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Hancock Jaffe Laboratories (NASDAQ:HJLI) announced FDA approval of its Investigational Device Exemption (IDE) for the VenoValve, designed to treat Chronic Venous Insufficiency (CVI). This pivotal trial, involving 75 patients across 20 U.S. centers, aims to assess the valve's safety and effectiveness. The company seeks to establish the VenoValve as a new standard in treating CVI, impacting approximately 2.4 million Americans. Previous trials showed promising results with significant improvements in patient outcomes. Patient enrollment is expected to begin in Q3 2021.
Hancock Jaffe Laboratories (NASDAQ:HJLI) has submitted an Investigational Device Exemption (IDE) application to the FDA for the VenoValve, an implantable valve aimed at treating Chronic Venous Insufficiency (CVI), affecting 2.4 million U.S. patients. CEO Robert Berman expressed optimism about IDE approval as a critical milestone. The VALVE Trial will involve 75 patients across 20 centers, assessing reflux and quality of life over six months. The company previously reported positive outcomes in an initial study. FDA review typically takes 3-6 months. Updates will be provided as the process unfolds.
Hancock Jaffe Laboratories (NASDAQ:HJLI) has received a notice of allowance from the USPTO for a patent on its VenoValve, targeting chronic venous insufficiency (CVI). This represents a significant step in their intellectual property strategy as the VenoValve addresses a critical unmet need for CVI patients. The company plans to use proceeds from a recent $41 million public offering to support the VenoValve's U.S. pivotal trial, with an IDE application expected by Q1 2021. CVI affects about 2.4 million people in the U.S., costing over $38 billion annually.
Hancock Jaffe Laboratories (NASDAQ:HJLI) has successfully completed a public offering, generating approximately $41.4 million in gross proceeds. The offering involved the sale of 5,914,284 shares of common stock and warrants for 2,971,142 shares. Funds will primarily be used to support the U.S. pivotal trial for their VenoValve, aimed at treating Chronic Venous Insufficiency (CVI). The company anticipates that this capital will support its operations through 2023 and advance its goal of addressing a significant medical need for CVI patients.
Hancock Jaffe Laboratories (NASDAQ:HJLI) has priced its upsized public offering to raise approximately $36 million before expenses, comprising 5,142,856 units priced at $7.00 each. Each unit includes a share of common stock and a warrant to purchase additional shares at the same price for five years. The offering is expected to close on or about February 11, 2021. The underwriter has a 45-day option to purchase up to 15% more shares to cover over-allotments. The securities were registered under effective SEC filings on February 8, 2021.
Hancock Jaffe Laboratories (NASDAQ: HJLI) announces successful completion of the VenoValve Pre-IDE meeting with the FDA. This meeting discussed the clinical need for the VenoValve and proposed study design for a pivotal trial. The previously completed first-in-human trial showed significant patient improvements with no device-related adverse events. HJLI plans a single-arm, multi-center study involving 75 patients, aiming for PMA approval potentially six months post-trial. The VenoValve targets chronic venous insufficiency (CVI), a condition affecting 2.4 million Americans with an estimated annual cost exceeding $38 billion.
Hancock Jaffe Laboratories (NASDAQ:HJLI) announced executive promotions, appointing Dr. Hamed Alavi as Vice President of Research and Development and Quality, and Craig Glynn as Chief Financial Officer. Dr. Alavi, previously Director of Research and Development, has expanded his department with five new hires. Mr. Glynn, originally Interim CFO, has contributed to successful capital raises since joining in April 2020. CEO Robert Berman highlighted their commitment and expertise as vital for the company’s growth, particularly during a challenging year. Hancock Jaffe develops bioprosthetic medical devices for cardiac and vascular health.
Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI) has announced compliance with NASDAQ's minimum bid requirements following confirmation from the NASDAQ Hearings Panel. The company successfully maintained a closing bid price of at least $1.00 per share for the necessary consecutive days, resolving all compliance issues. As a result, HJLI's securities will continue being listed on the NASDAQ without any further deficiencies. The company focuses on developing medical devices to enhance cardiac and vascular health, including the VenoValve and CoreoGraft.
Hancock Jaffe Laboratories (NASDAQ: HJLI) announced that two patients who underwent heart bypass surgeries using its CoreoGraft have shown good cardiac function at the 30-day mark post-surgery. The surgeries were completed in late October and early November. The CoreoGraft aims to eliminate the need for saphenous vein harvesting, a common practice in CABG surgeries. The potential U.S. market for CoreoGraft is estimated at over $2 billion annually, given the annual performance of approximately 200,000 CABG surgeries in the U.S.
Hancock Jaffe Laboratories (NASDAQ: HJLI) announced positive results from its first-in-human clinical study of the VenoValve, with the final patient showing significant improvement at one year post-surgery. Notable metrics include a 70% reduction in reflux, a 69% improvement in venous clinical severity scores, and a 100% pain reduction. All patients have now completed the trial. HJLI plans to submit an Investigational Device Exemption (IDE) application to the FDA for a pivotal trial, expected in Q1 2021. CVI affects approximately 2.4 million people in the U.S., with substantial healthcare costs.
