Company Description
Aclarion, Inc. (NASDAQ: ACON) is a commercial-stage healthcare technology company in the diagnostic imaging and spine care ecosystem. According to company disclosures, Aclarion focuses on leveraging Magnetic Resonance Spectroscopy ("MRS"), proprietary signal processing techniques, biomarkers, and augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain. The company is categorized in the Health Care and Social Assistance sector, within diagnostic imaging centers.
Aclarion’s initial focus is the chronic low back pain market through its flagship product, Nociscan. Nociscan is described as the first evidence-supported, software-as-a-service (SaaS) platform designed to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. For each lumbar disc being evaluated, Nociscan receives MRS data from an MRI machine via a cloud connection. In the cloud, Aclarion’s proprietary signal processing techniques extract and quantify chemical biomarkers that have been demonstrated to be associated with disc pain. These biomarker data are then entered into proprietary algorithms that indicate whether a disc may be a source of pain.
When used alongside other diagnostic tools, Nociscan is intended to provide critical insights into the location of a patient’s low back pain. This additional information can give physicians greater clarity when planning treatment strategies for patients with degenerative spine disease and chronic low back pain. Company communications emphasize that chronic low back pain affects an estimated 266 million people globally, underscoring the scale of the clinical problem Aclarion aims to address.
Business model and revenue generation
Based on available information, Aclarion operates a technology-enabled diagnostic support model. The Polygon description notes that the company’s revenues are derived from a single primary source: the delivery of Nociscan reports to medical professionals. This aligns with the characterization of Nociscan as a SaaS platform that processes MRS data and returns a report indicating whether specific lumbar discs may be painful. Substantially all revenues are reported to be generated from contracts with customers in the United States, although company news also references activity in the U.K. and E.U. markets.
The company’s communications describe Nociscan as cloud-based, with MRI-derived MRS data transmitted to Aclarion’s platform. After processing and biomarker quantification, physicians receive information that can be incorporated into their clinical decision-making. This structure supports a recurring, per-exam or per-report style of revenue, as implied by the reference to scan volumes and scan volume growth in recent updates.
Technology and clinical focus
Aclarion repeatedly highlights the combination of Magnetic Resonance Spectroscopy, biomarkers, and augmented intelligence algorithms as the core of its technology. Company materials describe how Nociscan converts MR spectroscopy signals into objective biomarkers associated with disc pain. These biomarkers are then analyzed by proprietary algorithms to indicate whether specific discs may be contributing to a patient’s chronic low back pain.
In multiple news releases, Aclarion characterizes Nociscan as an evidence-supported platform. The company references real-world evidence publications, including a cost-effectiveness analysis and a technology overview article in the International Journal of Spine Surgery’s Special Pain Issue, as well as participation in scientific meetings such as the International Society of Pain and Neuroscience (ISPN) annual meeting in London. These activities are presented as part of a broader effort to build and communicate clinical evidence for the role of disc chemistry and MR spectroscopy in diagnosing discogenic pain.
Market presence and clinical adoption
Company updates describe Aclarion as a commercial-stage enterprise with growing Nociscan scan volumes across U.S., U.K., and E.U. sites. Aclarion reports multiple consecutive quarters of year-over-year scan volume growth and notes the addition of new imaging centers and physician users. In the U.K., the company highlights that Nociscan has been reimbursed by three of the top four private insurers, giving access to millions of covered lives, and references its integration into the care pathway for chronic low back pain at a leading London spine clinic.
To support adoption, Aclarion has expanded its commercial team, including appointing a U.K. Commercial Director and a Commercial Director for the Eastern U.S. The company also notes engagement with healthcare providers and payors to support adoption and reimbursement pathways, and participation in societal-sponsored continuing medical education (CME) events to support clinician education and awareness.
Clinical trials and evidence generation
Aclarion places significant emphasis on clinical validation through its pivotal CLARITY trial (Chronic Low bAck pain Randomized Independent Trial studY). Company communications describe CLARITY as a multi-site trial designed to evaluate whether incorporating Nociscan into standard surgical planning can improve outcomes for patients undergoing surgery for chronic low back pain. The study is structured to randomize patients between surgeons who are blinded to Nociscan results and surgeons who are unblinded and can use Nociscan data to guide surgical planning.
Seven leading U.S. spine centers are reported to have completed regulatory and operational requirements to screen and enroll patients in CLARITY, including Texas Back Institute, University of Miami Health, Advocate Health, Northwestern Medicine, Scripps Health, Keck Medicine of USC, and Johns Hopkins University. The trial is intended to generate high-quality clinical evidence, including Level 1 evidence, to support future reimbursement discussions and broader commercial expansion.
Beyond CLARITY, Aclarion references multiple investigator-initiated real-world evidence trials, as well as published analyses that examine the clinical and economic value of Nociscan. For example, a cost-effectiveness analysis concluded that Nociscan was more effective and less costly than provocative discography, and a case study in the International Journal of Spine Surgery highlighted how Nociscan biomarker data influenced surgical decision-making for a patient with chronic low back pain.
Financial position and capital strategy
Recent company news and SEC filings indicate that Aclarion has focused on strengthening its balance sheet through equity financings. An 8-K filing dated October 13, 2025 describes a registered direct offering of common stock and pre-funded warrants, with aggregate gross proceeds expected to be approximately $2.5 million before fees and expenses. The company states that it intends to use the net proceeds to fund market development and clinical evidence, the CLARITY trial, product development and quality, general and administrative support, and other general corporate purposes.
Subsequent press releases report that Aclarion has maintained a debt-free balance sheet and raised additional equity capital, resulting in cash balances that extend the company’s operating runway into future years based on its current operating plans. Company commentary links this financial position to strategic flexibility for continued commercial growth, evidence generation, and partnership development.
Regulatory and market context
Aclarion’s SEC filings identify it as an emerging growth company. The company has an effective registration statement on Form S-3, which has been used to conduct registered direct offerings of common stock and pre-funded warrants. The diagnostic imaging and spine care context is reflected in Aclarion’s participation in specialized conferences and journals focused on pain, neurosurgery, and spine surgery, as well as in its engagement with payors and providers to support reimbursement and adoption.
Within the broader healthcare technology landscape, Aclarion positions Nociscan as a tool that integrates advanced imaging-derived biomarkers with AI-driven analysis. The company’s communications emphasize the potential for this approach to provide more objective information about discogenic pain, complement existing diagnostic modalities, and support more targeted treatment decisions for patients with chronic low back pain.
Key characteristics of Aclarion and Nociscan
- Healthcare technology company focused on chronic low back pain diagnosis.
- Uses Magnetic Resonance Spectroscopy, proprietary signal processing, biomarkers, and augmented intelligence algorithms.
- Nociscan is a cloud-based, evidence-supported SaaS platform that analyzes lumbar disc MRS data.
- Outputs biomarker-based indications of whether specific discs may be sources of pain.
- Revenue is derived from delivery of Nociscan reports to medical professionals, with substantially all revenues from U.S. customers as described in the Polygon summary.
- Engaged in clinical validation through the CLARITY pivotal trial and multiple real-world evidence studies.
- Active in U.S., U.K., and E.U. markets, with noted payer reimbursement in the U.K. private insurance sector.
- Uses equity financings and maintains a debt-free balance sheet according to recent company statements.