−Removed: Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities - continued
+Added: Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
+Added: for Common Equity
+Added: common equity is traded on the Nasdaq Capital Market under the symbols:
+Added: “PAVM.” with respect to our
+Added: common stock;
+Added: “PAVMZ” and “PAVMW” with respect to each of our Series Z Warrants and Series W Warrants,
+Added: respectively.
+Added: Subsequent to December 31, 2021 the Series W Warrants issued and outstanding as of December 31, 2021, expired unexercised
+Added: on January 29, 2022.
+Added: of March 29, 2022, there were 87,667,406 shares of our common stock outstanding.
+Added: Our shares of common stock are held by an estimated
+Added: 17,000 holders of record and we believe our shares of common stock are held by more than beneficial owners.
+Added: have not paid any cash dividends on our common stock to date.
+Added: Any future decisions regarding dividends will be made by our board of directors.
+Added: We do not anticipate paying dividends in the foreseeable future but expect to retain earnings to finance the growth of our business.
+Added: Our board of directors has complete discretion on whether to pay dividends.
+Added: Even if our board of directors decides to pay dividends,
+Added: the form, frequency and amount will depend upon our future operations and earnings, capital requirements and surplus, general financial
+Added: condition, contractual restrictions, amongst and other factors deemed relevant.
+Added: B Convertible Preferred Stock
+Added: Series B Convertible Preferred Stock is issued pursuant to the PAVmed Inc.
+Added: Certificate of Designation of Preferences, Rights, and Limitations
+Added: of Series B Convertible Preferred Stock (“Series B Convertible Preferred Stock Certificate of Designation”), has a par value
+Added: of $0.001 per share, no voting rights, a stated value of $3.00 per share, and at the holders’ election, shares of Series B Convertible
+Added: Preferred Stock is immediately convertible upon issuance into a corresponding number of shares of common stock of PAVmed Inc.
+Added: Series B Convertible Preferred Stock Certificate of Designation provides for dividends at a rate of 8% per annum based on the $3.00 per
+Added: share stated value, with such dividends compounded quarterly, accumulate, and are payable in arrears upon being declared by the Company’s
+Added: board of directors, with the dividends earned from April 1, 2018 through October 1, 2021 payable-in-kind (“PIK”) by the issue
+Added: of additional shares of Series B Convertible Preferred Stock.
+Added: The dividends may be settled after October 1, 2021, at the election of
+Added: the Company, through any combination of the issuance of shares of Series B Convertible Preferred Stock, shares of common stock of the
+Added: Company, and /or cash payment.
+Added: the years ended December 31, 2021 and 2020, respectively, at each of the respective holders’ election, a total of
+Added: 210,448 and 25,000 shares of Series B Convertible Preferred Stock were converted into the same number of shares of common stock
+Added: of PAVmed Inc.
+Added: the year ended December 31, 2021, the Company’s board-of-directors declared an aggregate of approximately $288 of Series B Convertible
+Added: Preferred Stock dividends, earned as of December 31, 2020, March 31, 2021, June 30, 2021, and September 30, 2021, which have been settled
+Added: by the issue of an additional aggregate 96,292 shares of Series B Convertible Preferred Stock.
+Added: During the year ended December 31,
+Added: 2020, the Company’s board-of-directors declared an aggregate of approximately $284 of Series B Convertible Preferred Stock dividends,
+Added: earned as of December 31, 2019, March 31, 2020, June 30, 2020, and September 30, 2020, which have been settled by the issue of an additional
+Added: aggregate 94,866 shares of Series B Convertible Preferred Stock.
+Added: to December 31, 2021, in January 2022, the Company’s board-of-directors declared a Series B Convertible Preferred Stock dividend
+Added: earned as of December 31, 2021 and payable as of January 1, 2022, of approximately $67, which will be settled by the issue of an additional
+Added: 22,291 shares of Series B Convertible Preferred Stock (with such dividend not recognized as a dividend payable as of December 31, 2021,
+Added: as the Company’s board of directors had not declared such dividends payable as of such date).
Sales of Unregistered Securities
−Removed: as previously disclosed in our current reports on Form 8-K and quarterly reports on Form 10-Q, we did not sell any unregistered
−Removed: securities or repurchase any of our securities during the fiscal year ended December 31, 2020.
−Removed: Selected Financial Data
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations
−Removed: following discussion and analysis of our consolidated financial condition and results of operations should be read together with
−Removed: our consolidated financial statements and related notes appearing elsewhere in this Annual Report on Form 10-K.
−Removed: Some of the information
−Removed: contained in this discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with
−Removed: respect to our plans and strategy for our business and related financing, includes forward-looking statements involving risks
−Removed: and uncertainties and should be read together with the “Forward-Looking Statements”
−Removed: and “Risk Factors”
−Removed: sections of this Annual Report on Form 10-K for a discussion of important factors which could cause actual results to differ materially
−Removed: from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
−Removed: Unless the context otherwise requires, references herein to “we”, “us”, and “our”, and to
−Removed: the “Company”
−Removed: or “PAVmed”
−Removed: are to PAVmed Inc.
−Removed: and its subsidiaries.
−Removed: and Subsidiaries (“PAVmed”
−Removed: or “the Company”) is a highly differentiated, multi-product, commercial-stage
−Removed: technology medical device company organized to advance a broad pipeline of innovative medical technologies from concept to commercialization,
−Removed: employing a business model focused on capital efficiency and speed to market.
−Removed: Since inception on June 26, 2014, the Company’s
−Removed: activities have focused on advancing its lead products towards regulatory approval and commercialization, protecting its intellectual
−Removed: property, and building its corporate infrastructure and management team.
−Removed: Company operates in one segment as a medical device company currently organized as “GI Health”, “Minimally Invasive
−Removed: Interventions”, “Infusion Therapy”, and “Emerging Innovations”.
−Removed: The Company has ongoing operations
−Removed: conducted through PAVmed Inc.
−Removed: and its majority-owned subsidiaries of Lucid Diagnostics, Inc.
−Removed: (“Lucid Diagnostics”
−Removed: or “LUCID”), and Solys Diagnostics, Inc.
−Removed: (“Solys Diagnostics”
−Removed: or “SOLYS”).
−Removed: and /or its subsidiaries have proprietary rights to the trademarks used herein, including, among others, PAVmed™, Lucid
−Removed: Diagnostics™, Caldus™, CarpX ®
−Removed: , DisappEAR™, EsoCheck ®
−Removed: , EsoGuard ®
−Removed: EsoCheck Cell Collection Device ®
−Removed: , EsoCure Esophageal Ablation Device™, NextCath™, NextFlo™, PortIO™,
−Removed: and “Innovating at the Speed of Life”™.
−Removed: Solely as a matter of convenience, trademarks and trade names referred
−Removed: to herein may or may not be accompanied with the requisite marks of “™”
−Removed: or “®”, however, the
−Removed: absence of such marks is not intended to indicate, in any way, PAVmed Inc.
−Removed: or its subsidiaries will not assert, to the fullest
−Removed: extent possible under applicable law, their respective rights to such trademarks and trade names.
−Removed: multiple products and services are in various phases of development, regulatory clearances, approvals, and commercialization.
−Removed: EsoCheck device received 510(k) marketing clearance from the U.S.
−Removed: Food and Drug Administration (“FDA”), in June
−Removed: 2019 as an esophageal cell collection device;
−Removed: and, EsoGuard has been established as a Laboratory Developed Test (“LDT”),
−Removed: and was launched commercially in December 2019 after Clinical Laboratory Improvement Amendment (“CLIA”) and College
−Removed: of American Pathologists accreditation of the test at Lucid Diagnostics commercial diagnostic laboratory partner ResearchDx
−Removed: Inc., headquartered in Irvine, California.
