Nociscan scan volumes increased +114% year-over-year in Q4 2025 – marking the third consecutive quarter of year-over-year growth across U.S., UK, and E.U. sites.
- Aclarion remains focused on expanding its commercial presence within key UK and U.S. healthcare markets. Efforts during the period included:
- The addition of 9 new imaging centers in 2025
- The addition of 22 new physician users in 2025
- Expansion of team with key leadership and commercial hires in the U.S. and UK
Strategic and Operational Highlights
- Continued advancement of Nociscan platform, with progress across clinical validation, commercial readiness, and customer engagement initiatives.
- Strengthened clinical evidence base, including ongoing and planned studies supporting the clinical and economic value of Nociscan.
- Expanded engagement with healthcare providers and payors, aimed at improving adoption and reimbursement pathways.
- Disciplined capital management, focused on extending operational runway while prioritizing value-creating milestones.
- Ongoing evaluation of strategic partnerships and growth opportunities to accelerate commercialization and market penetration.
- Bolstered intellectual property footprint with 4 new issued patents in 2025, with a total of 52 issued patents worldwide covering Aclarion's core technology and specific applications.
Clinical and Product Developments
- Launching the CLARITY trial in 2025 at 7 activated sites illustrates Aclarion’s ongoing commitment to leading with evidence and lays the groundwork for future commercial expansion.
- 2025 publications of real-world evidence demonstrate clinical utility and economic value.
- Cost-effectiveness analysis published in ClincoEconomics and Outcomes Research in April. The analysis concluded that Nociscan is more effective and less costly than provocative discography, illustrating that Nociscan saves $1,712 per patient and improves surgical success rates by 10%.
- MR Spectroscopy and Low Back Pain: A Novel Cloud-based Solution, Nociscan published in Special Pain Issue of the International Journal of Spine Surgery (IJSS) in December. The featured article included a technology overview of Nociscan and highlighted a successful case study.
In 2026, the Company expects to:
- Advance clinical validation efforts:
- Accelerate enrollment with goal of enrolling approximately 25% of patients in the CLARITY trial by the end of Q2 2026. An initial readout will be internally available after the initial cohort of patients complete their 3-month follow up visit.
- Complete and publish multiple investigator-initiated real world evidence trials.
- Expand major MRI manufacturer access growing the available global market size by greater than 30%.
- Support broader clinician education and awareness initiatives through accelerated participation at societal-sponsored CME events.
- Continue refining workflow integration to support scalability in clinical practice by launching version 2.8 of our Nociscan software in Q1.
- Actively collaborate with multiple commercial payers in the US market to evaluate broad reimbursement coverage of Nociscan.
Financial Highlights
As of December 31, 2025, the Company had $12.0 million in cash and no debt. During fiscal 2025, the Company successfully raised over $22.0 million in equity financing, strengthening its balance sheet and providing capital to support continued execution of its strategic and operational plans.
There were 854,371 common shares and 28,000 prefunded warrants outstanding as of December 31, 2025. On a fully diluted basis, this represents approximately $13.65 per share in cash.
Based on current operating plans, the Company believes its existing cash resources are sufficient to fund operations into the first half of 2027.
Management Commentary
“We are pleased with the progress Aclarion has made in strengthening our financial position, expanding clinical traction, and advancing Nociscan toward broader adoption,” said Brent Ness, CEO of Aclarion.
“Despite the early-stage nature of our commercial activities, the growth in scan volume particularly in the UK where we enjoy commercial payer reimbursement, and meaningful capital raises during 2025, reflect both momentum and investor confidence. We remain focused on execution through leadership team investments, evidence generation, and strategic partnerships to drive long-term value for patients, providers, payers and shareholders.”
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 expected date of the internal interim results, the potential benefits of our Nociscan technology, and the Company’s plans for future regulatory and commercialization activities, as well as the cash need to fund operating into 2027. 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, 2024, 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:
Jessica Starman
media@elev8newmedia.com
FAQ**
What specific factors contributed to the 114% increase in Quarterly Nociscan scan volumes year-over-year in Q4 2025, and how does this growth impact Aclarion Inc. Warrant ACONW's market position?
Considering Aclarion Inc. Warrant ACONW, what strategies is the company employing to ensure the successful enrollment of 25% of patients in the CLARITY trial by the end of Q2 2026?
How does the company plan to utilize its $12.0 million cash position to fuel growth and operational initiatives, specifically in relation to the development of Nociscan and supporting Aclarion Inc. Warrant ACONW?
What are the anticipated impacts of Nociscan's clinical validation results on reimbursement pathways, and how might this influence investor sentiment around Aclarion Inc. Warrant ACONW in 2026?
**MWN-AI FAQ is based on asking OpenAI questions about Aclarion Inc. Warrant (NASDAQ: ACONW).
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