Aclarion Provides Corporate Update Highlighting Scan Volume Growth and Key Upcoming Catalysts
Aclarion (NASDAQ:ACON) reported significant growth in its Nociscan scan volumes, with a 132% year-over-year increase from Q2 2024 to Q2 2025. The company achieved two consecutive quarters of scan volume growth for the first time, driven by new physician adoption and UK insurance coverage.
Key developments include: the enrollment of the first patient in the pivotal CLARITY trial, which aims to validate Nociscan's effectiveness in improving surgical outcomes for chronic low back pain; publication of a cost-effectiveness analysis showing Nociscan is more effective and less costly than provocative discography; and approval from three major UK private insurers, providing access to over 5.2 million people.
The company reaffirmed its cash runway through Q3 2026, with approximately $15M net cash on hand and no debt. Aclarion expects continued quarter-over-quarter growth throughout 2025 and anticipates internal interim CLARITY trial results by Q2 2026.
Aclarion (NASDAQ:ACON) ha registrato una crescita significativa nei volumi di scansione Nociscan, con un aumento del 132% su base annua dal secondo trimestre 2024 al secondo trimestre 2025. L'azienda ha raggiunto per la prima volta due trimestri consecutivi di crescita nei volumi di scansione, trainata dall'adozione da parte di nuovi medici e dalla copertura assicurativa nel Regno Unito.
Gli sviluppi chiave includono: l'arruolamento del primo paziente nello studio fondamentale CLARITY, che mira a convalidare l'efficacia di Nociscan nel migliorare i risultati chirurgici per il dolore cronico alla parte bassa della schiena; la pubblicazione di un'analisi di costo-efficacia che dimostra come Nociscan sia più efficace e meno costoso rispetto alla discografia provocatoria; e l'approvazione da parte di tre importanti assicuratori privati del Regno Unito, offrendo accesso a oltre 5,2 milioni di persone.
L'azienda ha confermato la disponibilità di liquidità fino al terzo trimestre 2026, con circa 15 milioni di dollari netti in cassa e nessun debito. Aclarion prevede una crescita continua trimestre dopo trimestre per tutto il 2025 e si aspetta i risultati intermedi interni dello studio CLARITY entro il secondo trimestre 2026.
Aclarion (NASDAQ:ACON) informó un crecimiento significativo en los volúmenes de escaneo de Nociscan, con un aumento interanual del 132% desde el segundo trimestre de 2024 hasta el segundo trimestre de 2025. La compañía logró dos trimestres consecutivos de crecimiento en el volumen de escaneos por primera vez, impulsado por la adopción de nuevos médicos y la cobertura de seguros en el Reino Unido.
Los desarrollos clave incluyen: la inscripción del primer paciente en el estudio pivotal CLARITY, que busca validar la efectividad de Nociscan para mejorar los resultados quirúrgicos en el dolor lumbar crónico; la publicación de un análisis de costo-efectividad que muestra que Nociscan es más efectivo y menos costoso que la discografía provocativa; y la aprobación de tres importantes aseguradoras privadas del Reino Unido, brindando acceso a más de 5.2 millones de personas.
La compañía reafirmó su liquidez hasta el tercer trimestre de 2026, con aproximadamente 15 millones de dólares netos en efectivo y sin deudas. Aclarion espera un crecimiento continuo trimestre tras trimestre durante 2025 y anticipa resultados interinos internos del estudio CLARITY para el segundo trimestre de 2026.
Aclarion (NASDAQ:ACON)은 노시스캔(Nociscan) 스캔 볼륨에서 큰 성장을 보고했으며, 2024년 2분기부터 2025년 2분기까지 전년 대비 132% 증가를 기록했습니다. 회사는 신규 의사 채택과 영국 보험 적용에 힘입어 처음으로 연속 두 분기 스캔 볼륨 성장을 달성했습니다.
주요 발전 사항으로는 만성 요통 수술 결과 개선에 대한 노시스캔의 효과를 검증하는 것을 목표로 하는 중추적인 CLARITY 임상시험 첫 환자 등록, 노시스캔이 도발성 디스크 조영술보다 효과적이고 비용이 적게 든다는 비용 효율성 분석 발표, 그리고 3개의 주요 영국 민간 보험사의 승인으로 520만 명 이상에게 접근 가능해진 점이 포함됩니다.
