Hancock Jaffe Laboratories to Conduct Analysis for FDA Submission Package for Bioprosthetic Heart Valve
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., July 11, 2018 (GLOBE NEWSWIRE) -- Hancock Jaffe Laboratories, Inc. (Nasdaq:HJLI) (Nasdaq:HJLIW), a company specializing in bioprosthetic medical devices to establish improved standards of care for treating cardiac and vascular diseases, today announced that it has initiated an analysis of its bioprosthetic heart valve in order to determine what additional testing is needed in order to submit an Investigational Device Extension (IDE) application to the United States Food and Drug Administration (FDA). The company has engaged Michael Nilo of Nilo Medical Consulting Group, to assist with the initial regulatory analysis. Mr. Nilo has significant insider experience with the FDA, having worked as a lead reviewer with the FDA’s cardiac medical device review team. The company has also retained Boston MedTech Advisors, which in addition to its expertise with the FDA and regulatory agencies throughout the world, also specializes in competitive market analyses and strategies f
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