7 unchanged sentences
(“LucidDx Labs”) and
−Removed: CapNostics, LLC.
+Added: CapNostics, LLC (“CapNostics”).
FORWARD-LOOKING
13 unchanged sentences
factors that may affect our actual results include:
−Removed: our limited operating history;
−Removed: our financial performance, including our ability to
−Removed: generate revenue;
−Removed: our ability to obtain regulatory approval for the commercialization
−Removed: of our products;
−Removed: our ability of our products to achieve market acceptance;
−Removed: our success in retaining or recruiting, or changes
−Removed: required in, our officers, key employees or directors;
−Removed: our potential ability to obtain additional financing
−Removed: when and if needed;
−Removed: our ability to protect our intellectual property;
−Removed: our ability to complete strategic acquisitions;
−Removed: our ability to manage growth and integrate acquired
−Removed: the potential liquidity and trading of our securities;
+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;
regulatory and operational risks;
−Removed: cybersecurity risks;
−Removed: risks related to SARS-CoV-2 /COVID-19 pandemic;
−Removed: the impact of the material weakness identified by our
−Removed: our estimates regarding expenses, future revenue, capital
−Removed: requirements and needs for additional financing.
+Added: cybersecurity
+Added: related to the COVID-19 pandemic;
+Added: risks related to our relationship with PAVmed;
+Added: estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
addition, our forward-looking statements do not reflect the potential impact of any future financings, acquisitions, mergers, dispositions,
12 unchanged sentences
believe that our lead products, the EsoGuard Esophageal DNA Test performed on samples collected with the EsoCheck Esophageal Cell Collection
−Removed: Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent
+Added: Device, constitute the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent
EAC deaths, through early detection of esophageal precancer in at-risk GERD patients.
−Removed: a DNA test performed on surface esophageal cells collected with EsoCheck in a brief noninvasive office procedure which has been shown
−Removed: to be over 90% sensitive and specific at detecting Barrett’s Esophagus (“BE”), a precancerous condition of the
−Removed: esophagus and all conditions along the BE-EAC spectrum.
+Added: is a DNA test performed on surface esophageal cells collected with EsoCheck in a brief noninvasive office procedure which has been
+Added: shown to be over 90% sensitive and specific at detecting Barrett’s Esophagus (“BE”), a precancerous condition of
+Added: the esophagus and all conditions along the BE-EAC spectrum.
(Moinova, et al.
+Added: Sci Transl Med.
2018 Jan 17;10(424):
−Removed: is a United States Food and Drug Administration FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter
−Removed: capable of sampling surface esophageal cells in a less than five-minute office procedure.
−Removed: We believe its proprietary
−Removed: Collect+Protect™ technology makes it the only noninvasive esophageal cell collection device capable of anatomically targeted
−Removed: and protected sampling to prevent dilution and contamination during device withdrawal.
+Added: is a swallowable balloon capsule catheter capable
+Added: of sampling surface esophageal cells in a less-than -five-minute, noninvasive office procedure.
+Added: We believe EsoCheck’s Collect+Protect™
+Added: technology makes it the only noninvasive esophageal cell collection device capable of anatomically targeted and protected sampling
+Added: to prevent dilution and contamination during device withdrawal.
+Added: We are party to an amended and restated
+Added: patent license agreement with CWRU, dated August 23, 2021 (the “Amended CWRU License Agreement”), which provides for the exclusive
+Added: worldwide license of the intellectual property rights for the proprietary technologies underlying EsoCheck and EsoGuard.
is commercialized in the U.S.
5 unchanged sentences
Beginning in March
−Removed: 2022, the EsoGuard LDT has been performed at our own CLIA-certified commercial clinical laboratory, located in Lake Forest, CA.
−Removed: also manufactures our EsoGuard Specimen Kits.
+Added: 2022, EsoGuard has been performed at our own CLIA-certified commercial clinical laboratory, located in Lake Forest, CA.
+Added: currently manufactures our EsoGuard specimen kits.
EsoCheck is commercialized in the U.S.
−Removed: as a 510(k) cleared esophageal cell collection
−Removed: device currently manufactured for us by our contract manufacturing partner, Sage Product Development Inc., located in Foxborough,
−Removed: We are in the process of transferring EsoCheck manufacturing to Coastline International Inc., a high-volume manufacturer
−Removed: headquartered in San Diego, CA with plants in Mexico.
