−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 Test, EsoCheck Esophageal Cell Collection Device, and EsoCure Esophageal
−Removed: 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 Intravenous
−Removed: Infusion Platform Technology;
−Removed: Health – implantable vascular healthcare platform through remote monitoring and data analytics;
−Removed: Innovations - Non-invasive laser-based glucose monitoring, single-use ventilators, resorbable pediatric ear tubes and mechanical
−Removed: 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.
−Removed: EsoGuard and EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly screening test for
−Removed: the early detection of adenocarcinoma of the esophagus (“EAC”) and Barrett’s Esophagus (“BE”), including
−Removed: dysplastic BE and related pre-cursors to EAC in patients with chronic gastroesophageal reflux (“GERD”).
−Removed: is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck.
−Removed: quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1).
−Removed: The assay was evaluated in a 408-patient multicenter
−Removed: case-control study published in Science Translational Medicine, and showed greater than 90% sensitivity and specificity at detecting
−Removed: esophageal precancer and all conditions along the BE-EAC spectrum, including on samples collected with EsoCheck (Moinova, et al.
−Removed: 2018 Jan 17;10(424):
−Removed: EsoGuard is commercially available in the U.S.
−Removed: as a Laboratory Developed Test (LDT) performed
−Removed: at our CLIA-certified laboratory partner, ResearchDx Inc.
−Removed: (“RDx”), which does business as “PacificDx”.
−Removed: Cell samples,
−Removed: including those collected with EsoCheck, as discussed below, are sent to RDx, for testing and analyses using our proprietary EsoGuard
−Removed: NGS DNA assay.
−Removed: is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells
−Removed: in a less than five-minute office.
−Removed: It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from
−Removed: which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells.
−Removed: When vacuum suction is applied, the
−Removed: balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted
−Removed: region during device withdrawal.
−Removed: We believe this proprietary Collect+Protect ™ technology makes EsoCheck the only noninvasive
−Removed: esophageal cell collection device capable of such anatomically targeted and protected sampling.
−Removed: is in development as an Esophageal Ablation Device, with the intent to allow a clinician to treat dysplastic BE before it can progress
−Removed: to EAC, a highly lethal esophageal cancer, and to do so without the need for complex and expensive capital equipment.
−Removed: We have successfully
−Removed: completed a pre-clinical feasibility animal study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal
−Removed: mucosal lining.
−Removed: We have also completed an acute and survival animal study of EsoCure ™ Esophageal Ablation Device, demonstrating
−Removed: successful direct thermal balloon catheter ablation of esophageal lining through working channel of standard endoscope.
−Removed: We plan to conduct
−Removed: additional development work and animal testing of EsoCure to support a future FDA 510(k) submission.
−Removed: December 2019, we secured “gapfill” determination for the EsoGuard PLA code 0114U through the United States Department of
−Removed: Health and Human Services (“HHS”) Centers for Medicare and Medicaid Services (“CMS”) Clinical Laboratory Fee
−Removed: Schedule (“CLFS”) process, which has allowed us to engage directly with Medicare contractor Palmetto GBA, LLC and its MolDx
−Removed: Program on CMS payment and coverage.
−Removed: In October 2020, CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective
−Removed: January 1, 2021.
−Removed: We are still awaiting Medicare local coverage determination from MolDx, which we understand is working to clear a significant
−Removed: backlog of reviews.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: Health - continued
−Removed: EsoCheck, and EsoCure
−Removed: are also aggressively pursuing EsoGuard U.S.
−Removed: private payor payment and coverage.
−Removed: We recently held our initial advisory board meetings
−Removed: with medical directors of major insurers to obtain feedback and guidance on the type of clinical data that will be helpful in securing
−Removed: payment and coverage.
−Removed: Although the claim cycle can be prolonged during the early commercialization of a new test, PacificDx is starting
−Removed: to receive out-of-network private insurance payments on our behalf.
−Removed: initial EsoGuard commercialization efforts focused on gastroenterology (GI) physicians who have generally embraced our message that EsoGuard
−Removed: has the potential to expand the funnel of BE-EAC patients who will need long-term EGD surveillance and, potentially, treatment with endoscopic
−Removed: esophageal ablation.
−Removed: We have previously relied upon a hybrid sales model with full-time sales management and approximately fifty independent
−Removed: sales representatives.
−Removed: We significantly expanded our full-time commercial team in 2021 and are actively recruiting full-time territory
−Removed: managers and sales representatives nationwide.
−Removed: EsoGuard testing has accelerated as pandemic-related healthcare facility limitations have
−Removed: are now expanding EsoGuard commercialization to target primary care physicians (PCPs).
−Removed: The vast majority of at-risk GERD patients are
−Removed: cared for by PCPs and never see a gastroenterologist.
−Removed: To assure sufficient testing capacity and geographic coverage during this expansion,
−Removed: we are building our own network of Lucid Test Centers, where Company employed clinical personnel will perform the EsoCheck procedure
−Removed: for EsoGuard testing.
−Removed: We have launched three pilot Lucid Test Centers in the Phoenix metropolitan area and have recently announced
−Removed: new test centers in Utah, Colorado, and Nevada.
−Removed: We are currently preparing for the launch an EsoGuard Telemedicine Program, in
−Removed: partnership with an independent third-party telemedicine provider, UpScriptHealth, that can accommodate EsoGuard self-referrals from
−Removed: direct-to-consumer marketing.
−Removed: active clinical research and development program seeks to expand the clinical evidence of our products’ efficacy to support our
−Removed: ongoing regulatory, reimbursement and commercial efforts, including a FDA PMA submission for approval of EsoGuard and EsoCheck as
−Removed: an in vitro device (“IVD”), as currently, EsoGuard and EsoCheck are permitted to be marketed separately, but not in combination.
−Removed: We are actively enrolling patients in two international multicenter clinical trials to support FDA PMA approval of EsoGuard, used
−Removed: with EsoCheck, as an IVD indicated to detect NDBE.
−Removed: ESOGUARD-BE-1 is a screening study which will enroll approximately 500 to 900 male
−Removed: GERD patients over 50 years of age with one other risk factor.
−Removed: ESOGUARD-BE-2 is a case control study which will enroll approximately
−Removed: 500 male GERD patients with a previous diagnosis of NDBE, LGD, HGD, or EAC, along with normal controls.
−Removed: February 2020, we received FDA “Breakthrough Device Designation” for EsoGuard as an IVD.
−Removed: The FDA Breakthrough Device
−Removed: Program was created to offer patients more timely access to breakthrough technologies which provide for more effective treatment or diagnosis
−Removed: of life-threatening or irreversibly debilitating human disease or conditions by expediting their development, assessment and review through
−Removed: enhanced communications and more efficient and flexible clinical study design, including more favorable pre/post market data collection
−Removed: Breakthrough Devices receive priority FDA review, and a bipartisan bill before Congress (H.R.
−Removed: 5333) seeks to require Medicare
−Removed: to temporarily cover all Breakthrough Devices for three years while determining permanent coverage.
−Removed: have received ISO 13485:2016 certification for Lucid’s quality management system and received CE Mark certification for EsoCheck
−Removed: in May 2021 which allows it to be marketed in CE Mark European countries, which include the European Economic Area (the EU, Norway, Iceland,
−Removed: and Lichtenstein), Switzerland, and, until July 1, 2023, the United Kingdom.
