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Renowned Investigators Awarded $8 Million NIH Grant to Study Lucid Diagnostics' EsoGuard® in At-Risk Patients without Symptomatic GERD

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Lucid Diagnostics (Nasdaq: LUCD) announced that a consortium of academic medical centers has received an $8 million NIH R01 grant for a five-year clinical study of its EsoCheck® and EsoGuard® technologies. The study will evaluate esophageal precancer detection in at-risk individuals without GERD symptoms.

The research, led by investigators from Case Western Reserve University and University Hospitals, will involve 800 patients across five research centers. The study aims to improve Barrett's Esophagus (BE) detection in non-GERD at-risk populations, who account for nearly half of esophageal cancer cases but are currently excluded from screening guidelines.

The study could potentially expand EsoGuard's target population for esophageal precancer testing. The technology was originally developed at CWRU and UH, with Lucid licensing the technologies exclusively in 2018.

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Positive

  • Secured $8M NIH grant funding for clinical study
  • Potential expansion of target market to non-GERD patients
  • Partnership with prestigious research institutions

Negative

  • Study results won't be available for 5 years
  • Current screening guidelines exclude non-GERD patients, limiting immediate market

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On the day this news was published, LUCD gained 5.26%, reflecting a notable positive market reaction.

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Lucid to support study of this expanded indication for esophageal precancer testing in partnership with NIH investigators

NEW YORK, Feb. 27, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that a consortium of prestigious academic medical centers, led by principal investigators from Case Western Reserve University (CWRU) and University Hospitals (UH), has been awarded an $8 million National Institutes of Health (NIH) R01 grant to conduct a five-year clinical study designed to evaluate esophageal precancer detection using Lucid's EsoCheck® Esophageal Cell Collection Device and EsoGuard® Esophageal DNA Test  among at-risk individuals without symptoms of chronic gastroesophageal reflux disease (GERD).

The study, "A Clinical Trial of Cancer Prevention by Biomarker Based Detections of Barrett's Esophagus and Its Progression," aims to evaluate the effectiveness of EsoCheck and EsoGuard in detecting esophageal precancer (Barrett's Esophagus or BE) to prevent esophageal cancer (EAC) within a non-GERD at-risk population. To accomplish this aim, 800 patients without GERD symptoms who meet the American Gastroenterological Association's (AGA) risk criteria for  screening will be recruited across five participating research centers: University Hospitals, University of Colorado, Johns Hopkins University, University of North Carolina, and Cleveland Clinic.

"Patients without GERD symptoms account for nearly half of prevalent esophageal cancer cases," said Amitabh Chak, M.D., Professor of Medicine and Oncology at CWRU, gastroenterologist at UH, and the Brenda and Marshall B. Brown Master Clinician in Innovation and Discovery at UH Seidman Cancer Center. "However, these individuals would be excluded from screening based on the American College of Gastroenterology (ACG) guidelines where chronic GERD is a mandatory prerequisite. We aim to utilize EsoCheck and EsoGuard to improve BE detection in this at-risk population that would otherwise go unscreened, and to do so in a manner that does not over-tax limited endoscopy resources. Given the dismal 20% five-year survival associated with esophageal cancer, increased detection and treatment of BE is the best strategy to meaningfully impact esophageal cancer-related mortality."

"We are excited to support this landmark study, continuing our longstanding collaboration with Drs. Amitabh Chak, Sanford Markowitz, and Joseph Willis, principal investigators on the NIH grant, and are gratified that the NIH has committed substantial resources focused on our technology," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "This study has the potential to significantly expand the target population for EsoGuard esophageal precancer testing."

The technology behind EsoGuard and EsoCheck was developed at CWRU and UH by faculty members Sanford Markowitz, M.D., Ph.D., Amitabh Chak, M.D., Joseph Willis, M.D., and Helen Moinova, Ph.D. They have collaborated closely with the Lucid team since Lucid licensed the technologies on an exclusive basis from CWRU in 2018.

About Lucid Diagnostics
Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients.

For more information about Lucid, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com.

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/renowned-investigators-awarded-8-million-nih-grant-to-study-lucid-diagnostics-esoguard-in-at-risk-patients-without-symptomatic-gerd-302387441.html

SOURCE Lucid Diagnostics

FAQ

What is the value and duration of the NIH grant awarded for LUCD's EsoGuard study?

The NIH awarded an $8 million R01 grant for a five-year clinical study.

How many patients will be enrolled in LUCD's new EsoGuard clinical trial?

800 patients without GERD symptoms who meet AGA's risk criteria will be recruited across five research centers.

Which research centers are participating in LUCD's EsoGuard study?

University Hospitals, University of Colorado, Johns Hopkins University, University of North Carolina, and Cleveland Clinic.

What percentage of esophageal cancer cases occur in patients without GERD symptoms?

Nearly half of prevalent esophageal cancer cases occur in patients without GERD symptoms.
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