Hancock Jaffe Prepares for the VenoValve United States Pivotal Trial

February 11, 2021—Hancock Jaffe Laboratories, Inc. announced it has successfully completed a public offering of its securities. The company advised that proceeds from the offering will be used to fund the proposed United States pivotal trial for its VenoValve. The funds will also be used for general working capital purposes. Approximately $41.4 million in gross proceeds were generated from the sale of 5,914,284 shares of common stock and warrants to purchase 2,971,142 common shares in the public offering.

According to the company, VenoValve is intended for the treatment of lower limb chronic venous insufficiency of the deep vein system. The company expects to file an application with the FDA in the first quarter of 2021 to receive investigational device exemption (IDE) approval for commencing the VenoValve United States pivotal trial.

On January 12, the company announced that it had successfully concluded its pre-IDE meeting with the FDA in advance of submitting an IDE application for VenoValve. Topics presented at the meeting included the background and clinical need for the VenoValve, proposed study design, patient monitoring for safety and efficacy, bench testing protocols, and the VenoValve first-in-human (FIH) results.

Hancock Jaffe reported that the proposed protocol for the United States pivotal trial is expected to be very similar to the protocol that was used for the VenoValve FIH study, which was successfully completed at the end of 2020 and which included endpoints for reflux time, Venous Clinical Severity Score (VCSS), Visual Analogue Scale (VAS), and Venous Insufficiency Epidemiological and Economic Study quality-of-life score. Patients enrolled in the FIH study experienced significant improvements in all study endpoints, with no device-related adverse events, noted the company.

Hancock Jaffe expects to propose a single-arm multicenter study of an estimated 75 patients. Depending on the results of the proposed pivotal study and in part because of the positive FIH results, the FDA indicated that the company could be eligible to apply for premarket approval (PMA) to market the VenoValve as early as 6 months after the last patient in the pivotal trial receives the VenoValve implant. The proposed study will also include a multiyear follow-up observation period.

The company advised that it will provide periodic updates regarding site selection, IDE approval, and other factors related to the proposed pivotal trial. In the event that the FDA has no major changes to the pre-IDE testing that has been completed, Hancock Jaffe expects to begin patient enrollment for the United States pivotal trial as early as the end of the second quarter of 2021.

Hancock Jaffe noted that 1-year results from the FIH trial for the VenoValve were released in December 2020. The data demonstrated significant improvement in all study endpoints, including reflux, VCSS, and VAS scoring for chronic pain, with a good safety profile. Interim results from the study were recently published online in Journal of Vascular Surgery by the company’s Chief Medical Officer, Marc H. Glickman, MD, and Jorge H. Ulloa, MD.