−Removed: In June 2021, we completed the European Directive 98/79/EC
−Removed: for In-Vitro Diagnostic Medical Devices (“IVDD”) CE Mark certification for EsoGuard after Lucid and its European Union (“EU”)
−Removed: authorized representative completed the Commission of the European Union (“EC”) declaration of conformity procedure, including
−Removed: the associated technical documentation, ensuring and declaring EsoGuard meets the essential requirements of the IVDD.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: Invasive Interventions
−Removed: is a minimally invasive surgical device for use in the treatment of carpal tunnel syndrome which received FDA 510(k) marketing clearance
−Removed: in April 2020, with the first commercial procedure successfully performed in December 2020.
−Removed: After an initial slowdown in commercialization
−Removed: related to COVID, more recently we have recruited new sales leadership and have recently trained seven new surgeons to perform the CarpX
−Removed: procedure with five more scheduled to undergo training.
−Removed: believe CarpX is designed to allow the physician to relieve the compression on the median nerve without an open incision or the need
−Removed: for endoscopic or other imaging equipment.
−Removed: To use CarpX, the operator first advances a guidewire through the carpal tunnel under the
−Removed: ligament, and then advanced over the wire and positioned in the carpal tunnel under ultrasonic and/or fluoroscopic guidance.
−Removed: CarpX balloon is inflated it creates tension in the ligament positioning the cutting electrodes underneath it and creates space within
−Removed: the tunnel, providing anatomic separation between the target ligament and critical structures such as the median nerve.
−Removed: Radiofrequency
−Removed: energy is briefly delivered to the electrodes, rapidly cutting the ligament, and relieving the pressure on the nerve.
−Removed: We believe CarpX
−Removed: 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 services, is
−Removed: particularly suitable to this mode of distribution.
−Removed: A high gross margin allows us to properly incentivize our distributors, which in
−Removed: turn allows us to attract the top distributors with the most robust networks in our targeted specialties.
−Removed: Independent distributors play
−Removed: 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, along
−Removed: 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 with
−Removed: larger strategic partners whereby we take full responsibility for the manufacturing of CarpX but outsource some or all of its distribution
−Removed: 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 received CE Mark certification for CarpX
−Removed: in May 2021 which allows it to be marketed in CE Mark European countries, which include the European Economic Area (the EU, Norway, Iceland,
−Removed: and Lichtenstein), Switzerland, and, until July 1, 2023, the United Kingdom.
−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 and
−Removed: does not have an indwelling intravascular component.
−Removed: It is designed to be highly resistant to occlusion and may not require regular flushing.
−Removed: It features simplified, near-percutaneous insertion and removal, without the need for surgical dissection or radiographic confirmation.
−Removed: It provides a near limitless number of potential access sites and can be used in patients with chronic total occlusion of their central
−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 dialysis
−Removed: patients or those with poor venous access in Colombia, South America and intend to fulfill the likely FDA request for human clinical
−Removed: data with a clinical safety study in the U.S.
−Removed: following FDA clearance of our Investigational Device Exemption (“IDE”) submission
−Removed: 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 (“IV”) infusion sets and
−Removed: disposable infusion pumps designed to eliminate the need for complex and expensive electronic infusion pumps for most of the estimated
−Removed: one million infusions of fluids, medications and other substances delivered each day in hospitals and outpatient settings in the U.S.
−Removed: NextFlo is designed to deliver highly accurate gravity-driven infusions independent of the height of the IV bag.
−Removed: It maintains constant
−Removed: flow by incorporating a proprietary, passive, pressure-dependent variable flow-resistor consisting entirely of inexpensive, easy-to-manufacture
−Removed: disposable mechanical parts.
−Removed: NextFlo testing has demonstrated constant flow rates across a wide range of IV bag heights, with accuracy
−Removed: rates comparable to electronic infusion pumps.
−Removed: may seek a long-term strategic partnership or acquiror with respect to NextFlo, as we continue to have periodic discussions continue
−Removed: with large strategic partners to license the NextFlo technology for disposable infusion pumps.
−Removed: Notwithstanding, we continue
−Removed: to advance the technology towards self-commercialization.
−Removed: We have initiated design freeze verification testing in preparation
−Removed: for final verification and validation testing of NextFlo IV Infusion Set, to support FDA 510(k) submission and clearance targeted for
−Removed: the first half of 2022.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: May 2021, we formed Veris Health, which is our newest majority majority-owned subsidiary, focused on digital health technology.
−Removed: connection with its formation, Veris Health acquired Oncodisc, a digital health company with groundbreaking tools to improve
−Removed: personalized cancer care through remote patient monitoring.
−Removed: was founded by experienced physician entrepreneurs, James Mitchell, M.D., who joins Veris Health as its full-time Chief Medical Officer,
−Removed: and Andrew Thoreson, M.D., who will serve as a Veris Health consultant.
−Removed: Oncodisc’s core technologies include the first intelligent
−Removed: implantable vascular access port with biologic sensors and wireless communication, combined with an oncologist-designed remote digital
−Removed: healthcare platform that provides patients and physicians with new tools to improve outcomes and optimize the delivery of cost-effective
−Removed: care through remote monitoring and data analytics.
−Removed: was founded in 2018 by Mitchell, a radiation-oncologist, and Thoreson, an interventional radiologist, who previously co-founded Redsmith,
−Removed: Inc., an interventional catheter company whose technology was acquired by C.R.
−Removed: Bard Inc., now BD Inc.
−Removed: BDX), in 2017.
−Removed: received a National Science Foundation (“NSF”) Small Business Innovation Research (“SBIR”) grant award to support
−Removed: its early work and completed both the MedTech Innovator Accelerator and UCSF Rosenman Institute Accelerator programs.
−Removed: groundbreaking vascular access port contains biologic sensors capable of generating continuous data on key physiologic parameters known
−Removed: to predict adverse outcomes in cancer patients undergoing treatment.
−Removed: Wireless communication to the patient’s smartphone and its
−Removed: cloud-based digital healthcare platform efficiently and effectively delivers actionable real time data to patients and physicians.
−Removed: technologies are the subject of multiple patent applications and one allowed patent awaiting final issuance.
−Removed: Veris Health is targeting
−Removed: FDA 510(k) clearance of the intelligent implantable vascular access port and launch of the remote digital healthcare platform for the
−Removed: last six months of 2022.
−Removed: planned Veris Health business model seeks to generate 100% recurring revenue through oncology practice and hospital-based subscriptions.
−Removed: These entities would purchase seats on the platform and pay a monthly remote monitoring charge to drive revenues from remote patient
−Removed: monitoring and device implantation under existing CPT codes, as well as established CMS Oncology Care Model (OCM) bonuses and CMS Quality
−Removed: Reporting Program incentives.
−Removed: Veris Health also anticipates strong demand for its intelligent implantable vascular access port and remote
−Removed: monitoring platform from oncology biotherapeutic companies to support clinical trials of their novel immunotherapy and chemotherapy agents
−Removed: with continuous physiologic data and transformative analytics.
−Removed: Innovations include a diversified and expanding portfolio of innovative products designed to address unmet clinical needs across a broad
−Removed: range of clinical conditions.
