Benzinga | May 26, 2021 09:31AM EDT

PAVmed Subsidiary Lucid Diagnostics Receives CE Mark Certification For Its EsoCheck Device

PAVmed Inc. (NASDAQ:PAVM, PAVMZ))) ("PAVmed"), a highly differentiated, multi-product, commercial-stage medical device company, and its major subsidiary Lucid Diagnostics Inc. ("Lucid"), today announced that Lucid's EsoCheck(r) Esophageal Cell Collection Device with Collect+Protect(tm) technology ("EsoCheck") has received CE Mark certification.

EU-based Notified Body T?V Rhineland LGA Products GMBH issued a CE Certificate, effective May 24, 2021, declaring that EsoCheck conforms to the essential requirements of Medical Device Directive 93/42/EEC. With CE Mark secured, EsoCheck 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.

EsoCheck is an FDA-cleared swallowable balloon capsule catheter, which allows a clinician to sample surface cells from the esophagus in a less than 5-minute non-invasive office procedure, the only such device capable of doing so in an anatomically targeted fashion, without sample dilution or contamination (EsoCheck animation). EsoCheck, paired with Lucid's EsoGuard(r) Esophageal DNA Test ("EsoGuard"), are 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. As a "General IVD" under Europe's In-Vitro Diagnostic Medical Devices Directive 98/79/EC, EsoGuard only requires self-certification, which Lucid and its authorized representative expect to complete in the very near future.

"Chronic heartburn is as ubiquitous, and esophageal cancer as deadly, in Europe as it is in the U.S. so this certification represents yet another important milestone in our mission to prevent deaths through the early detection of esophageal precancer and cancer," said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer, and Lucid's Executive Chairman. "Lucid has already developed strong relationships with European key opinion leaders in esophageal disease who are participating in our pivotal clinical trials. We look forward to leveraging these relationships and proceeding with a commercial launch in select European countries in the near future."