−Removed: CarpX device is a patented, single-use, disposable, minimally-invasive surgical device designed as a precision cutting tool
−Removed: to treat carpal tunnel syndrome while reducing recovery times that was cleared by the FDA under section 510(k) on April 2020
−Removed: and was launched commercially in August 2020 with the first commercial procedure successfully performed in December 2020.
−Removed: other products in development have not yet received clearance or approval to be marketed or sold in the U.S.
−Removed: or elsewhere.
−Removed: We have been granted patents by the United States Patent and Trademark Office (“USPTO”) for CarpX, PortIO, and
−Removed: and have acquired licenses to certain patents and intellectual property for:
−Removed: DisappEAR from Tufts University and a
−Removed: group of academic centers;
−Removed: the intellectual property licensed from Case Western Reserve University (“CWRU”) underlying
−Removed: the technology developed for the EsoGuard diagnostic LDT and the EsoCheck cell sample collection device;
−Removed: and for patents covering
−Removed: a proprietary nondispersive infrared technology to non-invasively detect glucose in tissue within the in-patient field of
−Removed: use from Liquid Sensing, Inc.
−Removed: (an unrelated third-party).
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: discussed herein below, our current lines-of-business are as follows:
−Removed: Health - EsoGuard Esophageal DNA Laboratory Developed Test, EsoCheck Esophageal Cell Collection Device,
−Removed: and EsoCure Esophageal Ablation Device with Caldus Technology;
−Removed: Invasive Interventions - CarpX Minimally Invasive Surgical Device for Carpal Tunnel Syndrome;
−Removed: Therapy - PortIO Implantable Intraosseous Vascular Access Device and NextFlo Highly Accurate Disposable
−Removed: Intravenous Infusion Platform Technology;
−Removed: Innovations - Non-invasive laser-based glucose monitoring, single-use ventilators, resorbable pediatric ear tubes
−Removed: and mechanical circulatory support cannulas.
−Removed: EsoCheck, and EsoCure
−Removed: and EsoCheck are based on patented technology licensed from Case Western Reserve University (“CWRU”) through our majority-owned
−Removed: subsidiary Lucid Diagnostics Inc.
−Removed: EsoGuard and EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly
−Removed: screening test for the early detection of adenocarcinoma of the esophagus (“EAC”) and Barrett’s Esophagus (“BE”),
−Removed: including dysplasia and related pre-cursors to EAC in patients with chronic gastroesophageal reflux (“GERD”).
−Removed: is based on our patented Caldus Technology developed by us to treat BE.
−Removed: is a molecular diagnostic esophageal DNA test shown in a published human study to be highly accurate at detecting BE, as well
−Removed: EsoCheck is a non-invasive cell collection device designed to sample cells from a targeted region of the esophagus in
−Removed: a five-minute office-based procedure, without the need for endoscopy.
−Removed: Both EsoGuard and EsoCheck are commercially available, as
−Removed: separately marketed products, for physicians to prescribe for U.S.
−Removed: is in development as an “Esophageal Ablation Device”
−Removed: with the intent to allow a clinician to treat dysplastic BE before
−Removed: it can progress to EAC, a highly lethal esophageal cancer, and to do so without the need for complex and expensive capital equipment.
−Removed: We have successfully completed a pre-clinical feasibility animal study of EsoCure demonstrating excellent, controlled circumferential
−Removed: ablation of the esophageal mucosal lining.
−Removed: We plan to conduct additional development work and animal testing of EsoCure to support
−Removed: a planned FDA 510(k) submission later in 2021.
−Removed: are currently marketing the EsoGuard diagnostic LDT through a network of independent representatives working with our in-house
−Removed: sales management.
−Removed: Center for Medicare and Medicaid Services (“CMS”), finalized the Clinical Laboratory Fee
−Removed: Schedule determination for the EsoGuard Esophageal DNA Test (CPT code 0114U) in the amount of $1,938.10, with such reimbursement
−Removed: expected to be applicable from January 1, 2021 to December 31, 2023.
−Removed: In addition, we have entered into a manufacturing agreement
−Removed: with medical device contract manufacturer Coastline International Inc.
−Removed: to serve as a high-volume, lower-cost manufacturer of the
−Removed: EsoCheck device.
−Removed: longer-term strategy is to secure a specific indication, based on published guidelines, for BE screening in certain at-risk populations
−Removed: using EsoGuard on samples collected with EsoCheck.
−Removed: This use of EsoGuard together with EsoCheck as a screening system must be cleared
−Removed: or approved by the FDA as an in vitro diagnostic (“IVD”), device.
−Removed: In September 2019, we entered into an agreement
−Removed: with a clinical research organization to assist us with two ongoing clinical trials for EsoGuard as an IVD device, which are actively
−Removed: enrolling patients and consist of a screening study (ESOGUARD-BE-1) and a case control study (ESOGUARD-BE-2).
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: Health - continued
−Removed: February 2020, we received a FDA “Breakthrough Device Designation”
−Removed: for EsoGuard as an IVD device.
−Removed: The FDA Breakthrough
−Removed: Device Program was created to offer patients more timely access to breakthrough technologies which provide for more effective
−Removed: treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions by expediting their development,
−Removed: assessment and review through enhanced communications and more efficient and flexible clinical study design, including more favorable
−Removed: pre/post market data collection balance.
−Removed: have received ISO 13485:2016 certification for Lucid Diagnostics quality management system and filed a European Union CE Mark
−Removed: regulatory submission for EsoCheck in November 2020, having confirmed that EsoGuard falls under the self-declaration category
−Removed: of the European Union regulatory requirements.
−Removed: Invasive Interventions
−Removed: a minimally invasive surgical device for use in the treatment of carpal tunnel syndrome, received FDA 510(k) marketing clearance
−Removed: in April 2020.
−Removed: CarpX is a minimally invasive surgical device for use in the treatment of carpal tunnel syndrome.
−Removed: We launched CarpX
−Removed: commercially in August 2020 with the first commercial procedure successfully performed in December 2020.
−Removed: believe CarpX is designed to allow the physician to relieve the compression on the median nerve without an open incision or the
−Removed: need for endoscopic or other imaging equipment.
−Removed: To use CarpX, the operator first advances a guidewire through the carpal tunnel
−Removed: under the ligament, and then advanced over the wire and positioned in the carpal tunnel under ultrasonic and/or fluoroscopic guidance.
−Removed: When the CarpX balloon is inflated it creates tension in the ligament positioning the cutting electrodes underneath it and creates
−Removed: space within the tunnel, providing anatomic separation between the target ligament and critical structures such as the median
−Removed: Radiofrequency energy is briefly delivered to the electrodes, rapidly cutting the ligament, and relieving the pressure
−Removed: on the nerve.
−Removed: We believe CarpX will be significantly less invasive than existing treatments.
−Removed: are commercializing CarpX through a network of independent U.S.
−Removed: sales representatives and/or inventory-stocking medical distributors
−Removed: together with our in-house sales management and marketing teams.
−Removed: Our focus on CarpX, and other high margin products and
−Removed: services, is particularly suitable to this mode of distribution.
−Removed: A high gross margin allows us to properly incentivize our distributors,
−Removed: which in turn allows us to attract the top distributors with the most robust networks in our targeted specialties.
−Removed: distributors play an even larger role in many parts of Europe, most of Asia and emerging markets worldwide.
−Removed: may eventually choose to build (or obtain through a strategic acquisition) our own sales and marketing team to commercialize CarpX,
−Removed: along with some or all of our products, if it is in our long-term interests.
