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Legacy Sponge-on-a-String Esophageal Cell Collection Device Subject of Class II FDA Recall
EsophaCap device recalled due to recent publication of serious device failures Lucid Diagnostics' EsoCheck® unaffected by recall and remains the gold standard
About this update from Lucid Diagnostics Inc.
[{"type":"text","content":"EsophaCap device recalled due to recent publication of serious device failures\nLucid Diagnostics' EsoCheck® unaffected by recall and remains the gold standard for non-endoscopic cell collection\nNEW YORK, May 9, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) (\"Lucid\" or the \"Company\") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (\"PAVmed\"), announced that the legacy EsophaCap sponge-on-a-string (SOS) esophageal cell collection device, which it briefly supplied to third-party institutions for their own research studies, has been subjected to a Class II FDA recall due to two serious device failures reported in a recent publication of one of these studies. EsophaCap is not a commercial Lucid product.\n\n \n \n \n \n \n \n\n \n\"Approximately 16,000 Americans tragically die each year from highly-lethal esophageal cancer. Professional society guidelines now recommend non-endoscopic biomarker testing to detect early esophageal precancer and prevent cancer,\" said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. \"Brillo pad-like sponge-on-a-string (SOS) devices, first introduced in the early 1990s, indiscriminately scrape cells from the stomach, esophagus and mouth, limiting their efficacy. In addition, troubling reports of serious device failures have plagued SOS devices for many years, leading to multiple Class II FDA recalls similar to this one. All SOS devices, including repackaged and/or rebranded versions, have fundamentally the same design and limitations as those that have been previously subjected to FDA recalls.\"\nDr. Aklog added, \"In stark contrast, Lucid's EsoCheck® Esophageal Cell Collection Device, with its patent-protected Collect+Protect™ technology, is a modern groundbreaking technology. EsoCheck allows for precise, targeted collection of cells for esophageal precancer testing using the EsoGuard® Esophageal DNA Test, resulting in unprecedented early precancer detection. EsoCheck's gentle approach to noninvasive cell collection is a dramatic and elegant improvement over decades-old SOS technology. It has proved particularly critical in detecting early short segment precancer (SSBE), which accounts for at least 70% of cases in the at-risk target population and is responsible for at least half of...