PAVmed Subsidiary Lucid Diagnostics Receives FDA 510(k) Clearance for EsoCheck

PAVmed Inc. announced that its majority owned subsidiary, Lucid Diagnostics Inc. has received U.S. Food and Drug Administration (FDA) 510(k) marketing clearance for its EsoCheck Cell Collection Device.
 
“I have spent my career seeking to improve the care of patients with gastroesophageal reflux disease and Barrett’s Esophagus and to prevent deaths from esophageal cancer. I have actively participated in the development of key advances in this field and am particularly excited that EsoCheck is now available as an FDA-cleared tool in our armamentarium. EsoCheck’s unique ability to sample cells from a targeted area of the esophagus has the potential to save lives through the early detection of esophageal abnormalities,” said Nicholas J. Shaheen M.D., MPH, professor of Medicine and Epidemiology and chief of the Division of Gastroenterology and Hepatology at the University of North Carolina School of Medicine, director of American College of Gastroenterology (ACG) Institute for Clinical Research and Education.
 
EsoCheck is a non-invasive cell collection device that is designed to sample cells from a targeted region of the esophagus in a five-minute office-based procedure, without the need for endoscopy. The patient swallows a vitamin pill-sized capsule containing a small inflatable balloon attached to a thin catheter. As the catheter is withdrawn, it swabs the target area for a sample of cells and protects that sample from contamination as the device is removed. The sampled cells can then be subjected to any commercially available diagnostic test. FDA determined that EsoCheck is substantially equivalent to legally marketed predicate devices for its indications for use, namely “the collection and retrieval of surface cells of the esophagus in the general population of adults, 22 years of age or older.”
 
“I am excited to report this major milestone for PAVmed and Lucid,” said Lishan Aklog, M.D., PAVmed’s chairman and CEO and Lucid’s executive chairman. “We are proud to have received FDA clearance for EsoCheck just over one year from the day we founded Lucid and licensed this groundbreaking technology from Case Western Reserve University. We look forward to offering EsoCheck to physicians and patients this summer and believe EsoCheck presents many advantages over existing sponge-on-a-string esophageal cell collection devices. These devices have a capsule which must be digested in the stomach before it can be used to sample cells, while EsoCheck can begin sampling immediately upon insertion. More importantly, EsoCheck’s Collect+Protect technology allows it to perform a targeted sample of the lower esophagus, while spherical sponge-on-a-string devices sample cells from the entire esophagus, throat and mouth which dilutes and contaminates the lower esophageal cells.”
 
PAVmed Inc. is a highly differentiated, multiproduct medical device company employing a unique business model designed to advance products to commercialization much more rapidly and with significantly less capital than the typical medical device company. This proprietary model enables PAVmed to pursue an expanding pipeline strategy with a view to enhancing and accelerating value creation. PAVmed’s diversified pipeline of products address unmet clinical needs encompassing a spectrum of clinical areas with regulatory pathways and market opportunities. Its five lead technologies provide approaches to carpal tunnel syndrome (CarpX), precancerous conditions of the esophagus (EsoGuard/EsoCheck), vascular access (PortIO), pediatric ear infections (DisappEAR) and medical infusions (NextFlo). The company is also developing products in other areas, such as catheters and tissue ablation, while seeking to further expand its pipeline through engagements with clinician innovators and academic medical centers.