Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics said today it finalized a licensing agreement with Case Western Reserve University to commercialize its EsoCheck non-invasive cell sampling device and DNA biomarker test.
The New York-based company said that the EsoCheck device has been shown to effectively and accurately detect Barrett’s Esophagus, which is a precursor to the most common and lethal forms of esophageal cancer caused by Gastroesophageal Reflux Disease.
The EsoCheck test is composed of a pill-sized capsule with a small inflatable balloon attached to a thin catheter. The patient swallows the capsule, which swabs the target area for a sample of cells as it is withdrawn, the company said.
Collected samples are then tested for biomarkers that have been shown to be accurate for detecting Barrett’s Esophagus.
As part of the licensing agreement, PavMed’s Lucid Diagnostics will own the exclusive worldwide right to develop both the device and biomarker test and the associated intellectual property.
“EsoCheck is a revolutionary technology that we believe will save many lives through the early detection of pre-cancerous conditions of the esophagus including Barrett’s Esophagus. We are proud to have been selected to be the exclusive commercial partner of Case Western Reserve University in this important endeavor. Based on the dramatic results of the recently published multicenter clinical study, we believe widespread EsoCheck screening has the potential to have as great an impact on esophageal cancer as widespread Pap screening has had in preventing cervical cancer, targeting an estimated immediately addressable domestic market of several billion dollars,” PavMed chair & CEO Dr. Lishan Aklog said in a press release.
PavMed said that it has launched a multicenter National Institutes of Health study of the EsoCheck, and that it is enrolling patients at Case Western Reserve University Hospital and other healthcare facilities.
“Our multicenter NIH study aims to establish the clinical evidence for EsoCheck’s widespread use as a screening test to detect Barrett’s Esophagus, eventually targeting the estimated 50 million Americans with and without heartburn who are at risk. The EsoCheck device is already being manufactured for human use in clinical trials and the EsoCheck DNA biomarker test is already being performed at a reference laboratory, which expects to receive CLIA certification later this year. As such, we will be able to aggressively pursue EsoCheck commercialization by seeking U.S. Food and Drug Administration (FDA) 510(k) clearance of the cell sampling device and a Laboratory Developed Test designation of the DNA biomarker test. We are targeting the first quarter of 2019 for the launch of the first commercial product in the U.S.,” principal investigator and EsoCheck co-inventor Dr. Amitabh Chak of the Case Western University School of Medicine said in a prepared statement.
Earlier this month, PavMed said that it filed a preliminary prospectus with the SEC for an offering of the rights to buy a new unit in exchange for each share of outstanding common stock.