PAVmed Signs Letter of Intent to License Groundbreaking Endoscopic Esophageal Imaging Technology
PAVmed (Nasdaq: PAVM) has signed a non-binding letter of intent with Duke University to license groundbreaking endoscopic imaging technology through a new subsidiary. The technology combines angle-resolved low coherence interferometry (a/LCI) with optical coherence tomography (OCT) to identify and treat esophageal precancer during upper endoscopy.
The technology, developed by Duke's Dr. Adam Wax in partnership with Dr. Nicholas Shaheen, has demonstrated 100% sensitivity and 88% overall accuracy in detecting precancerous changes. This innovative approach could replace traditional biopsies, enabling real-time detection and immediate treatment during the same endoscopic procedure.
Under the proposed agreement, PAVmed's subsidiary will receive exclusive worldwide license rights to the intellectual property. The company expects this technology to complement its EsoGuard diagnostic platform and attract strategic interest from endoscopic ablation companies.
PAVmed (Nasdaq: PAVM) ha sottoscritto una lettera di intenti non vincolante con la Duke University per ottenere la licenza di una tecnologia endoscopica avanzata tramite una nuova filiale. Il sistema unisce angle-resolved low coherence interferometry (a/LCI) e optical coherence tomography (OCT) per individuare e trattare lesioni precancerose dell'esofago durante l'endoscopia superiore.
La tecnologia, sviluppata dal Dr. Adam Wax in collaborazione con il Dr. Nicholas Shaheen, ha mostrato una sensitivity del 100% e un'accuratezza complessiva dell'88% nell'identificare alterazioni precancerose. Questo approccio innovativo potrebbe sostituire le biopsie tradizionali, permettendo la diagnosi in tempo reale e il trattamento immediato nello stesso intervento endoscopico.
Secondo l'accordo proposto, la filiale di PAVmed riceverà i diritti di licenza esclusiva mondiale sulla proprietà intellettuale. L'azienda prevede che la tecnologia integri la sua piattaforma diagnostica EsoGuard e susciti interesse strategico da parte di società specializzate in ablazione endoscopica.
PAVmed (Nasdaq: PAVM) ha firmado una carta de intenciones no vinculante con la Universidad de Duke para licenciar una innovadora tecnología de imagen endoscópica a través de una nueva subsidiaria. La tecnología combina angle-resolved low coherence interferometry (a/LCI) y optical coherence tomography (OCT) para detectar y tratar lesiones precancerosas del esófago durante la endoscopia superior.
Desarrollada por el Dr. Adam Wax junto al Dr. Nicholas Shaheen, la tecnología ha mostrado una sensibilidad del 100% y una precisión global del 88% en la identificación de cambios precancerosos. Este enfoque podría sustituir las biopsias convencionales, permitiendo la detección en tiempo real y el tratamiento inmediato en la misma intervención endoscópica.
Según el acuerdo propuesto, la subsidiaria de PAVmed obtendría derechos exclusivos de licencia a nivel mundial sobre la propiedad intelectual. La compañía espera que la tecnología complemente su plataforma diagnóstica EsoGuard y atraiga interés estratégico de empresas dedicadas a la ablación endoscópica.
PAVmed (나스닥: PAVM)은 듀크 대학과 새로운 자회사를 통해 획기적인 내시경 영상 기술의 라이선스를 위한 구속력 없는 양해각서를 체결했습니다. 이 기술은 각도 해석 저간섭 간섭계(a/LCI)와 광학단층촬영(OCT)을 결합해 상부 내시경 검사 중 식도 전암 병변을 발견하고 치료할 수 있습니다.
듀크의 Adam Wax 박사와 Nicholas Shaheen 박사가 공동 개발한 이 기술은 전암성 변화를 감지하는 데 있어 민감도 100% 및 전체 정확도 88%를 입증했습니다. 이 혁신적 접근법은 기존 생검을 대체해 실시간 검출과 동일한 내시경 시술 중 즉각적인 치료를 가능하게 할 수 있습니다.
제안된 계약에 따라 PAVmed 자회사는 지적재산에 대한 전 세계 독점 라이선스 권리를 획득할 예정입니다. 회사는 이 기술이 EsoGuard 진단 플랫폼을 보완하고 내시경 소작(ablation) 업체들로부터 전략적 관심을 끌 것으로 기대합니다.
PAVmed (Nasdaq: PAVM) a signé une lettre d'intention non contraignante avec l'université Duke pour concéder sous licence une technologie d'imagerie endoscopique innovante via une nouvelle filiale. La technologie associe l'angle-resolved low coherence interferometry (a/LCI) et l'optical coherence tomography (OCT) afin de détecter et traiter les lésions précancéreuses de l'œsophage lors d'une endoscopie haute.
