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PAVmed Inc. (Nasdaq: PAVM) is a cutting-edge medical device company focused on bringing innovative medical technologies from concept to commercialization with exceptional speed and efficiency. Headquartered in New York, PAVmed is led by three seasoned medical device entrepreneurs. The company is structured to develop and commercialize a diversified pipeline of breakthrough products that address unmet clinical needs, thereby enhancing and accelerating value creation through a business model centered on capital and time efficiency.
PAVmed operates in a single segment as a medical technology company, with three primary lines of business: Diagnostics, Medical Devices, and Digital Health. Through its majority-owned subsidiary, Lucid Diagnostics Inc. (Nasdaq: LUCD), the company offers products such as the EsoGuard Esophageal DNA Test and the EsoCheck Esophageal Cell Collection Device. These tools are designed for the early detection of esophageal precancer, aiming to prevent esophageal cancer by identifying at-risk patients early.
Another significant subsidiary is Veris Health Inc., which focuses on enhanced personalized cancer care through remote patient monitoring. Veris is developing an innovative implantable physiological monitor that interfaces with the Veris Cancer Care Platform, providing real-time health data to improve patient outcomes.
Recent notable achievements include a partnership between Lucid Diagnostics and the Esophageal Cancer Action Network (ECAN) to promote Esophageal Cancer Awareness Month, highlighting the critical link between chronic heartburn and esophageal cancer. Additionally, Lucid has published positive data from a National Cancer Institute-sponsored clinical validation study, which demonstrated EsoGuard's unprecedented early detection capabilities for esophageal precancer compared to traditional endoscopic methods.
PAVmed's commitment to innovation is further exemplified by its business updates and financial results discussions, providing shareholders and potential investors with transparent insights into the company's operational progress and strategic direction. The company's diversified approach in the medical technology sector positions it as a significant player in advancing healthcare and improving patient outcomes.
Lucid Diagnostics (Nasdaq: LUCD), a commercial-stage cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), has announced its participation in the 2024 Maxim Healthcare Virtual Summit. The event will feature a fireside chat with Dennis McGrath, Lucid's Chief Financial Officer, scheduled for Tuesday, October 15, 2024, at 11:30 AM Eastern Time.
Interested parties can attend the virtual fireside chat by visiting the provided link. Following the conference, a recording of the session will be available on Lucid's investor relations website. This participation demonstrates Lucid's commitment to engaging with investors and sharing insights about their cancer prevention diagnostics business.
Lucid Diagnostics (Nasdaq: LUCD) announced its participation in The MedTech Conference 2024, scheduled for October 15-17 in Toronto, Canada. The company will showcase its EsoGuard® and EsoCheck® technologies in the conference's Innovation Pavilion, offering live demonstrations to attendees. Lishan Aklog, M.D., Lucid's Chairman and CEO, will participate in a CEOs Unplugged event alongside industry leaders. Additionally, Shaun O'Neil, Lucid's President and COO, will deliver the company's presentation at the conference's Investor Forum.
Lucid's presence at the conference, organized by AdvaMed, provides an opportunity to engage with industry leaders, potential partners, and investors. The event is expected to attract over 1,500 companies and attendees from 45 countries, highlighting its significance in the medical technology industry.
Lucid Diagnostics Inc. (Nasdaq: LUCD) held its inaugural #CheckYourFoodTube Precancer Testing Event for former NFL players in Cincinnati, Ohio. The initiative aims to raise awareness about the link between chronic heartburn and esophageal cancer, and promote EsoGuard® Esophageal DNA Test for precancer detection. The event included an educational session and on-site testing for at-risk former NFL players.
Solomon Wilcots, former Cincinnati Bengals player, emphasized the importance of early detection and encouraged fellow athletes to take proactive steps. Dr. Lishan Aklog, Lucid's CEO, highlighted the opportunity to prevent esophageal cancer through awareness and testing. Lucid plans to expand these events to other cities nationwide, targeting former NFL players and their fans who have risk factors such as heartburn, age over 50, male gender, white race, obesity, smoking, or family history.
Lucid Diagnostics Inc. (Nasdaq: LUCD) announced that its EsoGuard® Esophageal DNA Test for early detection of esophageal precancer will be highlighted at the American Foregut Society's (AFS) 2024 Annual Meeting from September 26-28, 2024. Dr. Dan Lister, AFS President-elect, will lead a session titled "Finding Barrett's - Time to Ditch the Scope?" discussing EsoGuard as a non-invasive alternative to screening upper endoscopy.
This follows the AFS's recent open letter advocating for medical policy coverage of EsoGuard by commercial payors, emphasizing its strong scientific evidence and incorporation in AFS physicians' practices. The session will explore EsoGuard's role in triaging at-risk patients and enabling efficient use of endoscopy resources for early detection and prevention of esophageal cancer.
