Pavmed (NSDQ:PAVM) announced today that its majority-owned subsidiary Lucid Diagnostics entered into a clinical trial research agreement with the University of Pennsylvania to observe its EsoCheck esophageal cell collection device.
EsoCheck with “collect & protect technology” is designed to offer a less invasive, more efficient and cost-effective alternative to endoscopic biopsies when managing patients with eosinophilic esophagitis (EoE). Pavmed sees it as a way to replace endoscopy with a non-invasive device for patients with a condition requiring multiple and frequent invasive endoscopies with biopsies.
The device has FDA 510(k) clearance to sample cells from a targeted region of the esophagus in a five-minute office-based procedure, eliminating the need for endoscopy. According to a news release, EsoCheck was initially designed to facilitate the diagnosis of Barrett’s esophagus with Lucid’s EsoGuard esophageal DNA test, but it can be used to sample the esophageal cells to help diagnose and manage any esophageal condition.
Lucid’s agreement with Penn is slated to cover a research program called “Pilot Study of EsoCheck Compared to Biopsies and Brush Cytology During Endoscopy for Evaluation of Eosinophilic Esophagitis” led by Dr. Gary Falk, a professor of gastroenterology at the university.
“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,” Pavmed chairman & CEO Dr. Lishan Aklog, who is also Lucid’s executive chairman, said in the news release. “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.”