−Removed: We are evaluating a number of these product opportunities and intellectual property covering a wide spectrum
−Removed: of clinical conditions, which have either been developed internally or have been presented to us by clinician innovators and academic
−Removed: medical institutions for consideration of a partnership to develop and commercialize these products.
−Removed: This collection of products includes,
−Removed: without limitation, initiatives in non-invasive laser-based glucose monitoring, mechanical circulatory support cannulas, single-use ventilators
−Removed: and resorbable pediatric ear tubes.
−Removed: In June 2020, we announced the execution of a letter of intent to consummate a series of agreements
−Removed: to develop and utilize Canon Virginia’s commercial grade and scalable aqueous silk fibroin molding process to manufacture PAVmed’s
−Removed: DisappEAR molded pediatric ear tubes for commercialization.
−Removed: Furthermore, we are exploring other opportunities to grow our business and
−Removed: enhance shareholder value through the acquisition of pre-commercial or commercial stage products and/or companies with potential strategic
−Removed: corporate and commercial synergies.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: of the COVID-19 Pandemic
−Removed: in December 2019, an outbreak of a novel strain of a coronavirus occurred.
−Removed: The coronavirus spread on a global basis to other countries,
−Removed: including the United States.
−Removed: On March 11, 2020, the United Nations World Health Organization (“WHO”) declared a pandemic
−Removed: resulting from the spread of the coronavirus, with such pandemic commonly referred to by its resulting illness, “COVID-19”.
−Removed: The COVID-19 pandemic is ongoing, and we continue to monitor the ongoing impact of the COVID-19 pandemic on the United States national
−Removed: economy, the global economy, and our business.
+Added: Management’s Discussion and Analysis of Financial Condition and Results of Operations
+Added: following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read
+Added: together with our Annual Report on Form 10-K for the year ended December 31, 2021 (the “Form 10-K”) as filed with the Securities
+Added: and Exchange Commission (the “SEC”).
+Added: Unless the context otherwise requires, references herein to “we”, “us”,
+Added: and “our”, and to the “Company” or “PAVmed” are to PAVmed Inc.
+Added: and Subsidiaries, including each of
+Added: the PAVmed Inc.
+Added: and its majority-owned subsidiaries, including:
+Added: Lucid Diagnostics Inc.
+Added: (“Lucid Diagnostics” or “LUCID”),
+Added: Veris Health Inc.
+Added: (“Veris Health” or “VERIS”), and Solys Diagnostics, Inc.
+Added: (“Solys Diagnostics” or
+Added: FORWARD-LOOKING
+Added: Quarterly Report on Form 10-Q (this “Form 10-Q”), including the following discussion and analysis of our (unaudited) condensed consolidated
+Added: financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties.
+Added: All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results
+Added: of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking
+Added: The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,”
+Added: “could,” “intends,” “target,” “projects,” “contemplates,” “believes,”
+Added: “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or
+Added: other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these
+Added: identifying words.
+Added: Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ
+Added: significantly from the results discussed in the forward-looking statements.
+Added: Factors that might cause such differences include, but are
+Added: not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”
+Added: factors that may affect our actual results include:
+Added: limited operating history;
+Added: financial performance, including our ability to generate revenue;
+Added: ability to obtain regulatory approval for the commercialization of our products;
+Added: ability of our products to achieve market acceptance;
+Added: success in retaining or recruiting, or changes required in, our officers, key employees or directors;
+Added: potential ability to obtain additional financing when and if needed;
+Added: ability to protect our intellectual property;
+Added: ability to complete strategic acquisitions;
+Added: ability to manage growth and integrate acquired operations;
+Added: potential liquidity and trading of our securities;
+Added: regulatory and operational risks;
+Added: cybersecurity
+Added: related to SARS-CoV-2 /COVID-19 pandemic;
+Added: impact of the material weakness identified by our management;
+Added: estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
+Added: addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions,
+Added: joint ventures or investments we may make.
+Added: may not actually achieve the plans, intentions, and /or expectations disclosed in our forward-looking statements, and you should not
+Added: place undue reliance on our forward-looking statements.
+Added: You should read this Form 10-Q and the Form 10-K, and the documents we have filed
+Added: as exhibits to this Form 10-Q and the Form 10-K, completely and with the understanding our actual future results may be materially different
+Added: from what we expect.
+Added: We do not assume any obligation to update any forward-looking statements, whether as a result of new information,
+Added: future events or otherwise, except as required by applicable law.
+Added: Company is a highly differentiated, multi-product, commercial-stage medical technology company organized to advance a broad pipeline
+Added: of innovative medical technologies from concept to commercialization, employing a business model focused on capital efficiency and speed
+Added: Since the Company’s inception of PAVmed Inc.
+Added: on June 26, 2014, its activities have focused on advancing
+Added: its lead products towards regulatory approval and commercialization, protecting its intellectual property, and building its corporate
+Added: infrastructure and management team.
+Added: The Company has ongoing operations conducted through PAVmed Inc.
+Added: and its majority-owned subsidiaries.
+Added: Company operates in one segment as a medical technology company, with the following lines-of-business:
+Added: “Medical Devices”,
+Added: “Diagnostics”, “Digital Health”, and “Emerging Innovations”.
+Added: Our products, services, and
+Added: opportunities, as discussed herein and in Item 1 of Part I of the Form 10-K under the heading Business Background and Overview, are as
+Added: Diagnostics - EsoGuard Esophageal DNA Laboratory Developed Test,
+Added: EsoCheck Esophageal Cell Collection Device, and EsoCure Esophageal Ablation Device with Caldus Technology;
+Added: Medical Devices - CarpX Minimally Invasive Surgical Device for Carpal
+Added: Tunnel Syndrome;
+Added: Infusion Therapy - PortIO Implantable Intraosseous Vascular Access Device and NextFlo Highly Accurate Disposable
+Added: Intravenous Infusion Platform Technology;
+Added: Digital Health - Veris cancer healthcare platform and implantable
+Added: intelligent vascular port combining remote monitoring and data analytics;
+Added: Emerging Innovations -Include a diversified and expanding portfolio
+Added: of innovative products designed to address unmet clinical needs across a broad range of clinical conditions.
+Added: We are evaluating a
+Added: number of these product opportunities and intellectual property covering a wide spectrum of clinical conditions, which have either
+Added: been developed internally or have been presented to us by clinician innovators and academic medical institutions for consideration
+Added: of a partnership to develop and commercialize these products.
+Added: multiple products and services are in various phases of development, regulatory clearances, approvals, and commercialization.
+Added: EsoCheck device received 510(k) marketing clearance from the U.S.
+Added: Food and Drug Administration (“FDA”), in June 2019 and
+Added: European CE Mark Certification in May 2021 as an esophageal cell collection device;
+Added: and, EsoGuard has been established as a
+Added: Laboratory Developed Test (“LDT”), completed European CE Mark Certification in June 2021, and was launched commercially
+Added: in December 2019 after Clinical Laboratory Improvement Amendment (“CLIA”) and College of American Pathologists
+Added: (“CAP”) accreditation of the test at Lucid Diagnostics commercial diagnostic laboratory partner ResearchDx Inc.
+Added: (“RDx”), headquartered in Irvine, California.
+Added: On February 25, 2022, Lucid Diagnostics’ wholly owned subsidiary,
+Added: LucidDx Labs Inc.