−Removed: Both EsoGuard and EsoCheck have completed the CE Mark certification process.
−Removed: EsoGuard, us ed with EsoCheck was granted FDA Breakthrough
−Removed: Device designation and requires the completion of an international multicenter pre-market approval (“PMA”) clinical
−Removed: trial to be able to submit EsoGuard to the FDA for approval as an in vitro diagnostic device (“IVD”).
−Removed: Presently, the
−Removed: Company is focusing its clinical trial efforts and resources towards supporting insurance reimbursement adoption by government and
−Removed: private insurers.
−Removed: Consequently, with the Company prioritizing shorter term clinical utility studies to facilitate widespread
−Removed: insurance adoption, the completion of the BE-1 EsoGuard screening (as described below) study will be delayed indefinitely.
−Removed: Company expects to complete the EsoGuard BE-2 case control study (as described below) in due course.
−Removed: EsoGuard PLA code 0114U secured final Medicare payment determination of $1,938.01, effective January 1, 2021.
−Removed: We are awaiting Medicare
−Removed: local coverage determination.
−Removed: We are also aggressively pursuing EsoGuard U.S.
−Removed: private payor payment and coverage as well as payment in
+Added: as a 510(k) cleared esophageal cell
+Added: collection device currently manufactured for us by our contract manufacturing partner, Sage Product Development Inc., located in
+Added: Foxborough, MA.
+Added: As discussed below, we are in the process of transferring EsoCheck manufacturing to Coastline International Inc., a
+Added: high-volume manufacturer headquartered in San Diego, CA.
+Added: EsoCheck has completed the CE Mark certification
+Added: EsoGuard, used with EsoCheck, was granted Food and Drug Administration (“FDA”) Breakthrough Device designation and requires the completion of an
+Added: international multicenter pre-market approval (“PMA”) clinical trial to be able to submit EsoGuard to the FDA for
+Added: approval as an in vitro diagnostic device (“IVD”).
+Added: EsoGuard secured a final Medicare payment determination of $1,938.01, effective January 1, 2021.
+Added: We are awaiting a Medicare local
+Added: coverage determination (“LCD”), as discussed in more detail below.
+Added: We are also aggressively pursuing U.S.
+Added: private payor payment and coverage, as well as payment in Europe.
are working to expand EsoGuard commercialization across multiple channels by building a direct sales and marketing team targeting primary
5 unchanged sentences
with UpScript, LLC, an independent third-party telemedicine provider, that can accommodate EsoGuard self-referrals from direct-to-consumer
−Removed: Overview - continued
−Removed: In connection
−Removed: with our efforts to expand our presence in the diagnostic market, we are also developing EsoCure as an Esophageal Ablation Device, with
−Removed: the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal cancer, and to do so
−Removed: without the need for complex and expensive capital equipment.
−Removed: As described below, we recently entered into a license agreement with our
−Removed: parent company, PAVmed Inc., pursuant to which we were granted the rights to commercialize EsoCure.
−Removed: A successful pre-clinical feasibility
−Removed: animal study of EsoCure has been completed, demonstrating excellent, controlled circumferential ablation of the esophageal mucosal lining.
−Removed: An acute and survival animal study of EsoCure™ Esophageal Ablation Device has also been completed, demonstrating successful direct
−Removed: thermal balloon catheter ablation of esophageal lining through the working channel of a standard endoscope.
−Removed: We plan to conduct additional
−Removed: development work and animal testing of EsoCure to support a future FDA 510(k) submission.
−Removed: are a majority owned subsidiary of PAVmed.
−Removed: We are party to an amended and restated patent license agreement with CWRU, dated August 23,
−Removed: 2021 (“Amended CWRU License Agreement”), which provides for the exclusive worldwide license of the intellectual property
−Removed: rights for the proprietary technologies underlying EsoCheck and EsoGuard.
−Removed: Guideline Update - ACG and AGA
−Removed: In April 2022, the American College
−Removed: of Gastroenterology (“ACG”) updated its clinical guideline to support esophageal precancer (“Barrett’s Esophagus”-
−Removed: or “BE”) screening to prevent highly lethal EAC utilizing our EsoGuard® DNA Test on samples collected with our EsoCheck®
−Removed: Cell Collection Device.
