Aclarion Provides Corporate Update on Nociscan AI Technology Milestones
Aclarion, Inc. (Nasdaq: ACON) has provided a corporate update on their Nociscan AI technology, which aids in identifying chronic low back pain sources. Key milestones include:
1. Three of four largest private UK insurers now cover Nociscan
2. Partnership with ten prominent KOL surgeons in the US
3. Strategic partnership with ATEC to expand KOL network
4. Multiple commercial agreements in key US markets
5. Participation in NIH's BEST Trial with 800+ patients
6. Launch of CLARITY, a flagship clinical study
The company's technology is protected by 23 US patents and 17 international patents. Aclarion aims to establish Nociscan as a standard of care for chronic low back pain, addressing a $134 billion annual healthcare expenditure in the US.
Aclarion, Inc. (Nasdaq: ACON) ha fornito un aggiornamento aziendale sulla loro tecnologia Nociscan AI, che aiuta a identificare le fonti di dolore cronico alla schiena. Le principali pietre miliari includono:
1. Tre dei quattro principali assicuratori privati nel Regno Unito ora coprono Nociscan
2. Partnership con dieci rinomati chirurghi KOL negli Stati Uniti
3. Collaborazione strategica con ATEC per espandere la rete KOL
4. Numerosi accordi commerciali nei principali mercati statunitensi
5. Partecipazione al BEST Trial degli NIH con oltre 800 pazienti
6. Lancio di CLARITY, uno studio clinico di punta
La tecnologia dell'azienda è protetta da 23 brevetti statunitensi e 17 brevetti internazionali. Aclarion mira a stabilire Nociscan come standard di cura per il dolore cronico alla schiena, affrontando una spesa sanitaria annuale di 134 miliardi di dollari negli Stati Uniti.
Aclarion, Inc. (Nasdaq: ACON) ha proporcionado una actualización corporativa sobre su tecnología Nociscan AI, que ayuda a identificar las fuentes de dolor lumbar crónico. Los hitos clave incluyen:
1. Tres de los cuatro mayores aseguradores privados del Reino Unido ahora cubren Nociscan
2. Asociación con diez prestigiosos cirujanos KOL en EE. UU.
3. Asociación estratégica con ATEC para expandir la red KOL
4. Varios acuerdos comerciales en los principales mercados de EE. UU.
5. Participación en el BEST Trial de los NIH con más de 800 pacientes
6. Lanzamiento de CLARITY, un estudio clínico insignia
La tecnología de la empresa está protegida por 23 patentes en EE. UU. y 17 patentes internacionales. Aclarion tiene como objetivo establecer Nociscan como un estándar de atención para el dolor lumbar crónico, abordando un gasto anual en salud de 134 mil millones de dólares en EE. UU.
Aclarion, Inc. (Nasdaq: ACON)은 만성 요통의 원인을 식별하는 데 도움이 되는 Nociscan AI 기술에 대한 기업 업데이트를 제공했습니다. 주요 이정표는 다음과 같습니다:
1. 영국에서 가장 큰 4개 민간 보험사 중 3곳이 Nociscan을 보장함
2. 미국의 10명 유명 KOL 외과의사와 파트너십 체결
3. KOL 네트워크 확대를 위한 ATEC과의 전략적 파트너십
4. 주요 미국 시장에서 여러 상업적 계약 체결
5. 800명 이상의 환자와 함께 NIH의 BEST Trial 참여
6. 대표적인 임상 연구 CLARITY 출시
회사의 기술은 23개의 미국 특허와 17개의 국제 특허로 보호되고 있습니다. Aclarion은 만성 요통의 표준 치료법으로 Nociscan을 확립하여 미국에서 1,340억 달러에 달하는 연간 의료 지출 문제를 해결하는 것을 목표로 하고 있습니다.
Aclarion, Inc. (Nasdaq: ACON) a fourni une mise à jour de l'entreprise sur sa technologie Nociscan AI, qui aide à identifier les sources de douleur chronique au bas du dos. Les principales réalisations incluent :
1. Trois des quatre plus grands assureurs privés du Royaume-Uni couvrent désormais Nociscan
2. Partenariat avec dix chirurgiens KOL de premier plan aux États-Unis
3. Partenariat stratégique avec ATEC pour élargir le réseau KOL
4. Plusieurs accords commerciaux sur les principaux marchés américains
5. Participation à l'essai BEST des NIH avec plus de 800 patients
6. Lancement de CLARITY, une étude clinique phare
La technologie de l'entreprise est protégée par 23 brevets américains et 17 brevets internationaux. Aclarion vise à établir Nociscan comme une norme de soins pour la douleur chronique au bas du dos, abordant une dépense de santé annuelle de 134 milliards de dollars aux États-Unis.
