PAVmed Inc. has recently announced that Lucid Diagnostics has entered an agreement with UPenn (University of Pennsylvania) to perform clinical trial research for its EsoCheck device. Lucid Diagnostics is a subsidiary of PAVmed, a highly-differentiated multi-product medical device producer. The clinical trial agreement is designed to observe EsoCheck, Lucid’s esophageal cell collection/sampling device.

The clinical trial will assess this device (EsoCheck), with ‘collect and protect technology’, as a cost-effective, less invasive, and more efficient alternative to conventional means such as endoscopic biopsies for the treatment of patients with EoE (eosinophilic esophagitis). The non-invasive device is seen as a replacement for endoscopy, to avoid the necessity of EoE patients to go through several invasive biopsies & endoscopies.

EsoCheck is an FDA 510(k)-cleared, non-invasive device to collect cell and tissue samples from the targeted esophageal region. This office-based, 5-minute procedure can eliminate the patients’ need to go through the invasive procedure of endoscopy.

Sources familiar with the matter have stated that this device was primarily designed in conjunction with EsoGuard, a DNA test used primarily to identify biomarkers for diagnosing Barrett’s esophagus. However, the uses of the test were later expanded, and it is now also used to collect esophageal cell samples as well as manage & diagnose various esophageal conditions, including EoE.

The Lucid-UPenn agreement will involve an ‘EsoCheck Compared to Biopsies and Brush Cytology During Endoscopy for Evaluation of Eosinophilic Esophagitis’ pilot study led by gastroenterology professor at UPenn, Dr. Gary Falk.

Dr. Lishan Aklog, chairman & CEO of PAVmed and executive chairman of Lucid, has reportedly stated that the clinical trial agreement is indicative of the significant potential of Lucid’s versatile device, EsoCheck, for esophageal cell-collection, with other applications and usage. It is the only device that is capable of implementing protected and targeted esophageal cells sampling, and is also anticipated to prove as an efficient solution for managing eosinophilic esophagitis.

Source credit:

https://www.massdevice.com/pavmeds-lucid-diagnostics-enters-clinical-trial-with-u-of-penn/