+Added: Updated Clinical Guidelines and Guidance
+Added: April 2022, the American College of Gastroenterology (“ACG”) updated its
+Added: clinical guideline to support esophageal precancer (including BE) screening to prevent highly lethal EAC utilizing EsoGuard on samples
+Added: collected with EsoCheck.
The clinical guideline reiterates the ACG’s long-standing recommendation for esophageal precancer screening
7 unchanged sentences
The clinical guideline specifically mentions
−Removed: EsoCheck, along with the Company’s EsophaCap® device, as such swallowable, nonendoscopic esophageal cell collection devices,
−Removed: as well as methylated DNA biomarkers such as EsoGuard.
−Removed: The summary of evidence for this recommendation cites the seminal NIH-funded multicenter,
−Removed: case-control study published in 2018 in Science Translational Medicine, which demonstrated that EsoGuard is highly accurate at detecting
−Removed: esophageal precancer and cancer, including on samples collected with EsoCheck.
−Removed: In July 2022, the American Gastroenterology
−Removed: Association (“AGA”) published updated clinical guidance that mirrors the same furnished by the ACG as described above ,
−Removed: endorsing the use of non-invasive screening tools like our EsoCheck® Cell Collection Device, which is cited in its guideline,
−Removed: as an acceptable alternative to endoscopy to directly address the need for noninvasive screening tools that are easy to administer,
−Removed: patient friendly, and cost-effective for the detection of BE.
−Removed: The clinical practice update by the AGA also significantly expands the target
−Removed: population for esophageal precancer screening, including for EsoGuard and EsoCheck, by recommending, for the first time, screening in
−Removed: at-risk patients without symptoms of reflux.
−Removed: The AGA does so by adding a history of chronic GERD as merely an additional,
−Removed: seventh, risk factor to the six risk factors for BE and EAC that have traditionally identified at-risk symptomatic patients recommended
−Removed: for screening.
−Removed: As a result, chronic symptomatic GERD is no longer a mandatory prerequisite and asymptomatic patients with three of the
−Removed: other six risk factors (e.g., male sex, age greater than 50 years, White race, tobacco smoking, obesity, and family history of BE) are
−Removed: now considered appropriate for screening.
−Removed: Recent Developments - continued
−Removed: Business - continued
−Removed: Coverage Determination Update - CMS
−Removed: In April 2022, a proposed Local
−Removed: Coverage Determination (“LCD”) DL39256, entitled “Molecular Testing for Detection of Upper Gastrointestinal Metaplasia,
−Removed: Dysplasia, and Neoplasia” was published on the Center for Medicare and Medicaid Services (“CMS”) website by MAC Palmetto
−Removed: The proposed LCD is a further step in our efforts to secure Medicare coverage and payment for EsoGuard.
+Added: EsoCheck, along with our EsophaCap device, as such swallowable, nonendoscopic esophageal cell collection devices.
+Added: The clinical guideline
+Added: also mentions methylated DNA markers (like those detected by the EsoGuard test) as such a biomarker.
+Added: The summary of evidence for this
+Added: recommendation includes a reference to the seminal NIH-funded multicenter, case-control study published in 2018 in Science Translational
+Added: Medicine, which demonstrated that EsoGuard is highly accurate at detecting esophageal precancer and cancer, including on samples collected
+Added: with EsoCheck.
+Added: July 2022, the American Gastroenterology Association (“AGA”) published updated clinical guidance that mirrors the same
+Added: furnished by the ACG as described above , endorsing the use of non-invasive screening
+Added: tools like EsoCheck, which is cited in its guideline, as an acceptable alternative to endoscopy to directly address the need for
+Added: noninvasive screening tools that are easy to administer, patient friendly, and cost-effective for the detection of BE.
+Added: practice update by the AGA also significantly expands the target population for esophageal precancer screening, including for
+Added: EsoGuard and EsoCheck, by recommending, for the first time, screening in at-risk patients without symptoms of reflux.
+Added: so by adding a history of chronic GERD as merely an additional, seventh risk factor to the six risk factors for BE and EAC that have
+Added: traditionally identified at-risk symptomatic patients recommended for screening.
+Added: As a result, chronic symptomatic GERD is no longer
+Added: a mandatory prerequisite and asymptomatic patients with three of the other six risk factors (e.g., male sex, age greater than 50
+Added: years, White race, tobacco smoking, obesity, and family history of BE) are now considered at-risk patients
+Added: recommended for screening.