+Added: (“LucidDx Labs”) acquired from RDx certain licenses and other related assets necessary for LucidDx
+Added: Labs to operate its own new CLIA-certified, CAP-accredited clinical laboratory located in Lake Forest, CA.
+Added: In August 2021, Lucid
+Added: Diagnostics launched a strategic partnership with direct-to-consumer telemedicine company UpScriptHealth to support our
+Added: commercialization efforts.
+Added: Also in August 2021, we tested our first patients referred by primary care physicians
+Added: (“PCPs”) in our initial Lucid Test Centers opened in the Phoenix metropolitan area.
+Added: We have since expanded our Lucid
+Added: Test Centers into six additional cities expanding from its origin in the Southwest United States and stretching to the
+Added: Overview - continued
+Added: connection with our efforts to expand our presence in the diagnostic market, we are developing EsoCure as an Esophageal Ablation
+Added: Device, with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer,
+Added: and to do so without the need for complex and expensive capital equipment.
+Added: We have successfully completed a pre-clinical feasibility
+Added: animal study of EsoCure demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining.
+Added: completed an acute and survival animal study of EsoCure™ Esophageal Ablation Device, demonstrating successful direct thermal
+Added: balloon catheter ablation of esophageal lining through the working channel of a standard endoscope.
+Added: We plan to conduct additional
+Added: development work and animal testing of EsoCure to support a future FDA 510(k) submission.
+Added: CarpX is a minimally invasive surgical device for use
+Added: in the treatment of carpal tunnel syndrome which received FDA 510(k) marketing clearance in April 2020, with the first commercial
+Added: procedure successfully performed in December 2020.
+Added: After an initial slowdown in commercialization related to COVID, more recently
+Added: we have recruited new sales leadership and have recently trained eight new surgeons to perform the CarpX procedure with four more
+Added: scheduled to undergo training in the coming months.
+Added: Our limited-release commercialization efforts thru 2022 are focused on engaging
+Added: key opinion hand surgeons designed to solicit input for ergonomic improvements to the device, procedure development and surgical-time
+Added: optimization, and ease of use.
+Added: Concurrently, we are presently working on improvements to the device that will be released in stages
+Added: over the next several quarters
+Added: We believe CarpX is designed to allow the physician
+Added: to relieve the compression on the median nerve without an open incision or the need for endoscopic or other imaging equipment.
+Added: use CarpX, the operator first advances a guidewire through the carpal tunnel under the ligament, and then advanced over the wire
+Added: and positioned in the carpal tunnel under ultrasonic and/or fluoroscopic guidance.
+Added: When the CarpX balloon is inflated it creates
+Added: tension in the ligament positioning the cutting electrodes underneath it and creates space within the tunnel, providing anatomic
+Added: separation between the target ligament and critical structures such as the median nerve.
+Added: Radiofrequency energy is briefly delivered
+Added: to the electrodes, rapidly cutting the ligament, and relieving the pressure on the nerve.
+Added: We believe CarpX will be significantly
+Added: less invasive than existing treatments .
+Added: May 2021, we formed Veris Health, and concurrently, acquired Oncodisc Inc (“Oncodisc”), a digital health company
+Added: with ground breaking tools to improve personalized cancer care through remote patient monitoring.
+Added: Oncodisc’s core technologies
+Added: include the first intelligent implantable vascular healthcare platform that provides patients and physicians with new tools to improve
+Added: outcomes and optimize the delivery of cost-effective care through remote monitoring and data analytics.
+Added: Its vascular access port
+Added: contains biologic sensors capable of generating continuous data on key physiologic parameters known to predict adverse outcomes in
+Added: cancer patients undergoing treatment.
+Added: Wireless communication to the patient’s smartphone and its cloud-based digital healthcare
+Added: platform efficiently and effectively delivers actionable real time data to patients and physicians.
+Added: The technologies are the subject
+Added: of multiple patent applications and one allowed patent awaiting final issuance.
+Added: Our other products in development have not yet received
+Added: clearance or approval to be marketed or sold in the U.S.
+Added: to March 31, 2022, on April 4, 2022, the Company
+Added: entered into a Senior Secured Convertible Note in the amount of $27.5 million, pursuant to a Securities Purchase Agreement
+Added: (“SPA”) executed in March 2022 with an accredited institutional investor (“investor”).
+Added: Under the SPA,
+Added: the Company agreed to sell, and the investor agreed to purchase, up to an additional $22.5 million initial principal amount of
+Added: Senior Secured Convertible Notes (for an aggregate of $50.0 million in initial principal) upon the satisfaction of certain
+Added: The purchase price of the Secured Promissory Notes is $1,000 for each $1,100 in principal amount of the notes, representing
+Added: an original issue discount of $100 per $1,100 in principal amount of the notes.
+Added: A further discussion of the SPA dated, March 31,
+Added: 2022, can be found herein below under Liquidity and Capital Resources - PAVmed Inc - Private Placement - Securities Purchase
+Added: In March 2022, Lucid Diagnostics,
+Added: entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”).
+Added: Under the terms of
+Added: the facility, Cantor has committed to purchase up to $50 million of Lucid Diagnostics Inc.
+Added: common stock from time to time at the request
+Added: of Lucid Diagnostics Inc.
+Added: While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity
+Added: facility, insofar as it allows Lucid Diagnostics Inc.
+Added: to raise primary capital on a periodic basis at prices based on the existing market
+Added: of SARS-CoV-2 - COVID-19 Pandemic
+Added: in December 2019, there was an outbreak of a novel strain of a coronavirus occurred, with such coronavirus designated by the United
+Added: Nations (UN) World Health Organization (“WHO”) as the “Severe Acute Respiratory Syndrome Coronavirus 2” - or
+Added: “SARS-CoV-2”.
+Added: The SARS-CoV-2 spread on a global basis to other countries, including the United States.
+Added: 2020, the WHO declared a pandemic resulting from SARS-CoV-2, with such pandemic commonly referred to by its resulting illness of coronavirus
+Added: disease 2019, or “COVID-19”.
+Added: The COVID-19 pandemic is ongoing, and we continue to monitor the ongoing impact of the COVID-19
+Added: pandemic on the United States national economy, the global economy, and our business.
COVID-19 pandemic may have an adverse impact on our operations, supply chains, and distribution systems and /or those of our contractors
5 unchanged sentences
operational results and cash flows, to be dictated by the success of United States and global efforts to mitigate the spread of and /or
−Removed: to contain the coronavirus and the impact of such efforts.
−Removed: addition, the spread of the coronavirus has disrupted the United States’ healthcare and healthcare regulatory systems which could
−Removed: divert healthcare resources away from, or materially delay FDA approval with respect to our products.
+Added: to contain the SARS-CoV-2 and the impact of such efforts.
+Added: addition, the spread of the SARS-CoV-2 has disrupted the United States’ healthcare and healthcare regulatory systems which could
+Added: divert healthcare resources away from, or materially delay United States Food and Drug Administration (“FDA”) approval with
+Added: respect to our products.
our clinical trials have been and may be further affected by the COVID-19 pandemic, as site initiation and patient enrollment may be
4 unchanged sentences
we are continuing to monitor and assess the effects of the COVID-19 pandemic on our business, the ultimate impact of the COVID-19 pandemic
−Removed: (or a similar health epidemic) is highly uncertain and subject to change.