−Removed: We may also choose to enter into distribution agreements
−Removed: with larger strategic partners whereby we take full responsibility for the manufacturing of CarpX but outsource some or all of
−Removed: its distribution to a partner, particularly outside the United States, with its own robust distribution channels.
−Removed: have received ISO 13485:2016 certification for PAVmed’s quality management system and filed a European Union CE Mark regulatory
−Removed: submission for CarpX in December 2020.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: is a novel, patented, implantable, intraosseous vascular access device which does not require accessing the central venous system
−Removed: and does not have an indwelling intravascular component.
−Removed: It is designed to be highly resistant to occlusion and may not require
−Removed: regular flushing.
−Removed: It features simplified, near-percutaneous insertion and removal, without the need for surgical dissection or
−Removed: radiographic confirmation.
−Removed: It provides a near limitless number of potential access sites and can be used in patients with chronic
−Removed: total occlusion of their central veins.
−Removed: The absence of an intravascular component will likely result in a very low infection rate.
−Removed: on encouraging animal data, we are preparing to initiate a long-term (60-day implant duration) first-in-human clinical study in
−Removed: dialysis patients or those with poor venous access in Colombia, South America and intend to fulfill the likely FDA request for
−Removed: human clinical data with a clinical safety study in the U.S.
−Removed: following FDA clearance of our Investigational Device Exemption (“IDE”)
−Removed: submission to begin clinical testing in dialysis patients to support a future de novo regulatory submission.
−Removed: is a patented, disposable, and highly accurate infusion platform technology including intravenous, or “
−Removed: infusion sets and disposable infusion pumps designed to eliminate the need for complex and expensive electronic infusion pumps
−Removed: for most of the estimated one million infusions of fluids, medications and other substances delivered each day in hospitals and
−Removed: outpatient settings in the U.S.
−Removed: NextFlo is designed to deliver highly accurate gravity-driven infusions independent of the height
−Removed: of the IV bag.
−Removed: It maintains constant flow by incorporating a proprietary, passive, pressure-dependent variable flow-resistor consisting
−Removed: entirely of inexpensive, easy-to-manufacture disposable mechanical parts.
−Removed: NextFlo testing has demonstrated constant flow rates
−Removed: across a wide range of IV bag heights, with accuracy rates comparable to electronic infusion pumps.
−Removed: are seeking a long-term strategic partnership or acquiror.
−Removed: We have been running a formal M&A process for NextFlo targeting
−Removed: strategic and financial partners.
−Removed: The process is active with ongoing discussion with multiple parties and we are simultaneously
−Removed: progressing toward an initial FDA 510(k) submission for the NextFlo IV Infusion System planned for later in 2021.
−Removed: Innovations include a diversified and expanding portfolio of innovative products designed to address unmet clinical needs across
−Removed: a broad range of clinical conditions.
−Removed: We are evaluating a number of these product opportunities and intellectual property covering
−Removed: a wide spectrum of clinical conditions, which have either been developed internally or have been presented to us by clinician
−Removed: innovators and academic medical institutions for consideration of a partnership to develop and commercialize these products.
−Removed: collection of products includes, without limitation, initiatives in non-invasive laser-based glucose monitoring, mechanical circulatory
−Removed: support cannulas, single-use ventilators and resorbable pediatric ear tubes.
−Removed: In June 2020, we announced the execution of a letter
−Removed: of intent to consummate a series of agreements to develop and utilize Canon Virginia’s commercial grade and scalable aqueous
−Removed: silk fibroin molding process to manufacture PAVmed’s DisappEAR molded pediatric ear tubes for commercialization.
−Removed: we are exploring other opportunities to grow our business and enhance shareholder value through the acquisition of pre-commercial
−Removed: or commercial stage products and/or companies with potential strategic corporate and commercial synergies.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: the year ended December 31, 2020, we issued debt and equity resulting in approximately $35.9 million of gross proceeds, before
−Removed: placement agent fees and expenses and offering costs, summarized as follows:
−Removed: a private placement, we issued a Senior Secured Convertible Notes dated November 4, 2019, with a $14.0 million aggregate
−Removed: face value principal, referred to herein as the “November 2019 Senior Convertible Notes”.
−Removed: The November 2019 Senior
−Removed: Convertible Notes were comprised of a Series A and Series B, each with a $7.0 million face value principal, and each having
−Removed: a $0.7 million lender fee deducted from the cash proceeds when funded.
−Removed: The Series A was funded in November 2019 and the Series
−Removed: B was funded in March 2020.
−Removed: issued the November 2019 Senior Convertible Note - Series B on March 30, 2020, with a face value principal of $7.0 million,
−Removed: resulting in cash proceeds of $6.3 million after a $0.7 million of lender fee, and we additionally paid offering costs of
−Removed: $0.4 million, consisting of a financial advisory fee paid to the placement agent.
−Removed: As of December 31, 2020, the November
−Removed: 2019 Senior Convertible Notes (Series A and Series B) remaining unpaid outstanding face value principal was approximately
−Removed: $1.0 million, which was repaid-in-full subsequent to December 31, 2020, as discussed herein below in Liquidity and Capital
−Removed: issued a Senior Convertible Note, dated April 30, 2020, in a private placement, with a face value principal of $4.1 million,
−Removed: resulting in cash proceeds of $3.7 million after a $0.4 million lender fee, and we additionally paid total offering costs
−Removed: of $0.2 million, inclusive of a financial advisory fee paid to the placement agent and legal fees.
−Removed: As of December 31, 2020,
−Removed: the unpaid outstanding face value principal was $4.1 million, which was repaid-in-full subsequent to December 31, 2020,
−Removed: as discussed herein below in Liquidity and Capital Resources .
−Removed: issued a Senior Secured Convertible Note, dated August 6, 2020, in a private placement, with a face value principal of $7.75
−Removed: million, resulting in cash proceeds of $7.0 million after a $0.75 million lender fee, and we additionally paid total offering
−Removed: costs of $0.1 million of legal fees.
−Removed: As of December 31, 2020, the unpaid outstanding face value principal was $7.75 million,
−Removed: of which, subsequent to December 31, 2020, which was repaid-in-full subsequent to December 31, 2020, as discussed herein below
−Removed: in Liquidity and Capital Resources .
−Removed: December 2020, we issued a total of 10,647,500 shares of
−Removed: our common stock for gross proceeds of $17.0 million, with cash proceeds of $16.0 million after the payment of a placement
−Removed: agent fee and expenses of approximately $1.0 million, and we additionally paid offering costs of $0.1 million.
−Removed: shares of our common stock were issued in two registered direct offerings pursuant to respective Prospectus Supplement
−Removed: dated December 11, 2020 and December 18, 2020, each with respect to our effective shelf registration statement on Form S-3
−Removed: to December 31, 2020, on January 5, 2021, we issued 6,000,000 shares of our common stock for gross proceeds of $13.4
−Removed: million, with cash proceeds of $12.4 million, after the payment of $0.9 million of a placement agent fee and expenses, and
−Removed: we additionally paid offering costs of $0.1 million.
−Removed: The shares of our common stock were issued in a registered direct
−Removed: offering pursuant to a Prospectus Supplement dated January 5, 2021 with respect to our effective shelf registration statement
−Removed: on Form S-3 (File No.
−Removed: to December 31, 2020, on February 23, 2021 we issued 9,782,609 shares of our common stock for proceeds of $41.6 million, before
−Removed: underwriter expenses of $0.1 million, and we additionally incurred estimated offering costs of $0.4 million.
−Removed: The shares of
−Removed: our common stock were issued in an underwritten registered offering pursuant to a final Prospectus Supplement dated February
−Removed: 23, 2021 with respect to our effective shelf registration statement on Form S-3 (File No.
−Removed: 333-248709 and File No.
