Aclarion Announces Completion of First Nociscan Exams in LIFEHAB Trial
Aclarion (NASDAQ: ACON) has announced the completion of the first Nociscan exams for patients enrolled in the LIFEHAB Trial in Norway. This randomized controlled trial is comparing lumbar interbody fusion surgery with multidisciplinary rehabilitation for 202 patients with chronic low back pain. Nociscan, Aclarion's technology, uses magnetic resonance spectroscopy (MRS) biomarkers to help identify patient improvement following treatment.
The trial began enrolling patients in Q2 2024, with six patients completing Nociscan exams by late August. Aclarion's CEO, Brent Ness, expressed excitement about the trial's progress and Nociscan's potential role in determining optimal treatment options. The company is also involved in other research studies, including trials in Rome and two NIH studies, as it aims to establish Nociscan as the gold standard for disc treatment decisions in low back pain research.
Aclarion (NASDAQ: ACON) ha annunciato il completamento dei primi esami Nociscan per pazienti arruolati nel LIFEHAB Trial in Norvegia. Questo studio controllato randomizzato confronta la chirurgia di fusione intersomatica lombare con la riabilitazione multidisciplinare per 202 pazienti affetti da dolore lombare cronico. Nociscan, la tecnologia di Aclarion, utilizza sospettori di risonanza magnetica (MRS) per aiutare a identificare il miglioramento dei pazienti dopo il trattamento.
Lo studio ha iniziato ad arruolare pazienti nel Q2 2024, con sei pazienti che hanno completato gli esami Nociscan entro la fine di agosto. Il CEO di Aclarion, Brent Ness, ha espresso entusiasmo per i progressi dello studio e il potenziale ruolo di Nociscan nel determinare le opzioni di trattamento ottimali. L'azienda è anche coinvolta in altri studi di ricerca, compresi gli studi a Roma e due studi NIH, mentre mira a stabilire Nociscan come standard d'oro per le decisioni relative al trattamento del disco nella ricerca sul dolore lombare.
Aclarion (NASDAQ: ACON) ha anunciado la finalización de los primeros exámenes Nociscan para pacientes inscritos en el LIFEHAB Trial en Noruega. Este ensayo controlado aleatorizado compara la cirugía de fusión intersomática lumbar con la rehabilitación multidisciplinaria para 202 pacientes con dolor lumbar crónico. Nociscan, la tecnología de Aclarion, utiliza biomarcadores de espectroscopia de resonancia magnética (MRS) para ayudar a identificar la mejora de los pacientes tras el tratamiento.
El ensayo comenzó a reclutar pacientes en el Q2 2024, con seis pacientes que completaron los exámenes Nociscan a finales de agosto. El CEO de Aclarion, Brent Ness, expresó su entusiasmo por el progreso del ensayo y el potencial papel de Nociscan para determinar las opciones de tratamiento óptimas. La empresa también participa en otros estudios de investigación, incluidos ensayos en Roma y dos estudios de los NIH, mientras busca establecer a Nociscan como el estándar de oro para las decisiones de tratamiento de discos en la investigación sobre el dolor lumbar.
Aclarion (NASDAQ: ACON)은 노르웨이에서 LIFEHAB 시험에 등록된 환자를 위한 첫 번째 Nociscan 검사의 완료를 발표했습니다. 이 무작위 대조 시험은 만성 요통이 있는 202명의 환자를 대상으로 요추 체간 유합 수술과 다학제 재활을 비교하고 있습니다. Aclarion의 기술인 Nociscan은 자기 공명 분광법(MRS) 바이오마커를 사용하여 치료 후 환자의 개선 상태를 파악하는 데 도움을 줍니다.
이 시험은 2024년 2분기에 환자 모집을 시작했으며, 8월 말까지 6명의 환자가 Nociscan 검사를 완료했습니다. Aclarion의 CEO인 브렌트 네스는 시험의 진행 상황과 최적의 치료 옵션을 결정하는 데 있어 Nociscan의 잠재적 역할에 대한 기대감을 표명했습니다. 회사는 또한 로마에서의 시험과 두 개의 NIH 연구를 포함하여 다른 연구에도 참여하며, Nociscan을 요통 연구에서 디스크 치료 결정의 기준으로 삼기 위해 노력하고 있습니다.