−Removed: Any such effect could have a materially adverse impact
−Removed: on our consolidated financial condition, consolidated results of operations, and /or consolidated cash flows.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
+Added: (or a similar health epidemic) is highly uncertain and subject to change, and therefore, its impact on our consolidated financial condition,
+Added: consolidated results of operations, and /or consolidated cash flows, the adverse impact could be material.
of Operations
−Removed: is recognized with respect to the EsoGuard Commercialization Agreement, dated August 1, 2021, between the Company’s majority-owned
+Added: was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1, 2021, between the Company’s majority-owned
subsidiary, Lucid Diagnostics Inc., and ResearchDX Inc.
−Removed: (“RDx”), CLIA certified commercial laboratory service provider.
+Added: (“RDx”), a CLIA certified commercial laboratory service provider.
+Added: On February 25, 2022, the EsoGuard Commercialization Agreement was terminated upon the execution of an Asset Purchase
+Added: Agreement between LucidDx Labs Inc., a wholly-owned subsidiary of Lucid Diagnostics Inc.
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement is inclusive of:
6 unchanged sentences
including rent expense and supplies.
−Removed: operations expenses
−Removed: operations expenses consist primarily of salaries and related costs for employees engaged in sales and marketing activities and
−Removed: employees engaged with third-party payor reimbursement contract negotiation and management, as well as advertising and promotion expenses.
−Removed: We anticipate our commercial
−Removed: operations expenses will increase in the future, as we anticipate an increase in payroll and related expenses related to the
−Removed: roll-out of our commercial sales and marketing operations as we execute on our business strategy.
+Added: and marketing expenses
+Added: and marketing expenses consist primarily of salaries and related costs for employees engaged in sales and marketing activities, as well
+Added: as advertising and promotion expenses.
+Added: We anticipate our sales and marketing expenses will increase in the future, as we anticipate an
+Added: increase in payroll and related expenses related to the roll-out of our commercial sales and marketing operations as we execute on our
+Added: business strategy.
and administrative expenses
and administrative expenses consist primarily of salaries and related costs for personnel, travel expenses, facility-related costs, professional
−Removed: fees, accounting and legal services, consultants and expenses associated with obtaining and maintaining patents within our intellectual
−Removed: property portfolio.
+Added: fees, accounting and legal services, employees involved in third-party payor reimbursement contract negotiations and consultants and
+Added: expenses associated with obtaining and maintaining patents within our intellectual property portfolio.
anticipate our general and administrative expenses will increase in the future, as we anticipate an increase in payroll and related expenses
3 unchanged sentences
insurance premiums and investor relations costs.
−Removed: Management’s Discussion and Analysis of Financial
−Removed: Condition and Results of Operations - continued
Results of Operations - continued
+Added: Overview - continued
and development expenses
12 unchanged sentences
improvements or extending the utility of the lead products in our pipeline, including CarpX, EsoCheck and EsoGuard, along with advancing
−Removed: our DisappEAR, PortIO, NextFlo, non-invasive glucose monitoring and digital health products through their respective development phase.
+Added: our PortIO and NextFlo products, our Digital Health product, and two of our Emerging Innovation product candidates through
+Added: their respective development phase, including our DisappEAR reabsorable ear tubes product and a non-invasive glucose monitoring product.
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 upon
−Removed: repayment of such convertible notes;
−Removed: and interest expense with respect to one of our convertible notes.
−Removed: of Dollar Amounts
−Removed: dollar amounts in this Item 2.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented
−Removed: in thousands, if not otherwise noted as being presented in millions, except for the number of shares and per share amounts.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: of Operations - continued
−Removed: months ended September 30, 2021 versus September 30, 2020
−Removed: the three months ended September 30, 2021, revenue was $0.2 million as compared to no revenue in the corresponding period in the prior
−Removed: The $0.2 million increase principally relates to our EsoGuard Commercialization Agreement, dated August 1, 2021, which resulted
−Removed: in revenue recognition of $0.1 million per month in each of August and September 2021.
−Removed: the three months ended September 30, 2021, cost of revenue was approximately $0.1 million as compared to no cost of revenue for the corresponding
+Added: income and expense, net, consists principally of changes in fair value of our contingent consideration and our convertible notes
+Added: and losses on extinguishment of debt upon repayment of such convertible notes.
+Added: Presentation of Dollar Amounts
+Added: All dollar amounts in this Management’s
+Added: Discussion and Analysis of Financial Condition and Results of Operations are presented in thousands of dollars, if not otherwise indicated
+Added: as being presented as dollars in millions, except for the number of shares and per share amounts.
+Added: months ended March 31, 2022 as
+Added: compared to three months ended March 31, 2021
+Added: the three months ended March 31, 2022, revenue was $0.2 million as compared to no revenue in the corresponding period in the prior year.
+Added: The $0.2 million relates to our EsoGuard Commercialization Agreement, dated August 1, 2021, which resulted in revenue recognition of
+Added: $0.1 million per month beginning August 2021 - through the February 25, 2022 termination date of such agreement.
+Added: the three months ended March 31, 2022, cost of revenue was approximately $0.4 million as compared to no cost of revenue in the corresponding
period in the prior year.
−Removed: The $0.1 million increase principally relates to costs associated with our commercialization agreement that
−Removed: started in August 2021.
−Removed: operations expenses
−Removed: the three months ended September 30, 2021, commercial operations costs were approximately $2.4 million as compared to $0.7 million for
−Removed: the corresponding period in the prior year, with the $1.7 million increase principally resulting from approximately $1.1 million with
−Removed: respect to increased staffing in commercial operations, including sales, marketing, and payor reimbursement personnel, higher stock-based
−Removed: compensation expense of $0.3 million;
−Removed: and approximately $0.3 million with respect to increased consulting and professional services fees.
−Removed: and administrative expenses
−Removed: the three months ended September 30, 2021, general and administrative costs were approximately $6.0 million as compared to $2.2 million
−Removed: for the corresponding period in the prior year, with the $3.8 million increase principally related to:
−Removed: approximately
−Removed: $2.3 million increase in compensation related costs principally related to higher stock-based compensation expense and increased
−Removed: staffing levels;
−Removed: approximately
−Removed: $1.4 million in consulting services related to patents, regulatory compliance, legal processes for contract review and public company
+Added: The $0.4 million increase principally relates to costs associated with the EsoGuard Commercialization Agreement
+Added: and marketing expenses
+Added: the three months ended March 31, 2022, sales and marketing costs were approximately $3.9 million, compared to $1.4 million for the corresponding
+Added: period in the prior year.
+Added: The net increase of $2.5 million was principally related to:
approximately
−Removed: $0.1 million in general business expenses.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: of Operations - continued
−Removed: months ended September 30, 2021 versus September 30, 2020 - continued
−Removed: and development expenses
−Removed: the three months ended September 30, 2021, research and development costs were approximately $5.3 million, compared to $2.6 million for
−Removed: the corresponding period in the prior year, with the $2.7 million increase principally related to:
+Added: $1.6 million increase in compensation related costs principally related to an increase in headcount and severance expense incurred
+Added: for 2 former employees;
approximately
−Removed: $0.5 million increase in compensation related costs principally related to increased staffing levels, higher stock-based compensation
+Added: $0.4 million increase in stock based compensation from RSA grants to Lucid and PAVmed employees and non-employees, and an increase
+Added: in stock options granted corresponding with the increase in the number of employees;
approximately
−Removed: $2.2 million in increased development costs, particularly increased clinical trial activities, and consulting fees with respect
−Removed: to CarpX, NextFlo, Port IO, EsoCure, EsoGuard, a glucose monitoring project, and a digital health project.
