Medical device company PAVmed has finalised its definitive licensing agreement with Case Western Reserve University for the development and commercialisation of EsoCheck technology to diagnose Barrett’s Esophagus.
Originally proposed in April this year, the deal involves the grant of an exclusive worldwide licence by the university to a newly-formed PAVmed subsidiary, Lucid Diagnostics.
The licensed portfolio consists of additional biomarkers to detect changes in the oesophagus for screening, diagnosis, disease staging, monitoring and prognosis.
In turn, the university received a minority equity stake in Lucid Diagnostics, while PAVmed retained around 82% of the equity interest.
The deal is subject to select regulatory and commercialisation milestones, and the university is eligible for royalties based on revenue and a certain proportion of any additional proceeds.
EsoCheck is comprised of a non-invasive cell sampling device and a DNA biomarker test that demonstrates high accuracy in detecting Barrett’s Esophagus, an oesophageal condition which could lead to cancer.
The office-based alternative to endoscopy can be performed in five minutes and involves the administration of a silicone-covered capsule that carries a small inflatable balloon linked to a thin catheter.
During withdrawal, the catheter swabs the target site for a sample of cells and protects it against contamination while the device is retracted.
The obtained sample is tested for a panel of methylated DNA biomarkers that have been validated to be accurate in detecting Barrett’s Esophagus.
EsoCheck is being evaluated in a multi-centre National Institutes of Health (NIH) study in patients at Case Western Reserve University Hospital and other academic medical centres across the US.
PAVmed chairman and CEO Lishan Aklog said: “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 commercialisation by seeking US Food and Drug Administration (FDA) 510(k) clearance of the cell sampling device and a Laboratory Developed Test designation of the DNA biomarker test.”
The company intends to commercially launch EsoCheck in the US in the first quarter of next year.