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PAVmed Subsidiary Lucid Diagnostics Partners with University of Pennsylvania to Evaluate EsoCheck™ in Eosinophilic Esophagitis (EoE) Patients
Study to assess EsoCheck as a less invasive, more efficient, and cost-effective alternative to endoscopic biopsies for rapidly emerging allergy-mediated
About this update from Pavmed Inc.
[{"type":"text","content":"Study to assess EsoCheck as a less invasive, more efficient, and cost-effective alternative to endoscopic biopsies for rapidly emerging allergy-mediated condition which currently requires multiple and frequent invasive endoscopies\n NEW YORK, March 02, 2020 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today announced that its majority owned subsidiary, Lucid Diagnostics Inc. (“Lucid”), 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 an FDA 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. (EsoCheck animation). 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. The Lucid-Penn agreement covers a research program entitled “Pilot Study of EsoCheck Compared to Biopsies and Brush Cytology During Endoscopy for ...