Hancock Jaffe Laboratories (HJLI) specialize in manufacturing and distributing bioprosthetic (tissue-based) devices to provide improved standards of care for cardiovascular issues. The Company stock has surged in the extended-hours session today as it recorded up 25.88% to $10.75.
What are they currently up to?
HJLI currently has two lead product candidates: the VenoValve, a porcine-derived valve intended to treat the symptoms of Chronic Venous Insufficiency, and the CoreoGraft, a bovine-derived conduit suitable for coronary artery bypass surgery.
Most Recent Development
Hancock Jaffe Laboratories, Inc. (NASDAQ: HJLI) has reported that it’s VenoValve Pre-IDE meeting with the U.S. Food and Drug Administration was completed. Several topics were discussed at the meeting, including results from a VenoValve pilot study, the VenoValve clinical trial design, patient monitoring protocols for safety and efficacy, bench tests, and safety analysis.
In light of the results of VenoValve’s first-in-human study, which was concluded at the end of 2020 following rigorous testing of the device and extensive follow-up, the proposed protocol for the United States pivotal trial is expected to be very similar. All study endpoints were significantly improved in patients enrolled in the first-in-human study, with no device-related adverse events.
More than 2.4 million Americans suffer from CVI caused by reflux in the deep venous system. According to estimates, CVI accounts for over $38 Billion in direct medical costs in the U.S. right now. There are currently no FDA approved devices, nor are there effective treatments for deep venous CVI.
A significant increase in medical device manufacturing has taken place in recent years, with a vast diversity of products available. Modern clinical practice relies increasingly on medical devices. The market for these devices is significant and growing.