회사는 약 1,500만 달러 순현금을 보유하고 부채가 없으며, 2026년 3분기까지 현금 운용 기간을 재확인했습니다. Aclarion은 2025년 내내 분기별 성장을 지속할 것으로 예상하며, 2026년 2분기까지 내부 중간 CLARITY 시험 결과를 기대하고 있습니다.
Aclarion (NASDAQ:ACON) a annoncé une croissance significative des volumes de scans Nociscan, avec une augmentation de 132 % d'une année sur l'autre entre le deuxième trimestre 2024 et le deuxième trimestre 2025. La société a enregistré pour la première fois deux trimestres consécutifs de croissance du volume de scans, portée par l'adoption par de nouveaux médecins et la couverture par les assurances au Royaume-Uni.
Les développements clés comprennent : l'inscription du premier patient dans l'essai pivot CLARITY, visant à valider l'efficacité de Nociscan pour améliorer les résultats chirurgicaux chez les patients souffrant de douleurs lombaires chroniques ; la publication d'une analyse de coût-efficacité montrant que Nociscan est plus efficace et moins coûteux que la discographie provocatrice ; et l'approbation par trois grands assureurs privés britanniques, offrant un accès à plus de 5,2 millions de personnes.
La société a confirmé sa trésorerie disponible jusqu'au troisième trimestre 2026, avec environ 15 millions de dollars nets en caisse et aucune dette. Aclarion prévoit une croissance continue trimestre après trimestre tout au long de 2025 et anticipe des résultats intermédiaires internes de l'essai CLARITY d'ici le deuxième trimestre 2026.
Aclarion (NASDAQ:ACON) meldete ein signifikantes Wachstum bei den Nociscan-Scanvolumina mit einem 132%igen Anstieg im Jahresvergleich vom zweiten Quartal 2024 bis zum zweiten Quartal 2025. Das Unternehmen erreichte erstmals zwei aufeinanderfolgende Quartale mit steigendem Scanvolumen, angetrieben durch die Einführung bei neuen Ärzten und die Versicherungsschutz in Großbritannien.
Wichtige Entwicklungen umfassen: die Einschreibung des ersten Patienten in die entscheidende CLARITY-Studie, die die Wirksamkeit von Nociscan zur Verbesserung der chirurgischen Ergebnisse bei chronischen Rückenschmerzen validieren soll; die Veröffentlichung einer Kosten-Nutzen-Analyse, die zeigt, dass Nociscan effektiver und kostengünstiger als die provokative Diskographie ist; sowie die Zulassung durch drei große private Versicherer in Großbritannien, die Zugang für über 5,2 Millionen Menschen ermöglichen.
Das Unternehmen bestätigte seine Liquiditätsreserve bis zum dritten Quartal 2026, mit etwa 15 Millionen US-Dollar Nettobarmitteln und keiner Verschuldung. Aclarion erwartet für das Jahr 2025 ein kontinuierliches Wachstum von Quartal zu Quartal und rechnet mit internen Zwischenergebnissen der CLARITY-Studie bis zum zweiten Quartal 2026.
- 132% year-over-year increase in Nociscan scan volumes
- First-ever consecutive quarterly growth in scan volumes achieved
- Coverage approval from three of top four UK private insurers, reaching 5.2 million people
- Cost-effectiveness analysis shows Nociscan saves $1,712 per patient and improves surgical success rates by 10%
- Strong cash position with $15M net cash and no debt, runway through Q3 2026
- Expansion of intellectual property portfolio to 24 US patents and 13 European patents
- Current industry average success rate for surgical intervention is only 54%
- Full CLARITY trial enrollment not expected until Q4 2026
- Limited U.S. customer additions due to lack of Category I insurance coverage
Insights
Aclarion reports 132% YOY scan growth as UK insurance coverage expands, while CLARITY trial progresses toward potential market validation in 2026.
Aclarion's Q2 2025 update reveals significant momentum for its Nociscan platform, which helps physicians identify sources of chronic low back pain using biomarkers and AI algorithms. The 132% year-over-year scan volume growth represents a critical inflection point, marking two consecutive quarters of growth for the first time in the company's history.
