NEW YORK– PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical technology company, today announced that its majority owned subsidiary Lucid Diagnostics Inc. (“Lucid”) has begun testing patients referred by primary care physicians (“PCPs”) at three Lucid Test Centers in the Phoenix metropolitan area. Patients with chronic heartburn, also known as gastroesophageal reflux disease (“GERD”), who are referred to the centers undergo a rapid non-invasive office procedure, performed by Lucid-employed clinical personnel, using Lucid’s EsoCheck® Cell Collection Device (“EsoCheck”) to collect surface esophageal cells for its EsoGuard® Esophageal Test (“EsoGuard”).
“This launch represents a major milestone for Lucid and our EsoGuard commercialization efforts,” said Lishan Aklog M.D., PAVmed’s Chairman and Chief Executive Officer and Lucid’s Executive Chairman. “An important pillar of our growth strategy is to expand EsoGuard commercialization across multiple channels by targeting PCPs and consumers, in addition to the gastroenterologists who have been our main target to date. We are excited that PCPs in the Phoenix area can now refer their at-risk GERD patients for a simple, office-based test to detect esophageal precancer before it progresses to esophageal cancer.”
“We believe these Lucid Test Centers will play an important role in expanding EsoGuard referrals as the vast majority of GERD patients are cared for by PCPs, not gastroenterologists. We also believe, based on our analysis, that each center can be operated with very modest fixed costs and attractive margins. After completing the pilot program in Phoenix, we intend to steadily expand our Lucid Test Centers to other metropolitan areas, first in selected Western U.S. states and then nationwide. These test centers will also support the next phase of this pilot program—an EsoGuard Telemedicine Program, operated in partnership with UpScript, our independent third-party telemedicine provider, to accommodate EsoGuard self-referrals from direct-to-consumer marketing.”
Millions of patients with GERD are at risk of developing esophageal precancer and highly lethal esophageal cancer. EsoGuard is a next-generation sequencing based DNA methylation assay performed on esophageal cells collected using Lucid’s EsoCheck device in a less-than five-minute office procedure. Lucid believes EsoGuard and EsoCheck constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths, through the early detection of esophageal precancer in at-risk GERD patients.
The three Lucid Test Centers operate in leased medical office suites located in Scottsdale, Tempe and Glendale, Arizona and are staffed by an EsoCheck-trained nurse practitioner and medical assistant employed by Lucid. Lucid estimates that a single nurse practitioner will be able to perform up to twenty EsoCheck procedures per day and expects each center to cover its personnel and medical office leases costs with only a few tests per week. Lucid has hired its first sales representative specifically tasked with calling on PCPs and whose efforts, working with regional business and market development managers, are now driving EsoGuard referrals to the Phoenix area test centers.
Prior to launching these centers, Lucid established a robust supporting regulatory and compliance infrastructure, including engaging highly experienced, dedicated healthcare regulatory and compliance counsel, adding dozens of new standard operating procedures to its quality management system, and updating elements of its contractual agreement with its CLIA-certified laboratory partner to align with certain regulations. Lucid also established a new Quality & Compliance Committee of its board of directors to provide board-level oversight and recruited Dr. Jacque Sokolov, a highly experienced expert in Board oversight of compliance and quality for public healthcare companies, to serve on its board and chair the committee.
