Benzinga | May 24, 2021 09:30AM EDT

PAVmed Says Data Presented At Digestive Disease Week 2021 Support Clinical Utility of Co's Subsidiary Lucid Diagnostics' EsoCheck And EsoGuard Technologies

PAVmed Inc. (NASDAQ:PAVM, PAVMZ))))) ("PAVmed"), a highly differentiated, multi-product, commercial-stage medical technology company, and its major subsidiary Lucid Diagnostics Inc. ("Lucid"), today announced that David M. Poppers, M.D. Ph.D., Clinical Professor, Division of Gastroenterology and Hepatology at NYU Grossman School of Medicine, presented data on his team's initial experience using Lucid's EsoCheck(r) Esophageal Cell Collection Device with Collect+Protect(tm) technology ("EsoCheck") and EsoGuard(r) Esophageal DNA Test ("EsoGuard") at the Digestive Disease Week 2021 medical conference, in a presentation entitled EsoCheck/EsoGuard A Novel, Simple, Outpatient Technology for the Early Detection of Esophageal Intestinal Metaplasia, Dysplasia, and Adenocarcinoma.

EsoCheck is an FDA-cleared swallowable balloon capsule catheter which allows a clinician to perform anatomically targeted and protected sampling of surface cells from the esophagus in a less than 5-minute non-invasive office procedure.

EsoGuard is a commercially available molecular diagnostic test which assesses DNA methylation at 31 sites on two genes. EsoGuard has been shown to be highly accurate at detecting esophageal precancer (nondysplastic or dysplastic Barrett's Esophagus, or BE) and esophageal cancer (esophageal adenocarcinoma, or EAC), which are complications of chronic heartburn (gastroesophageal reflux disease, or GERD), in a 408-patient NIH-sponsored clinical trial published in Science Translational Medicine.

Each year, approximately 20,000 U.S. GERD patients develop EAC and over 80% will die within five years. EAC is nearly always invasive at diagnosis and is highly lethal even in its earlier stages. Unfortunately, less than 10% of at-risk GERD patients recommended for screening undergo traditional invasive upper gastrointestinal endoscopy (EGD). The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened according to guidelines and undergone surveillance and curative endoscopic esophageal ablation of dysplastic BE.

Dr. Poppers and his team at NYU Langone Medical Center in New York City used EsoCheck to obtain esophageal cell samples from 99 patients (age range 24-75, median age 50, 78.7% male) over a period of one month and submitted these samples for EsoGuard testing. Of the 79 samples for which results were available, 18 (22.8%) were positive, 54 (68.4%) were negative and 7 (8.7%) were not evaluable due to insufficient DNA. The patients who received positive tests were referred for EGD to confirm their diagnosis and receive the appropriate follow-up or treatment.

"The use of EsoCheck and EsoGuard represent a simple and straightforward technique to screen patients for BE and EAC," according to Dr. Poppers. "The procedure is well tolerated and is typically accomplished in 3 to 5 minutes. It can be easily performed without sedation in an outpatient setting, even as part of an initial clinical visit if warranted. What is noteworthy in this study is that we found instances of patients with BE who might never have been referred for endoscopic screening."

"We are grateful to Dr. Poppers for collecting and presenting these encouraging data from his team's initial experience with EsoCheck and EsoGuard," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer and Lucid's Executive Chairman. "These findings are consistent with our growing real-world clinical experience with EsoCheck and EsoGuard, the first and only commercially available diagnostic technologies capable of serving as a widespread screening tool to prevent deaths through the early detection of esophageal precancer and cancer in at-risk chronic heartburn patients. We believe these tools could have as great an impact preventing esophageal deaths as widespread Pap test screening has had in preventing cervical cancer deaths."

Digestive Disease Week(r) (DDW) is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine, and technology.