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Company Overview
Aclarion Inc (ACON) is a healthcare technology company that leverages the power of Magnetic Resonance Spectroscopy (MRS), proprietary biomarker analysis, and augmented intelligence algorithms to optimize clinical treatments, specifically addressing the pervasive challenge of chronic low back pain. At its core, Aclarion has developed a revolutionary SaaS platform, Nociscan, which noninvasively assists physicians in distinguishing between painful and nonpainful discs. This cutting‐edge solution integrates MRS data collected from standard MRI machines with advanced signal processing techniques to extract and objectively quantify chemical biomarkers associated with disc pain.
Technological Innovation and Clinical Approach
Nociscan stands out in the realm of spine diagnostics by seamlessly combining medical imaging with sophisticated cloud-based algorithms. Once MRS data is transmitted from an MRI, the proprietary system applies unique signal processing methods to capture high-quality biomarker data. This data is then analyzed using augmented intelligence processes to inform clinical decision making, thereby offering a level of diagnostic precision that traditional invasive procedures cannot match.
Operational Model and Revenue Generation
The company’s revenue model is predominantly focused on delivering detailed Nociscan reports to healthcare providers. These reports are generated from contractual arrangements with medical facilities and key specialty centers across the United States. By focusing on a single, high-impact revenue stream, Aclarion is able to dedicate its resources to continuous research and development, solidifying its position as an innovator in noninvasive spine diagnostics.
Clinical Impact and Market Significance
Chronic low back pain remains one of the most common yet challenging conditions to diagnose and manage. Aclarion’s Nociscan provides critical decision support by objectively identifying the chemical biomarkers associated with disc pain, thus aiding physicians in pinpointing the actual source of discomfort. This not only improves the accuracy of treatment plans but also enhances the overall patient care pathway, reducing unnecessary invasive procedures. The strategic use of MRS data in a noninvasive manner marks a significant advance in diagnostic methodology and reinforces the company’s reputation for clinical precision.
Evidence-Based Approach and Industry Recognition
Central to Aclarion’s strategy is the demonstration of strong clinical evidence. The platform is supported by multiple peer-reviewed studies and clinical trials that underscore its efficacy and accuracy. The company’s emphasis on collaborating with key opinion leaders and renowned spine surgeons further solidifies its authority in the healthcare space. Moreover, the continuous evolution of its proprietary technology, combined with strategic partnerships with major imaging providers, positions Aclarion as a pivotal player in the diagnostic imaging and spine care market.
Competitive Landscape and Differentiators
In a market that has traditionally relied on invasive diagnostic procedures such as provocative discography, Aclarion offers a fresh, evidence-supported alternative. Its use of augmented intelligence to enhance the interpretation of MRS data, coupled with a robust patent portfolio and strategic commercial agreements, ensures that it remains at the forefront of innovation. By reducing the need for subjective assessments and invasive methods, Nociscan provides a practical solution that aligns with modern clinical workflows and safety standards.
Clinical Integration and Future Applications
The successful integration of Nociscan into clinical protocols across various imaging centers has demonstrated its practical utility. Physicians have reported that the objective data provided helps refine treatment strategies, ensuring that only the discs contributing to pain are targeted. This has significant implications for both surgical and non-surgical treatment decisions, leading to enhanced outcomes and potentially lower overall healthcare costs. While the system is currently deployed within the chronic low back pain market, its underlying technology suggests potential applications in broader diagnostic contexts, underscoring the transformative potential of leveraging MRS and biomarker data.
Conclusion
Aclarion Inc epitomizes innovation in healthcare technology by harnessing advanced MRS, proprietary signal processing, and AI-enhanced algorithms to address a major clinical challenge. Its SaaS platform, Nociscan, is designed to offer objective, reproducible insights that empower physicians to deliver targeted, effective treatments for chronic low back pain. With a focus on evidence-based clinical outcomes and strategic partnerships that amplify its market presence, Aclarion continues to set a high standard in diagnostic precision and patient care within the healthcare industry.
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.
Aclarion (Nasdaq: ACON), a healthcare technology company specializing in chronic low back pain diagnosis through biomarkers and AI algorithms, has announced the submission of an 8-K filing for stakeholder review. The company plans to file its 10-K by the end of March 2025, accompanied by a comprehensive corporate update.
Aclarion (NASDAQ: ACON) has announced expansion plans for its Nociscan technology across multiple sites in New York and New Jersey through RadNet affiliates. Lenox Hill Radiology (LHR), operating 79 locations in New York, and New Jersey Imaging Network (NJIN), with 33 locations, will increase Nociscan accessibility in response to growing market demand.
The expansion builds on existing Nociscan sites and is facilitated by increased MR Spectroscopy (MRS) availability and enhanced remote operations capabilities within RadNet. LHR Park Avenue serves leading spine physicians from private practices and organizations like Weill Cornell, while NJIN-Union supports both local and out-of-market referrals through convenient airport access.
Nociscan is the first evidence-supported SaaS platform that helps physicians noninvasively identify painful discs in the lumbar spine, demonstrating a 97% surgical success rate when all pain-positive discs identified by Nociscan are treated.
