Patients with chronic heartburn in Phoenix, Denver, Salt Lake City, and Las Vegas can now request video telemedicine doctor assessments and referrals for a fast, office-based EsoGuard test to treat esophageal precancerous lesions before they progress to fatal cancers It is tested
New York--(BUSINESS WIRE)--Lucid Diagnostics Inc. (NASDAQ: LUCD) ("Lucid") is a commercial-stage cancer preventive medical diagnosis company and also PAVmed Inc. (NASDAQ stock) Code: PAVM, PAVMZ) ("PAVmed"), today announced that it has launched the EsoGuard telemedicine program in cooperation with UpScriptHealth, a leading national direct-to-consumer telemedicine company.
Patients with chronic heartburn in the four metropolitan areas of Phoenix, Denver, Salt Lake City and Las Vegas can now access a Lucid-branded web-based telemedicine platform and request that telemedicine doctors managed by the independent UpScriptHealth treat them Video evaluation of his condition. If clinically indicated, the patient will be referred to the local Lucid testing center or other clinical facility that provides rapid, office-based testing to use Lucid's EsoGuard® DNA Esophageal Test ("EsoGuard") to detect precancerous lesions of the esophagus. A direct-to-consumer marketing campaign using radio, television, billboards, and digital media will be launched, tested, and refined in the Phoenix market before entering other Lucid testing center cities.
"Many (if not most) patients with chronic heartburn use widely available, hyped, over-the-counter heartburn medications to treat their symptoms without a doctor’s supervision — completely unaware that they may have precancerous esophageal cancer. Disease and cancer risk,” said Lishan Aklog, MD, Lucid’s chairman and chief executive officer. "An important pillar of our growth strategy is educating consumers about the link between chronic heartburn and esophageal cancer, and the availability of rapid, office-based tests to detect precancerous lesions of the esophagus before it progresses to cancer."
"The launch of Lucid's EsoGuard telemedicine program is a very important milestone. It completes the foundation of our multi-channel EsoGuard commercialization strategy directly targeting primary care physicians (PCP), gastroenterologists and now consumers. We believe Based on the experience of other successful early cancer detection companies, direct-to-consumer telemedicine projects can have a wide range of impacts, accelerate commercialization, and drive long-term growth. We are fortunate to have an ideal partner for UpScriptHealth, which is an online healthcare A pioneer in prescriptions, we have a nationwide network of telemedicine doctors because we want to expand the EsoGuard telemedicine program and the network of Lucid testing centers regionally and nationwide."
The Lucid testing center currently operates in leased medical office suites in three locations in Phoenix and three locations in Denver, Salt Lake City, and Las Vegas. Lucid plans to add an upcoming testing center in the Pacific Northwest, and then steadily expand across the country. Each test center is staffed with clinical staff hired by Lucid, who use Lucid's EsoCheck® cell collection device ("EsoCheck") to collect esophageal cells, which are sent to EsoGuard for testing. Lucid estimates that a nurse practitioner can perform up to 20 EsoCheck procedures per day, and hopes that each center will only need to perform a few tests a week to pay for its staff and medical office rental costs.
Since its launch, the testing center has been seeing patients being referred by their PCP for EsoGuard testing. Now, patients responding to direct-to-consumer participation can request a video telemedicine evaluation through the EsoGuard telemedicine program by contacting 1-888-FOODTUBE or registering on www.EsoGuardConsultation.com. If there are clinical indications, the telemedicine doctor will refer the patient to the Lucid testing center or other clinical institutions for EsoGuard testing. The EsoGuard test results will be reported to the doctor, who will refer the patient for gastroenterological evaluation if necessary.
Millions of patients with GERD are at risk of developing esophageal precancerous lesions and highly fatal esophageal cancer (EAC). More than 80% of EAC patients die within five years of diagnosis, making it the second most deadly cancer in the United States. Even in patients diagnosed with early EAC, the mortality rate is high. In the past 40 years, the incidence of EAC in the United States has increased by 500%, while the incidence of other common cancers has decreased or remained flat. In almost all cases, EAC will progress quietly until it shows new symptoms of advanced disease. All EACs are thought to be caused by precancerous lesions of the esophagus, which occurs in approximately 5% to 15% of high-risk GERD patients. It can monitor whether the early esophageal precancerous lesions have progressed to advanced esophageal cancer, which can be cured by endoscopic esophageal ablation and reliably prevent the progression to cancer.
Millions of GERD patients with multiple risk factors have been recommended by clinical practice guidelines for pre-esophageal cancer screening, including age over 50, male, white, obese, smoking history, and family history of esophageal precancerous lesions or cancer. Unfortunately, less than 10% of people who are recommended for screening have received traditional invasive endoscopic screening. The profound tragedy of EAC diagnosis is that if high-risk GERD patients were screened, and then monitored and cured, possible death could have been avoided. The only missing factor in a viable esophageal cancer prevention plan is the lack of extensive screening tools that can detect precancerous lesions of the esophagus. Lucid believes that EsoGuard and EsoCheck are missing elements and constitute the first and only commercially available test that can be used as a wide-ranging screening tool to early detect esophageal precancerous lesions in patients with high-risk GERD and prevent death from esophageal cancer.
