Aclarion Announces CLARITY Trial for Nociscan Now Fully Funded
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) ha ottenuto quasi 20 milioni di dollari in proventi lordi nel 2025 per finanziare completamente il suo fondamentale studio CLARITY, uno studio prospettico, randomizzato e multicentrico progettato per convalidare l'efficacia di Nociscan nel migliorare i risultati chirurgici per i pazienti con dolore cronico alla parte bassa della schiena.
Lo studio CLARITY, condotto dal Dr. Nicholas Theodore della Johns Hopkins, arruolerà 300 pazienti in più sedi. Nociscan è la prima piattaforma SaaS supportata da evidenze che aiuta i medici a identificare i dischi dolorosi nella colonna lombare tramite spettroscopia RM e intelligenza artificiale, mostrando un tasso di successo chirurgico del 97% a un anno di follow-up quando tutti i dischi dolorosi identificati da Nociscan vengono trattati.
La tecnologia affronta una significativa sfida globale per la salute, con circa 266 milioni di persone in tutto il mondo che soffrono di malattie degenerative della colonna vertebrale e dolore alla parte bassa della schiena.
Aclarion (NASDAQ: ACON) ha obtenido casi 20 millones de dólares en ingresos brutos en 2025 para financiar completamente su ensayo clave CLARITY, un estudio prospectivo, aleatorizado y multicéntrico diseñado para validar la efectividad de Nociscan en la mejora de los resultados quirúrgicos para pacientes con dolor lumbar crónico.
El ensayo CLARITY, dirigido por el Dr. Nicholas Theodore de Johns Hopkins, inscribirá a 300 pacientes en múltiples sitios. Nociscan es la primera plataforma SaaS respaldada por evidencia que ayuda a los médicos a identificar discos dolorosos en la columna lumbar a través de Espectroscopia de RM y IA, mostrando una tasa de éxito quirúrgico del 97% a un año de seguimiento cuando se tratan todos los discos positivos al dolor identificados por Nociscan.
La tecnología aborda un desafío significativo para la salud global, con aproximadamente 266 millones de personas en todo el mundo que padecen enfermedades degenerativas de la columna vertebral y dolor lumbar.
Aclarion (NASDAQ: ACON)은 2025년에 약 2천만 달러의 총 수익을 확보하여 만성 요통 환자의 수술 결과 개선을 위한 Nociscan의 효과를 검증하기 위해 설계된 중요한 CLARITY 시험을 완전히 자금 조달할 것입니다.
존스 홉킨스의 Nicholas Theodore 박사가 이끄는 CLARITY 시험은 여러 장소에서 300명의 환자를 모집할 예정입니다. Nociscan은 MRI 스펙트로스코피와 인공지능(AI)을 통해 요추의 고통스러운 디스크를 식별하는 데 도움을 주는 최초의 증거 기반 SaaS 플랫폼으로, Nociscan에서 식별한 모든 통증 양성 디스크가 치료될 경우 1년 후 수술 성공률이 97%에 달합니다.
이 기술은 전 세계에서 약 2억 6천6백만 명이 퇴행성 척추 질환과 요통으로 고통 받고 있는 중요한 글로벌 건강 문제를 해결합니다.
Aclarion (NASDAQ: ACON) a sécurisé près de 20 millions de dollars de recettes brutes en 2025 pour financer entièrement son essai clé CLARITY, une étude prospective, randomisée et multicentrique conçue pour valider l'efficacité de Nociscan dans l'amélioration des résultats chirurgicaux chez les patients souffrant de douleurs lombaires chroniques.
L'essai CLARITY, dirigé par le Dr Nicholas Theodore de Johns Hopkins, recrutera 300 patients sur plusieurs sites. Nociscan est la première plateforme SaaS soutenue par des preuves qui aide les médecins à identifier les disques douloureux dans la colonne lombaire grâce à la spectroscopie IRM et à l'IA, montrant un taux de succès chirurgical de 97 % à un an de suivi lorsque tous les disques douloureux identifiés par Nociscan sont traités.
