Business
PAVmed Reports Fourth Quarter 2018 Financial Results and Provides Business Update
Conference call to be held on April 4, 2019 at 4:30 p.m. Eastern timeNEW YORK, April 04, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the
About this update from Pavmed Inc.
[{"type":"text","content":"Conference call to be held on April 4, 2019 at 4:30 p.m. Eastern timeNEW YORK, April 04, 2019 (GLOBE NEWSWIRE) -- PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the \"Company\" or \"PAVmed\"), a highly differentiated, multiproduct medical device company, today reported financial results for the three and 12 months ended December 31, 2018 and provided a business update.MANAGEMENT COMMENTARY\"I am very pleased with the progress PAVmed has made during what has been a very active and productive fourth quarter of 2018 and in recent months,\" said Lishan Aklog, M.D., PAVmed's Chairman and Chief Executive Officer. \"We have achieved several important milestones across our lead product pipeline and are poised to complete several more in this quarter.\"HighlightsRefinanced senior secured debt under favorable terms, including a lower coupon rate and no attached warrants, strengthening our balance sheet by removing the July 2019 debt maturity overhang and increasing our working capital runway;Reached a consensus with the FDA on the parameters of the CarpX™ minimally-invasive carpal tunnel device's first-in-human (FIH) safety study and completed the complex logistics necessary to initiate and complete the treatment phase of the study in Christchurch, New Zealand in the coming weeks;Completed the EsoGuard™ (formerly EsoCheck™ Dx) methylated DNA biomarker diagnostic test's Laboratory Developed Test (LDT) validation process and filed for a Proprietary Laboratory Analysis (PLA) diagnostic CPT billing code through the American Medical Association, which is the first step in securing Medicare reimbursement;Completed the EsoCheck™ esophageal cell collection device's GLP animal study as well as additional manufacturing verifications requested by FDA to support its 510(k) pathway regulatory clearance;Launched a world-class Lucid Diagnostics medical advisory board consisting of internationally renowned experts in gastroesophageal reflux disease (GERD), Barrett's Esophagus (BE) and esophageal cancer, with specific expertise and experience in developing the current published society guidelines on the management of BE;Appointed a veteran life sciences industry executive with extensive experience in the development and execution of clinical and regulatory strategy, including sophisticated clinical trials, as Lucid's Chief Medical Officer;Completed the PortIO™ implan...