Patients diagnosed with esophageal adenocarcinoma (EAC) have a 5-year survival rate of only 20 percent. The main treatment for esophageal cancer is esophagectomy – a century-old procedure that requires significant surgical expertise – and the procedure alone carries a mortality rate as high as 18 percent. The most important risk factor for EAC is Barrett’s Esophagus (BE). There are no known options for reversal of Barrett’s disease in its early and more advanced stages. Currently, the standard of care for BE is endoscopic surveillance to detect early neoplasia. Although surgical removal of BE is possible, it is associated with a high risk of stricture, but applying a new material called Esophagel™ could mitigate this risk by providing favorable conditions for the esophagus to heal.

Technology Description

Esophagel™ is a hydrogel derived from the extracellular matrix (ECM) of tissues. The hydrogel is a liquid at room temperature and forms a gel at body temperature (37°C). It adheres to the esophageal mucosa. The components of the ECM can control inflammation and provide a normal favorable environment for cells. The hydrogel can be delivered to the esophagus by minimally invasive methods such as endoscopy or oral administration. Esophagel™ has beneficial effects such as the mitigation of scarring and stricture and the control of the immune response.

Advantages

  • Improves patient outcome and reduces cost by enabling earlier intervention
  • Modulates esophageal cell behavior and key signaling pathways
  • Can be administered orally or endoscopically to the mucosa or submucosal space
  • Forms stable get within 5 minutes and is muco-adhesive
  • Strong intellectual property position (2 issued patents, 3 in prosecution)

Applications

  • Treatment of Barrett’s Esophagus
  • Prevention of stricture after esophageal mucosal dissection
  • Submucosal fluid cushion for endoscopic mucosal resection – endoscopic submucosal dissection

IP Status

Granted patents for gelation method and production of ECM, a patent for sterilization of material is pending, and a provisional patent is filed for use of ECM in esophageal applications.

Stage of Development

Proof of concept experiments for submucosal fluid cushion application are complete. Clinically relevant pre-clinical studies for reversal/mitigation of Barrett’s disease and for prevention of stricture after resection are currently in progress. FDA pre-submission is in preparation.

Notable Mentions

  • Pitt Innovation Challenge (PInCh) 2016 winner ($100,000)