Shares of Hancock Jaffe Laboratories (NASDAQ: HJLI) are rising premarket after the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation status to the VenoValve, the company's lead product.
The VenoValve is set to begin a US trial for the potential treatment of a condition called Chronic Venous Insufficiency (CVI).
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.
“We are very pleased to have the opportunity to work with the FDA on an expedited basis as we try to bring relief to the millions of patients who suffer from deep venous CVI and who currently have no effective treatment options,” said Hancock Jaffe CEO Robert Berman.
“The VenoValve significantly improved the lives of the patients in our first-in-human study, and we hope to replicate that success in our SAVVE U.S. clinical trial.”
Preparation to enroll 75 patients at up to 20 centres for the SAVVE trial are almost complete, with the first patient expected to be enrolled in the study within the next 60 days.
The company's shares are up 39.7% premarket at $9.18.
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