Aclarion, Inc. (Nasdaq: ACON) hat ein Unternehmens-Update zu ihrer Nociscan AI-Technologie bereitgestellt, die bei der Identifizierung von chronischen Rückenschmerzzufluchten hilft. Wichtige Meilensteine sind:
1. Drei der vier größten privaten Versicherer im Vereinigten Königreich decken jetzt Nociscan ab
2. Partnerschaft mit zehn prominenten KOL-Chirurgen in den USA
3. Strategische Partnerschaft mit ATEC zur Erweiterung des KOL-Netzwerks
4. Mehrere kommerzielle Vereinbarungen in wichtigen US-Markten
5. Teilnahme an der BEST-Studie der NIH mit über 800 Patienten
6. Einführung von CLARITY, einer führenden klinischen Studie
Die Technologie des Unternehmens ist durch 23 US-Patente und 17 internationale Patente geschützt. Aclarion strebt an, Nociscan als Standardbehandlung für chronische Rückenschmerzen zu etablieren und damit eine jährliche Gesundheitsausgabe von 134 Milliarden Dollar in den USA anzugehen.
- Three of four largest private insurance payers in the UK now cover Nociscan
- Partnership with ten prominent Key Opinion Leader (KOL) surgeons in the US
- Strategic partnership with ATEC to expand KOL network and physician relationships
- Multiple commercial agreements providing access to Nociscan in key US markets
- Participation in NIH's BEST Trial with over 800 patients
- Launch of CLARITY, a flagship clinical study to compare outcomes with and without Nociscan
- Technology protected by 23 US patents, 17 international patents, and 12 pending applications
- Economic Value Analysis (EVAL) suggests potential savings of $1,700 per patient using Nociscan
- None.
Aclarion's corporate update highlights several positive developments, but the lack of concrete financial figures makes it challenging to assess the immediate impact on the company's financials. However, the progress in gaining payer coverage, particularly in the UK, is a significant milestone. This could potentially lead to increased adoption and revenue growth in the near future.
The strategic partnership with ATEC and the expansion into the personal injury and workers' compensation markets present new growth opportunities. The company's focus on building clinical evidence and economic value analysis (EVAL) could strengthen its position for future payer negotiations and market adoption.
While the company appears to be making strides, investors should note that Aclarion is still in the early stages of commercialization. The lack of current revenue figures and the continued investment in clinical trials suggest that profitability may still be some time away. Investors should closely monitor future announcements for concrete financial metrics and payer adoption rates to better gauge the company's progress towards profitability.
Aclarion's Nociscan AI technology shows promise in addressing the significant issue of chronic low back pain, which costs Americans an estimated
The company's clinical evidence strategy is robust, with multiple studies underway or completed. The CLARITY trial, a prospective, randomized, multi-center study, could provide compelling data to support wider adoption. The positive results from Dr. Gornet's study, showing improved clinical outcomes after two years when surgery followed Nociscan data, are particularly encouraging.
The EVAL analysis, suggesting potential savings of
Aclarion's strategy of partnering with Key Opinion Leaders (KOLs) to drive payer coverage is a smart approach in the medical device industry. The success in the UK, where 3 of the 4 largest private insurers now cover Nociscan, provides a promising model for US expansion.
The partnership with ATEC, a major spine implant company, could significantly accelerate KOL engagement and market penetration. This collaboration aligns well with the trend towards data-driven, personalized medicine in spine care.
The expansion into the personal injury and workers' compensation markets is a strategic move, given the high stakes and need for objective data in these cases. However, the adoption rate in these specialized markets may differ from general spine care and investors should watch for specific metrics in this segment.
While the company's progress is impressive, the lack of specific adoption rates or revenue figures makes it difficult to gauge market traction. Investors should look for concrete metrics on physician adoption, scan volumes and revenue growth in future updates to better assess Aclarion's market position and growth trajectory.