Cette technologie s'attaque à un défi de santé mondial significatif, avec environ 266 millions de personnes dans le monde souffrant de maladies dégénératives de la colonne vertébrale et de douleurs lombaires.
Aclarion (NASDAQ: ACON) hat 2025 fast 20 Millionen Dollar Bruttoerlöse gesichert, um seine zentrale CLARITY-Studie vollständig zu finanzieren, eine prospektive, randomisierte, multizentrische Studie, die darauf abzielt, die Wirksamkeit von Nociscan zur Verbesserung der chirurgischen Ergebnisse für Patienten mit chronischen Rückenschmerzen zu validieren.
Die CLARITY-Studie, geleitet von Dr. Nicholas Theodore von Johns Hopkins, wird 300 Patienten an mehreren Standorten rekrutieren. Nociscan ist die erste evidenzgestützte SaaS-Plattform, die Ärzten hilft, schmerzhafte Bandscheiben in der Lendenwirbelsäule durch MRT-Spektroskopie und KI zu identifizieren und zeigt eine 97%ige chirurgische Erfolgsquote bei einjähriger Nachuntersuchung, wenn alle von Nociscan identifizierten schmerzhaften Disks behandelt werden.
Die Technologie geht eine bedeutende globale gesundheitliche Herausforderung an, da weltweit etwa 266 Millionen Menschen an degenerativen Wirbelsäulenerkrankungen und Rückenschmerzen leiden.
- Secured $20 million in gross proceeds for complete CLARITY trial funding
- 97% surgical success rate at one-year follow-up with Nociscan-guided treatment
- Large addressable market of 266 million potential patients worldwide
- None.
Insights
The securing of
What sets Nociscan apart is its unique combination of MR Spectroscopy and AI to objectively quantify chemical biomarkers associated with disc pain. The preliminary
The trial's comprehensive funding eliminates execution risk and positions Aclarion to potentially secure broad payer coverage. This is important because current diagnostic methods for chronic low back pain are largely subjective, leading to suboptimal surgical outcomes and unnecessary procedures. A validated, objective diagnostic tool could substantially reduce healthcare costs by improving surgical selection and outcomes.
The 300-patient enrollment across multiple sites is statistically significant and well-designed to demonstrate clinical utility. If successful, Nociscan could become the new standard of care in spine surgery, potentially generating substantial recurring revenue through its SaaS model while significantly improving patient care.
The Company has secured nearly
CLARITY is a prospective, randomized, multicenter study to validate Nociscan’s ability to improve surgical outcomes
Nociscan aims to become the gold standard in identifying sources of low back pain through MR Spectroscopy (MRS) and Augmented Intelligence (AI)
BROOMFIELD, Colo., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, announced today that it has secured full funding for its pivotal CLARITY trial which is designed to demonstrate Nociscan’s clinical and economic value in spine surgery.
Chief Strategy Officer Ryan Bond stated, “This milestone ensures we reach the study’s conclusion, potentially unlocking broad payer coverage and redefining chronic low back pain treatment.”
Since January 1, 2025, Aclarion has raised nearly
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. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain and demonstrates a
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
This press release is for informational purposes only and is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or to buy any securities or a solicitation of any proxy, consent, vote or approval with respect to any securities of Aclarion, Inc. No offer, sale, issuance or transfer of securities shall be made in any jurisdiction in which such offer, sale, issuance or transfer would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
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, 2023, 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.
646.823.8656
ksmith@pcgadvisory.com
Media Contacts:
Jodi Lamberti
SPRIG Consulting
612.812.7477
jodi@sprigconsulting.com
FAQ
What is the size of Aclarion's (ACON) CLARITY trial funding secured in 2025?
How many patients will be enrolled in Aclarion's CLARITY trial for Nociscan?
What is the success rate of Nociscan-guided spine surgeries?
Who is leading Aclarion's CLARITY trial for Nociscan?
What is the global market potential for Aclarion's Nociscan technology?
