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PAVmed, Case Western Reserve University sign licensing deal for EsoCheck technology

Published 15 May 2018

Multi-product medical device company PAVmed has signed a definitive licensing agreement with Case Western Reserve University to develop and commercialize its EsoCheck technology.

EsoCheck is a rapid office-based alternative to diagnostic endoscopy that combines a non-invasive cell sampling device with a DNA biomarker test.

Together these have been shown to be highly accurate in detecting Barrett’s Esophagus, the primary precursor to the most common and lethal form of esophageal cancer caused by Gastroesophageal Reflux Disease (GERD), commonly known as heart burn or acid reflux.

In a simple five-minute test, the patient swallows a vitamin pill-sized capsule containing a small inflatable balloon attached to a thin catheter. As the catheter is withdrawn, it swabs the target area for a sample of cells and protects that sample from contamination as the device is removed.

The sample is then tested for a panel of methylated DNA biomarkers that have been shown to be highly accurate in detecting Barrett’s Esophagus. These data were recently published in a seminal report on a multicenter human clinical study (Moinova, et al. Science Translational Medicine 2018 Jan 17;10(424)).

Pursuant to the licensing agreement, newly-formed PAVmed subsidiary Lucid Diagnostics Inc. now owns the exclusive worldwide right to develop and commercialize both the EsoCheck cell sampling device and the DNA biomarker test, as well as additional related intellectual property.

PAVmed Chairman and CEO Lishan Aklog said: “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.”

A large multicenter National Institutes of Health (NIH) study of EsoCheck is underway and actively enrolling patients at Case Western Reserve University Hospital and other leading academic medical centers including the Cleveland Clinic, Johns Hopkins, Mayo Clinic, Washington University St. Louis and the University of North Carolina.

Esophageal adenocarcinoma (EAC) is the most common cancer of the esophagus whose incidence has risen many fold over recent decades. Its prognosis remains dismal with a five-year survival of less than 20%.

The primary cause of EAC cancer is GERD, commonly known as heartburn or acid reflux, where stomach acid refluxes into the lower esophagus.

According to published epidemiological data, an estimated 15-30% of adults suffer from GERD symptoms at least once per week. Repeated exposure of the lower esophagus to refluxing acid can lead to Barrett’s Esophagus, a transformation of the lower esophageal lining, which is a precursor to precancerous dysplasia and ultimately EAC cancer itself. Nearly all patients diagnosed with EAC cancer have evidence of Barrett’s Esophagus, but only 10% have it detected prior to EAC cancer. Barrett’s Esophagus can be successfully treated, usually with non-surgical approaches, if detected before EAC cancer develops.

The EsoCheck kit includes a cell-sampling device consisting of a vitamin pill-sized, silicone-covered capsule containing a small deflated balloon attached to a thin silicone catheter.

In a five-minute, office-based test, the patient swallows the capsule until it reaches the stomach, at which point the balloon is inflated with air. As the catheter is withdrawn, the balloon swabs the lower esophagus for cells. After a specified distance, the balloon is deflated, pulling the cell sample into the capsule, which protects it from dilution or contamination as it passes back through the upper esophagus and mouth.

DNA is extracted from the cells and tested for a panel of methylated DNA biomarkers (mVIM and mCCNA1) developed by the laboratory of EsoCheck co-inventor Sanford Markowitz, M.D., Ph.D., the Ingalls Professor of Cancer Genetics, medical oncologist at University Hospitals Seidman Cancer Center, NCI Outstanding Investigator Awardee, and head of the NIH-Case GI Cancers Program of Research Excellence (GI SPORE) and GI cancer genetics program at the Case Comprehensive Cancer Center.

Pursuant to the definitive licensing agreement, Case Western Reserve University has granted Lucid Diagnostics Inc., a PAVmed subsidiary, an exclusive perpetual worldwide license of the intellectual property rights for the EsoCheck cell sampling device and DNA biomarker test and all derivatives.

The licensed portfolio includes additional biomarkers under a broad field of use for “the detection of changes in the esophagus for screening, diagnosing, disease staging, disease monitoring and disease prognosis.”

In return, Case Western Reserve University and its faculty inventors have received a non-cash license fee in the form of a minority equity interest in Lucid Diagnostics, with PAVmed retaining an approximately 82% equity interest.

The agreement will be subject to certain regulatory and commercialization milestones, with the university receiving royalties based on revenue and a specified portion of any additional proceeds.

Source: Company Press Release