+Added: Local Coverage Determination
+Added: In April 2022, a
+Added: proposed LCD DL39256, entitled “Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and
+Added: Neoplasia” was published on the Center for Medicare and Medicaid Services (“CMS”) website by the Medicare Administrative Contractor (“MAC”) Palmetto GBA.
+Added: proposed LCD is a further step in our efforts to secure Medicare coverage and payment for EsoGuard.
proposed LCD, which the CMS website explicitly characterizes as a “work in progress” for “public review,” outlines
−Removed: criteria that MolDX expects upper gastrointestinal precancer and cancer molecular diagnostic tests to meet.
+Added: criteria that MAC Palmetto GBA’s Molecular Diagnostic Services Program (“MolDX”) expects upper gastrointestinal precancer and cancer molecular diagnostic tests to meet.
These criteria include active
18 unchanged sentences
the MAC has had the opportunity to assess and consider the comments and input from the written comment period and the open meeting.
−Removed: the MAC Palmetto GBA release of a proposed LCD, Noridian Healthcare Solutions published a proposed LCD entitled Molecular Testing for
−Removed: Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia DL39262.
−Removed: The proposed LCD mirrors the MAC Palmetto GBA proposed
−Removed: We have used the Noridian Healthcare Solutions open meeting held on May 26, 2022, and the written comment period that ended on June
−Removed: 11, 2022 to bring the same essential information that we provided to the MAC Palmetto GBA to maintain consistency in our approach and
−Removed: advocate appropriately.
−Removed: BE-1 and BE-2 Clinical Trials
−Removed: In 2021 Lucid Diagnostics Inc.
−Removed: began conducting two concurrent clinical
−Removed: trials, including each of:
−Removed: the “EsoGuard screening study” (“BE-1”);
−Removed: and the “EsoGuard case-control study”
−Removed: (“BE-2”), to expand the clinical evidence for the technologies and to support a United States Food and Drug Administration
−Removed: (“FDA”) pre-market approval (“PMA”) of the use of EsoGuard and EsoCheck as an in-vitro diagnostic medical device
−Removed: However, in light of the recently published proposed Local Coverage Determination (“LCD”) DL39256, the
−Removed: recently updated AGA guidance, and the ACG update to its clinical guideline that supports screening to prevent highly lethal esophageal
−Removed: cancer (“EAC”) utilizing our EsoGuard® DNA Test on samples collected with our EsoCheck® Cell Collection Device, the
−Removed: Company has determined to prioritize its clinical trial efforts and resources towards supporting studies that will help secure insurance
−Removed: reimbursement adoption by government and private insurers.
−Removed: Consequently, we have decided to delay for the time being the BE-1 trial while
−Removed: continuing to enroll GERD patients with a previous diagnosis of nondysplastic BE, low-grade dysplasia, high-grade dysplasia, or EAC in
−Removed: the BE-2 case-control study through Q2 2023.
−Removed: Recent Developments - continued
−Removed: Business - continued
−Removed: In May 2022 LucidDx Labs, Inc.
−Removed: entered into a participating provider agreement with MediNcrease Health Plans, LLC (“MediNcrease”).
−Removed: A national directly-contracted,
−Removed: multi-specialty PPO provider network with over 8 million lives covered through its clients and payers, which include regional and national
−Removed: health plans, insurance companies, third party administrators, self-insured employer groups, municipalities, unions and other entities
−Removed: involved in the management of medical claims.
−Removed: Pursuant to the agreement, persons covered by MediNcrease clients and payers will have in-network
−Removed: access to our EsoGuard® DNA test.
−Removed: The agreement provides rates of reimbursement as a percent of charges for services rendered to such
−Removed: covered persons by LucidDx Labs, including the performance of the EsoGuard® DNA test.
−Removed: June and July 2022, LucidDx Labs Inc.
−Removed: continued to expand its in-network base by entering into participating provider agreements
−Removed: with Galaxy Health Network, Three Rivers Provider Network, and Prime Health Services (collectively, “the PPOs”), as well
−Removed: as Alivio Health.
−Removed: The PPOs cover millions of lives through the provider networks they have compiled for their clients, including
−Removed: third-party administrators, insurance companies, self-insured companies, corporations, and government entities to access, while
−Removed: Alivio provides its clients access to its specialized diagnostic laboratory network.
−Removed: Pursuant to the agreement, persons covered by
−Removed: the PPOs will have in-network access to our EsoGuard® DNA test.