−Removed: Income and Expense
−Removed: in fair value of convertible debt
−Removed: the three months ended September 30, 2020, non-cash income (expense) recognized for the change in the fair value of our convertible notes
−Removed: was approximately $0.4 million of other income.
−Removed: There was no such change in fair value during the three months ended September 30,
−Removed: 2021, as the convertible notes were repaid-in-full as of March 31, 2021.
−Removed: from Extinguishment of Debt
−Removed: the three months ended September 30, 2020, a loss from extinguishment of debt of approximately $0.7 million was recognized, with such
−Removed: loss resulting from the difference between:
−Removed: the face value principal repayments and the corresponding payments of the interest thereon;
−Removed: as compared to the fair value of the shares of our common stock issued upon conversion of such convertible note, with such fair value
−Removed: measured as the respective issue date closing quoted price per share of our common stock.
−Removed: There was no such loss from extinguishment
−Removed: of debt during the three months ended September 30, 2021, as the convertible notes were repaid-in-full as of March 31, 2021.
−Removed: our unaudited condensed consolidated financial statements Note 8, Debt , for additional information with respect to the
−Removed: convertible notes.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: of Operations - continued
−Removed: months ended September 30, 2021 versus September 30, 2020
−Removed: the nine months ended September 30, 2021, revenue was $0.2 million as compared to no revenue in the corresponding period in the
−Removed: The $0.2 million increase principally relates to our EsoGuard Commercialization Agreement, dated August 1, 2021, which resulted
−Removed: in revenue recognition of $0.1 million per month in each of August and September 2021.
−Removed: the nine months ended September 30, 2021, cost of revenue was approximately $0.1 million as compared to no cost of revenue for
−Removed: the corresponding period in the prior year.
−Removed: The $0.1 million increase principally relates to costs associated with our commercialization
−Removed: agreement that started in August 2021.
−Removed: operations expenses
−Removed: the nine months ended September 30, 2021, commercial operations were approximately $5.8 million as compared to $1.5 million for the corresponding
−Removed: period in the prior year, with the $4.3 million increase principally resulting from approximately $2.3 million with respect to increased
−Removed: staffing in commercial operations, including sales, marketing, and reimbursement personnel, higher stock-based compensation expense of
−Removed: $0.7 million and approximately $1.3 million with respect to increased consulting and professional services fees.
+Added: $0.5 million increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees.
and administrative expenses
−Removed: the nine months ended September 30, 2021, general and administrative costs were approximately $16.1 million as compared to $6.9 million
−Removed: for the corresponding period in the prior year, with the $9.2 million increase was principally related to:
+Added: the three months ended March 31, 2022, general and administrative costs were approximately $9.4 million, compared to $3.4 million for
+Added: the corresponding period in the prior year.
+Added: The net increase of $6.0 million was principally related to:
approximately
−Removed: $7.0 million increase in compensation related costs principally related to higher stock-based compensation expense and increased
−Removed: staffing levels, and
+Added: $1.1 million increase in compensation related costs principally related to an increase in headcount;
approximately
−Removed: $2.0 million in consulting services related to patents, regulatory compliance, legal processes for contract review and public company
+Added: $1.8 million increase in stock based compensation from RSA grants to Lucid and PAVmed employees and non-employees, and an increase
+Added: in stock options granted corresponding with the increase in the number of employees;
approximately
+Added: $2.3 million in consulting services related to patents, regulatory compliance, legal processes for contract review, transition of
+Added: public relations and investor relations firms, and public company expenses;
+Added: approximately
$0.8 million in general business expenses.
and development expenses
−Removed: the nine months ended September 30, 2021, research and development costs were approximately $12.9 million as compared to $7.3 million
−Removed: for the corresponding period in the prior year, with the $5.6 million increase principally related to:
+Added: the three months ended March 31, 2022, research and development costs were approximately $5.9 million as compared to $3.3 million for
+Added: the corresponding period in the prior year.
+Added: The net increase $2.6 million was principally related to:
approximately
−Removed: $0.8 million increase in compensation related costs principally related to increased staffing levels, higher stock-based compensation
+Added: $2.1 million increase in development costs, particularly in clinical trial activities and outside professional and consulting fees
+Added: with respect to EsoCheck, EsoCure, CarpX, NextFlo, Port IO, our Digital Health product, and one of our Emerging Innovation product
+Added: candidates (the non-invasive glucose monitoring product);
approximately
−Removed: $4.8 million in increased development costs, particularly increased clinical trial activities, and consulting fees with respect
−Removed: to CarpX, NextFlo, Port IO, EsoCure, EsoGuard, a glucose monitoring project and a digital health project.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
−Removed: of Operations - continued
−Removed: months ended September 30, 2021 versus September 30, 2020 - continued
+Added: $0.5 million increase in compensation related costs and related to expanded clinical and engineering staff.
+Added: Three months ended March 31, 2022 as compared
+Added: to three months ended March 31, 2021 - continued
Income and Expense
−Removed: the nine months ended September 30, 2021, our PPP loan related to the CARES Act of $0.3 million was forgiven by the Small Business Administration.
−Removed: No principal or interest payments were ever made and accordingly we recorded a gain of $0.3 million.
in fair value of convertible debt
−Removed: the nine months ended September 30, 2021, the non-cash income (expense) recognized for the change in the fair value of our convertible
−Removed: notes was approximately $1.7 million of other income, as compared to $5.5 million of other expense for the nine months ended September
−Removed: The change in the fair value adjustment of the convertible notes is principally related to each of the convertible notes being
−Removed: repaid-in-full during the nine months ended September 30, 2021, as discussed herein below under “ Other Income and Expense -
−Removed: Loss from Extinguishment of Debt ”.
−Removed: Note 7, Financial Instruments Fair Value Measurements , of our unaudited condensed consolidated financial statements for
−Removed: a further discussion of the change in fair value of our convertible notes, and Note 8, Debt, of our unaudited condensed consolidated
−Removed: financial statements for a further discussion the Series A and Series B November 2019 Senior Convertible Notes.
+Added: the three months ended March 31, 2021, the non-cash income (expense) recognized for the change in the fair value of our convertible notes
+Added: was approximately $1.7 million.
+Added: The change in the fair value adjustment of the convertible notes is principally related to each of the
+Added: convertible notes being repaid-in-full during the three months ended March 31, 2021, as discussed herein below under “Other Income
+Added: and Expense - Loss from Extinguishment of Debt”.
from Extinguishment of Debt
−Removed: the nine months ended September 30, 2021, a debt extinguishment loss in the aggregate of approximately $3.7 million was recognized in
−Removed: connection with the convertible notes, as discussed below.
−Removed: January 5, 2021, the repayment of the remaining face value principal of the November 2019 Senior Convertible Note of approximately
−Removed: $956, along with the payment of interest thereon of approximately $7, were settled with the issuance of 667,668 shares of our common
−Removed: stock, with a fair value of approximately $1,723 (with such fair value measured as the respective conversion date quoted closing
−Removed: price of our common stock), resulting in the recognition of a loss from extinguishment of debt of approximately $760 in the six months
−Removed: ended June 30, 2021;
+Added: the three months ended March 31, 2021, a debt extinguishment loss in the aggregate of approximately $3.7 million was recognized in connection
+Added: with the convertible notes, as discussed below.