−Removed: to December 31, 2020, as of March 12, 2021, a total of 773,842 Series Z Warrants were exercised for cash at a $1.60 per share
−Removed: of our common stock, resulting in the issue of a corresponding number of shares of our common stock.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: of SARS-CoV-2 - COVID-19 Pandemic
−Removed: in December 2019, there was an outbreak of a novel strain of a coronavirus occurred, with such coronavirus designated by the United
−Removed: Nations (UN) World Health Organization (“WHO”) as the “Severe Acute Respiratory Syndrome Coronavirus 2”
−Removed: - or “SARS-CoV-2”.
−Removed: The SARS-CoV-2 spread on a global basis to other countries, including the United States of America
−Removed: (“USA”
−Removed: “U.S.”
−Removed: or “United States”).
−Removed: On March 11, 2020, the WHO declared a pandemic resulting
−Removed: from SARS-CoV-2, with such pandemic commonly referred to by its resulting illness of “COVID-19”
−Removed: (“coronavirus
−Removed: disease-2019”), and is referred to herein as the “COVID-19 pandemic”.
−Removed: The COVID-19 pandemic is ongoing, and
−Removed: we continue to monitor the ongoing impact of the COVID-19 pandemic on the United States national economy, the global economy,
−Removed: and our business.
−Removed: COVID-19 pandemic may have an adverse impact on our operations, supply chains, and distribution systems and /or those of our contractors
−Removed: of our laboratory partner, and increase our expenses, including as a result of impacts associated with preventive and precautionary
−Removed: measures being taken, restrictions on travel, quarantine polices, and social distancing.
−Removed: Such adverse impact may include, for
−Removed: example, the inability of our employees and /or those of our contractors or laboratory partner to perform their work or curtail
−Removed: their services provided to us.
−Removed: expect the significance of the COVID-19 pandemic, including the extent of its effect on our consolidated financial condition and
−Removed: consolidated operational results and cash flows, to be dictated by the success of United States and global efforts to mitigate
−Removed: the spread of and /or to contain the SARS-CoV-2 and the impact of such efforts.
−Removed: addition, the spread of the SARS-CoV-2 has disrupted the United States’
−Removed: healthcare and healthcare regulatory systems which
−Removed: could divert healthcare resources away from, or materially delay United States Food and Drug Administration (“FDA”)
−Removed: approval with respect to our products.
−Removed: our clinical trials have been and may be further affected by the COVID-19 pandemic, as site initiation and patient enrollment
−Removed: may be delayed, for example, due to prioritization of hospital resources toward the virus and /or illness response, as well as
−Removed: travel restrictions imposed by governments, and the inability to access clinical test sites for initiation and monitoring.
−Removed: COVID-19 pandemic may have an adverse impact on the economies and financial markets of many countries, including the USA, resulting
−Removed: in an economic downturn that could adversely affect demand for our products and services and /or our product candidates.
−Removed: we are continuing to monitor and assess the effects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19
−Removed: pandemic (or a similar health epidemic) is highly uncertain and subject to change, and therefore, its impact on our consolidated
−Removed: financial condition, consolidated results of operations, and /or consolidated cash flows, the adverse impact could be material.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: of Operations
−Removed: and administrative expenses
−Removed: and administrative expenses consist primarily of salaries and related costs for personnel, travel expenses, facility-related costs,
−Removed: professional fees, accounting and legal services, consultants and expenses associated with obtaining and maintaining patents within
−Removed: our intellectual property portfolio.
−Removed: anticipate our general and administrative expenses will increase in the future, as we anticipate an increase in payroll and related
−Removed: expenses related to the roll-out of our commercial sales and marketing operations.
−Removed: We also anticipate continued expenses related
−Removed: to being a public company, including audit, legal, regulatory, and tax-related services associated with maintaining compliance
−Removed: as a public company, insurance premiums and investor relations costs.
−Removed: and development expenses
−Removed: and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses
−Removed: incurred for the research and development of our products, including:
−Removed: costs charged to us by various external contract research organizations we contract with to conduct preclinical studies and
−Removed: engineering studies;
−Removed: and benefit costs associated with our clinical and engineering personnel;
−Removed: associated with regulatory filings;
−Removed: license fees;
−Removed: of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes;
−Removed: design engineering studies.
−Removed: plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products
−Removed: as well as new innovations.
−Removed: Our research and development activities are focused principally on obtaining FDA approvals and developing
−Removed: product improvements or extending the utility of the lead products in our pipeline, including CarpX, EsoCheck and EsoGuard, along
−Removed: with advancing our DisappEAR, PortIO, NextFlo, and non-invasive glucose monitoring products through their respective development
−Removed: Income and Expense, net
−Removed: income and expense, net, consists principally of changes in fair value of our convertible notes, losses on extinguishment of debt
−Removed: upon repayment of such convertible notes;
−Removed: and interest expense recognized in connection with one of our convertible notes.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: ended December 31, 2020 versus December 31, 2019
−Removed: and administrative expenses
−Removed: the year ended December 31, 2020, general and administrative costs were approximately $12.4 million, compared to $7.7 million
−Removed: for the year ended December 31, 2019.
−Removed: The net increase of $4.7 million was principally related to:
−Removed: approximately
−Removed: $2.3 million increase in compensation related costs principally related to sales staffing levels and other costs related to
−Removed: our commercial launch of EsoGuard and CarpX;
−Removed: approximately
−Removed: $2.0 million in consulting services related to patents, regulatory compliance, legal processes for contract review, and public
−Removed: company expenses;
−Removed: approximately
−Removed: $0.3 million in general business expenses.
−Removed: and development expenses
−Removed: the year ended December 31, 2020, research and development costs were approximately $11.0 million as compared to $6.6 million
−Removed: for the corresponding period in the prior year, with the approximate $4.4 million increase principally related to:
−Removed: approximately
−Removed: $4.0 million increase in clinical trial costs and outside professional and engineering services with respect to CarpX, NextFlo,
−Removed: Port IO, EsoGuard and our glucose monitoring product;
−Removed: approximately
−Removed: $0.4 million increase in compensation related costs related to expanded clinical and engineering staff.
−Removed: Income and Expense
−Removed: in fair value of convertible debt
−Removed: the year ended December 31, 2020, the (non-cash) expense recognized for the change in the fair value of our convertible notes
−Removed: was approximately $6.0 million, inclusive of the recognition of other expense of approximately $1.9 million of lender fees incurred
−Removed: with respect to the convertible notes, as compared to $1.1 million for the year ended December 31, 2019, resulting in an increase
−Removed: of approximately $4.9 million principally related to:
−Removed: increase in the face principal amount of our convertible notes of approximately $18.1 million, inclusive of $1.9 million in
−Removed: other fair value input assumptions, an increase in the Company’s common stock price between the periods resulting in
−Removed: a higher estimated fair value of the convertible notes;
−Removed: total of approximately $1.9 million of lender fees recognized as other expense, inclusive of approximately $0.7 million with
−Removed: respect to our November 2019 Senior Secured Convertible Note - Series B ;
−Removed: approximately $0.4 million with respect to our April
−Removed: 2020 Senior Convertible Note;
−Removed: and approximately $0.8 million with respect to our August 2020 Senior Secured Convertible Note.
−Removed: These fees were $0.7 million in the corresponding prior year period with respect to our November 2019 Senior Convertible Note
−Removed: Note 8, Financial Instruments Fair Value Measurement , and Note 9, Outstanding Debt , of our consolidated
−Removed: financial statements for a further discussion of the change in fair value of our convertible notes, and “—Liquidity
−Removed: and Capital Resources”, below.
