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Hancock Jaffe Laboratories (NASDAQ:HJLI) will present updates on its clinical studies for VenoValve and CoreoGraft during the Ladenburg Thalmann R&D Showcase Webinar on December 16, 2020, at 1:00 PM ET. The presentation will feature key investigators, including Dr. Marc Glickman, discussing the advancements in these medical devices aimed at improving cardiac and vascular health. Registration for live participation is limited, and a replay will be available after the event.
Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) announced a 1-for-25 reverse stock split, effective November 30, 2020, to comply with Nasdaq listing requirements. This action will reduce the number of outstanding shares from approximately 55.9 million to 2.2 million. Shareholders' positions will be adjusted automatically, and fractional shares will be rounded up. The split aims to increase the market price per share. This decision received shareholder approval on September 15, 2020, and details are available in the proxy statement filed with the SEC on August 12, 2020.
Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) announced the publication of interim results from the VenoValve first-in-human trial in the Journal of Vascular Surgery Venous and Lymphatic Disorders. The study shows promise in treating Chronic Venous Insufficiency (CVI), a condition affecting 2.4 million in the U.S. The VenoValve aims to improve reflux and alleviate symptoms for these patients. The company plans to file an IDE application with the FDA for a pivotal trial in Q1 2021. Further results are expected through Q4 2020 as the study concludes.
Hancock Jaffe Laboratories (NASDAQ:HJLI) announced a Pre-IDE meeting with the FDA on December 22, 2020 to discuss the pivotal trial for their VenoValve device, which addresses Chronic Venous Insufficiency (CVI). The meeting will cover design, functionality, and trial protocols. The company aims to integrate FDA feedback into its IDE application, anticipated for submission in Q1 2021. Approximately 2.4 million Americans suffer from CVI, leading to significant medical costs exceeding $38 billion annually, highlighting the need for effective treatment options.
Hancock Jaffe Laboratories (NASDAQ: HJLI) announced the successful completion of the first heart bypass surgery using the CoreoGraft in its first-in-human study. The patient, a 65-year-old male, underwent triple coronary artery bypass graft surgery and has since been discharged. The CoreoGraft aims to replace conventional saphenous vein grafts, which face high failure rates. The U.S. market for CABG surgeries is estimated at over $2 billion annually, highlighting significant potential for HJLI’s innovative device. Follow-up visits are scheduled at 30, 90, 180, and 365 days post-surgery.
Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) has submitted a Pre-Investigational Device Exemption (Pre-IDE) filing to the FDA and requested a meeting to discuss key areas ahead of its IDE application for the VenoValve pivotal trial. The VenoValve addresses Chronic Venous Insufficiency affecting 2.4 million Americans, with annual medical costs exceeding $38 billion. The company aims to file the IDE application in Q1 2021, contingent on the Pre-IDE meeting's outcome. HJLI's CEO expressed optimism about this pivotal milestone for the VenoValve project.
Hancock Jaffe Laboratories (NASDAQ:HJLI) announced that the first surgeries for its CoreoGraft first-in-human study are scheduled for late October. This trial will involve up to five patients needing coronary artery bypass grafting (CABG) at Italian Hospital Asuncion, Paraguay. The CoreoGraft aims to replace saphenous vein grafts, which have high failure rates. Approximately 200,000 CABG surgeries occur annually in the U.S., presenting a market opportunity of over $2 billion. HJLI will provide patient updates after the surgeries.
Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) has engaged Syntactx LLC to support its VenoValve U.S. pivotal trial. Syntactx will help with strategy, clinical operations, regulatory affairs, and safety as HJLI prepares for trial approval. The partnership involves industry experts with extensive experience in vascular devices. HJLI is currently preparing a Pre-IDE submission for the FDA, expecting to meet with the agency in late 2020 or early 2021. Approximately 2.4 million people in the U.S. suffer from chronic venous insufficiency (CVI), which has significant healthcare costs.
Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) announced a registered direct offering of approximately $5.1 million of common stock and warrants. The offering price is $0.535 per unit, complying with Nasdaq regulations. The gross proceeds will support development of its lead products, VenoValve and CoreoGraft, as well as general corporate purposes. The closing is anticipated around October 9, 2020. The warrants, exercisable at $0.41 per share, will expire in seven years, with a registration statement for underlying shares to be filed with the SEC.
Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) has received an extension from the Nasdaq Hearings Panel allowing it to continue listing on The Nasdaq Capital Market until December 28, 2020. This extension enables the company to demonstrate compliance with the minimum $1.00 bid price requirement by achieving a closing bid price of at least $1.00 for 10-20 consecutive business days. HJLI is actively taking steps to meet these requirements and will update shareholders on its compliance efforts.