+Added: January 5, 2021, the repayment of the remaining face value principal of the November 2019 Senior Convertible Note, along with
+Added: the payment of interest thereon, of approximately $1.0 million, were settled with the issuance of 667,668 shares of
+Added: our common stock, with a fair value of approximately $1,7 million (with such fair value measured as the respective conversion
+Added: date quoted closing price of our common stock), resulting in the recognition of a loss from extinguishment of debt of approximately
+Added: $0.8 million in the six months ended June 30, 2021;
January 30, 2021, we paid in cash a $350 partial principal repayment of the Senior Convertible Note dated April 30, 2020 (“April
3 unchanged sentences
in the recognition of a loss from extinguishment of debt of approximately $2,955 in the six months ended June 30, 2021.
−Removed: the prior year period of nine months ended September 30, 2020, a loss from extinguishment of debt of approximately $4.6 million was recognized,
−Removed: with such loss resulting from the difference between:
−Removed: the face value principal repayments and the corresponding payments of the interest
−Removed: as compared to the fair value of the shares of our common stock issued upon conversion of such convertible note, with such fair
−Removed: value measured as the respective issue date closing quoted price per share of our common stock.
−Removed: our unaudited condensed consolidated financial statements Note 8, Debt , for additional information with respect to the
−Removed: convertible notes.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
+Added: our unaudited condensed consolidated financial statements Note 12 , Debt , for additional information with respect
+Added: to the convertible notes.
and Capital Resources
1 unchanged sentence
purchase warrants, and debt.
−Removed: the nine months ended September 30, 2021 we issued shares of our common stock and received proceeds from the exercise of our Series Z
−Removed: Warrants, as discussed herein below, which resulted in approximately $59.7 million of gross proceeds, before placement agent fees and
−Removed: expenses and additional offering costs incurred by us.
−Removed: Additionally, we repaid-in-full the outstanding principal balances of all our
−Removed: convertible notes.
−Removed: January 5, 2021, we issued 6,000,000 shares of our common stock for gross proceeds of approximately $13,440, before a placement agent
−Removed: fee and expenses of approximately $951, and offering costs incurred by us of approximately $71;
−Removed: and, on February 23, 2021, we issued
−Removed: 9,782,609 shares of our common stock for proceeds of approximately $41,576, before offering costs incurred by us of approximately $290.
−Removed: the nine months ended September 30, 2021, a total of 2,927,125 of our Series Z Warrants were exercised at their exercise price of $1.60
−Removed: per share of our common stock, resulting in the issue of the same number of our shares of common stock, with cash proceeds of
−Removed: approximately $4,115 received as of September 30, 2021, and $568 received subsequent to September 30, 2021 on October 4, 2021.
−Removed: Subsequent to September 30, 2021, as of November 18, 2021, a total of 1,946,259 of our Series Z Warrants were exercised
−Removed: for cash at the $1.60 per share exercise price, resulting in the issue of the same number of shares of our common stock.
−Removed: Additionally,
−Removed: in the nine months ended September 30, 2021, we repaid-in-full all of the outstanding principal balances of our convertible notes, as
−Removed: discussed herein above under “ Other Income and Expense - Loss from Extinguishment of Debt ”.
−Removed: to September 30, 2021, on October 14, 2021, Lucid Diagnostics, a majority-owned subsidiary of PAVmed, completed an initial
−Removed: public offering (“IPO”) of its common stock under an effective registration statement on Form S-1 (SEC File No.
−Removed: wherein a total of 5.0 million IPO shares of common stock of Lucid Diagnostics Inc.
−Removed: were issued, with such total IPO shares inclusive
−Removed: of 571,428 shares issued to PAVmed Inc., at an IPO offering price of $14.00 per share, resulting gross proceeds of $70.0 million, before
−Removed: underwriting fees of $4.9 million, and approximately $0.7 million of offering costs incurred by Lucid Diagnostics.
−Removed: our unaudited condensed consolidated financial statements Note 8, Debt , for a discussion of our convertible notes;
−Removed: 11, Common Stock and Common Stock Purchase Warrants , for a further discussion of and the issue of our common stock.
−Removed: are subject to all of the risks and uncertainties typically faced by medical device and diagnostic and medical device companies that
−Removed: devote substantially all of their efforts to the commercialization of their initial product and services and ongoing research and development
−Removed: and clinical trials.
−Removed: We expect to continue to experience recurring losses from operations and will continue to fund our operations with
−Removed: debt and/or equity financing transactions.
−Removed: Notwithstanding, however, with the cash on-hand as of the date hereof, we expect to be able
−Removed: to fund our future operations for one year from the date of the issue of our unaudited condensed consolidated financial statements as
−Removed: included herein in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2021.
−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations - continued
+Added: We are subject to all of the risks and uncertainties typically faced by medical device and diagnostic and
+Added: medical device companies that devote substantially all of their efforts to the commercialization of their initial product and services
+Added: and ongoing R&D and clinical trials.
+Added: We expect to continue to experience recurring losses from operations, and will continue to fund
+Added: our operations with debt and/or equity financing transactions.
+Added: Notwithstanding, however, with the cash on-hand as of March 31, 2022,
+Added: we expect to be able to fund our future operations for one year from the date of the issue of our unaudited condensed consolidated financial
+Added: statements, as included in this Quarterly Report on Form 10-Q for the period ended March 31, 2022.
+Added: Stock Transactions
+Added: the three months ended March 31, 2022:
+Added: issued 237,499 shares of our common stock
+Added: for cash proceeds of approximately $241 upon exercise of stock options granted under the PAVmed Inc 2014 Equity Plan,
+Added: as such equity plan is discussed in Note 13, Stock-Based Compensation , of our unaudited condensed consolidated
+Added: financial statements.
+Added: issued 194,240 shares of our common stock under the
+Added: Employee Stock Purchase Plan (“ESPP”), as such ESPP is discussed in Note 13, Stock-Based Compensation ,
+Added: of our unaudited condensed consolidated financial statements.
+Added: to March 31, 2022, on April 4, 2022, the Company entered into a Senior Secured Convertible Note in the amount of
+Added: $27.5 million, pursuant to the SPA with an accredited institutional investor.
+Added: Under the SPA, the Company agreed to sell, and the
+Added: investor agreed to purchase, up to an additional $22.5 in additional initial principal amount of Senior Secured Convertible Notes
+Added: (for an aggregate of $50.0 million in initial principal amount of Secured Promissory Notes) upon the satisfaction of certain
+Added: conditions (as more fully described below).
+Added: The notes are being offered and sold in a registered direct offering under the
+Added: Company’s effective shelf registration statement (the “Offering”).
+Added: The purchase price of the Secured Promissory
+Added: Notes is $1,000 for each $1,100 in principal amount of the notes, representing an original issue discount of $100 per $1,100 in
+Added: principal amount of the notes.
+Added: We herein refer to the Senior Secured Convertible Notes issued or issuable under the SPA as March
+Added: to the SPA we completed an initial closing for the sale of $27.5 million in principal amount of March 2022 Notes, of which the
+Added: investor funded and the Company received cash proceeds of $24.9 million on April 5, 2022, after deduction of lender fees.