−Removed: from Extinguishment of Debt
−Removed: the year ended December 31, 2020, a debt extinguishment loss of approximately $6.5 million was recognized in connection with the
−Removed: Senior Secured Convertible Notes issued November 4, 2019 and December 27, 2018, with such debt extinguishment loss resulting from
−Removed: the difference between the sum of the face value principal repayments and the corresponding interest thereon as compared to the
−Removed: fair value of the shares of our common stock issued upon conversion of such convertible notes.
−Removed: In the prior year period ended
−Removed: December 31, 2019, a debt extinguishment loss of approximately $1.8 million was recognized in connection with the Senior Secured
−Removed: Convertible Note issued December 27, 2018.
−Removed: See Note 9, Outstanding Debt , of our consolidated financial statements for a
−Removed: further discussion of our convertible notes.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: ended December 31, 2020 versus December 31, 2019 - continued
−Removed: Senior Secured Convertible Notes dated Nov 4, 2019 are comprised of a Series A and Series B, each with a $7.0 million face value
−Removed: principal (“November 2019 Senior Convertible Notes), with the Series A previously funded on November 4, 2019 and the Notes
−Removed: Series B funded on March 30, 2020 (as further discussed herein below).
−Removed: During the period from November 2019 to its funding on
−Removed: March 30, 2020, the Series B incurred interest expense at 3.0% per annum based on its $7.0 million face value principal.
−Removed: regard, interest expense of approximately $0.1 million was recognized in each of the year ended December 31, 2020 and 2019 (during
−Removed: the period when the Series B was unfunded from November 4, 2019 to March 29, 2020).
−Removed: have total estimated federal and state net operating loss (“NOL”) carryforward of approximately $63 million and $40.0
−Removed: million as of December 31, 2020 and 2019, respectively, which is available to reduce future taxable income, of which approximately
−Removed: $13.8 million have statutory expiration dates commencing in 2035, and approximately $49.2 million which do not have a statutory
−Removed: expiration date.
−Removed: The State and Local NOL carryforwards of approximately $63.0 million have statutory expiration dates commencing
−Removed: We have total estimated research and development (“R&D”) tax credit carryforward of approximately $0.4
−Removed: million as of December 31, 2020 which are available to reduce future tax expense and have statutory expiration dates commencing
−Removed: A valuation allowance reserve equal to the full amount of the deferred tax assets, net of deferred tax liabilities,
−Removed: has been recognized as a charge to income tax expense as of December 31, 2020 and 2019.
−Removed: March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was enacted in response to the
−Removed: pandemic resulting from the outbreak of a novel strain of a coronavirus designated as the “Severe Acute Respiratory Syndrome
−Removed: Coronavirus 2”
−Removed: - or “SARS-CoV-2”.
−Removed: The pandemic resulting from SARS-CoV-2 is commonly referred to by its resulting
−Removed: illness of “coronavirus disease-2019”
−Removed: (“COVID-19”), and is referred to herein as the COVID-19 pandemic.
−Removed: other provisions, the CARES Act increases the limitation on the allowed business interest expense deduction from 30 percent to
−Removed: 50 percent of adjusted taxable income for tax years beginning January 1, 2019 and 2020 and allows businesses to immediately expense
−Removed: the full cost of Qualified Improvement Property, retroactive to tax years beginning on or after January 1, 2018.
−Removed: Additionally,
−Removed: the CARES Act permits net operating loss carryovers (“NOLs”) and carrybacks to offset 100% of taxable income for taxable
−Removed: years beginning before 2021.
−Removed: In addition, the CARES Act allows NOLs incurred in 2018, 2019, and 2020 to be carried back to each
−Removed: of the five preceding taxable years to generate a refund of previously paid income taxes.
−Removed: While we are currently evaluating the
−Removed: impact of these CARES Act provisions, it is not expected, at this time, to have a material impact on our consolidated income tax
−Removed: our consolidated financial statements Note 13, Income Taxes , for additional information with respect to our income
−Removed: tax provision, deferred tax assets, and deferred tax liabilities.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: and Capital Resources
−Removed: have financed our operations principally through the public and private issuances of our common stock, preferred stock, common
−Removed: stock purchase warrants, and debt.
−Removed: We are subject to all of the risks and uncertainties typically faced by medical device and
−Removed: diagnostic and medical device companies that devote substantially all of their efforts to the commercialization of their initial
−Removed: product and services and ongoing R&D and clinical trials.
−Removed: We expect to continue to experience recurring losses from operations,
−Removed: and will continue to fund our operations with debt and equity financing transactions.
−Removed: Notwithstanding, however, together with
−Removed: the cash on-hand as of December 31, 2020, and the cash proceeds from the issue of shares of common stock of the Company subsequent
−Removed: to December 31, 2020 in January and February 2021, as discussed herein below, we expect to be able
−Removed: to fund our future operations for one year from the date of the issue of our consolidated financial statements as included in
−Removed: our Annual Report on Form 10-K for the year ended December 31, 2020.
−Removed: the year ended December 31, 2020 and 2019 we issued convertible notes and shares of our common stock, as discussed herein below,
−Removed: which resulted in approximately $35.9 million and $12.5 million, respectively, of gross proceeds, before placement agent fees
−Removed: and expenses and additional offering costs incurred by us.
−Removed: to December 31, 2020, in January and February 2021, we issued shares of our common stock for gross proceeds of approximately $55.0
−Removed: million before placement agent and underwriter fees and expenses and additional offering costs incurred by us, as discussed herein
−Removed: Additionally, subsequent to December 31, 2020, we repaid-in-full the remaining outstanding principal balances of each of
−Removed: our convertible notes, inclusive of the “November 2019 Senior Convertible Notes”
−Removed: as of January 5, 2021 upon conversion
−Removed: into shares of our common stock;
−Removed: and both the “April 2020 Senior Convertible Note”
−Removed: and the “August 2020 Senior
−Removed: Convertible Note”
−Removed: as of March 2, 2021, upon cash repayments, each as discussed herein below.
−Removed: Secured Convertible Notes dated November 4, 2019 - Series A (November 4, 2019) and Series B (March 30, 2020) (“
−Removed: 2019 Senior Convertible Notes ”)
−Removed: previously consummated a private placement with an accredited investor in November 2019 of the issue of a Senior Secured Convertible
−Removed: Note with a $14.0 million aggregate face value principal, referred to herein as the “November 2019 Senior Convertible Notes”.
−Removed: The November 2019 Senior Convertible Notes were comprised of a Series A and Series B, each with a $7.0 million face value principal,
−Removed: and each having a $0.7 million lender fee deducted from the cash proceeds when funded, as well as the payment of additional offering
−Removed: costs, inclusive of a financial advisory fee paid to the placement agent and legal fees.
−Removed: issued the November 2019 Senior Convertible Note - Series A on November 4, 2019, with a face value principal of $7.0 million,
−Removed: resulting in cash proceeds of $6.3 million after a $0.7 million lender fee, and we paid additional offering costs of $0.6 million,
−Removed: inclusive of a financial advisory fee paid to the placement agent and legal fees.
−Removed: the election of the holder, under its prepayment terms, the November 2019 Senior Convertible Note - Series B was issued on March
−Removed: 30, 2020, with a face value principal of $7.0 million, resulting in cash proceeds of $6.3 million after a $0.7 million of lender
−Removed: fee, and we additionally paid offering costs of $0.4 million, consisting of a financial advisory fee paid to the placement agent.
−Removed: November 2019 Senior Convertible Notes accrued interest at 7.875% per annum, upon the respective Series A and Series B being funded
−Removed: by the investor.
−Removed: During the period from November 2019 to its funding on March 30, 2020, the November 2019 Senior Convertible Notes
−Removed: - Series B incurred interest expense at 3.0% per annum based on its $7.0 million face value principal.