The growth is primarily driven by newly secured insurance coverage in the UK, where three of the four largest private insurers now cover Nociscan, providing access to over 5.2 million potential patients. This UK market serves as a strategic proving ground where reimbursement precedes physician adoption – a model that could accelerate Aclarion's expansion into other markets.
The company's CLARITY trial represents the second key value driver, designed to validate Nociscan's ability to improve surgical outcomes beyond the industry's modest 54% success rate. With eight Phase I sites engaged and the first patient enrolled in June at Texas Back Institute, the trial is proceeding on schedule. Internal interim results from three-month outcomes are expected in Q2 2026, potentially providing early validation before the full trial concludes.
Recent publications strengthen Aclarion's reimbursement case, particularly a peer-reviewed cost-effectiveness analysis showing Nociscan is both more effective and less costly than provocative discography, saving
The company's selective customer acquisition strategy has added strategic partners like Scripps Health while expanding in the UK market through The London Clinic. With a debt-free balance sheet and
For investors, the critical metrics to watch are continued quarter-over-quarter scan volume growth through 2025 and early CLARITY trial outcomes in Q2 2026, which could dramatically accelerate insurance coverage in the US market.
- Nociscan YOY scan volume increased
132% from Q2 2024 to Q2 2025 fueled by new physician adoption and insurance company coverage in the UK - Company has achieved two consecutive quarters of scan volume growth for the first time and expects continued QOQ growth for the remainder of the year
- Cost-effectiveness analysis demonstrating Nociscan is more effective and less costly than provocative discography published in peer-reviewed journal adding critical evidence in support of payer coverage
- Pivotal CLARITY trial proceeding on schedule with first patient enrolled to validate Nociscan’s ability to improve surgical outcomes for chronic low back pain, with internal interim results expected in Q2 2026
- Reaffirms cash runway through Q3 2026 to prove out the key catalysts of demonstrating significant scan volume growth and visibility into the success of CLARITY
BROOMFIELD, Colo., Aug. 05, 2025 (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 announced that scan volume has achieved significant year over year growth of
Scan volume growth is a key catalyst for driving revenue and securing favorable payments from insurance companies. Given the steady cadence of new physician adoption, the activation of new commercial sites in the U.S., CLARITY study sites completing the onboarding process, and the approval from three of the top four private insurance payers in the UK to cover Nociscan, the Company believes it is on a steady trajectory to deliver consistent quarter over quarter scan volume growth through the remainder of 2025 and beyond.
Aclarion is pursuing two core key catalysts to drive value.
The first is scan volume growth in the UK where the obstacle of not having approval from insurers to pay for Nociscan has been removed. Over 5.2 million people in the UK now have access to Nociscan through their insurance provider. This market serves as a bellwether for all future markets where reimbursement precedes broad physician adoption. The Company is pursuing an aggressive strategy in this market to drive awareness and adoption, first through our partners at The London Clinic, and then throughout the London market. In an encouraging sign, early results in the UK are driving the majority of Nociscan volume increases the Company is currently reporting and management expects to see this accelerate.
“The first half of 2025 was marked by significant scan volume growth as we continue to gain commercial traction and build upon the clinical and economic evidence through real-world studies and the CLARITY trial,” states Brent Ness, CEO, Aclarion. “Seeing the volume grow in London following the positive coverage example of Axa, Vitality and Aviva in the UK market with our customer, The London Clinic, validates our strategy and fuels our confidence that the payer community will move to encourage use of Nociscan leading to consistent revenue growth.”
The second key catalyst the Company is focused on to drive value is the CLARITY trial, as results of this trial are expected to be a critical drive to securing widespread insurance coverage in the United States. The Company believes CLARITY represents the first ever prospective randomized trial to link a non-invasive AI (augmented intelligence) algorithm to better surgical outcomes for patients with low back pain. With chronic low back pain being part of the highest cost diagnosis in the U.S., and clinical results from surgical intervention showing an average success rate of only
CLARITY is designed to prove that when a surgeon uses Nociscan in conjunction with their current surgical planning process, they achieve successful surgical outcomes for chronic low back pain that far exceed the industry average of
The Company has now engaged eight Phase I sites with four sites fully onboarded and activated: Texas Back Institute, University of Miami Health, Advocate Health, and Northwestern Medicine. The remaining 4 Phase I sites are expected to be activated by end of year. The Texas Back Institute enrolled the first patient in June and the Company is on track to fully enroll all 300 patients by Q4 2026.
