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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.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) announced a partnership through its subsidiary, Lucid Diagnostics Inc., with UpScriptHealth to launch the EsoGuard Telemedicine Program. This program aims to provide chronic heartburn patients with remote evaluations and referrals for the EsoGuard Esophageal DNA Test. Initially launching in Arizona, the program is expected to expand nationwide, enhancing patient access to early detection of esophageal cancer. CEO Lishan Aklog emphasizes the significance of addressing healthcare gaps and promoting awareness regarding chronic heartburn's link to esophageal cancer.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) appoints Tim Baxter, former President of Samsung Electronics North America, to its Board of Directors, enhancing its leadership with a seasoned technology expert. Baxter, who will chair the Nomination Committee, brings extensive experience in innovation and business strategy, with a focus on technology integration in healthcare. Concurrently, David Battleman and David Weild IV are stepping down from the Board. This change aims to leverage Baxter's expertise to drive growth through PAVmed's digital health initiatives and products aimed at improving patient care.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) announced the completion of European IVDD CE Mark certification for its EsoGuard® Esophageal DNA Test through its subsidiary, Lucid Diagnostics Inc. This certification allows EsoGuard to be marketed across CE Mark European nations, including the EU and Switzerland. EsoGuard is the first molecular diagnostic test for early detection of esophageal precancer and cancer, proving highly accurate in a study of 408 patients. PAVmed's CEO anticipates Europe as a significant market due to the prevalence of chronic heartburn and esophageal cancer.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) has launched a new subsidiary, Veris Health Inc., which has acquired Oncodisc Inc., an oncology digital health company. This acquisition aims to enhance personalized cancer care through a novel implantable vascular access port with biologic sensors and a digital health platform. Veris is targeting a $2 to $3 billion market, focusing on remote patient monitoring and subscription-based revenue models. The management anticipates significant synergies with existing infrastructure and aims for FDA clearance of its products by mid-2022.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) announces that its subsidiary, Lucid Diagnostics, has received CE Mark certification for the EsoCheck® Esophageal Cell Collection Device. Effective May 24, 2021, this certification allows EsoCheck to be marketed in CE Mark countries, including the EU and the UK until July 1, 2023. EsoCheck is a unique, FDA-cleared device enabling non-invasive sampling of esophageal cells, aimed at early detection of esophageal cancer. The company plans to initiate a commercial launch in select European markets in the near future.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) has received CE Mark certification for its CarpX® device, enabling its marketing in European countries. The certification, issued by TÜV Rhineland LGA Products GMBH, confirms the device's compliance with European medical device regulations, effective May 24, 2021. CarpX is a minimally invasive tool for treating carpal tunnel syndrome, which promises reduced recovery times. The company anticipates a robust market opportunity in Europe, matching that of the U.S. as it moves towards a commercial launch.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) presented promising data on its diagnostic tools, EsoCheck® and EsoGuard®, for detecting esophageal precancer in chronic heartburn patients. Data from 99 patients showed a 22.8% positive detection rate for precancerous cells. The study highlights the ease of use and efficiency of the non-invasive EsoCheck procedure, which can be performed without sedation. CEO Lishan Aklog emphasized the potential impact of these tools in preventing esophageal cancer deaths, akin to the role of Pap tests in cervical cancer detection.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) reported a net loss of $9.5 million for Q1 2021, or $(0.13) per share, contrasted with a loss of $14.5 million in the same period last year. Cash reserves increased to $49 million, sufficient to fund operations into 2023. The company's subsidiary, Lucid Diagnostics, is expanding its commercial team to enhance EsoGuard® testing and plans to go public with a controlling majority retained by PAVmed. Lucid processed 78 EsoGuard tests in Q1 and aims to launch three test centers in Phoenix, AZ. Further, they are engaged in international clinical studies and regulatory submissions.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) announced that Dr. David Poppers will present initial findings on Lucid’s EsoCheck® and EsoGuard® at the Digestive Disease Week 2021 conference, taking place virtually from May 21-23. Dr. Poppers, a Clinical Professor at NYU Langone Medical Center, will address the early detection of esophageal intestinal metaplasia, dysplasia, and adenocarcinoma. The conference is the largest event in the gastroenterology field, sponsored by prominent medical associations.
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) announces the expansion of its commercial leadership team at Lucid Diagnostics Inc. with the addition of four experienced executives. This move aims to support the growth strategy focused on the EsoGuard® Esophageal DNA Test's commercialization across multiple channels. Key appointments include John Rubano as Director of Sales, John Ridge as VP of Market Access and Reimbursement, Brian Denney as National Sales Training Manager, and Paul Wickern as Strategic Accounts Manager. Together, they bring over 75 years of combined experience to enhance market penetration and reimbursement efforts.
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