Hancock Jaffe’s VenoValve FIH 2-Year Data Suggest Benefit to Treat Chronic Venous Insufficiency

August 19, 2021—Hancock Jaffe Laboratories, Inc. announced that 2-year postimplantation data from the first-in-human (FIH) trial of the company’s VenoValve show promise for the treatment of chronic venous insufficiency (CVI).

As summarized by the company, key highlights of the data for the device include the following:

• Reflux decreased from an average of 1.95 to an average of 0.72, which is a 63% improvement.
• Disease manifestations (measured by revised Venous Clinical Severity Score [VCSS]) decreased from an average of 13.38 to an average of 5.38, which is a 60% improvement.
• Pain (measured by Visual Analogue Scale [VAS]) decreased from an average of 7.25 to an average of 0.50, which is a 93% improvement.
• There were no safety issues or venous ulcer recurrences.

Jorge Ulloa, MD, who is Principal Investigator for the VenoValve FIH trial, presented the findings at the Society for Vascular Surgery (SVS) 2021 Vascular Annual Meeting held August 18-21 in San Diego, California.

Hancock Jaffe stated that the reported data is from a group of eight patients that participated in the VenoValve FIH study and who agreed to participate in a 1-year postimplantation follow-up study. Three additional FIH patients elected to not participate in the postimplantation study but reported no negative VenoValve-related events during the 1-year follow-up period.

The average post-VenoValve implantation time for this cohort of patients is 2 years. The comparative results are based on pre-VenoValve levels compared to the patients’ most recent office visit, noted the company. Additionally, Dr. Ulloa’s SVS slide presentation will be available on the Hancock Jaffe website.

Marc Glickman, MD, who is Senior Vice President and Chief Medical Officer at Hancock Jaffe, commented in the company's press release, “This data is exactly the result that we were looking for as we begin our VenoValve SAVVE pivotal trial. Our patients are continuing to benefit from the VenoValve, with no safety issues and no ulcer recurrences. CVI in the deep venous system has frustrated patients and physicians for decades and our primary investigators for the [Surgical Antireflux Venous Valve Endoprosthesis (SAVVE)] study are as excited and enthusiastic as we are about the upcoming study.”

On August 3, the company announced, that the FDA granted Breakthrough Device designation for the VenoValve.

Additionally, the Company advised that it plans to begin enrollment within the next 60 days for the SAVVE United States pivotal trial of the VenoValve device. Information about participating in the SAVVE trial is available at www.venovalve.com.

The SAVVE trial will include 75 patients at up to 20 sites. The primary endpoints for the SAVVE trial will be the same as for the first-in-human trial: the primary safety endpoint is the occurrence of major adverse events (MAEs) in < 10% of patients at 30 days post-VenoValve implantation. The primary effectiveness endpoint is improvement of reflux ≥ 30% at 6 months after VenoValve implantation. MAEs are defined as the composite of all-cause mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis, or pulmonary embolism. Improvement of VCSS and VAS scores are also included in the SAVVE study as secondary endpoints, stated Hancock Jaffe.