Aclarion (NASDAQ: ACON) a annoncé l'achèvement des premiers examens Nociscan pour les patients inscrits au LIFEHAB Trial en Norvège. Cet essai contrôlé randomisé compare la chirurgie de fusion intersomatique lombaire à la réhabilitation multidisciplinaire pour 202 patients souffrant de douleurs lombaires chroniques. Nociscan, la technologie d'Aclarion, utilise des biomarqueurs de spectroscopie par résonance magnétique (MRS) pour aider à identifier l'amélioration des patients après le traitement.
L'essai a commencé à recruter des patients au deuxième trimestre de 2024, avec six patients ayant terminé les examens Nociscan d'ici fin août. Brent Ness, le PDG d'Aclarion, a exprimé son enthousiasme pour les progrès de l'essai et le potentiel rôle de Nociscan dans la détermination des options de traitement optimales. L'entreprise est également impliquée dans d'autres études de recherche, y compris des essais à Rome et deux études des NIH, alors qu'elle vise à établir Nociscan comme la référence en matière de décisions de traitement des disques dans la recherche sur les douleurs lombaires.
Aclarion (NASDAQ: ACON) hat den Abschluss der ersten Nociscan-Untersuchungen für Patienten, die an der LIFEHAB-Studie in Norwegen teilnehmen, bekannt gegeben. Diese randomisierte kontrollierte Studie vergleicht die lumbale interbody Fusion mit multidisziplinärer Rehabilitation bei 202 Patienten mit chronischen Rückenschmerzen. Nociscan, die Technologie von Aclarion, verwendet magnetresonanzspektroskopie (MRS) Biomarker, um zu helfen, die Verbesserung des Patienten nach der Behandlung zu identifizieren.
Die Studie begann im 2. Quartal 2024 mit der Rekrutierung von Patienten, und bis Ende August hatten sechs Patienten die Nociscan-Untersuchungen abgeschlossen. Brent Ness, der CEO von Aclarion, zeigte sich begeistert vom Fortschritt der Studie und dem potenziellen Beitrag von Nociscan zur Bestimmung optimaler Behandlungsoptionen. Das Unternehmen ist auch an weiteren Forschungsstudien beteiligt, darunter Versuche in Rom und zwei NIH-Studien, während es anstrebt, Nociscan als den Goldstandard für Entscheidungen zur Behandlung von Bandscheiben in der Forschung zu Rückenschmerzen zu etablieren.
- Aclarion's Nociscan technology is being used in multiple high-profile clinical trials, including LIFEHAB, NIH studies, and a trial in Rome
- The LIFEHAB trial is progressing on schedule, with patient enrollment and Nociscan exams underway
- Nociscan is gaining traction in the research market, potentially leading to wider adoption and recognition
- Successful results from these trials could support reimbursement efforts in single-payer healthcare systems like Norway's
- Results from the LIFEHAB trial and other studies are still pending, creating uncertainty about Nociscan's efficacy
- The company is still in the process of driving Nociscan to become a standard of care, indicating it has not yet achieved widespread clinical adoption
Insights
The completion of the first Nociscan exams in the LIFEHAB trial marks a significant milestone for Aclarion's technology. This randomized controlled trial, comparing lumbar interbody fusion surgery with multidisciplinary rehabilitation, could provide crucial data on the efficacy of Nociscan in identifying optimal treatment options for chronic low back pain. The inclusion of Nociscan in this study, alongside its use in NIH and Rome trials, strengthens its potential as a diagnostic tool.
However, it's important to note that with only
Aclarion's strategy of targeting the research market as an early adopter for Nociscan is shrewd. This approach allows the company to gather valuable data and build credibility within the scientific community before pushing for wider clinical adoption. The multiple ongoing trials (LIFEHAB, NIH and Rome) provide diversified data sources, potentially strengthening Nociscan's case for reimbursement in various healthcare systems.
