Annual report pursuant to Section 13 and 15(d)

The Company and Description of the Business

The Company and Description of the Business
12 Months Ended
Dec. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
The Company and Description of the Business

Note 1 — The Company and Description of the Business


PAVmed Inc. (“PAVmed” or the “Company”) is a highly-differentiated multi-product technology medical device company organized to advance a broad pipeline of innovative medical technologies from concept to commercialization, employing a business model focused on capital efficiency and speed to market. The Company is focused on advancing its lead products towards regulatory approval and commercialization, protecting its intellectual property, and building its corporate infrastructure and management team. The Company operates in one segment as a medical device company.


On May 8, 2018, Lucid Diagnostics Inc. (“Lucid”) a majority-owned subsidiary of the Company, was incorporated in the State of Delaware. On May 12, 2018, Lucid Diagnostics Inc. entered into the “EsoGuard License Agreement” with Case Western Reserve University (“CWRU”), with respect to the “EsoGuard Technology”. See Note 7, Agreements Related to Acquired Intellectual Property Rights, for a discussion of the “EsoGuard License Agreement”.


On October 7, 2019, Solys Diagnostics Inc. (“Solys”) a majority-owned subsidiary of the Company, was incorporated in the State of Delaware. Upon formation, Solys Diagnostics Inc. entered into a research and development license agreement with Liquid Sensing, Inc., a subsidiary of Airware, Inc., each an unrelated-third-party, under which was granted to Solys Diagnostics Inc. a perpetual worldwide license to develop and commercialize products based on intellectual property portfolio covering the use of “Nondispersive Infrared” (“NDIR”) laser technology with respect to the potential development of technology to noninvasively measure interstitial concentrations of glucose or other substances through the skin. PAVmed Inc. and Airware Inc. have entered into a shareholder’s agreement which, among other customary terms, limits certain transfers of their respective ownership interests in Solys Diagnostics Inc. See Note 7, Agreements Related to Acquired Intellectual Property Rights, for a further discussion of such license agreement.


To date, the Company has not recognized revenue. The ability to generate revenue depends upon the Company’s ability to successfully complete the development, obtain regulatory approval, and to initiate commercialization of its product candidates. The only product to obtain regulatory clearance to date is EsoCheck, which has received 510(k) marketing clearance from the FDA as a generic esophageal cell collection device. In late December 2019 EsoGuard completed CLIA/CAP certification as a Laboratory Developed Test (LDT) making it commercially available at Lucid’s contract diagnostic laboratory service provider in California. Our current research and development activities are focused principally on obtaining FDA approval and clearance and initializing commercialization of the other lead products in our product portfolio pipeline, such as EsoGuard IVD, CarpX and PortIO, while advancing DisappEAR and NextFlo through development. The Company will also engage in research and development activities on other product candidates commensurate with the Company’s available capital resources. The Company plans to incur research and development expenses for the foreseeable future from the continued development of its current and future product candidates.


The Company has financed its operations principally through the issuances of its common stock, preferred stock, warrants, and debt, including: proceeds from private offerings of its common stock and common stock purchase warrants prior to the April 8, 2016 closing of its IPO; proceeds from the April 28, 2016 closing of the IPO; and, subsequent issue of shares of convertible preferred stock and common stock purchase warrants in private placements, the issue of shares of common stock of the Company and common stock purchase warrants under effective registration statements; and the issue of debt. See Note 12, Debt, Note 13, Preferred Stock, and Note 14, Stockholders’ Equity and Common Stock Purchase Warrants, for further information with respect to the various financing transactions.


PAVmed and its subsidiaries have proprietary rights to the trademarks used herein, including, among others, PAVmed™, Lucid Diagnostics™, Caldus™, CarpX™, DisappEAR™, EsoCheck™, EsoGuard™, EsoCheck Cell Collection Device™, EsoCure Esophageal Ablation Device™, NextCath™, NextFlo™, PortIO™, and “Innovating at the Speed of Life” ™. Solely as a matter of convenience, trademarks and trade names referred to herein may or may not be accompanied with the requisite marks of “™” or “®”, however, the absence of such marks is not intended to indicate, in any way, PAVmed Inc. or its subsidiaries will not assert, to the fullest extent possible under applicable law, their respective rights to such trademarks and trade names.