Hancock Jaffe Laboratories receives update on VenoValve application from INVIMA
Hancock Jaffe Laboratories announced that it has received an update from INVIMA in Bogota on the status of Hancock Jaffe's application for its first-in-human trial for the VenoValve. INVIMA officials confirmed that its members have completed their review of the Hancock Jaffe application and have no substantive issues or questions at this time. The next step is for the Hancock Jaffe application to be presented for approval to INVIMA's Medical Device and Other Technologies Committee at its upcoming December meeting. Patient enrollment will begin immediately after the application for the first-in-human trial is approved by INVIMA. At that time, Hancock Jaffe will make arrangements to export the VenoValves to Colombia. VenoValves for the first-in-human trial have been manufactured and inspected, and are ready for shipment. The dates for the first implantations will be announced after INVIMA approval.