However, investors should be aware that the path from research adoption to clinical standard of care can be long and uncertain. While the company's focus on research partnerships is promising, it may take considerable time before this translates into significant revenue growth. The key metrics to watch will be the outcomes of these trials and any subsequent moves towards reimbursement, particularly in single-payer systems like Norway's.
While the progress in the LIFEHAB trial is positive news for Aclarion, it's important to note that the company is still in its early stages of commercialization. As a small-cap medical technology company (NASDAQ: ACON), Aclarion's financial performance will likely be volatile in the near term.
The focus on research partnerships could lead to deferred revenue recognition, as clinical trials typically have long timelines. Investors should closely monitor Aclarion's cash burn rate and funding situation, as R&D-intensive companies often require significant capital before reaching profitability. The potential for Nociscan to become a standard in low back pain diagnosis presents a substantial market opportunity, but realizing this potential will require successful trial outcomes and navigating the complex healthcare reimbursement landscape.
Initial LIFEHAB Enrolled Patients Receive Nociscan Exams to Help Evaluate How Biomarkers in the Discs of the Lumbar Spine Correspond With Treatment Response
LIFEHAB is a Randomized Controlled Trial in Norway Comparing Lumbar Interbody Fusion Surgery With Multidisciplinary Rehabilitation
LIFEHAB Joins the NIH and Rome in Selecting Nociscan as a Technology to Help Determine Which Discs to Treat and the Technology’s Role in Selecting Optimal Treatment Options
BROOMFIELD, CO, Sept. 10, 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 completion of the first Nociscan exams for patients enrolled in the LIFEHAB Trial in Norway. The randomized controlled trial studying 202 patients with low back pain greater than 1 year in duration will compare treatment outcomes between lumbar interbody fusion surgery and multidisciplinary rehabilitation. Nociscan was selected for use in the study to help evaluate how magnetic resonance spectroscopy (MRS) biomarkers can identify patient improvement following treatment.
Patient enrollment in LIFEHAB began in the second quarter of 2024. The initial enrolled patients began completing Nociscan exams in the last week of August. Thus far six (6) patients have completed their Nociscan exams.
“We are excited to see the LIFEHAB Trial progressing on schedule and look forward to the results of the study and to the role we expect Nociscan data to play in not only helping physicians determine which discs to treat but in potentially helping to predict which treatment option is optimal for a particular patient,” said Brent Ness, Aclarion CEO. “Although we talk frequently about driving Nociscan to standard of care for clinical use, the research market is proving to be an early adopter of our technology.”
Aclarion is currently awaiting the results of a completed trial in Rome where Nociscan technology was used in a study evaluating regenerative technologies as well as the results of two NIH studies evaluating the role of Nociscan in treating chronic low back pain.
“We see Nociscan moving at an accelerated pace of adoption in the research market and look forward to announcing more partnerships as we continue to drive Nociscan to what we expect to be the gold standard for determining which discs to treat in research protocols on low back pain,” said Ryan Bond, Chief Strategy Officer of Aclarion.
Aclarion believes the results of the LIFEHAB trial, combined with other compelling evidence, marks a key step toward achieving successful reimbursement in a single-payer national health insurance system like Norway.
LIFEHAB is the latest customer-sponsored clinical trial involving Nociscan and the Company looks forward to announcing additional partnerships as Nociscan expands its adoption in the research market.
For more information on the LIFEHAB Trial:
https://classic.clinicaltrials.gov/ct2/show/NCT06169488
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.
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FAQ
What is the LIFEHAB Trial and how is Aclarion's Nociscan technology involved?
How many patients have completed Nociscan exams in the LIFEHAB Trial as of September 2024?
What other research studies is Aclarion (ACON) involved in besides the LIFEHAB Trial?
What is Aclarion's (ACON) goal for its Nociscan technology in the research market?