PAVmed Inc. (Nasdaq: PAVM) announced efforts to regain compliance with Nasdaq's listing requirements, including the deconsolidation of Lucid Diagnostics (Nasdaq: LUCD) from PAVmed's financial statements. This move will no longer reflect Lucid's operating losses in PAVmed's consolidated financials, while maintaining PAVmed's holdings of Lucid common stock. The deconsolidation is part of a series of steps to address Nasdaq's determination that PAVmed had not met continued listing standards for 180 consecutive days.
PAVmed also announced board changes, including the appointment of Dr. Sundeep Agrawal, a seasoned biotech investor, to replace departing directors. The company will request a hearing before a Nasdaq Hearings Panel to appeal the delisting determination, expected in October.
Lucid Diagnostics (Nasdaq: LUCD) announced its participation as the sole Diamond Sponsor at the 20th International Society for Diseases of the Esophagus (ISDE) World Congress in Edinburgh, Scotland, from September 22-24, 2024. The company will showcase its EsoGuard® Esophageal DNA Test for early detection of esophageal precancer.
Lucid will host a symposium on Non-Endoscopic Screening for Barrett's Esophagus, chaired by experts Dr. Vani Konda and Dr. Nicholas Shaheen. The panel discussion will include Dr. Vivek Kaul and Dr. Rehan Haidry. This event highlights Lucid's commitment to being a leading voice in esophageal cancer prevention through early detection of precancer.
The ISDE World Congress is a global platform for collaboration and knowledge exchange among experts in esophageal diseases, covering topics such as diagnostics, novel therapies, and latest advancements in the field.
Lucid Diagnostics (Nasdaq: LUCD) has signed a memorandum of understanding (MOU) with Front Line Mobile Health to enhance early detection of esophageal cancer in firefighters. The collaboration aims to expand patient access to Lucid's EsoGuard® Esophageal DNA test through co-marketing initiatives. Firefighters face a 62% higher risk of developing esophageal cancer, making this partnership important for their health and safety.
The MOU builds on Lucid's previous collaboration with Front Line, which facilitated a major #CheckYourFoodTube Precancer Testing Event. By leveraging Front Line's resources and expertise in caring for firefighters, Lucid aims to increase access to esophageal precancer testing and drive revenue through contracted high-volume testing events.
Lucid Diagnostics, a subsidiary of PAVmed, has published an analytical validation study of its EsoGuard® Esophageal DNA test in the peer-reviewed journal Diagnostics. The study demonstrates excellent analytical performance of the EsoGuard assay on samples collected with the EsoCheck® Esophageal Cell Collection Device for diagnosing esophageal precancer (Barrett's Esophagus) and esophageal adenocarcinoma.
Key findings include:
- 89% analytical sensitivity
- 100% analytical specificity
- 96% analytical accuracy
- 100% inter- and intra-assay precision
EsoGuard uses next-generation sequencing to detect DNA methylation at 31 sites on two genes associated with conditions along the BE-EAC spectrum. This study complements EsoGuard's existing clinical validity and utility evidence base.
The American Foregut Society (AFS) has formally requested health insurance providers to update their medical policies to include Lucid Diagnostics' (Nasdaq: LUCD) EsoGuard® Esophageal DNA test as a covered service. This move aims to enhance early detection of esophageal precancer (Barrett's Esophagus) and prevent highly lethal esophageal cancer. The AFS, a leading society of gastroenterologists and surgeons, highlighted the strong scientific evidence supporting EsoGuard as a minimally invasive screening alternative to endoscopy.
The AFS emphasized that expanding access to EsoGuard will empower providers with an essential triage for upper endoscopy, enabling early detection of Barrett's Esophagus. As a point-of-care test in primary care offices, EsoGuard can reduce health disparities in endoscopy access. The society urged immediate coverage of the test, aligning with recent gastroenterology society guidelines and state legislation mandating coverage of such biomarker tests.
PAVmed Inc. (NASDAQ: PAVM) provided a business update and Q2 2024 financial results. Key highlights include:
- Lucid reported record quarterly EsoGuard® test volume of 3,147, up 31% from Q1
- EsoGuard revenue was $1.0 million, up 514% year-over-year
- Veris Health launched a pilot program with The Ohio State's James Cancer Hospital
- Q2 operating expenses were $14.6 million
- GAAP net loss was $10.9 million or $(1.19) per share
- Non-GAAP adjusted loss was $7.7 million or $(0.84) per share
- Cash and equivalents of $25.5 million as of June 30, 2024
The company is focused on strengthening finances by making subsidiaries independently financeable. Lucid remains PAVmed's strongest asset, while Veris Health and PortIO are pursuing independent financing.
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