Hancock Jaffe Laboratories reports objectives for upcoming CoreoGraft study
Hancock Jaffe Laboratories announced its objectives for its upcoming CoreoGraft study at the Texas Heart Institute. The study will begin the week of January 28. The CoreoGraft animal study will focus on short term graft patency and graft viability. Five CoreoGrafts will be surgically implanted over a three-week period and continuously monitored for thirty days for flow rates and patency using transonic probes. The implantable probe will verify flows and patency of the grafts. Following the monitoring part of the trial, the CoreoGrafts will undergo pathology examinations to look for evidence of cellular abnormalities that might lead to failure or impact graft performance. HJLI expects to provide an update after the first implantation. The performance results of the study and the pathology are expected to be released in April of 2019. Provided that the study is successful, Hancock Jaffe would then seek a Pre-FDA meeting to discuss the additional pre-clinical testing that will be necessary for in-human trials. In addition to the CoreoGraft study, HJLI will begin first-in-human testing of its VenoValve(R), a potential cure for severe cases of chronic venous insufficiency, a debilitating condition caused by venous reflux in the lower extremities and which afflicts 4.5 million people in the U.S.