−Removed: The agreements provides rates of reimbursement as a percentage
−Removed: of charges for services rendered to such covered persons by LucidDx Labs, including the performance of the EsoGuard test.
−Removed: Company-Owned
−Removed: Commercial Clinical Laboratory
−Removed: our wholly-owned subsidiary, LucidDx Labs Inc., we entered into an asset purchase agreement (“APA”) dated February 25,
−Removed: 2022, with ResearchDx, Inc.
−Removed: (“RDx”), an unrelated third-party - “APA-RDx”.
−Removed: Under the APA-RDx, LucidDx Labs
−Removed: acquired certain assets from RDx which were combined with LucidDx Labs purchased and leased property and equipment to establish
−Removed: a Company-owned CLIA certified, CAP accredited commercial clinical laboratory capable of performing the EsoGuard® Esophageal DNA
−Removed: assay, inclusive of DNA extraction, next generation sequencing (“NGS”) and specimen storage.
−Removed: Prior to consummation of
−Removed: the APA-RDx, RDx provided such laboratory services to us at its owned CLIA-certified, CAP-accredited clinical laboratory.
−Removed: Recent Developments - continued
−Removed: Business - continued
−Removed: Payor Billing and Revenue Cycle Management
−Removed: As part of the transition to
−Removed: our own Company-owned commercial clinical laboratory, we also contracted with a revenue cycle management (“RCM”) service provider
−Removed: to submit third-party reimbursement claims on our behalf.
−Removed: The RCM service provider will have complete oversight of payer claims, appeals
−Removed: processes, patient billing, online payment collection, and claims tracking.
−Removed: With the appropriate licenses and certifications for billing
−Removed: and credentialing secured, and our recently having put in place the necessary back office systems, claims for approximately 1,000 tests
−Removed: performed since the establishment of our own lab are now being processed, including 850 tests in the three months ended June 30, 2022
−Removed: (although not having yet secured reimbursed rates from Medicare and Medicaid, the Company does not know the amount per claim it will receive
−Removed: from payors).
−Removed: Refer to Note 3 of our Condensed Consolidated Financial Statements for more information on Revenue from Contracts
−Removed: with Customers.
−Removed: Presently, recognized revenue for GAAP purposes is subject to actual amounts collected during the period.
−Removed: Accordingly, since the RCM began submitting claims processed from our own lab subsequent to June 30, 2022, there were no collections during
−Removed: the three months ended June 30, 2022.
−Removed: EsoCure License Agreement with PAVmed Inc.
−Removed: EsoCure has been in development
−Removed: as an esophageal ablation device by PAVmed.
−Removed: In April 2022, following the approval from both ours and the PAVmed Inc.
−Removed: boards of directors,
−Removed: we and PAVmed Inc.
−Removed: entered into an intercompany license agreement (“EsoCure License Agreement”), pursuant to which we were
−Removed: granted the rights to commercialize EsoCure.
−Removed: The EsoCure License Agreement, includes a royalty arrangement whereby we will pay PAVmed
−Removed: a 5% royalty on all EsoCure sales up to $100 million per calendar year, and an 8.0% royalty on annual sales in excess of $100 million
−Removed: per calendar year.
−Removed: We are obligated to reimburse PAVmed Inc.
−Removed: for any ongoing development costs and cumulative patent expenses associated
−Removed: with the licensed technology.
−Removed: On October 5, 2021, PAVmed Subsidiary Corp, a wholly-owned
−Removed: subsidiary of PAVmed Inc., acquired 100% of the outstanding membership interest of CapNostics, LLC (“CapNostics”), an unrelated
−Removed: third-party, for total (gross) purchase consideration of approximately $2.1 million in cash, paid at the closing of the transaction.
−Removed: Subsequently,
−Removed: Lucid Diagnostics Inc.
−Removed: and PAVmed Subsidiary Corp entered into an agreement, effective April 1, 2022, pursuant to which PAVmed Subsidiary
−Removed: Corp assigned to Lucid Diagnostics Inc.
−Removed: 100% of the membership interest in CapNostics, LLC, inclusive of an acquired defensive technology
−Removed: intangible asset, and a $2.1 million payment obligation Due To:
−Removed: Additionally, Lucid Diagnostics Inc.
−Removed: was also assigned on a prospective basis effective April 1, 2022, the consulting
−Removed: agreement with the previous principal owner of CapNostics, LLC.
