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PAVMED INC DL-,001 WKN: A2AQDJ ISIN: US70387R1068 Kürzel: 1P5 Forum: Aktien Thema: Hauptdiskussion

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6. Jul, 14:10:36 Uhr, Berlin
Kommentare 18
Schorsch11
Schorsch11, 12.01.2020 13:56
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UPCOMING MILESTONES Complete CLIA/CAP certification and commercially launch the EsoGuard™ Esophageal DNA Test as a Laboratory Developed Test (LDT) – the first such DNA test designed to detect Barrett’s Esophagus, a precursor to deadly esophageal cancer, in December; Launch two multi-center EsoGuard/EsoCheck clinical trials to support regulatory clearance as an FDA-registered In-Vitro Diagnostic (IVD) Barrett’s Esophagus screening test, in January; Resubmit CarpX™ U.S. Food and Drug Administration (FDA) 510(k) application in early January, incorporating data from successful first-in-human (FIH) clinical safety study; Complete ongoing formal M&A process seeking to secure a strategic partner or acquirer for the NextFlo Infusion System and provide a source of non-dilutive capital to the Company; Secure FDA sign-off on protocol for a small PortIO™ clinical safety study during a scheduled January 8, 2020 in-person pre-submission meeting – the final requirement to support PortIO’s FDA de novo application – and launch the study in New Zealand in Q1 2020; Launch a long-term PortIO clinical study in Columbia, South America to demonstrate up to 60-day maintenance free implant durations in humans, in Q1 2020; Initiate a pilot human clinical trial of EsoCheck in Eosinophillic Esophagitis (EoE), a prevalent inflammatory disease of the esophagus, in Q1 2020; Complete DisappEAR six-month GLP animal study and finalize partnership agreement with large strategic partner to produce commercial-scale aqueous silk to support future FDA 510(k) submission and commercialization. PRODUCT UPDATES CarpX Minimally Invasive Carpal Tunnel Device 20 patients underwent successful CarpX procedures, completing the enrollment and treatment portion of the FIH clinical safety study; All 20 patients met the study’s primary effectiveness endpoint; All 17 patients who completed their final 90-day follow-up have met the study’s primary safety endpoint; PAVmed expects to achieve 100% follow-up with the three remaining patients who are scheduled to complete their 90-day follow-up in the coming days; FDA 510(k) re-submission targeted for early January.
Schorsch11
Schorsch11, 12.01.2020 13:56
0
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