Hancock Jaffe Laboratories (NSDQ:HJLI) said today that it won regulatory approval from Colombia’s INVIMA, the country’s FDA equivalent, to launch a first-in-human trial of its VenoValve device.
The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg vein valves after deep vein thrombosis, the Irvine, Calif.-based company said.
Hancock Jaffe said it is now making arrangements to export VenoValves into Colombia, as well as to begin screening and enrollment of patients in the study. The company said it will provide an update once initial patient enrollment is completed and implantation dates are set.
The study aims to initially enroll between five and 10 patients who suffer from severe chronic venous insufficiency, the company said.
“The first quarter of 2019 will be monumental for our company as we begin the VenoValve study in Bogota, and the CoreoGraft study at the Texas Heart Institute. The knowledge gained from in-human testing of the VenoValve will be invaluable for the continued development of the product and will provide us with the feedback to make any necessary product modifications before approaching the FDA regarding our U.S. pivotal trial,” CEO Robert Berman said in a press release.
In November, Hancock Jaffe said that Colombia’s INVIMA completed their review of the company’s application for a first-in-human trial of its VenoValve.
