 Conference call to be held today at 4:30 p.m. Eastern timeNEW YORK, Aug. 18, 2020 GLOBE NEWSWIRE -- PAVmed Inc. Nasdaq: PAVM, PAVMZ the Company or PAVmed, a highly differentiated, multi-product, commercial-stage medical device company, today reported financial results for the three and six months ended June 30, 2020 and provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. Lucid and Solys Diagnostics Inc. Solys.The second quarter of 2020 and subsequent weeks constitute an unprecedented period of major accomplishments for PAVmed and its subsidiaries, despite significant Covid-19 headwinds in the late spring and early summer, said Lishan Aklog, M.D., PAVmeds Chairman and Chief Executive Officer. These accomplishments include a preliminary CMS payment determination, FDA clearance and commercial launch of a lead product, consummation of critical partnership agreements, and steady progress on the commercial, clinical, regulatory, development and intellectual property fronts. Our expanding team of talented professionals, joined by world-class partners and advisors, and supported by a strong balance sheet, are well-poised to build on these accomplishments and achieve important value-inflection milestones in the coming months.RECENT ACCOMPLISHMENTS Secured U.S. Center for Medicare and Medicare Services CMS Clinical Laboratory Fee Schedule Test Code Preliminary Determination for EsoGuardTM Esophageal DNA Test CPT code 0114U of 1,938.01 in 38 states and 2,690.00 in 12 states including Florida, New Jersey and Pennsylvania and two U.S. territories. Received 510k marketing clearance from the U.S. Food and Drug Administration FDA for CarpXTM minimally invasive carpal tunnel device. Commercially launched CarpX, including FDA commercial device registration and listing in the GUDID database, as well as the initial release of inventory for fulfillment by third party logistics and warehousing partner HealthLink Europe and International. Expanded commercial management team to seven professionals adding in the quarter a CarpX national sales manager, a Lucid regional sales manager, and a marketing director to support an independent sales organization of 35 professionals. Accelerated Lucid commercial activities, with active sales processes involving over 500 customers and product in stock at approximately 50 clinical sites. Resumed in-person procedural training. Activated 27 sites for ESOGUARD BE-1 and 2 clinical trials in support of FDA registration of EsoGuardEsoCheck as an In-Vitro Diagnostic IVD device. Resumed enrollment with six new patients and successful EsoCheck administration in all patients. Enrolled first patient in clinical trial evaluating EsoCheck in Eosinophilic Esophagitis EoE patients at the University of Pennsylvania. Entered into a definitive agreement with global manufacturer Canon Inc.s United States manufacturing and technology center, Canon Virginia, Inc. to develop and utilize Canon Virginias commercial grade aqueous silk fibroin molding process to manufacture its DisappEARTM molded pediatric ear tubes for commercialization. Entered into a manufacturing agreement with medical device contract manufacturer Coastline International Inc. to serve as a high-volume, lower-cost manufacturer of PAVmed and Lucid products including EsoCheck and NextFlo. Successfully completed European Union notified body stage 1 audits of PAVmed and Lucid quality management systems in support of upcoming CE Mark regulatory submissions of PAVmed and Lucid products. Successfully completed pre-clinical feasibility animal study of its EsoCureTM Esophageal Ablation Device demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining. Successfully completed preliminary human testing of Solys laser-based non-invasive blood glucose device demonstrating testing accuracy within established FDA and ISO 15197 regulatory standards in normal human volunteers with moderate post-prandial hyperglycemia. Granted U.S. patent for EsoCheckTM Cell Collection Device 10,660,621 and CaldusTM Technology underlying EsoCure 10,687,883 as well as Chinese patent for CarpX. Diagnostics industry titan, Stanley Lapidus, founder, former Chairman and CEO of Exact Sciences, joined Lucid as a Strategic Advisor. Received approximately 10.6 million in net proceeds from two private placements of Senior Convertible Promissory Notes with an existing institutional investor.UPCOMING KEY ACTIVITIES AND MILESTONES Accelerate and expand EsoGuard and EsoCheck commercial activities as elective clinical procedures continue to resume from Covid-19 limitations. Expand EsoGuard educational and marketing activities targeting physicians and consumers, including upcoming Access Health segment on the Lifetime Network highlighting Barretts Esophagus as well as the role of EsoGuard and EsoCheck. Begin CarpX commercial activities focusing on key opinion leaders and innovators capable of serving as CarpX trainers, proctors and educators. Secure CMS coverage determination for EsoGuard and extend payment and coverage process to private payors. Complete stage 2 audits of PAVmed and Lucids quality management systems and submit EU CE Mark regulatory clearance applications for EsoCheck, EsoGuard, CarpX and PortIOTM. Activate remaining 27 U.S. and European clinical trial sites for ESOGUARD-BE-1 and 2 and accelerate clinical trial enrollment as elective clinical procedures continue to resume from Covid-19 limitations. Complete ongoing clinical trial evaluating EsoCheck in EoE patients at the University of Pennsylvania. Launch clinical trial of EsoCheck with BE progression markers at Fred Hutchinson Cancer Research Center in Seattle. Launch additional Lucid-sponsored clinical trials of EsoGuard and EsoCheck to support commercial activities including EsoGuard registry, Barretts Esophagus EGD Yield study and Integrated Health System Referral study. Complete MA process and consummate licensing agreement for NextFloTM technology in disposable infusion pumps. Complete device qualification and FDA 510k submission for NextFlo Intravenous Infusion System. Secure FDA clearance for an Investigational Device Exemption IDE to begin a clinical safety study in the U.S. evaluating PortIO in dialysis patients with a one-week implant duration to support its de novo application. Initiate PortIO long-term clinical study in Colombia, South America to demonstrate up to 60-day maintenance free implant durations in humans. Advance Solys development to achieve FDA and ISO 15197 accuracy standards for a full range of glucose measurements including severe hyperglycemia.FINANCIAL RESULTSFor the three months ended June 30, 2020, research and development expenses were 2.1 million and general and administrative expenses were 2.9 million. GAAP net loss attributable to common stockholders was 5.6 million, or 0.13 per common share. As illustrated below and for the purpose of helping the reader understand the effect of derivative accounting and other non-cash income and expenses on the Companys financial results, the Company reported a non-GAAP adjusted loss for the three months ended June 30, 2020 of 4.2 million, or 0.09 per common share.PAVmed had cash and cash equivalents of 7.1 million as of June 30, 2020, compared with 6.2 million as of December 31, 2019. Subsequently, in early August 2020, the Company received approximately 7 million in proceeds from a private placement with an existing institutional investor for the sale of a Senior Secured Convertible Note.The unaudited financial results for the three and six months ended June 30, 2020 as reported to the SEC on Form 10-Q can be obtained at or MeasuresTo supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles GAAP, management provides certain non-GAAP financial measures of the Companys financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation and amortization EBITDA and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense, loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, and loss on debt extinguishment. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.Non-GAAP financial measures are presented with the intent of providing greater transparency to information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from or as an alternative to, the most directly comparable GAAP financial measures.Non-GAAP financial measures are provided to enhance readers overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains and losses that may not be indicative of our core operating results and business outlook. 