−Removed: the year ended December 31, 2020, with respect to the November 2019 Senior Convertible Notes, approximately $13.0 million of principal
−Removed: repayments and approximately $0.5 million of interest thereon non-installment payments were settled through the issuance of 8,854,004
−Removed: shares of our common stock with a fair value of approximately $18.8 million.
−Removed: As of December 31, 2020, the November 2019 Senior
−Removed: Convertible Notes remaining unpaid outstanding face value principal was approximately $1.0 million, which was repaid-in-full subsequent
−Removed: to December 31, 2020, as discussed herein below.
−Removed: to December 31, 2020, on January 5, 2021, the November 2019 Senior Secured Convertible Note remaining amount due of approximately
−Removed: $1.0 million was settled with the issuance of 667,668 shares of the Company’s common stock with a fair value of approximately
−Removed: $1.7 million (with such fair value measured as the respective conversion date quoted closing price of our common stock), with
−Removed: such final conversion resulting in the November 2019 Senior Secured Convertible Notes being paid-in-full as of January 5, 2021.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: and Capital Resources - continued
−Removed: Convertible Note dated April 30, 2020 - (“April 2020 Senior Convertible Note”)
−Removed: April 2020, in a private placement with an accredited investor, we issued a Senior Convertible Note dated April 30, 2020, with
−Removed: a face value principal of $4.1 million, resulting in cash proceeds of approximately $3.7 million, after a lender fee of approximately
−Removed: $0.4 million (the “April 2020 Senior Convertible Note”).
−Removed: The April 2020 Senior Convertible Note has a contractual
−Removed: maturity date of April 30, 2022, and an annual interest rate of 7.875%, payable in cash on a monthly basis.
−Removed: As of December 31,
−Removed: 2020, the April 2020 Senior Convertible Note unpaid outstanding face value principal was $4.1 million, which was repaid-in-full
−Removed: subsequent to December 31, 2020, as discussed herein below.
−Removed: Secured Convertible Note dated August 6, 2020 (“August 2020 Senior Convertible Note”)
−Removed: August 2020, in a private placement with an accredited investor, we issued a Senior Secured Convertible Note dated August 6, 2020,
−Removed: with a face value principal of $7.8 million, resulting in cash proceeds of approximately $7.0 million, after a lender fee of approximately
−Removed: $0.8 million (the “August 2020 Senior Secured Convertible Note”).
−Removed: The August 2020 Senior Secured Convertible Note
−Removed: has a contractual maturity date of August 5, 2022, and an annual interest rate of 7.875%, payable in cash on a monthly basis.
−Removed: As of December 31, 2020, the August 2020 Senior Secured Convertible Note unpaid outstanding face value principal was $7.75 million,
−Removed: which was repaid-in-full subsequent to December 31, 2020, as discussed herein below.
−Removed: Repayments - April 2020 Senior Convertible Note and August 2020 Senior Convertible Note
−Removed: to December 31, 2020:
−Removed: on January 30, 2021, we paid in cash a $0.3 million partial principal repayment of the April 2020 Senior
−Removed: Convertible Note;
−Removed: and on March 2, 2021, we paid in cash a total of $14.5 million of principal repayments, resulting in both the
−Removed: April 2020 Senior Convertible Note and the August 2020 Senior Convertible Note being repaid-in-full as of such date.
−Removed: of Common Stock
−Removed: the year ended December 31, 2020, we issued a total of 10,647,500 shares of our common stock for gross proceeds of $17.0 million,
−Removed: with cash proceeds of $15.9 million after the payment of a placement agent fee and expenses of approximately $1.0
−Removed: million, and we additionally paid offering costs of $0.1 million.
−Removed: The shares of our common stock were issued in two registered
−Removed: direct offerings pursuant to a respective Prospectus Supplement dated December 11, 2020 and December 18, 2020, each with
−Removed: respect to our effective shelf registration statement on Form S-3 (File No.
−Removed: to December 31, 2020, on January 5, 2021, we issued 6,000,000 shares of our common stock for gross proceeds of $13.4
−Removed: million, with cash proceeds of $12.4 million, after the payment of $0.9 million of a placement agent fee and expenses, and we
−Removed: additionally paid offering costs of $0.1 million.
−Removed: The shares of our common stock were issued in a registered direct offering,
−Removed: pursuant to a Prospectus Supplement dated January 5, 2021 with respect to our effective shelf registration statement on Form S-3
−Removed: to December 31, 2020, on February 23, 2021 we issued 9,782,609 shares of our common stock for proceeds of $41.6 million, before
−Removed: underwriter expenses of $0.1 million, and we additionally incurred estimated offering costs of $0.4 million.
−Removed: The shares of our
−Removed: common stock were issued in an underwritten registered offering pursuant to a final Prospectus Supplement dated February 23, 2021
−Removed: with respect to our effective shelf registration statement on Form S-3 (File No.
−Removed: 333-248709 and File No.
−Removed: to December 31, 2020, as of March 12, 2021, a total of 773,842 Series Z Warrants were exercised for cash at a $1.60 per share
−Removed: of our common stock, resulting in the issue of a corresponding number of shares of our common stock.
−Removed: the previous year ended December 31, 2019, we issued a total of 5,480,000 shares of our common stock for gross proceeds of $5.5
−Removed: million, with cash proceeds of $5.4 million after the payment of a total of $0.1 million of a placement agent fee and expenses,
−Removed: and the payment of additional offering costs.
−Removed: The shares of our common stock were issued in three registered direct
−Removed: offerings pursuant to a respective Prospectus Supplement dated April 12, 2019, May 8, 2019, and June 25, 2019, each with
−Removed: respect to our effective shelf registration statement on Form S-3 (File No.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: Accounting Policies and Significant Judgments and Estimates
−Removed: discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements,
−Removed: which have been prepared in accordance with generally accepted accounting principles in the United States of America, or U.S.
−Removed: The preparation of these consolidated financial statements requires us to make estimates and assumptions affecting the reported
−Removed: amounts of assets, liabilities, and equity, along with the disclosure of contingent assets and liabilities at the date of the
−Removed: consolidated financial statements and the reported amounts of expenses during the corresponding periods.
−Removed: In accordance with U.S.
−Removed: GAAP, we base our estimates on historical experience and on various other assumptions we believe are reasonable under the circumstances.
−Removed: Actual results may differ from these estimates under different assumptions or conditions.
−Removed: While our significant accounting policies
−Removed: are described in more detail in our consolidated financial notes, we believe the following accounting policies to be critical
−Removed: to the judgments and estimates used in the preparation of our consolidated financial statements.
−Removed: and Development Expense
−Removed: and development expenses are recognized as incurred and include the salary and stock-based compensation of employees engaged in
−Removed: product research and development activities, and the costs related to the Company’s various contract research service providers,
−Removed: suppliers, engineering studies, supplies, and outsourced testing and consulting fees, as well as depreciation expense and rental
−Removed: costs for equipment used in research and development activities, and fees incurred for access to certain facilities of contract
−Removed: research service providers.
−Removed: Instruments and Fair Value Measurements
−Removed: Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”)
−Removed: Topic 820, Fair Value Measurement, (ASC 820) defines fair value as the price which would be received to sell an asset or
−Removed: paid to transfer a liability in an orderly transaction between market participants at a transaction measurement date.
−Removed: 820 three-tier fair value hierarchy prioritizes the inputs used in the valuation methodologies, as follows:
−Removed: based on quoted prices for identical assets and liabilities in active markets.
−Removed: based on observable inputs other than quoted prices included in Level 1, such as quoted
−Removed: prices for similar assets or liabilities in active markets, quoted prices for identical
−Removed: or similar assets and liabilities in markets which are not active, or other inputs observable
−Removed: or can be corroborated by observable market data.