Aclarion (Nasdaq: ACON) has secured its first commercial agreement with Scripps Health in San Diego, expanding access to its Nociscan technology. The agreement brings the diagnostic solution to Southern California's largest healthcare system, serving over 3.2M people in the San Diego Metro area.
Nociscan, which uses MR Spectroscopy and AI to identify chronic low back pain sources, will be available at Scripps Green Hospital. Dr. Robert Eastlack, Orthopedic Surgeon at Scripps Health, emphasized the technology's value in providing additional diagnostic information for patients previously referred to Beverly Hills for the procedure.
Scripps Health operates five hospitals and 19 outpatient facilities, treating 500,000 patients annually through 2,600 affiliated physicians. The system will implement Nociscan both in clinical practice and research trials, supporting their mission to advance spine care.
Aclarion (NASDAQ: ACON), a healthcare technology company specializing in MRS and AI for back and neck pain treatment optimization, has announced the adjournment of its Special Meeting of Stockholders originally scheduled for February 28, 2025.
The meeting has been rescheduled to March 5, 2025, at 9:30 a.m. Mountain Time at the company's Broomfield, Colorado office. The adjournment aims to solicit additional votes for proposals outlined in the company's proxy statement filed with the SEC on February 3, 2025.
The record date remains January 6, 2025. Previously submitted proxies will remain valid unless revoked. Shareholders can modify their votes until 11:59 p.m. Mountain Time on March 4, 2025, either through Internet voting or by submitting a new signed proxy.
Aclarion (Nasdaq: ACON) announced its participation in the 2025 Spine Summit, where Dr. Nicholas Theodore will showcase the company's NOCISCAN technology. NOCISCAN is a pioneering SaaS platform that combines MR Spectroscopy with augmented intelligence to help physicians identify the location of chronic low back pain.
Dr. Theodore, who serves as Professor at Johns Hopkins University School of Medicine and holds multiple director positions, will present 'NOCISCAN, Augmented Intelligence, and Low Back Pain Decision Support' on February 21, 2025. The technology is particularly significant given that approximately 266 million people worldwide suffer from degenerative spine disease and low back pain.
NOCISCAN is the first evidence-supported platform that noninvasively helps physicians distinguish between painful and nonpainful discs in the lumbar spine by objectively quantifying chemical biomarkers associated with disc pain.
Aclarion (NASDAQ: ACON) has received its 24th US patent through a Notice of Allowance from the USPTO. This patent expands the company's ability to use Magnetic Resonance Spectroscopy (MRS) for identifying propionic acid (PA) throughout the body as a potential biomarker for infection and pain. Previously, Aclarion's patents PA identification by MRS to intervertebral discs only.
The company's technology leverages MRS, a capability of common MRI scanners, to analyze chemical biomarkers within soft tissues. While traditional MRS post-processing faces challenges in generating quality data, Aclarion's patented innovations address these limitations, ensuring more reliable spectral data analysis for their Nociscan solution and other MRS applications.
Aclarion (NASDAQ: ACON) has announced Northwestern Medicine as the first site for its pivotal CLARITY trial, designed to demonstrate Nociscan's clinical and economic value in spine surgery. Northwestern Medicine, which led over 6,900 clinical studies with 372,561 participants in 2024, will participate in this groundbreaking randomized controlled trial.
The CLARITY trial is a fully funded, prospective, multi-center study that will evaluate 300 patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain. The study will compare surgical outcomes between surgeons who are blinded and unblinded to Nociscan results. Nociscan is the first evidence-supported SaaS platform that helps physicians distinguish between painful and nonpainful discs in the lumbar spine through MR Spectroscopy and AI technology.
Aclarion (NASDAQ: ACON) has secured nearly $20 million in gross proceeds in 2025 to fully fund its pivotal CLARITY trial, a prospective, randomized, multicenter study designed to validate Nociscan's effectiveness in improving surgical outcomes for chronic low back pain patients.
The CLARITY trial, led by Dr. Nicholas Theodore of Johns Hopkins, will enroll 300 patients across multiple sites. Nociscan is the first evidence-supported SaaS platform that helps physicians identify painful discs in the lumbar spine through MR Spectroscopy and AI, showing a 97% surgical success rate at one-year follow-up when all Nociscan-identified pain-positive discs are treated.
The technology addresses a significant global healthcare challenge, with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain.
Aclarion (NASDAQ: ACON) announced its participation in the Selby Spine Conference, where Dr. Sigurd Berven will present the company's NOCISCAN platform. The presentation, titled 'MR Spectroscopy, Augmented Intelligence, and Low Back Pain – A New Gold Standard,' will showcase how NOCISCAN combines MR Spectroscopy with AI to help physicians identify biomarkers associated with disc pain that are invisible on traditional MRI scans.
NOCISCAN is the first evidence-supported SaaS platform that noninvasively helps physicians distinguish between painful and nonpainful discs in the lumbar spine. This technology addresses a significant global healthcare challenge, as approximately 266 million people worldwide suffer from degenerative spine disease and low back pain. The presentation is scheduled for January 31, 2025, at 5:55 PM in Deer Valley, UT.
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