+Added: the MAC Palmetto GBA release of a proposed LCD, the MAC Noridian Healthcare Solutions published a proposed LCD entitled Molecular
+Added: Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia DL39262.
+Added: The proposed LCD mirrors the MAC
+Added: Palmetto GBA proposed LCD.
+Added: We have used the MAC Noridian Healthcare Solutions open meeting held on May 26, 2022, and the written
+Added: comment period that ended on June 11, 2022 to bring the same essential information that we provided to the MAC Palmetto GBA to
+Added: maintain consistency in our approach and advocate appropriately.
+Added: Status of Clinical Trials
+Added: 2021, we began conducting two concurrent clinical trials, the “EsoGuard
+Added: screening study” (“BE-1”) and the “EsoGuard case-control study” (“BE-2”), to expand the clinical
+Added: evidence for the technologies and to support FDA pre-market approval (“PMA”) of the use of EsoGuard and EsoCheck as an in-vitro
+Added: diagnostic medical device (“IVD”).
+Added: However, in light of the MAC Palmetto GBA’s recently published proposed LCD DL39256,
+Added: the recently updated AGA guidance, and the ACG update to its clinical guideline that supports screening to prevent highly lethal EAC utilizing
+Added: a biomarker test like EsoGuard on samples collected with a swallowable, nonendoscopic capsule device like EsoCheck, we have determined
+Added: to prioritize our clinical trial efforts and resources towards supporting studies that will help secure insurance reimbursement adoption
+Added: for EsoGuard by government and private insurers.
+Added: Consequently, we have decided to delay for the time being the BE-1 trial
+Added: while continuing to enroll GERD patients with a previous diagnosis of nondysplastic BE, low grade dysplasia, high grade dysplasia, or
+Added: EAC in the BE-2 case-control study through Q2 2023.
+Added: EsoCure Esophageal Ablation Device
+Added: connection with our efforts to expand our presence in the diagnostic market, we are also developing a third product, the EsoCure Esophageal
+Added: Ablation Device, with the intent to allow a clinician to treat dysplastic BE before it can progress to EAC, a highly lethal esophageal
+Added: cancer, and to do so without the need for complex and expensive capital equipment.
+Added: As described in Note 5, Due To PAVmed Inc.
+Added: we entered into a license agreement with our parent company, PAVmed, pursuant to which we were granted the rights to commercialize EsoCure.
+Added: A successful pre-clinical feasibility animal study of EsoCure has been completed, demonstrating excellent, controlled circumferential
+Added: ablation of the esophageal mucosal lining.
+Added: An acute and survival animal study of EsoCure has also been completed, demonstrating successful
+Added: direct thermal balloon catheter ablation of esophageal lining through the working channel of a standard endoscope.
+Added: We plan to conduct
+Added: additional development work and animal testing of EsoCure to support a future FDA 510(k) submission.
+Added: Reimbursement
+Added: – Private Payer
+Added: part of the transition to our own CLIA-certified commercial clinical laboratory, we contracted with a revenue cycle management (“RCM”)
+Added: service provider to submit third-party reimbursement claims on our behalf.
+Added: The RCM service provider has joint oversight of payer claims,
+Added: appeals processes, patient billing, online payment collection, and claims tracking.
+Added: On August 1, 2022, our new RCM company began submitting
+Added: claims to third-party payers.
+Added: At the point when submission by the RCM began, more than 2,000 claims had accumulated since the commencement
+Added: of our laboratory operations on February 25, 2022.
+Added: These claims and other claims that were subsequently generated
+Added: are now being processed, including 1,088 tests in the three months ended September 30, 2022.
+Added: to Note 3 of our Condensed Consolidated Financial Statements for more information on Revenue from Contracts with Customers.
+Added: Cell Collection Device Update
+Added: October 2022, the FDA announced they completed their review of the EsoCheck 510(k) (#K222366) premarket notification of intent to market
+Added: the device and granted the use of the EsoCheck Cell Collection Device for the collection and retrieval of surface cells of the esophagus
+Added: in the general population of adults and adolescents, 12 years of age and older.
+Added: This action by the FDA now expands the targeted US patient
+Added: population to include adolescents not previously covered by the Company’s initial EsoCheck 510(k) clearance.
+Added: Manufacturing Update
+Added: October 4, 2022, we completed our first full day of manufacturing of EsoCheck at Coastline International Inc., a high-volume medical
+Added: device manufacturer.