Développée par le Dr Adam Wax en partenariat avec le Dr Nicholas Shaheen, la technologie a démontré une dans la détection des modifications précancéreuses. Cette approche pourrait remplacer les biopsies traditionnelles, permettant une détection en temps réel et un traitement immédiat au cours du même geste endoscopique.
Dans le cadre de l'accord proposé, la filiale de PAVmed recevra des droits de licence exclusifs mondiaux sur la propriété intellectuelle. La société estime que la technologie complétera sa plateforme diagnostique EsoGuard et suscitera l'intérêt stratégique des entreprises spécialisées dans l'ablation endoscopique.
PAVmed (Nasdaq: PAVM) hat eine unverbindliche Absichtserklärung mit der Duke University unterzeichnet, um über eine neue Tochtergesellschaft eine bahnbrechende endoskopische Bildgebungstechnologie zu lizenzieren. Die Methode kombiniert angle-resolved low coherence interferometry (a/LCI) mit optical coherence tomography (OCT), um während der oberen Endoskopie präkanzeröse Veränderungen der Speiseröhre zu erkennen und zu behandeln.
Die von Dr. Adam Wax in Zusammenarbeit mit Dr. Nicholas Shaheen entwickelte Technologie zeigte eine Sensitivität von 100% und eine Gesamtgenauigkeit von 88% bei der Erkennung präkanzeröser Veränderungen. Dieser neuartige Ansatz könnte herkömmliche Biopsien ersetzen und die Echtzeit-Erkennung sowie die sofortige Behandlung im selben endoskopischen Eingriff ermöglichen.
Nach dem vorgeschlagenen Abkommen würde die Tochtergesellschaft von PAVmed exklusive weltweite Lizenzrechte an dem geistigen Eigentum erhalten. Das Unternehmen erwartet, dass die Technologie seine diagnostische Plattform EsoGuard ergänzt und strategisches Interesse von Anbietern endoskopischer Ablation anzieht.
- Technology demonstrated 100% sensitivity in detecting precancerous changes
- Enables real-time detection and immediate treatment in single procedure
- Exclusive worldwide licensing rights for the technology
- Potential to improve patient outcomes and procedural efficiency
- Synergistic with PAVmed's existing EsoGuard platform
- Letter of intent is non-binding
- License agreement not yet finalized or executed
- Technology still requires development and regulatory clearance
Insights
PAVmed's new esophageal imaging technology license could transform precancer treatment with real-time detection capabilities, addressing a growing clinical need.
PAVmed's letter of intent to license Duke University's advanced esophageal imaging technology represents a potentially significant advancement in gastroenterology diagnostics. The technology combines angle-resolved low coherence interferometry (a/LCI) with optical coherence tomography (OCT) to identify esophageal dysplasia (precancer) in real-time during endoscopic procedures.
The clinical value proposition is compelling. Current diagnostic approaches rely on traditional biopsies that are subject to sampling error and require weeks for pathology results before treatment decisions can be made. In contrast, this technology could enable immediate detection and same-session treatment of precancerous lesions, dramatically improving the patient care pathway.
Early clinical research validating this approach has shown promising results, with 100% sensitivity and 88% overall accuracy for a/LCI alone. A more recent pilot study using the integrated a/LCI+OCT technology demonstrated comparable sensitivity with improved specificity, though full results await peer-reviewed publication.
From a business perspective, PAVmed is creating a dedicated subsidiary for this technology, following their established corporate structure model. Lucid Diagnostics (PAVmed's existing subsidiary) will serve as both a strategic and equity partner. This approach allows for focused development while leveraging PAVmed's shared services infrastructure.
The technology appears well-positioned to complement PAVmed's existing EsoGuard diagnostic, creating potential synergies as increased EsoGuard adoption would drive more patients toward endoscopic evaluation where this new imaging technology would be utilized. The backing of prominent esophageal experts, including Dr. Nicholas Shaheen and technology developer Dr. Adam Wax, adds significant credibility to the clinical potential.
