Shares of Hancock Jaffe Laboratories Inc. (HJLI) were down -4.14% to $6.71 in after-hours trades. The HJLI stock closed the last session at $7.00, gaining 6.54% or $0.43. In the session, the HJLI stock fluctuated between $6.62 and $8.60. Approximately 35.42 million shares of HJLI stock were traded, which exceeded its 50-day average of 0.78 million and topping its Year to Date average of 0.58 million.
HJLI stock has gained -13.45% in the last 12 months, and in the last week, the stock has moved up 17.85%. Over the last six months, HJLI stock has lost -23.08%, and over the last three months, it has increased by 12.90%. Since the beginning of the year, HJLI stock has returned -19.08%. Following an FDA grant, the price of HJLI stock dropped after hours after gaining value in regular trading.
HJLI Stock has received which grant?
Hancock Jaffe specializes in the development and manufacture of bioprosthetic (tissue-based) medical devices which have the potential to improve the treatment of cardiovascular and arterial diseases. Right now, HJLI is focusing on two lead products. HJLI’s VenoValve is a porcine-based valve specifically designed for medically treating reflux associated with Chronic Venous Insufficiency by surgically implanting it in the deep veins. HJLI is set to start its pivotal US study of VenoValve in the near future. CoreoGraft is HJLI’s second lead product. This is an off-the-shelf coronary artery bypass conduit made from bovine tissue.
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation status to VenoValve, announced Hancock Jaffe in a statement today.
Through its Breakthrough Devices Program, the FDA established priority review for devices that could treat or diagnose debilitating or life-threatening diseases or conditions more effectively. An initial study in humans, published by VenoValve in December of 2020, showed:
- Approximately 54% of patients with reflux have improved.
- On average, HJLI experienced a 56% improvement in disease manifestations (determined by rVCSS scores).
- The HJLI also reported an average pain improvement of 76%, based on VAS scores.
Further, HJLI recognized no significant adverse events (SAEs) within 30 days of VenoValve implantation.
What will HJLI be trying to accomplish?
Similarly to the first-in-human trial, HJLI’s pivotal SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) clinical trial in the U.S. will also include primary endpoints. According to HJLI, the primary safety endpoint is the occurrence of MAE in less than 10% of patients 30 days following VenoValve implantation, while the primary effectiveness endpoint is reflux improvement equal to or greater than 30% six months after VenoValve surgery. It is expected that Hancock Jaffe (HJLI) will enroll the first patient in the SAVVE pivotal trial within the next 60 days, with 75 patients enrolled at 20 centers across the United States.