+Added: By mid-2023, we expect to transition from our current manufacturer, Sage Product Development Inc., to Coastline
+Added: International Inc., as the manufacturing process is further optimized.
+Added: March 2022, we entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”).
+Added: terms of the facility, Cantor has committed to purchase up to $50 million of our common stock from time to time upon our request.
+Added: While there are distinct differences, the facility is structured similarly to a traditional at-the-market
+Added: equity facility, insofar as it allows us to raise primary capital on a periodic basis at prices based on the existing market price.
+Added: Through September 30, 2022, 680,263 shares of our common stock were issued under this facility for total
+Added: proceeds of $1.8 million.
of Operations
−Removed: Revenue was recognized with respect to the EsoGuard
−Removed: Commercialization Agreement, dated August 1, 2021, between the Company and ResearchDx Inc.
−Removed: (“RDx”), a CLIA certified commercial
−Removed: laboratory service provider.
−Removed: On February 25, 2022, the EsoGuard Commercialization Agreement was terminated upon the execution of an Asset
−Removed: Purchase Agreement between the Company’s wholly-owned subsidiary LucidDx Labs Inc.
+Added: Company recognized revenue resulting from the delivery of patient EsoGuard test results for which cash collections have occurred or payment
+Added: was reasonably assured.
+Added: Additionally, revenue was recognized with respect to the EsoGuard Commercialization Agreement, dated August 1,
+Added: 2021, between the Company and RDx, a CLIA certified commercial laboratory service provider.
+Added: 25, 2022, the EsoGuard Commercialization Agreement was terminated upon the execution of an Asset Purchase Agreement between the Company’s
+Added: wholly-owned subsidiary of LucidDx Labs Inc.
+Added: of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of test collection kits, royalties and the cost of services to
+Added: process tests and provide results to physicians.
+Added: We incur expenses for tests in the period in which the activities occur, therefore,
+Added: gross margin as a percentage of revenue may vary from quarter to quarter due to costs being incurred in one period that relate to revenues
+Added: recognized in a later period.
+Added: expect that gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies,
+Added: patient compliance rates, payer mix, the levels of reimbursement, and payment patterns of payers and patients.
cost of revenue recognized with respect to the revenue recognized under the EsoGuard Commercialization Agreement is inclusive of:
8 unchanged sentences
and marketing expenses
−Removed: and marketing expenses consist primarily of the portion of the MSA Fee allocated to sales and marketing expenses, which are principally
−Removed: employee related costs of PAVmed employees, as well as advertising and promotion expenses.
−Removed: We anticipate our sales and marketing expenses
−Removed: will increase in the future, as we anticipate an increase in payroll and related expenses related to the roll-out of our commercial sales
−Removed: and marketing operations as we execute on our business strategy.
+Added: and marketing expenses consist primarily of salaries and related costs for employees engaged in sales and marketing activities, as well
+Added: as the portion of the MSA Fee allocated to sales and marketing expenses, which are principally employee related costs of PAVmed employees.
+Added: We anticipate our sales and marketing expenses will increase in the future, as we anticipate an increase in payroll and related expenses
+Added: related to the roll-out of our commercial sales and marketing operations as we execute on our business strategy.
and administrative expenses
2 unchanged sentences
general and administrative expenses.
−Removed: anticipate our general and administrative expenses will increase in the future, as we anticipate an increase in the MSA Fee allocated
−Removed: to general and administrative expense, related to continued expansion of our overall business operations.
−Removed: We also anticipate expenses
−Removed: related to being a public company, including professional services fees for legal, accounting, tax, audit, employees involved in third-party
−Removed: payor reimbursement contract negotiations and regulatory services associated with maintaining compliance as a public company, along with
−Removed: insurance premiums, investor relations, and other corporate expenses.
−Removed: Results of Operations - continued
−Removed: Overview - continued
+Added: anticipate our general and administrative expenses will increase in the future related to continued expansion of our overall business
+Added: We also anticipate expenses related to being a public company, including professional services fees for legal, accounting,
+Added: tax, audit, employees involved in third-party payor reimbursement contract negotiations and regulatory services associated with maintaining
+Added: compliance as a public company, along with insurance premiums, investor relations, and other corporate expenses.
and development expenses
1 unchanged sentence
for the development of our technologies and conducting clinical trials, including:
−Removed: costs charged to us by various external contract research organizations we contract with to conduct preclinical studies and engineering
−Removed: costs associated with regulatory filings;
−Removed: patent license fees;
−Removed: cost of laboratory supplies and acquiring, developing,
−Removed: and manufacturing preclinical prototypes;
−Removed: product design engineering studies;
−Removed: fees associated with conducting clinical trials for
−Removed: our EsoGuard diagnostic assay;
−Removed: MSA Fee allocated to research and development, as such
−Removed: MSA Fee are discussed below.
