Duke University to License Endoscopic Esophageal Imaging Tech to PAVmed

PAVmed Inc. has executed a non-binding letter of intent with Duke University to license, through a newly-formed subsidiary, Duke’s technology to identify and facilitate the treatment of advanced esophageal precancer (dysplasia) during upper endoscopy.

The technology—a multi-modality probe combining angle-resolved low coherence interferometry (a/LCI) with optical coherence tomography (OCT)—could allow for a more efficient and effective alternative to traditional biopsies, according to the company

“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., Bozymski-Heizer Distinguished Professor, and senior associate dean for Clinical Research at the University of North Carolina, Chapel Hill School of Medicine and UNC Health.

Dr. Shaheen is an international authority on esophageal precancer and cancer. He is a past president of the International Society for Diseases of the Esophagus (ISDE) and is the lead author of major society guidelines on diagnosing and managing 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.

“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,” Dr. Shaheen stated. “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.”

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 biomedical imaging expert, focusing on early cancer detection techniques, and has co-authored more than 400 publications. He serves as editor-in-chief of Optical Engineering 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,” Dr. Wax commented. “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 100% sensitivity and overall accuracy of 88% when used alone. More recently, they completed a pilot clinical study using this integrated a/LCI and OCT technology, which demonstrated comparable sensitivity and improved specificity for detecting dysplasia during endoscopic surveillance for early precancer and prior to endoscopic eradication therapy for advanced precancer. The results have been submitted for peer-reviewed publication.

“We are delighted to partner on this endoscopic imaging technology and look forward to the opportunity to advance its commercialization,” PAVmed Chairman and CEO Lishan Aklog, M.D., said “Widespread EsoGuard adoption is expected to significantly increase the number of patients diagnosed with esophageal precancer. The 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.

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. 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 esophageal cancer death risk. 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.

Entering its second century, Duke University is consistently ranked among the top U.S. research universities and is home to leading graduate and professional schools in business, divinity, engineering, the environment, law, medicine, nursing, and public policy. Located in Durham, N.C., Duke’s global reach extends through the Duke-NUS Graduate Medical School in Singapore, Duke Kunshan University in China, and various international research and education programs.