Newly-formed PAVmed subsidiary to license endoscopic imaging technology designed to identify and facilitate ablative treatment of esophageal dysplasia
Lucid Diagnostics to collaborate with PAVmed as a strategic and equity partner on the technology
"This groundbreaking technology has the potential to fundamentally transform how we diagnose and treat esophageal precancer, while simultaneously improving patient outcomes, procedural efficiency, and healthcare resource utilization," said Nicholas Shaheen, M.D., M.P.H., Bozymski-Heizer Distinguished Professor, and Senior Associate Dean for Clinical Research at the University of
"We anticipate that widespread non-endoscopic biomarker testing will drive substantially more patients to confirmatory endoscopy, surveillance, and treatment. Currently, the diagnosis of esophageal dysplasia—which directly guides treatment—relies on traditional biopsies, which are prone to sampling error and may delay treatment decisions for weeks. In contrast, this a/LCI + OCT technology offers the potential for real-time detection, enabling, for the first time, immediate treatment of dysplasia during the same endoscopic procedure. Once developed and cleared, I believe it would be of significant utility to clinicians caring for patients with Barrett's esophagus," Dr. Shaheen added.
Dr. Shaheen is an international authority on esophageal precancer and cancer. He is the past President of the International Society for Diseases of the Esophagus (ISDE) and is the lead author of the major society guidelines on the diagnosis and management of esophageal precancer and cancer. He also played an instrumental role in the development and widespread utilization of endoscopic treatments to eradicate this precancer and prevent progression to cancer.
The a/LCI technology was developed by Duke biomedical engineer Adam Wax, Ph.D., in partnership with Dr. Shaheen. Dr. Wax is Professor of Biomedical Engineering and Physics at Duke University and member of the Duke Cancer Institute. He is a leading expert in the field of biomedical imaging, focusing on early cancer detection techniques, and has co-authored over 400 publications. He serves as Editor-in-Chief of Optical Engineering, a leading journal in this space, and as a Fellow of the American Institute for Medical and Biological Engineering, the International Society for Optics and Photonics, and the Optical Society of America.
"We have been developing light scattering technologies for many years, showing their ability to detect cancer and precancer by measuring cell nuclei, but our recent work combining the approach with OCT imaging could unlock its use in the clinic," said Dr. Wax. "By providing a platform that fits in with endoscopy, the combination of light scattering and OCT is poised to enable new diagnostic capabilities for detecting and treating esophageal precancer without a biopsy."
Prior clinical research performed by Dr. Shaheen and Dr. Wax has shown that a/LCI can accurately detect precancerous changes in the esophagus during live examinations with
"We are delighted to partner on this endoscopic imaging technology and look forward to the opportunity to advance its commercialization," said PAVmed Chairman and Chief Executive Officer, Lishan Aklog, M.D. "Widespread EsoGuard adoption is expected to significantly increase the number of patients diagnosed with esophageal precancer. The exceptional performance of this technology to date promises to make the evaluation and treatment of these patients more streamlined, timely, and effective in preventing progression to cancer. Its significant clinical and commercial potential should attract strong interest from strategics active in the endoscopic ablation space. The venture fits seamlessly within PAVmed's corporate structure of independently financeable subsidiaries operating under a shared services infrastructure and builds on the successful academic medical center partnership model that launched Lucid. It is especially compelling as it leverages the unmatched expertise in esophageal precancer across PAVmed and Lucid."
Under the terms outlined in the letter of intent, PAVmed, through the newly-formed subsidiary, will enter into a definitive license agreement for the exclusive worldwide license of the intellectual property rights for the a/LCI + OCT technology. The letter of intent does not constitute a binding contract, and the proposed license will not be become effective unless and until a definitive license agreement has been executed by all parties.
About PAVmed and its Subsidiaries
PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors. Its subsidiary, Lucid Diagnostics Inc. (NASDAQ: LUCD), is a commercial-stage cancer prevention medical diagnostics company that markets the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device—the first and only commercial tools for widespread early detection of esophageal precancer to mitigate the risks of esophageal cancer deaths. Its other subsidiary, Veris Health Inc., is a digital health company focused on enhanced personalized cancer care through remote patient monitoring using implantable biologic sensors with wireless communication along with a custom suite of connected external devices. Veris is concurrently developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris Cancer Care Platform.
For more and for more information about PAVmed, please visit pavmed.com.
For more information about Lucid Diagnostics, please visit luciddx.com.
For more information about Veris Health, please visit verishealth.com.
About Duke University
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Forward-Looking Statements
This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of PAVmed's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance PAVmed's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed's clinical and preclinical studies; whether and when PAVmed's products are cleared by regulatory authorities; market acceptance of PAVmed's products once cleared and commercialized; PAVmed's ability to raise additional funding as needed; and other competitive developments. These factors are difficult or impossible to predict accurately and many of them are beyond PAVmed's control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect PAVmed's future operations, see Part I, Item 1A, "Risk Factors," in PAVmed's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.
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