Hancock Jaffe Stock Surges On FDA Breakthrough Designation For Its Venous Insufficiency Device

  • The FDA has granted Breakthrough Device Designation status to  Hancock Jaffe Laboratories Inc's HJLI VenoValve, the Company's lead product, currently set to begin its U.S. pivotal trial. 
  • The VenoValve, a porcine-based valve, is a potential treatment for Chronic Venous Insufficiency that occurs when valves inside the leg's veins fail, causing blood to flow in the wrong direction (reflux), creating increased pressure inside of the veins of the leg. 
  • Preparation to begin enrollment of 75 patients at up to 20 centers throughout the U.S. for the SAVVE pivotal trial is being finalized. 
  • Enrollment will start within the next 60 days. 
  • Price Action: HJLI shares are up 25.6% at $8.25 during the premarket session on the last check Tuesday.
  • Related content: Benzinga's Full FDA Calendar.
Market News and Data brought to you by Benzinga APIs
Posted In: Long IdeasNewsHealth CareFDAMoversTrading IdeasGeneralBriefsFDA Breakthrough Designation
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!