Lucid Diagnostics, Penn State to Evaluate EsoCheck in Eosinophilic Esophagitis Patients

PAVmed Inc., a multiproduct medical device company, announced that its majority owned subsidiary, Lucid Diagnostics Inc., has entered into a clinical trial research agreement with the University of Pennsylvania (Penn) for a clinical trial designed to evaluate whether Lucid’s EsoCheck Esophageal Cell Collection Device with Collect+Protect Technology (EsoCheck) provides a less invasive, more efficient, and cost-effective alternative to endoscopic biopsies in the management of patients with Eosinophilic Esophagitis.
 
Eosinophilic esophagitis (EoE) is a rapidly emerging allergy-mediated inflammatory condition of the esophagus similar to and often associated with inflammatory bowel disease (IBD). Although underappreciated by the medical community and frequently confused with gastroesophageal reflux disease (GERD), EoE has a prevalence comparable to IBD and exacts a significant burden on patients. It can lead to swallowing difficulties, esophageal scarring, food impaction and pain. Current treatment includes oral steroids and an elimination diet. Since inflammation can persist despite resolution of symptoms, treatment courses can be very difficult and costly for patients, requiring multiple and frequent invasive endoscopies with biopsies. To date efforts to replace endoscopy with a non-invasive diagnostic device have proven unsuccessful.
 
EsoCheck is a U.S. Food and Drug Administration 510(k)-cleared non-invasive device designed to sample cells from a targeted region of the esophagus in a five-minute office-based procedure, without the need for endoscopy. Although EsoCheck was originally designed to facilitate the diagnosis of Barrett’s Esophagus in conjunction with Lucid’s EsoGuard Esophageal DNA Test, it can also be used to sample esophageal cells to assist in the diagnosis and management of any esophageal condition including EoE.

Watch a video about the EsoCheck device here.
 
The Lucid-Penn agreement covers a research program entitled “Pilot Study of EsoCheck Compared to Biopsies and Brush Cytology During Endoscopy for Evaluation of Eosinophilic Esophagitis” (the Study) led by principal investigator Gary W. Falk, M.D., M.S., AGAF. Dr. Falk is a professor of Gastroenterology, the clinical co-director of the Joint Center for Digestive, Liver and Pancreatic Medicine at the Perelman School of Medicine at the University of Pennsylvania, and the co-director of the Penn Medicine Esophageal and Swallowing Center at the Hospital of the University of Pennsylvania. He is also a director of the International Society for Diseases of the Esophagus and past president of the American Society of Gastrointestinal Endoscopy (ASGE).
 
“We are excited to partner with Dr. Falk and his team at the University of Pennsylvania to explore yet another application for our versatile EsoCheck Cell Collection Device, the only esophageal cell collection device capable of performing targeted and protected sampling of esophageal cells” said Lishan Aklog, M.D., PAVmed’s chairman and CEO and Lucid’s executive chairman. “Dr. Falk is one of the world’s leading experts on EoE and we hope this research partnership will yield results that can dramatically improve the care of long-suffering EoE patients.”
 
The trial is a prospective cross-sectional pilot feasibility study of ten patients with suspected or established EoE scheduled for a clinically indicated upper endoscopy. The patients will undergo esophageal sampling using EsoCheck followed by endoscopy, including brushings and biopsies. The primary endpoint of the trial is the sensitivity and specificity of EsoCheck versus endoscopic biopsy in the assessment of EoE.
 
“There is a major unmet need for the development of non-invasive tools as an alternative to standard endoscopy in the management of EoE. I am excited to partner with Lucid on this important investigator initiated clinical trial,” said Dr. Falk. “I approached Lucid to collaborate on this project because EsoCheck is a new device capable of collecting esophageal cells without dilution and contamination. EoE is an important condition which can result in significant complications and impairment in quality of life that merits active treatment with close monitoring. Our EoE patients very much need an alternative to multiple and frequent endoscopies to monitor and tailor their treatment program. I look forward to evaluating the data derived from the trial and evaluating the potential of using EsoCheck as part of a non-invasive EoE monitoring program.”