Aclarion, Inc. (ACON) - 10-K Summary for Fiscal Year Ended December 31, 2025
Business Context and Reporting Period
Aclarion, Inc. is a healthcare technology company developing a SaaS platform (NOCISCAN) that leverages Magnetic Resonance Spectroscopy (MRS) and proprietary biomarkers to non-invasively identify painful intervertebral discs in patients with chronic low back pain. The company operates as a single reporting segment. This report covers the fiscal year ended December 31, 2025. Aclarion is classified as an "emerging growth company" and a "smaller reporting company."
Key Financial Metrics
| Metric | 2025 | 2024 |
|---|---|---|
| Revenue | $75,730 | $45,724 |
| Gross Profit | $6,828 | $(38,934) |
| Net Loss | $(7,233,629) | $(6,992,927) |
| Cash and Cash Equivalents (End of Period) | $12,040,789 | $463,661 |
| Accumulated Deficit | $(58,495,940) | $(51,262,311) |
| Operating Expenses | $7,059,219 | $5,474,113 |
Note: Revenue growth of 65.6% was driven by increased scan volumes in the UK market following local insurance coverage decisions. The company generated a gross profit in 2025 compared to a gross loss in 2024.
Material Changes vs. Prior Period
- Revenue Growth: Revenue increased by $30,006 (65.6%) primarily due to growing volume of NOCISCAN reports sold in the UK.
- Operating Expenses: Total operating expenses increased by $1.59 million (29%). Sales and marketing expenses nearly doubled ($924k increase) due to the initiation of the CLARITY Trial and expanded marketing efforts. General and administrative expenses rose by $516k, driven by higher incentive bonus accruals and insurance costs.
- Liquidity Position: Cash and cash equivalents increased significantly from $463,661 in 2024 to $12.04 million in 2025. This was achieved through aggregate gross proceeds of approximately $22.6 million from various registered direct offerings and public offerings during the year.
- Debt Status: The company retired all unsecured non-convertible notes in 2024; consequently, interest expense was $0 in 2025 compared to $535,470 in 2024.
- One-Time Costs: The company incurred $672,625 in penalties and settlements in 2025, primarily related to a $687,500 settlement of a dispute under an investment banking agreement.
Guidance, Outlook, and Risks
Outlook and Strategy: Management believes current cash resources will fund operations through the first quarter of 2028. The primary near-term growth strategy is securing payer contracts for Category III CPT codes and converting them to permanent Category I codes. The company is expanding commercial operations in the US and UK and is actively enrolling patients in the CLARITY Trial to generate real-world evidence.
Management Commentary: The company successfully remediated a material weakness in internal controls over financial reporting identified in 2024. A new Chief Financial Officer was hired in September 2025 to strengthen financial oversight.
Risks and Contingencies:
- Reimbursement Uncertainty: Commercial success depends on converting temporary Category III CPT codes to Category I codes and securing widespread third-party payer coverage. Failure to do so would limit sales to a direct patient-pay model.
- Capital Requirements: The company has a history of losses and will require additional funding to achieve profitability. Future capital raises may result in dilution.
- Regulatory Compliance: The company faces risks related to FDA regulation of its software products (NOCICALC and NOCIGRAM) and EU Medical Device Regulation (MDR) compliance, which requires re-certification by a Notified Body by December 2028.
- Technology Dependence: The NOCISCAN platform is currently compatible only with specific MRI scanner models from Siemens and Philips. Loss of compatibility or relationships with these vendors could materially harm the business.
Key Facts for Investor Verification
- Cash Runway: Verify the company's burn rate and confirm the assertion that cash reserves ($12.04M) are sufficient to fund operations into Q1 2028.
- Reimbursement Progress: Monitor the status of Category III CPT code conversion to Category I and the number of US insurance payers granting coverage.
- CLARITY Trial: Track enrollment numbers and preliminary data from the CLARITY Trial, which is critical for demonstrating clinical efficacy to payers.
- Scanner Compatibility: Assess progress in expanding compatibility beyond Siemens and Philips to other MRI manufacturers to reduce supply chain risk.
- Internal Controls: Confirm the continued effectiveness of the remediated internal controls over financial reporting in future filings.