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Legacy Sponge-on-String Esophageal Cell Collection Device Class II Item FDA Recall

  • The EsophaCap device has been recalled due to recent publication of serious device failures
  • EsoCheck by Lucid Diagnostics® it is not affected by recall and remains the gold standard for non-endoscopic cuvettes
  • collection

NEW YORK , May 9, 2024 /PRNewswire/ — Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid” or the “Company”), a commercial-stage medical diagnostics cancer prevention company and majority shareholder of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (“PAVmed”), announced that its legacy EsophaCap sponge-on-a-string (SOS) esophageal cell collection device, which it briefly provided to third-party institutions for their own scientific research, has been recalled by the FDA Class II due to two major device failures reported in a recent publication of one of these studies. EsophaCap is not a commercial Lucid product.

Lucid Diagnostics Inc.  offers the first and only commercial tools for the universal early detection of esophageal pre-cancerous conditions and cancer - the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device.  (PRNewsfoto/Lucid Diagnostics)

“Each year, approximately 16,000 Americans tragically die from highly lethal esophageal cancer. Professional society guidelines now recommend non-endoscopic biomarker testing to detect early esophageal precancerous disease and prevent cancer,” he says. Lishan Aklog, MD, president and CEO of Lucid. “Brillo’s sponge-on-a-string (SOS) devices, first introduced in the early 1990s, indiscriminately scrape cells from the stomach, esophagus and mouth, limiting their effectiveness. Additionally, disturbing reports of serious device failures have plagued SOS devices for many years leading to multiple Class II failures FDA recalls one similar to this. All SOS devices, including repackaged and/or rebranded versions, have substantially the same design and limitations as those previously subject to the FDA recall.”

Dr. Aklog added, “Unlike Lucid EsoCheck® Device for collecting esophageal cells, thanks to the patented Collect+Protect™ technology, is a modern, groundbreaking technology. EsoCheck allows for precise, targeted collection of cells for pre-cancer testing of the esophagus EsoGuard® Esophageal DNA test, leading to unprecedented early detection of pre-cancer. EsoCheck’s gentle approach to non-invasive cell collection is a dramatic and elegant improvement over decades-old SOS technology. It has proven particularly important in detecting short-segment early pre-malignancy (SSBE), which accounts for at least 70% of cases in the target at-risk population and is responsible for at least half of all future cancers. Unlike most SOS devices, EsoCheck has never caused any serious adverse events or been associated with reported device failures in over 10,000 procedures.”

The technology behind EsophaCap SOS was first approved by the FDA in 1993 and then again in 2020 (K203450). Lucid acquired this technology for research purposes in 2021 and has delivered it to two academic institutions for ongoing studies through early 2022. In a recently published research article on one of these studies, two patients suffered severe device failures, most notably SOS detachment, one of them required invasive endoscopic retrieval. These disconnections were similar to previously reported disconnections of the Cytosponge, SOS cell collection device manufactured by Medtronic, which led to two FDA Class II recalls, including an open global recall in June 2023, which remains in effect. In the latest recall, Medtronic told the FDA that patients “may be at increased risk of sponge detaching from the string when removing the device from the patient, which may lead to device fragments in the patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with primary procedure), supraglottic airway obstruction, and aspirationIn the attached urgent safety notice sent to UK customers, Medtronic said that “Nine (9) customer complaints where the sponge separated from the string while removing the device from the patient. All nine (9) patients underwent an unplanned, urgent secondary intervention (upper GI endoscopy) during which a detached sponge was collected from the stomach or esophagus” in the period from December 2022 to May 2023.

As a documented manufacturer, Lucid has proactively informed the FDA of reported device failures and has concluded that an EsophaCap SOS Class II recall is required, effective April 25, 2024. Notification letters were sent to two research institutions that were equipped with the devices .

About Conscious Diagnostics

Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. (Nasdaq:PAVM). Lucid is focusing on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing precancerous conditions and esophageal cancer. EsoGuard Lucida® Esophageal DNA testing performed on samples collected during a short, non-invasive office procedure using the EsoCheck tool® Esophageal cell collection device – the first and only commercially available tools designed to prevent cancer and cancer-related deaths through widespread, early detection of precancerous esophageal disease in at-risk patients.

More information can be found at www.luciddx.com and more information about parent company PAVmed can be found at www.pavmed.com.

Forward-looking statements

This press release contains forward-looking statements that involve risks and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based on the current beliefs and expectations of Lucid’s management, are subject to risks and uncertainties that could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, but are not limited to, volatility in the price of Lucid’s common stock; general economic and market conditions; uncertainties inherent in research and development, including the costs and time required to bring Lucid products to regulatory compliance; whether regulatory authorities will be satisfied with the design and results of Lucid’s clinical and preclinical studies; whether and when Lucid products are approved by regulators; market acceptance of Lucid products following approval and commercialization; Lucida’s ability to obtain additional funds as needed; and other competitive solutions. Additionally, Lucid continues to monitor the COVID-19 pandemic and its impact on Lucid’s business. These factors are difficult or impossible to predict accurately, and many are beyond Lucida’s control. In addition, from time to time, new risks and uncertainties may emerge that are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid’s future operations, see Part I, Item 1A, “Risk Factors” in Lucid’s most recent Annual Report on Form 10-K filed with the Department of Securities and Exchange Commission Exchange Commission as they may be updated in Part II, Item 1A, “Risk Factors” in any quarterly report on Form 10-Q filed by Lucid Diagnostics after its most recent annual report. Lucid disclaims any intention or obligation to publicly update or revise any forward-looking statements to reflect any changes in its expectations or in events, conditions or circumstances on which those expectations may be based or that may affect the likelihood that actual results will differ from those contained in forward-looking statements.

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SOURCE Lucid Diagnostics


Company codes: NASDAQ-NMS:LUCD, NASDAQ-SMALL:PAVM