Hancock Jaffe Submits Application to INVIMA for First-In-Human VenoValve Trial in Colombia
Hancock Jaffe Laboratories, Inc. (HJLI)
US:NASDAQ Investor Relations:
seekingalpha.com/article/4130510-medical-device-firm-hancock-jaffe-laboratories-files-terms-20-million-ipo
Company Research
Source: GlobeNewswire
IRVINE, Calif., Sept. 24, 2018 (GLOBE NEWSWIRE) -- Hancock Jaffe Laboratories, Inc. (Nasdaq: HJLI, HJLIW), a company specializing in medical devices that restore cardiac and vascular health, announced today that it has completed and submitted its application to INVIMA (the Colombian equivalent of the US FDA) for approval of its first-in-human trial for the VenoValve®. INVIMA is the last regulatory approval that HJLI needs in order to begin its first-in-human testing in Colombia. HJLI expects to receive a response from INVIMA within 60 days. In order to facilitate the INVIMA application process and its first-in-human trial in Columbia, HJLI has hired Bioaccess™, a U.S. based contact research organization (CRO) that specializes in obtaining regulatory approval and in facilitating clinical trials in Colombia. Bioaccess will continue to provide CRO assistance to HJLI throughout its trial in Colombia. “The Colombian first-in-human study is a monumental milestone for our company and we
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