Lucid Diagnostics Chairman & CEO, Dr. Lishan Aklog, Highlights EsoCheck® Esophageal Cell Collection Device during Congressional Testimony
- Lucid Diagnostics Inc. showcases EsoCheck's advanced cell collection technology during a Congressional testimony.
- EsoCheck's Collect & Protect® technology enables precise, noninvasive esophageal cell collection.
- The device leads to unprecedented early precancer detection results and high patient satisfaction.
- EsoCheck's efficiency allows for high-volume testing events with excellent DNA yields.
- Data from nearly 1,500 patients undergoing EsoCheck cell collection show a 98% success rate.
- EsoGuard® Esophageal DNA Test, using samples collected with EsoCheck, demonstrates exceptional esophageal precancer and cancer detection results.
- Contrastingly, 'sponge-on-a-string' technologies lack EsoCheck's precision and protection features.
- Older technologies show poor sensitivity and cases of mechanical failure in studies.
- SOS devices lack the ability to anatomically target cell collection and protect cells from contamination.
- No negative aspects were highlighted in the press release.
Insights
The technology behind Lucid Diagnostics' EsoCheck represents a significant advancement in the early detection of esophageal precancer and cancer. From an oncological perspective, the ability to collect cells in a targeted manner without invasive procedures is a substantial improvement. It minimizes patient discomfort and risk and it is likely to increase patient compliance with screening recommendations. The high DNA yield and patient satisfaction scores reported suggest that EsoCheck could become a standard tool in esophageal cancer prevention strategies. Early detection is crucial in improving cancer outcomes and EsoCheck's precision could potentially lead to earlier interventions and better survival rates for patients with esophageal precancerous conditions.
The data presented on EsoCheck's effectiveness in cell collection and the subsequent use of EsoGuard for DNA testing is compelling. The reported 98% success rate in cell collection and the positive patient responses indicate robust performance of the device. Moreover, the absence of mechanical failures reinforces the reliability of the technology. The transition to a high-volume, low-cost contract manufacturer in 2022 could also suggest a strategic move to scale up production in anticipation of growing demand, which may impact Lucid Diagnostics' market share and profitability positively. Investors should monitor peer review outcomes of the BETRNet consortium's data for further validation that could drive adoption rates.
Lucid Diagnostics' positioning of EsoCheck in the market is noteworthy. The contrast with older 'sponge-on-a-string' technologies, which have shown poor sensitivity and mechanical failure issues, underscores EsoCheck's competitive edge. The market for noninvasive diagnostic tools is expanding and Lucid's FDA clearance for EsoCheck places them at a vantage point within this niche. This technological edge, combined with strategic manufacturing decisions, sets the stage for potential market expansion and increased investor interest. The focus on patient access to innovative medical technology aligns with current healthcare trends favoring noninvasive and patient-friendly diagnostic options, which may lead to broader insurance coverage and reimbursement policies favoring EsoCheck's adoption.
Contrasts EsoCheck's powerful cell collection capabilities to "cruder, decades-old" technologies during comments on patient access to medical technology innovation
"EsoCheck is a deceptively simple tool which allows precise, targeted collection of lower esophageal cells for precancer testing," Dr. Aklog said. "EsoCheck's gentle approach to noninvasive cell collection is a dramatic and elegant improvement over cruder, decades-old technology, which involves dragging a Brillo Pad-like 'sponge-on-a-string', indiscriminately scraping cells from the stomach, esophagus and mouth." Dr. Aklog further noted, in separate comments, that "EsoCheck's advanced features are a major contributor to EsoGuard's unprecedented early precancer detection results."
EsoCheck and its patented, groundbreaking Collect & Protect® technology was invented by physician scientists at Case Western Reserve University, licensed by Lucid in 2018, and received FDA clearance in 2019. Manufacturing was transferred to a high-volume, low-cost contract manufacturer in 2022. EsoCheck is a vitamin pill-sized capsule containing a soft silicone balloon attached to a thin silicone catheter. When the balloon is inflated, subtle ridges on its surface are exposed, which permit gentle swabbing of the cells from the lower esophagus where esophageal precancer and cancer occur. When deflated, the balloon retracts into the capsule, protecting the sample from dilution and contamination by cells outside the target area during retrieval. Collect & Protect® technology allows precise, anatomically targeted collection of esophageal cells in a doctor's office, in less than two minutes, without the need for anesthesia or sedation. The efficiency of the cell collection process has allowed EsoCheck to be used in dozens of high-volume precancer testing events over the past year, with a single operator able to sample up to fifty patients in a day. No mechanical failures of the EsoCheck device have been reported to date. Data on nearly 1,500 patients undergoing EsoCheck cell collection, presented at Digestive Disease Week 2023, showed that
So-called "sponge-on-a-string" ("SOS") technologies were introduced in the early 1990's, as an alternative to invasive upper gastrointestinal endoscopy, with the launch of the EsophaCap® device (which Lucid acquired in 2022). A large medical device company briefly marketed the Cytosponge® device in conjunction with Trefoil Factor 3 (TFF-3), a non-molecular, conventional immunohistochemical test, before withdrawing it from the U.S. market. Data presented in 2021 from a
About Lucid Diagnostics
Lucid Diagnostics Inc. is a commercial-stage medical diagnostics company focused on cancer prevention, and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck Esophageal Cell Collection Device, is the first and only commercially available diagnostic test capable of serving as a widespread screening tool for at-risk patients to mitigate the risks of cancer and cancer deaths through early detection of esophageal precancer.
For more information, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com.
Forward-Looking Statements
This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid's clinical and preclinical studies; whether and when Lucid's products are cleared by regulatory authorities; market acceptance of Lucid's products once cleared and commercialized; Lucid's ability to raise additional funding as needed; and other competitive developments. In addition, Lucid continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid's businesses. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid's control. In addition, new risks and uncertainties may arise from time to time and 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 Securities and Exchange Commission, as the same 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 statement to reflect any change 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 the forward-looking statements.
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SOURCE Lucid Diagnostics
FAQ
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