Successful milestones achieved and upcoming include peer-reviewed publications, commercial agreements, and payer coverage decisions
Progressing with proven path toward standard of care addressing chronic low back pain, the largest expenditure in US healthcare costing Americans an estimated
More than
Technology protected by 23 issued US patents, 17 issued international patents, and 12 pending patent applications
Three of four largest private insurance payers in the UK now covering Nociscan
Partnership with ten prominent KOL surgeons signed on to assist Aclarion in successfully gaining traction and reimbursement throughout the United States
BROOMFIELD, CO, Sept. 12, 2024 (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, today provided a corporate update. The update reviews the successful achievement of several recent key milestones and provides perspective on the positive implications of those catalysts as the Company continues to establish Nociscan as a standard of care decision support tool for the treatment of patients with chronic low back pain.
“We are excited with the recent positive success we have been awarded as Aclarion has consistently achieved stated catalysts of value creation that fall into a very concise framework proven to bring disruptive technological advancements to standard of care in the healthcare sector,” said Brent Ness, CEO of Aclarion. “We intend to lead a positive diagnostic transformation in spine care through clinical and economic evidence that proves the promising value of Nociscan. The building blocks we have executed over the past two years have recently led to the achievement of our most important catalyst to date which is multiple private insurance companies in the UK electing to pay for Nociscan. Payer coverage is critical to driving Nociscan to standard of care. We are providing this corporate update to share the process involved in achieving this milestone, how that process is being replicated at many sites throughout the U.S., how we are coordinating clinical studies in support of payment, and why increasing payer coverage decisions are critical catalysts for driving the valuation of our company. We are clearly excited not only by our recent successes but even more so for our upcoming near term catalysts.”
The cornerstone of Aclarion’s strategy to drive payer coverage is to partner with Key Opinion Leader (KOL) physicians who see the value of Nociscan in their practice and advocate for insurance coverage so the physician can provide better care to more patients. Aclarion now has a panel of 10 of the top spine surgeon leaders in the world aligned and actively speaking on behalf of the efficacy and clinical utility of adding Nociscan to the evaluation of patients who suffer from chronic low back pain. “These KOLs are participating in the collection of clinical data, they are engaging insurance companies and benefits management entities to advocate for coverage decisions and representing Nociscan as an important technology worthy of societal endorsement,” said Ryan Bond, Chief Strategy Officer of Aclarion. “We believe the quality of a company’s KOL network is a direct reflection of the importance and promise of any new technology and our list of KOLs is more like that of a multibillion-dollar industry leader than an emerging technology disruptor.”
Aclarion’s KOL advocacy strategy applied to the UK has led to great success and is a model of what the Company expects to see replicated with their KOLs in the United States. Physicians in the UK originally set out to evaluate Nociscan technology across 30 patients to determine if the technology was helpful. After comparing Nociscan to invasive discography across only 20 patients, the UK physicians saw the value of Nociscan and converted their trial agreement into a permanent commercial agreement between Aclarion and The London Clinic, a major provider of spine care in London. As part of that conversion, Aclarion was able to secure increased payments. To ensure a large segment of their patients would have unfettered access to Nociscan, the UK KOLs, in conjunction with The London Clinic, then approached the largest private health insurance providers in the UK for payment. Three of the top four payers have now agreed to pay for Nociscan thus far.
Payer coverage decisions like those achieved in the UK represent potentially trajectory changing milestones as they pave the way for broad physician adoption and predictable revenue. Aclarion is now adding sales and marketing resources into London to accelerate this adoption and the potential revenue inherent in these payer coverage decisions. The Company is simultaneously executing this same physician-led strategy throughout the United States through its KOL panel.
To expand access to more KOLs, Aclarion entered into a strategic partnership with ATEC, a major spine implant company with a specific interest in leveraging pre-surgical data to drive better outcomes through its Alpha-Informatics platform. The partnership calls for leveraging ATEC’s extensive physician relationships to expand Aclarion’s KOL advocacy strategy to additional surgeons.
In support of its mission to drive Nociscan to standard of care, Aclarion has executed multiple commercial agreements providing access to Nociscan at multiple MRI scanners in key markets such as New York, New Jersey, Arizona, Colorado, and Michigan. This groundwork will assist in executing the strategic agreement in place with ATEC to evaluate the use of Nociscan with their KOLs. “We believe in the importance of biochemical markers within the treatment paradigm and by partnering with Aclarion, we can progress toward a mutual objective to integrate and advance technologies that improve the predictability and reproducibility of spine patient care,” stated Pat Miles, CEO of ATEC.
