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Hancock Jaffe Laboratories, Inc.: Hancock Jaffe Concludes Successful VenoValve Pre-IDE Meeting with FDA


Hancock Jaffe Laboratories, Inc.: Hancock Jaffe Concludes Successful VenoValve Pre-IDE Meeting with FDA
IRVINE, CA / ACCESSWIRE / January 12, 2021 /
Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that it has successfully concluded its VenoValve Pre-IDE meeting with the U.S. Food and Drug Administration ( FDA ). Topics presented at the meeting included the background and clinical need for the VenoValve, proposed study design, patient monitoring for safety and efficacy, bench testing protocols, and the VenoValve first-in-human results.
The proposed protocol for the U.S. pivotal trial is expected to be very similar to the protocol that was used for the VenoValve first-in-human study, which was successfully completed at the end of 2020, and which included endpoints for reflux time (the backwards flow of blood), VCSS scores (disease manifestations), VAS scores (pain), and VIENES quali ....

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UK health minister confident vaccine targets will be hit


By Reuters Staff
1 Min Read
LONDON, Jan 11 (Reuters) - Britain’s health minister Matt Hancock on Monday said that he was confident that ambitious COVID-19 vaccination targets would be met after reaching an average of 210,000 shots a day between Thursday and Sunday.
“We’ve got a continued increase in the rate of vaccination. This is happening right across all four nations of the UK,” he said at a news conference of the government’s target of vaccinating 15 million of the elderly, vulnerable and frontline workers by mid-February.
“It means that we are on track to meet that target. It’s not going to be easy but we are going to get there.” ....

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