Aclarion Launches Second Clinical Utility and Economic (CLUE) Trial Site With First Surgeon in New Jersey
Aclarion, Inc. (Nasdaq: ACON) has expanded its Clinical Utility and Economic (CLUE) Trial to New Jersey, with Dr. Justin Kubeck of Ocean Pain and Spine joining the study. The CLUE trial aims to demonstrate how Nociscan's AI-generated data impacts treatment decisions for chronic low back pain. Nociscan is Aclarion's SaaS platform that noninvasively helps physicians identify painful discs in the lumbar spine by quantifying chemical biomarkers associated with disc pain.
Dr. Kubeck is the second surgeon to join CLUE, following Dr. John Keller in Michigan. Aclarion expects more spine surgeons to participate, rapidly providing data to payers on Nociscan's impact on treatment planning. The company aims to address the global issue of degenerative spine disease and low back pain, which affects 266 million people worldwide.
Aclarion, Inc. (Nasdaq: ACON) ha ampliato il suo Clinical Utility and Economic (CLUE) Trial nel New Jersey, con Dr. Justin Kubeck di Ocean Pain and Spine che si unisce allo studio. L'obiettivo del trial CLUE è dimostrare come i dati generati dall'AI di Nociscan influenzino le decisioni terapeutiche per il dolore lombare cronico. Nociscan è la piattaforma SaaS di Aclarion che aiuta non in modo invasivo i medici a identificare i dischi dolorosi nella colonna vertebrale lombare, quantificando i biomarcatori chimici associati al dolore del disco.
Il Dr. Kubeck è il secondo chirurgo a unirsi al CLUE, dopo il Dr. John Keller del Michigan. Aclarion si aspetta che altri chirurghi spinali partecipino, fornendo rapidamente dati ai pagatori sull'impatto di Nociscan nella pianificazione del trattamento. L'azienda mira ad affrontare il problema globale delle malattie degenerative della colonna vertebrale e del dolore lombare, che colpisce 266 milioni di persone in tutto il mondo.
Aclarion, Inc. (Nasdaq: ACON) ha ampliado su Clinical Utility and Economic (CLUE) Trial en Nueva Jersey, con Dr. Justin Kubeck de Ocean Pain and Spine uniéndose al estudio. El ensayo CLUE tiene como objetivo demostrar cómo los datos generados por AI de Nociscan impactan las decisiones de tratamiento para el dolor lumbar crónico. Nociscan es la plataforma SaaS de Aclarion que ayuda a los médicos a identificar no invasivamente los discos dolorosos en la columna lumbar, cuantificando los biomarcadores químicos asociados con el dolor de disco.
El Dr. Kubeck es el segundo cirujano en unirse al CLUE, después del Dr. John Keller en Michigan. Aclarion espera que más cirujanos de columna participen, proporcionando rápidamente datos a los pagadores sobre el impacto de Nociscan en la planificación del tratamiento. La compañía tiene como objetivo abordar el problema global de las enfermedades degenerativas de la columna vertebral y del dolor lumbar, que afecta a 266 millones de personas en todo el mundo.
Aclarion, Inc. (Nasdaq: ACON)는 Dr. Justin Kubeck가 연구에 합류하면서 Clinical Utility and Economic (CLUE) Trial을 뉴저지로 확대했습니다. CLUE 시험은 Nociscan의 AI 생성 데이터가 만성 요통에 대한 치료 결정을 어떻게 영향을 미치는지를 보여주는 것을 목표로 하고 있습니다. Nociscan은 Aclarion의 SaaS 플랫폼으로, 의사가 디스크 통증과 관련된 화학 바이오마커를 정량화하여 비침습적으로 요추에 있는 고통스러운 디스크를 식별할 수 있도록 도와줍니다.
Kubeck 박사는 미시간의 John Keller 박사에 이어 CLUE에 합류한 두 번째 외과의입니다. Aclarion은 더 많은 척추 외과 의사들이 참여하여 Nociscan의 치료 계획에 미치는 영향을 보험자에게 신속하게 제공할 것으로 예상하고 있습니다. 이 회사는 전 세계 2억 6천6백만 명에게 영향을 미치는 퇴행성 척추 질환과 요통이라는 글로벌 문제를 해결하는 것을 목표로 하고 있습니다.
Aclarion, Inc. (Nasdaq: ACON) a élargi son Clinical Utility and Economic (CLUE) Trial au New Jersey, avec Dr. Justin Kubeck d'Ocean Pain and Spine rejoignant l'étude. L'essai CLUE vise à démontrer comment les données générées par l'IA de Nociscan influencent les décisions de traitement pour la douleur lombaire chronique. Nociscan est la plateforme SaaS d'Aclarion qui aide non invasivement les médecins à identifier les disques douloureux dans la colonne lombaire en quantifiant les biomarqueurs chimiques associés à la douleur du disque.
Dr. Kubeck est le deuxième chirurgien à rejoindre le CLUE, après Dr. John Keller au Michigan. Aclarion s'attend à ce que d'autres chirurgiens spinal participent, fournissant rapidement des données aux payeurs sur l'impact de Nociscan sur la planification du traitement. L'entreprise vise à traiter la problématique mondiale des maladies dégénératives de la colonne vertébrale et des douleurs lombaires, qui touchent 266 millions de personnes dans le monde.