+Added: to certain conditions being met or waived, from time to time after such time stockholder approval for an increase in our authorized shares
+Added: from 150 million to 250 million is obtained, but before March 31, 2024, one or more additional closings for up to the remaining principal
+Added: amount of March 2022 Notes may occur, upon five trading days’ notice by us to the investor.
+Added: The aggregate principal amount of March
+Added: 2022 Notes that may be offered in the additional closings may not be more than $22.5 million.
+Added: The investor’s obligation to purchase
+Added: the notes at each additional closing is subject to certain conditions set forth in the March 2022 SPA (including minimum price and volume
+Added: thresholds, maximum ratio of debt to market capitalization, and minimum market capitalization), which may be waived by the Required Holders
+Added: (as defined in the March 2022 SPA).
+Added: Under the March 2022 SPA, the investor will be required to purchase March 2022 Notes in the additional
+Added: closings if such conditions are met or waived.
+Added: In addition, from and after March 31, 2023, the investor may by written notice to us elect
+Added: to require us to issue up to $22.5 million in initial principal amount of March 2022 Notes, so long as in doing so it would not cause
+Added: the ratio of (a) the outstanding principal amount of the March 2022 Notes (including the additional March 2022 Notes), accrued and unpaid
+Added: interest thereon and accrued and unpaid late charges to (b) our average market capitalization over the prior ten trading days, to exceed
+Added: If we fail to complete the sale of the additional March 2022 Notes contemplated by any such written notice, or if the investor
+Added: is unable to deliver any such notice prior to March 31, 2024 as a result of the limitation described in the preceding sentence, then
+Added: we will be obligated to pay a break-up fee to the investor at such time in an aggregate amount equal to $1.35 million.
+Added: Liquidity and Capital Resources - continued
+Added: We will not pay any selling
+Added: commission to any party in connection with the Offering, although we will pay a financial advisory fee equal to 1.8% of the gross proceeds
+Added: from the Offering to an independent financial advisor.
+Added: We estimate that the net cash proceeds will be approximately $20.4 million from
+Added: the additional closings of the Offering, after deducting the estimated expenses of the Offering, assuming the sale of all of the March
+Added: The March 2022 Notes have a
+Added: voluntary fixed conversion price of $5.00 per share, a stated interest rate of 7.875% per annum, and a maturity of 24 months (subject
+Added: to extension in certain circumstances).
+Added: The March 2022 Notes will be secured by all our existing and future assets (including those of
+Added: our significant subsidiaries, other than Lucid and its subsidiaries), but including only 9.99% of Lucid’s outstanding common stock
+Added: held by us, pursuant to a security agreement by and between the Company and the investor.
+Added: the date six months after the issuance of a March 2022 Note, on the 1st and 10th trading day of each calendar month thereafter, and on
+Added: the maturity date (each an “Installment Date”), the Company will make an amortization payment on the March 2022 Note in an
+Added: amount equal to the initial principal balance of the note divided by the total number of such amortization payments (such that the entire
+Added: initial principal balance will be repaid by the maturity date), plus any amounts that have been deferred or accelerated to the applicable
+Added: installment date, plus all accrued and unpaid interest and any late charges (the “Installment Amount”).
+Added: Each Installment
+Added: Amount will be satisfied in shares of the Company’s common stock, subject to certain customary equity conditions (including
+Added: minimum price and volume thresholds) at 100% of the Installment Amount or otherwise (or at our election, in whole or in part) in cash
+Added: at 115% of the Installment Amount.
+Added: The conversion price for any Installment Amount so converted will be based on the then current market
+Added: price, but not more than the fixed conversion price then in effect and not less than a floor price.
+Added: The March 2022 Notes also may required
+Added: to be repaid in shares of our common stock, at a price per share of our common stock based on the then current market price,
+Added: but not more than the fixed conversion price then in effect and not less than a floor price, upon the occurrence of certain events of
+Added: We may be required to repay the March 2022 Notes, in cash, at a premium to the outstanding principal balance, upon the
+Added: occurrence of an event of default or upon a Change of Control (as defined in the March 2022 Notes).
+Added: will be subject to certain customary affirmative and negative covenants regarding the rank of the March 2022 Notes, the incurrence of
+Added: indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of
+Added: dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates,
+Added: among other customary matters.
+Added: We also will be subject to financial covenants requiring that (i) the amount of our available cash equal
+Added: or exceed $8.0 million at all times, (ii) the ratio of (a) the outstanding principal amount of the March 2022 Notes, accrued and unpaid
+Added: interest thereon and accrued and unpaid late charges to (b) our average market capitalization over the prior ten trading days, not exceed
+Added: 30%, and (iii) that our market capitalization shall at no time be less than $75 million.
+Added: The March 2022 Notes include certain customary
+Added: events of default.
+Added: Diagnostics Inc - Committed Equity Facility
+Added: In March 2022, Lucid Diagnostics
+Added: entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”).
+Added: Under the terms of
+Added: the facility, Cantor has committed to purchase up to $50 million of Lucid Diagnostics Inc.
+Added: common stock from time to time at the request
+Added: of Lucid Diagnostics Inc.
+Added: While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity
+Added: facility, insofar as it allows Lucid Diagnostics Inc.
+Added: to raise primary equity capital on a periodic basis at prices based on the existing
+Added: market price.
Accounting Policies and Significant Judgments and Estimates
−Removed: discussion and analysis of our (unaudited) consolidated financial condition and consolidated results of operations is based on our unaudited
−Removed: condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in
−Removed: the United States of America (“U.S.
−Removed: The preparation of these unaudited condensed consolidated financial statements
−Removed: requires us to make estimates and assumptions affecting the reported amounts of assets, liabilities, and equity, along with the disclosure
−Removed: of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts
−Removed: of expenses during the corresponding periods.
+Added: discussion and analysis of our (unaudited) financial condition and consolidated results of operations is based on our unaudited condensed
+Added: consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United
+Added: States of America (“U.S.
+Added: The preparation of these unaudited condensed consolidated financial statements requires
+Added: us to make estimates and assumptions affecting the reported amounts of assets, liabilities, and equity, along with the disclosure of
+Added: contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of
+Added: expenses during the corresponding periods.
In accordance with U.S.
4 unchanged sentences
Please see Note 2, Summary of Significant Accounting Policies and Recent Accounting Standards Updates , of our unaudited
−Removed: condensed consolidated financial statements included in this Form 10-Q, for a summary of significant accounting policies.
−Removed: reference is made to Part I, Item 7, “ Management’s Discussion and Analysis of Financial Condition and Results of Operation ”
−Removed: in our previously filed Annual Report on Form 10-K for the year ended December 31, 2020 (“Form 10-K), for a summary of our critical
−Removed: accounting policies and significant judgments and estimates.
−Removed: There have been no other material changes to our critical accounting policies
−Removed: or significant judgments and estimates as discussed in our Form 10-K, except as discussed in Note 2, Summary of Significant Accounting
−Removed: Policies and Recent Accounting Standards Updates , of our unaudited condensed consolidated financial statements included in this Form
+Added: condensed consolidated financial statements included herein in this Form 10-Q, for a summary of significant accounting policies.
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.