As the CLARITY trial progresses, the Company will be conducting an internal analysis of three month clinical outcomes to get a preliminary look at how impactful Nociscan is in driving better early clinical outcomes. Although the formal CLARITY protocol calls for evaluating outcomes at the standard one and two year follow up milestones, management believes three month outcomes will provide highly predictive information about the ultimate formal results of the trial. The Company expects to have visibility into a meaningful number of three month patients in the second quarter of 2026. This information is expected to be a significant milestone and key catalyst for the Company.
Additional 2025 key milestones and highlights include:
- EVIDENCE and PUBLICATIONS. A core component of driving payment coverage for Nociscan is building clinical evidence and more specifically, getting this evidence published in peer-reviewed journals. In 2Q25, Clinicoeconomics and Outcomes Research published an independent cost-effectiveness analysis of Nociscan, led by a renowned healthcare economist from UCSF. 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 by10% . In addition to the cost-effectiveness analysis, Aclarion continues to invest in the development of real-world evidence with customers in the UK and US. Finally, in 4Q24, Siemens Healthineers published a featured Nociscan Case Study on their global website, MAGNETOM WORLD. Siemens Healthineers is a global market share leader in medical imaging, in-vitro diagnostics, and advanced therapies. - CUSTOMERS. In the absence of Category I coverage by private health insurance companies in the U.S., and Aclarion’s focus on driving scan volume in the UK, the Company remains very selective with regards to adding new customers outside of the UK. Three strategic U.S. customers were added in the first half of 2025, including Scripps Health in San Diego and the Spine Institute of Louisiana, both of whom are prioritizing development of real-world evidence. Additionally Medical Imaging Center of Southern California expanded Nociscan access to a second location in Santa Monica. Aclarion will continue to add customer sites in markets with strategic relevance and customers committed to excellence in spine care.
- CONFERENCES. A key component to securing payment for Nociscan in the U.S. is demonstrating the support of surgeons and securing the backing of key spine societies. Participating in professional conferences is a leading strategy to establish relevance and credibility amongst surgeons and their societies. In 1H25, Aclarion participated in six important industry conferences where use of MR Spectroscopy was discussed as a distinct innovation in low back pain. Nociscan specifically was presented by leading spine surgeons at three different conferences: the 28th Annual Selby Spine Conference, the 2025 Spine Summit, and the 20th Annual State of Spine Surgery Think Tank. The Company will continue to participate in key industry conferences in 2H25 including Bridging the Gap, the International Society of Pain & Neuroscience (ISPN) conference in London, Sonntag Spine Symposium, the NASS 40th Annual Meeting, The Radiological Society of North America, and the Minimally Invasive Spine Society.
- INTELLECTUAL PROPERY. In February, Aclarion secured its 24th US patent to protect expanded applications of Magnetic Resonance Spectroscopy (MRS) data processing to identify pain and infection biomarkers throughout the body. Currently Aclarion holds 24 US-issued patents, 13 European issued patents, as well as several pending patent applications. The Company is in the process of auditing its intellectual property portfolio to evaluate spinning off additional companies in partnership with private investors to optimize the value of the patent portfolio for shareholders without increasing burn.
- FUNDING. At the end of 1Q25, Aclarion announced a funding update that included raising nearly
$15M (net) cash on hand, as well as eliminating all debt, no preferred equity, and no warrants with strike prices near the current market. These funding activities helped to ensure that Aclarion is fully NASDAQ compliant and funded to execute on the strategic objectives highlighted in company communications and outlined in this update. The Company reaffirms it is adequately funded through Q3 2026 to prove out the key catalysts of demonstrating significant scan volume growth in the UK and securing early visibility into the success of CLARITY.
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 and has the potential to drive better surgical outcomes.
For more information about CLARITY, please visit: CLARITY Trial
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, 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:
Jennie Kim
SPRIG Consulting
jennie@sprigconsulting.com
FAQ
What was Aclarion's (ACON) Nociscan scan volume growth in Q2 2025?
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How does Nociscan compare to provocative discography in terms of cost-effectiveness?
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