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HANCOCK JAFFE LABORATORIES, INC.

(HJLI)
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Hancock Jaffe Laboratories Gets Breakthrough Device Designation for VenoValve

08/03/2021 | 06:46am EDT

By Chris Wack

Hancock Jaffe Laboratories Inc. said the U.S. Food and Drug Administration has granted breakthrough device designation status to VenoValve, its lead product, which is set to begin its U.S. pivotal trial.

The FDA's breakthrough devices program was established to enable priority review for devices that provide more effective treatment or diagnosis of life threatening or irreversibly debilitating diseases or conditions.

The medical device company said VenoValve is a potential treatment for chronic venous insufficiency, which occurs when valves inside of the veins of the leg fail, causing blood to flow in the wrong direction and creating increased pressure inside of the veins of the leg.

The primary endpoint for the new U.S. trial will be the occurrence of material adverse effects in less than 10% of patients at 30 days post-VenoValve implantation, and the primary effectiveness endpoint is improvement of reflux equal to or greater than 30% at six months following VenoValve surgery.

Hancock Jaffe shares were up 37% to $9 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

08-03-21 0846ET

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Financials (USD)
Sales 2021 - - -
Net income 2021 -12,4 M - -
Net Debt 2021 - - -
P/E ratio 2021 -6,87x
Yield 2021 -
Capitalization 81,7 M 81,7 M -
Capi. / Sales 2021 -
Capi. / Sales 2022 -
Nbr of Employees 19
Free-Float 90,4%
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Mean consensus BUY
Number of Analysts 1
Last Close Price 9,41 $
Average target price 26,00 $
Spread / Average Target 176%
EPS Revisions
Managers and Directors
Robert Andrew Berman Chief Executive Officer & Director
Craig T. Glynn Chief Financial Officer & Treasurer
Marc H. Glickman Chief Medical Officer & Senior Vice President
Hamed Alavi Vice President-Research, Development & Quality
Francis Duhay Independent Director
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