−Removed: based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions
−Removed: made by other market participants.
−Removed: These valuations require significant judgment.
−Removed: Company evaluates its financial instruments to determine if those instruments or any embedded components of those instruments
−Removed: potentially qualify as derivatives required to be separately accounted for in accordance with FASB ASC Topic 815, Derivatives
−Removed: and Hedging (ASC 815).
−Removed: The accounting for warrants issued to purchase shares of common stock of the Company is based on the
−Removed: specific terms of the respective warrant agreement, and are generally classified as equity, but may be classified as a derivative
−Removed: liability if the warrant agreement provides required or potential full or partial cash settlement.
−Removed: A warrant classified as a derivative
−Removed: liability, or a bifurcated embedded conversion or settlement option classified as a derivative liability, is initially measured
−Removed: at its issue-date fair value, with such fair value subsequently adjusted at each reporting period, with the resulting fair value
−Removed: adjustment recognized as other income or expense.
−Removed: If upon the occurrence of an event resulting in the warrant liability or the
−Removed: embedded derivative liability being subsequently classified as equity, or the exercise of the warrant or the conversion option,
−Removed: the fair value of the derivative liability will be adjusted on such date-of-occurrence, with such date-of-occurrence fair value
−Removed: adjustment recognized as other income or expense, and then the derivative liability will be derecognized at such date-of-occurrence
−Removed: recurring and non-recurring estimated fair value measurements are subjective and are affected by changes in inputs to the valuation
−Removed: models, including the Company’s common stock price, and certain Level 3 inputs, including, the assumptions regarding the
−Removed: estimated volatility in the value of the Company’s common stock price;
−Removed: the Company’s dividend yield;
−Removed: the likelihood
−Removed: and timing of future dilutive transactions, as applicable, along with the risk-free rates based on U.S.
−Removed: Treasury security yields.
−Removed: Changes in these assumptions can materially affect the estimated fair values.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: Accounting Policies and Significant Judgments and Estimates - continued
−Removed: Value Option (“FVO”) Election
−Removed: Senior Secured Convertible Notes and Senior Convertible Note are each a debt host financial instrument containing embedded features
−Removed: and /or options which would otherwise be required to be bifurcated from the debt-host and recognized as separate derivative liabilities
−Removed: subject to initial and subsequent periodic estimated fair value measurements under ASC 815.
−Removed: Notwithstanding, FASB ASC
−Removed: Topic 825, Financial Instruments , (“ASC 825”) provides for the “fair value option”
−Removed: (“FVO”)
−Removed: In this regard, ASC 825-10-15-4 provides for the FVO election (to the extent not otherwise prohibited by
−Removed: ASC 825-10-15-5) to be afforded to financial instruments, wherein the financial instrument is initially measured at its issue-date
−Removed: estimated fair value and then subsequently remeasured at estimated fair value on a recurring basis at each reporting period date,
−Removed: with changes in the estimated fair value recognized as other income (expense) in the consolidated statement of operations.
−Removed: this regard, as provided for by ASC 825-10-50-30(b), the estimated fair value adjustment is presented in a single line item within
−Removed: other income (expense) in the consolidated statement of operations.
−Removed: Further, as required by ASC 825-10-45-5, to the extent a portion
−Removed: of the fair value adjustment is attributed to a change in the instrument-specific credit risk, such portion would be recognized
−Removed: as a component of other comprehensive income (“OCI”).
−Removed: Notwithstanding, there was no such portion of the fair value
−Removed: adjustment attributed to a change in the instrument-specific credit risk in the years ended December 31, 2020 and 2019.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: Accounting Policies and Significant Judgments and Estimates - continued
−Removed: awards are made to members of the board of directors of the Company, the Company’s employees and non-employees, under each
−Removed: of the PAVmed Inc.
−Removed: 2014 Long-Term Incentive Equity Plan and the Lucid Diagnostics Inc.
−Removed: 2018 Long-Term Incentive Equity Plan.
−Removed: the year ended December 31, 2020, stock-based compensation is recognized in accordance with the provisions of FASB ASC Topic 718,
−Removed: Compensation - Stock Compensation (“ASC 718”), as amended by FASB Accounting Standard Update (ASU)
−Removed: 2018-07 (“ASU 2018-07”).
−Removed: The provisions of ASU 2018-07 amended ASC 718 to align the accounting for stock-based awards
−Removed: granted to nonemployees with the requirements for accounting for stock-based payments to employees;
−Removed: and to supersede the previous
−Removed: guidance of FASB ASC Topic 505-50, Equity-Based Payments to Non-Employees (“ASC 505-50”).
−Removed: The adoption as of
−Removed: January 1, 2020, of the updated provisions of ASC 718, as amended by ASU 2018-07, had no effect on the Company’s consolidated
−Removed: financial statements.
−Removed: the year ended December 31, 2020, with respect to stock-based awards granted to members of the board of directors, employees,
−Removed: and non-employees, the Company recognizes stock-based compensation in accordance with the provisions of ASC 718, as amended by
−Removed: ASU 2018-07, wherein the grant-date estimated fair value of the stock-based award is recognized on a straight-line basis over
−Removed: the requisite service period, which is generally the vesting period of the respective stock-based award, with such straight-line
−Removed: recognition adjusted, as applicable, so the cumulative expense recognized is at-least equal-to-or-greater-than the estimated fair
−Removed: value of the vested portion of the respective stock-based award as of the reporting date.
−Removed: the previous year ended December 31, 2019, the Company recognized stock-based compensation of stock-based awards granted to members
−Removed: of its board of directors and employees in accordance with ASC 718, as described above;
−Removed: and with respect to non-employees the
−Removed: Company recognized stock-based compensation in accordance with previous provisions of ASC 505-50, wherein, the expense of stock-based
−Removed: awards granted to non-employees was recognized on a vesting date basis by fixing the fair value of vested non-employee stock options
−Removed: as of their respective vesting date.
−Removed: The fair value of vested non-employee stock options was not subject-to further remeasurement
−Removed: at subsequent reporting dates.
−Removed: The estimated fair value of the unvested non-employee stock options was remeasured to then current
−Removed: fair value at each subsequent reporting date, until such time when the stock options vest, at which time the fair value is fixed,
−Removed: as noted above.
−Removed: The estimated fair value of stock-based awards granted to non-employees was recognized on a straight-line basis
−Removed: over the requisite service period, which was generally the vesting period of the respective non-employee stock-based award, with
−Removed: such straight-line recognition adjusted so the cumulative expense recognized was at-least equal-to-or-greater-than the estimated
−Removed: fair value of the vested portion of the respective stock-based award.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: Accounting Policies and Significant Judgments and Estimates - continued
−Removed: Company accounts for income taxes using the asset and liability method, as required by FASB ASC Topic 740, Income Taxes ,
−Removed: (“ASC 740”).
−Removed: Current tax liabilities or receivables are recognized for estimated income tax payable and/or
−Removed: refundable for the current year.
−Removed: Deferred tax assets and deferred tax liabilities are recognized for estimated future tax consequences
−Removed: attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective
−Removed: tax basis, along with net operating loss and tax credit carryforwards.
−Removed: Deferred tax assets and deferred tax liabilities are measured
−Removed: using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to
−Removed: be recovered or settled.
−Removed: Changes in deferred tax assets and deferred tax liabilities are recorded in the provision for income
−Removed: ASC 740, a “more-likely-than-not”
−Removed: criterion is applied when assessing the estimated realization of deferred tax assets
−Removed: through their utilization to reduce future taxable income, or with respect to a deferred tax asset for tax credit carryforward,
−Removed: to reduce future tax expense.
