Benzinga | Jun 10, 2021 09:31AM EDT

PAVmed Reports Its Lucid Diagnostics Completes European CE Mark Certification Of Its EsoGuard Esophageal DNA Test

PAVmed Inc. (NASDAQ:PAVM, PAVMZ))) ("PAVmed"), a highly differentiated, multi-product, commercial-stage medical device company, today announced that its major subsidiary, Lucid Diagnostics Inc. ("Lucid"), has completed European IVDD CE Mark certification of its EsoGuard(r) Esophageal DNA Test ("EsoGuard").

Lucid and its EU authorized representative completed the EC declaration of conformity procedure, including the associated technical documentation, ensuring and declaring that EsoGuard meets the essential requirements of Europe's In-Vitro Diagnostic Medical Devices Directive 98/79/EC ("IVDD"). EsoGuard may now be marketed in CE Mark European countries, which include the European Economic Area (the EU, Norway, Iceland, and Lichtenstein), Switzerland, and, until July 1, 2023, the United Kingdom.

EsoGuard is a molecular diagnostic test, performed on surface esophageal cells collected with Lucid's EsoCheck(r) Cell Collection Device in a brief non-invasive office procedure. It is the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through early detection of esophageal precancer and cancer in at-risk chronic heartburn patients. It has been shown to be highly accurate at detecting these conditions in a 408-patient human study published in Science Translational Medicine.

"We believe Europe will be an important market for EsoGuard and EsoCheck, where chronic heartburn is as ubiquitous, and esophageal cancer as deadly, as it is in the U.S.," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer, and Lucid's Executive Chairman. "We look forward to leveraging the strong relationships we have already built with European key opinion leaders in esophageal disease who are participating in our pivotal clinical trials, and proceeding with a commercial launch in select European countries in the near future."