PAVmed Provides Update on CarpX™ Clinical Safety Study
PAVmed Inc. (PAVM)
US:NASDAQ Investor Relations:
ir.pavm.com
Company Research
Source: GlobeNewswire
NEW YORK, Dec. 13, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multiproduct medical device company, today provided an update on its CarpX™ first-in-human (FIH) 510(k) clinical safety study. This week, senior PAVmed personnel met with the local investigators in New Zealand and completed an on-site review of the study data. Full 90-day follow-up is now 90% complete (18 of 20 patients) and 90-day clinical follow-up is 95% complete (19 of 20 patients) – with one patient completing clinical follow-up but not yet completing electrodiagnostic testing. The research team continues to pursue the two incomplete follow-up patients. The study has, however, already exceeded the minimum 80% follow-up rate requested by the U.S. Food and Drug Administration (FDA) with no device-related adverse events. The team has concluded that the device appears to have met the study’s primary effectiveness and safety endpoints. PAVmed is now pr
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PAVM
Sec Filings
- 4/26/24 - Form 8-K
- 3/25/24 - Form 10-K
- 3/14/24 - Form 8-K
- PAVM's page on the SEC website