Hancock Jaffe Laboratories Receives FDA Breakthrough Designation for VenoValve

Hancock Jaffe Laboratories Inc., a developer of medical devices that restore cardiac and vascular health, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation status to the VenoValve, the Company’s lead product, which is currently set to begin its U.S. pivotal trial. The FDA’s Breakthrough Devices Program was established to enable priority review for devices that provide more effective treatment or diagnosis of life threatening or irreversibly debilitating diseases or conditions.   
 
The VenoValve is a potential treatment for a condition called Chronic Venous Insufficiency (CVI), a disease that afflicts approximately 2.4 million people in the U.S. CVI occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and creating increased pressure inside of the veins of the leg (venous hypertension). CVI is a debilitating condition that can make everyday tasks such as bathing, sleeping, and walking extremely difficult for patients. There are currently no effective treatments for deep venous CVI.
 
“We are very pleased to have the opportunity to work with the FDA on an expedited basis as we try to bring relief to the millions of patients who suffer from deep venous CVI and who currently have no effective treatment options,” said Hancock Jaffe CEO Robert Berman. “The VenoValve significantly improved the lives of the patients in our first-in-human study, and we hope to replicate that success in our SAVVE U.S. clinical trial.”   
 
Data from the VenoValve first-in-human study, presented in December of 2020, indicated that average patient improvement in reflux was 54 percent, average improvement in disease manifestations (measured by rVCSS scores) was 56 percent, and average improvement in pain (measured by VAS scores) was 76 percent, all at one-year post-VenoValve surgery compared to pre-surgery levels. In addition, there were no material adverse events (MAEs) at 30 days post-VenoValve implantation.   
 
The primary endpoints for the Company’s SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial will be the same as for the first-in-human trial: the primary safety endpoint is the occurrence of MAE in less than 10 percent of patients at 30 days post-VenoValve implantation, and the primary effectiveness endpoint is improvement of reflux equal to or greater than 30 percent at six months following VenoValve surgery. MAEs are defined as the composite of all-cause mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis (DVT), or pulmonary embolism. Improvement of VCSS and VAS scores are also included in the SAVVE study as secondary endpoints. 
 
Preparation to begin enrollment of 75 patients at up to 20 centers throughout the U.S. for the SAVVE pivotal trial is being finalized, with the first patient expected to be enrolled in the study within the next 60 days.