−Removed: A valuation allowance is established, when necessary, to reduce deferred tax assets, net of deferred
−Removed: tax liabilities, when the assessment indicates it is more-likely-than-not, the full or partial amount of the net deferred tax
−Removed: asset will not be realized.
−Removed: As a result of the evaluation of the positive and negative evidence bearing upon the estimated realizability
−Removed: of net deferred tax assets, and based on a history of operating losses, it is more-likely-than-not the deferred tax assets will
−Removed: not be realized, and therefore a valuation allowance reserve equal to the full amount of the deferred tax assets, net of deferred
−Removed: tax liabilities, has been recognized as a charge to income tax expense as of December 31, 2020 and 2019.
−Removed: Company recognizes the benefit of an uncertain tax position it has taken or expects to take on its income tax return if such a
−Removed: position is more-likely-than-not to be sustained upon examination by the taxing authorities, with the tax benefit recognized being
−Removed: the largest amount having a greater than 50% likelihood of being realized upon ultimate settlement.
−Removed: As of December 31, 2020, the
−Removed: Company does not have any unrecognized tax benefits resulting from uncertain tax positions.
−Removed: Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision.
−Removed: were no amounts accrued for penalties or interest as of December 31, 2020 and December 31, 2019 or recognized during the years
−Removed: ended December 31, 2020 and 2019.
−Removed: The Company is not aware of any issues under review to potentially result in significant payments,
−Removed: accruals, or material deviations from its position.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: Accounting Policies and Significant Judgments and Estimates - continued
−Removed: Accounting Standards Updates
−Removed: noted herein above, as of January 1, 2020, the Company adopted the amended guidance of ASC 718 with respect to stock-based awards
−Removed: granted to non-employees, as amended by ASU 2018-07, which aligned the accounting for stock-based payments to nonemployees for
−Removed: goods and services with the requirements for accounting for stock-based awards granted to employees under ASC 718.In this regard,
−Removed: ASU 2018-07 provides for stock-based payments to non-employees to be measured at the grant date fair value of the equity instruments
−Removed: to be provided to the nonemployee when the goods or services have been delivered.
−Removed: Prior to the ASU 2018-07 amendment, nonemployee
−Removed: share-based payments were accounted for under the superseded provisions of ASC 505-50.
−Removed: The adoption of such amended guidance did
−Removed: not have an effect on the Company’s consolidated financial statements.
−Removed: of January 1, 2020, the Company adopted ASU 2018-13, Fair Value Measurement (Topic 820):
−Removed: Disclosure Framework—Changes
−Removed: to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurement.
−Removed: The adoption of ASU 2018-13 did not have an effect on the Company’s consolidated financial statements.
−Removed: of January 1, 2020, the Company adopted the guidance of ASU 2017-11, issued by the FASB in July 2017, Earnings Per Share (Topic
−Removed: 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815) - Part I - Accounting for Certain
−Removed: Financial Instruments with Down-Round Features, and Part II - Replacement of the Indefinite Deferral for Mandatorily Redeemable
−Removed: Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception.
−Removed: Principally, ASU 2017-11 amendments simplify the accounting for certain financial instruments with down-round features.
−Removed: amendments require companies to disregard the down-round feature when assessing whether the instrument is indexed to its own stock,
−Removed: for purposes of determining liability or equity classification.
−Removed: Companies that provide earnings per share data will adjust their
−Removed: basic earnings per share calculation for the effect of the down-round feature when triggered (i.e., when the exercise price of
−Removed: the related equity-linked financial instrument is adjusted downward because of the down-round feature) and will also recognize
−Removed: the effect of the trigger within equity.
−Removed: Additionally, ASU 2017-11 also addresses “navigational concerns”
−Removed: FASB ASC related to an indefinite deferral available to private companies with mandatorily redeemable financial instruments and
−Removed: certain noncontrolling interests, which has resulted in the existence of significant “pending content”
−Removed: The FASB decided to reclassify the indefinite deferral as a scope exception, which does not have an accounting effect.
−Removed: of ASU 2017-11 is effective for public business entities, as defined in the ASC Master Glossary, for fiscal years beginning after
−Removed: December 15, 2018, including interim periods within those fiscal years.
−Removed: With respect to all other entities, including the Company
−Removed: under its JOBS Act EGC Accounting Election, as discussed herein below, the guidance of ASU 2017-11 was effective for fiscal years
−Removed: beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020.
−Removed: The adoption of
−Removed: the ASU 2017-11 guidance as of January 1, 2020 did not have an effect on the Company’s consolidated financial statements.
−Removed: August 2020, the FASB issued ASU 2020-06, Debt –
−Removed: Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
−Removed: and Hedging –
−Removed: Contracts in Entity’s Own Equity (Subtopic 815 –
−Removed: 40) , (“ASU 2020-06”).
−Removed: simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible
−Removed: instruments and contracts on an entity’s own equity.
−Removed: The ASU 2020-06 amendments are effective for fiscal years beginning
−Removed: after December 15, 2023, and interim periods within those fiscal years.
−Removed: Early adoption is permitted, but no earlier than fiscal
−Removed: years beginning after December 15, 2020, including interim periods within those fiscal years.
−Removed: The Company’s adoption of
−Removed: the ASU 2020-06 guidance as of January 1, 2021 is not expected to have an effect on the Company’s consolidated financial
−Removed: December 2019, the FASB issued ASU No.
−Removed: 2019-12, “Income Taxes:
−Removed: Simplifying the Accounting for Income Taxes”,
−Removed: (“ASU 2019-12”).
−Removed: The guidance of ASU 2019-12 removes certain exceptions for recognizing deferred taxes for investments,
−Removed: performing intra-period allocation, and calculating income taxes in interim periods, and adds revised guidance to reduce complexity
−Removed: in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group.
−Removed: Adoption of the guidance of ASU 2019-12 is required for annual and interim financial statements beginning after December 15, 2020.
−Removed: The Company’s adoption of the ASU 2019-12 guidance as of January 1, 2021 is not expected to have an effect on the Company’s
−Removed: consolidated financial statements.
−Removed: ASC 842, Leases , (ASU No.
−Removed: 2016-02, Leases , February-2016 - “ASU 2016-02”
−Removed: ) which established a
−Removed: right-of-use (“ROU”) model requiring a lessee to recognize a ROU asset and a lease liability for all leases with terms
−Removed: greater-than 12 months.
−Removed: Leases are classified as either finance or operating, with classification affecting the pattern of expense
−Removed: recognition in the income statement.
−Removed: The ASC 842 effective date for the Company is December 31, 2022 for its annual financial
−Removed: statement, and for interim quarterly financial statements commencing March 31, 2023.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: Accounting Policies and Significant Judgments and Estimates - continued
−Removed: are an “emerging growth company”
−Removed: or EGC, as defined in the JOBS Act, and are eligible to take advantage of certain
−Removed: exemptions from various reporting requirements applicable to other public companies who are not an ECG, including, but not limited
−Removed: to, only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly
−Removed: reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
−Removed: not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure
−Removed: obligations regarding executive compensation in our periodic reports and proxy or information statements, and not being required
−Removed: to adopt certain new and revised accounting standards until those standards would otherwise apply to private companies.
−Removed: irrevocably elected to avail ourselves of the extended time for the adoption of new or revised accounting standards, and, therefore,
−Removed: will not be subject to the same new or revised accounting standards as public companies who are not an ECG.
−Removed: sheet arrangements
−Removed: do not have any off-balance sheet arrangements.
−Removed: Quantitative and Qualitative Disclosure About Market Risk
+Added: as previously disclosed in our current reports on Form 8-K and quarterly reports on Form 10-Q, we did not sell any unregistered securities
+Added: or repurchase any of our securities during the fiscal year ended December 31, 2021.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.