Aclarion, Inc. (Nasdaq: ACON) hat seine Clinical Utility and Economic (CLUE) Studie auf New Jersey ausgeweitet, wobei Dr. Justin Kubeck von Ocean Pain and Spine der Studie beigetreten ist. Die CLUE-Studie hat zum Ziel, zu demonstrieren, wie die durch KI generierten Daten von Nociscan die Behandlungsentscheidungen bei chronischen Rückenschmerzen beeinflussen. Nociscan ist die SaaS-Plattform von Aclarion, die Ärzten nicht-invasiv hilft, schmerzhafte Bandscheiben in der Lendenwirbelsäule zu identifizieren, indem sie chemische Biomarker quantifiziert, die mit Bandscheibenschmerzen assoziiert sind.
Dr. Kubeck ist der zweite Chirurg, der sich CLUE anschließt, nach Dr. John Keller in Michigan. Aclarion erwartet, dass weitere Wirbelsäulenchirurgen teilnehmen werden, um schnell Daten über den Einfluss von Nociscan auf die Therapieplanung an die Kostenträger zu liefern. Das Unternehmen zielt darauf ab, das globale Problem der degenerativen Wirbelsäulenerkrankungen und der Rückenschmerzen zu adressieren, die weltweit 266 Millionen Menschen betreffen.
- Expansion of CLUE trial to New Jersey, indicating growing interest in Nociscan technology
- Addition of Dr. Justin Kubeck as the second surgeon to join the trial
- Expected steady increase in participating spine surgeons
- Potential to rapidly provide compelling data to payers on Nociscan's impact on treatment decisions
- Nociscan addresses a large global market of 266 million people suffering from degenerative spine disease and low back pain
- None.
Insights
The launch of Aclarion's second CLUE trial site marks a significant step in validating Nociscan's clinical utility. This multi-center trial aims to quantify how often Nociscan's AI-driven data alters initial treatment plans for chronic low back pain patients. The expansion to New Jersey, with Dr. Justin Kubeck joining, suggests growing interest from spine specialists.
The trial's focus on real-world evidence is important for potential payer adoption. By demonstrating Nociscan's impact on treatment decision-making, Aclarion could accelerate insurance coverage, a key factor for widespread adoption. However, investors should note that while promising, the trial is still in its early stages and concrete results are yet to be seen.
Aclarion's Nociscan represents a novel approach to chronic low back pain diagnosis. By leveraging biomarkers and AI algorithms, it offers an objective method to identify painful discs, potentially reducing diagnostic ambiguity. This technology addresses a significant market, with
The CLUE trial's expansion indicates growing clinical interest, which could accelerate market penetration if results are positive. However, investors should consider that healthcare technology adoption can be slow and Aclarion will need to demonstrate clear clinical and economic benefits to achieve widespread acceptance.
CLUE is a Multi-center Trial to Identify how Often Nociscan’s AI Data Changes the Initial Treatment Plan for Patients With Chronic Low Back Pain
Dr. Justin Kubeck Will Initiate CLUE in New Jersey at Ocean Pain and Spine in Toms River
BROOMFIELD, CO, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today the expansion of the multi-center CLUE Trial to New Jersey. Justin Kubeck, MD, orthopedic spine surgeon and founder of Ocean Pain and Spine in Toms River, NJ will join an expanding network of spine surgeons participating in CLUE to build a growing body of data supporting the real-world value of adding Nociscan’s AI generated data to existing diagnostic evaluation methods for the treatment of chronic low back pain.
Dr. Kubeck is the second surgeon to join CLUE since the trial was announced earlier this month, joining Dr. John Keller, a neurosurgical spine surgeon in Michigan. The Company expects a steady cadence of spine surgeons to join CLUE in the coming months to rapidly provide compelling data to payers as to how frequently Nociscan has a significant impact on the decision-making process during the critical stage when surgeons are planning the optimal treatment for their patient.
“I always tell new patients that we need to see what makes sense for their individual circumstances – whether it’s medication, or therapy, or ultimately, surgery,” explained Dr. Kubeck. “There is a protocol that I follow; I don’t ever just go in and do surgery. For me, developing the best treatment plan for an individual patient is very proceduralized. Once we determine the problem, then I say, ‘Here’s what you can expect, here are your options, and here is what we will decide together.’ Nociscan will be an invaluable decision support tool when evaluating diagnosis and treatment.”
Globally, 266 million people suffer 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. Biomarker data is entered into proprietary algorithms to highlight 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.
"Real world evidence is incredibly valuable when evaluating the influence and utility of an emerging diagnostic tool and when this evidence can be rapidly secured by experienced surgeons through a trial like CLUE, it becomes a critical tool for driving early payer coverage decisions,” stated Ryan Bond, Chief Strategy Officer at Aclarion. “We welcome the inbound interest that has launched our CLUE trial at multiple sites and encourage others to reach out at info@aclarion.com if they are interested in bringing Nociscan to their patients and participating in the CLUE trial.”
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:
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SPRIG Consulting
612.812.7477
jodi@sprigconsulting.com
FAQ
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