The payer world consists of more than standard commercial health insurance providers. In the U.S., personal injury and worker compensation cases make up a large part of the low back pain market and the stakes of securing the right diagnosis are extremely high. In this market in particular, a premium is placed on data that is objectively obtained and can help physicians determine the best treatment options.
By partnering with Justin Kubeck, MD, an orthopedic spine surgeon in New Jersey, Aclarion is expanding into the personal injury and workers compensation market with the same physician-led strategy that is driving positive results in London. Dr. Kubeck explained, “I’ll be leading an effort to educate a discrete population of attorneys and judges who adjudicate PI and WC cases throughout the state on the potential benefits of Nociscan for these high stake cases.”
For KOLs to be most effective in driving payers to cover Nociscan, favorable clinical and economic data from clinical trials is an important requirement. Evidence continues to mount in favor of utilizing Nociscan to determine discogenic pain over the current invasive gold standard of provocative discography and for making treatment decisions when provocative discography data is not available.
The Company was invited to participate in the National Institute of Health’s (NIH) Biomarkers for Evaluating Spine Treatments (BEST) Trial which enrolled over 800 patients at 12 leading academic teaching institutions across the United States, with a subset of 200 undergoing advanced biomarker profiling, which included Nociscan. Results from the trial are anticipated in the near term while the revenue produced from the trial has helped fund Aclarion’s march toward full commercial launch.
The Company has published two peer reviewed journal articles based on the results of a pivotal study conducted by Dr. Matt Gornet showing that clinical outcomes improved and were durable after two years when Nociscan results were concordant with the surgical treatment of a patient versus when surgery did not follow the Nociscan data for identifying painful discs. Bob Eastlack, MD stated, “This is an outcomes result, not just a clinical equivalency to a gold standard diagnostic study. Outcomes are what drive payer coverage decisions.”
To quantify the savings inherent in utilizing Nociscan across the spine surgery population of the United States based on the conclusions of the Gornet study, the Economic Value Analysis of Low back pain (EVAL) analysis was commissioned and executed by the Center for Disruptive Musculoskeletal Innovations (CDMI). The results of EVAL concluded that the use of Nociscan improves outcomes and reduces costs, conservatively saving the US healthcare system nearly half a billion dollars annually and by more than
Building on the clinical success as evidenced by the Gornet study and the favorable economic analysis of EVAL, the Company has launched CLARITY, its flagship clinical study. CLARITY is a prospective, randomized, multi-center trial comparing the outcomes of patients undergoing surgery for chronic discogenic back pain when Nociscan is used in the decision-making process versus when Nociscan is not being used in the decisioning process. Based on the results of the Gornet Trial, Aclarion believes CLARITY will result in compelling data that will rapidly lead to coverage decisions from every major insurance provider in the country and endorsements from all the major spine societies. Nicholas Theodore, MD, FACS, FAANS, Director of Neurosurgical Spine Center, Johns Hopkins, and Professor of Neurosurgery, Orthopaedics and Biomedical Engineering is the Principal Investigator for CLARITY.
Additional compelling peer-reviewed data has been published in the International Journal of Spine Surgery that highlights Nociscan as a Gold Standard for noninvasive identification for painful lumbar discs. The LIFEHAB trial continues to pay for the use of Nociscan in the 202-patient study as a key component in their evaluation of surgical vs non-surgical treatment efficacy. The Company expects to announce additional sponsor-supported research studies that generate additional revenue.
Aclarion has expanded its IP position in the MR spectroscopy space and leads on every relevant front as a platform technology that leverages MR spectroscopy and biomarker data for the identification of painful discs. Over the past two years, two key patents have been added. One to expand our IP position when using newer AI analysis techniques to analyze spectroscopy data to identify biomarkers and another to identify bacterial biomarkers associated with pain.
In the months ahead, investors can rely on continued success in adding peer reviewed evidence publications, signing additional commercial agreements, and most importantly, expanding positive payer coverage decisions.
For more information about the BEST Trial, please visit: www.besttrial.org
For information about BACPAC, please visit: https://heal.nih.gov/research/clinical-research/back-pain
For more information about REACH, please visit: www.bacpac-reach.org
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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