HJLI - Hancock Jaffe (HJLI) stock jumps 40% on Breakthrough Device tag for VenoValve

Hancock Jaffe Laboratories (NASDAQ:HJLI) soars 39.6% premarket in reaction to the announcement that the 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 designation, akin to Breakthrough Therapy status for a drug, provides for more intensive guidance on development by the FDA, the involvement of more senior agency personnel, the assignment of a case manager and priority review of the marketing application. The VenoValve is a potential treatment for a condition called Chronic Venous Insufficiency (CVI), which 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). The primary endpoints for the Company's SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. trial will be: the primary safety endpoint is the occurrence of MAE in <10% of

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Hancock Jaffe (HJLI) stock jumps 40% on Breakthrough Device tag for VenoValve