EsoGuard is a bisulfite-converted next-generation sequencing (NGS) DNA test performed on esophageal surface cells collected using EsoCheck. It quantifies the methylation of 31 sites on two genes, vimentin (VIM) and cyclin A1 (CCNA1). The test was evaluated in a 408-patient, multi-center, case-control study published in Science Translational Medicine, and showed more than 90% sensitivity and specificity in detecting esophageal precancerous lesions and cancer . EsoGuard is available in the United States as a laboratory development test (LDT) performed in a CLIA/CAP accredited laboratory.
EsoCheck is a non-invasive swallowable balloon capsule catheter device that has passed FDA 510(k) and CE mark certification. It can sample surface esophageal cells in less than five minutes of office procedures. It consists of a hard plastic capsule the size of a vitamin pill. The capsule is tied to a thin silicone tube. A soft silicone balloon with a textured ridge extends from the tube and gently wipes the cells on the surface of the esophagus. When vacuum suction is applied, the balloon and sampling cells are pulled into the capsule, protecting them from contamination and dilution of cells outside the target area during device withdrawal. Lucid believes that this proprietary Collect+Protect™ technology makes EsoCheck the only non-invasive esophageal cell collection device capable of this anatomical targeted and protective sampling. The samples were sent to Lucid's third-party CLIA-certified laboratory partner by overnight express mail for EsoGuard testing.
Lucid Diagnostics Inc. (NASDAQ: LUCD) is a commercial-stage cancer preventive medical diagnosis company and a subsidiary of PAVmed Inc. (NASDAQ: PAVM). Lucid focuses on millions of patients with gastroesophageal disease (GERD) (also known as chronic heartburn) who are at risk of developing esophageal precancerous lesions and cancer. Lucid's EsoGuard® esophageal DNA test is performed using its EsoCheck® esophageal cell collection device on samples collected through a short non-invasive office procedure. It is the first and only one that can be used as a broad screening tool to prevent cancer and cancer deaths The commercially available diagnostic tests provide early detection of esophageal precancerous lesions in patients with high-risk GERD. EsoGuard is commercialized in the United States as a laboratory development test (LDT). EsoCheck is commercialized in the United States as a 510(k)-cleared esophageal cell collection device. Used together with EsoCheck, EsoGuard was awarded the FDA Breakthrough Device designation and was the subject of two large, actively registered international multicenter clinical trials to support FDA PMA approval. Lucid is building a network of Lucid testing centers where high-risk GERD patients can undergo the EsoCheck program for EsoGuard testing.
This press release contains forward-looking statements. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements are based on the current beliefs and expectations of Lucid management and involve risks and uncertainties that may cause actual results to differ from the forward-looking statements. The risks and uncertainties that may cause such discrepancies include, among other things, fluctuations in the price of Lucid common stock; general economic and market conditions; uncertainties inherent in research and development, including the cost of advancing Lucid's products to regulatory submissions And time; whether regulatory agencies will be satisfied with the design and results of Lucid’s clinical and preclinical studies; whether and when Lucid’s products have been approved by regulatory agencies; once Lucid’s products have been approved and commercialized, market acceptance; according to Lucid The ability to raise additional funds is needed; and other competitive developments. In addition, Lucid has been monitoring the COVID-19 pandemic and its impact on Lucid's business. Lucid predicts that the importance of the COVID-19 pandemic, including its impact on its financial and operational results, will depend on the success of efforts to contain the pandemic and the impact of these efforts on Lucid's business. These factors are difficult or impossible to be accurate It is predicted that many of these factors are beyond Lucid's control. In addition, new risks and uncertainties may appear 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, please refer to Lucid's Registration Statement No. 333-259721 filed with the US Securities and Exchange Commission. Lucid assumes no intention or obligation to publicly update or modify any forward-looking statements to reflect any changes in its expectations or the events, conditions or circumstances on which these expectations may be based, or that may affect the actual results. Different possibilities come from the forward-looking statements Content.
Investor Lisa DeScenza LaVoieHealthScience (617) 351-0243 ldescenza@lavoiehealthscience.com
Media Kristi Bruno LaVoieHealthScience (617) 865-3940 PAVmed@lavoiehealthscience.com
Lucid Diagnostics, a subsidiary of PAVmed, has partnered with UpScriptHealth to launch the EsoGuard telemedicine program.
Investor Lisa DeScenza LaVoieHealthScience (617) 351-0243 ldescenza@lavoiehealthscience.com
Media Kristi Bruno LaVoieHealthScience (617) 865-3940 PAVmed@lavoiehealthscience.com