+Added: costs charged to us by various external contract research organizations we contract with to conduct clinical and preclinical studies
+Added: and engineering design and development;
+Added: associated with regulatory filings;
+Added: license fees;
+Added: of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes;
+Added: design engineering studies;
+Added: associated with conducting clinical trials for our EsoGuard diagnostic assay;
+Added: Fee allocated to research and development, as such MSA Fee are discussed below.
plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as
well as new innovations.
−Removed: Our research and development activities are focused principally on obtaining FDA approvals and developing product
+Added: Our research and development activities, including our clinical trials, are focused principally on obtaining FDA approvals, facilitating insurer reimbursement, encouraging physician adoption and developing product
improvements or extending the utility of the lead products in our pipeline, including EsoCheck and EsoGuard.
−Removed: of Dollar Amounts
−Removed: dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented in thousands
−Removed: of dollars, if not otherwise indicated as being presented as dollars in millions, except for the number of shares and per share amounts.
of Operations - continued
−Removed: months ended June 30, 2022 as compared to three months ended June 30, 2021
−Removed: Company did not recognize revenue nor cost of revenue during the three months ended June 30, 2022 and June 30, 2021.
−Removed: and marketing expenses
−Removed: the three months ended June 30, 2022, sales and marketing costs were approximately $3.9 million, compared to $1.0 million for the corresponding
+Added: of Dollar Amounts
+Added: dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars in millions, except for per share amounts.
+Added: months ended September 30, 2022 as compared to three months ended September 30, 2021
+Added: the three months ended September 30, 2022, revenue was $0.1 million as compared to $0.2 million in the corresponding period in the prior
+Added: The $0.1 million decrease principally relates to the termination of the EsoGuard Commercialization Agreement with RDx, as the Company
+Added: transitioned to its own laboratory operations effective February 25, 2022.
+Added: The decrease was offset by revenue for our EsoGuard Esophageal
+Added: DNA Test performed in our own CLIA laboratory for the three months ended September 30, 2022.
+Added: the three months ended September 30, 2022, cost of revenue was approximately $1.6 million as compared to $0.1 million for the corresponding
period in the prior year.
+Added: The $1.5 million increase principally related to:
+Added: approximately
+Added: $0.2 million increase in compensation related costs as a result of an increase in headcount;
+Added: approximately
+Added: $0.4 million increase in EsoCheck and EsoGuard supplies usage costs;
+Added: approximately
+Added: $0.9 million increase in laboratory operations costs.
+Added: and marketing expenses
+Added: the three months ended September 30, 2022, sales and marketing costs were approximately $3.9 million, compared to $0.9 million for the
+Added: corresponding period in the prior year.
The net increase of $3.0 million was principally related to:
approximately
−Removed: $2.5 million increase in compensation related costs, including stock-based compensation of approximately $0.4 million in stock based
−Removed: compensation with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc.
−Removed: 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees,
−Removed: and an increase in stock options granted corresponding with the increase in the number of employees principally related to an increase
−Removed: in headcount;
+Added: $2.9 million increase in compensation related costs, including stock-based compensation of approximately $0.4 million with respect
+Added: to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc.
+Added: 2018 Equity Plan to Lucid Diagnostics and
+Added: PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase in headcount;
approximately
−Removed: $0.5 million increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees;
−Removed: approximately $0.1 million
−Removed: decrease in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred
−Removed: through PAVmed.
+Added: $0.1 million increase in consulting and outside professional services fees.
and administrative expenses
−Removed: the three months ended June 30, 2022, general and administrative costs were approximately $7.3 million, compared to $3.1 million for
−Removed: the corresponding period in the prior year.
+Added: the three months ended September 30, 2022, general and administrative costs were approximately $5.7 million, compared to $3.5 million
+Added: for the corresponding period in the prior year.
The net increase of $2.2 million was principally related to:
approximately
−Removed: $0.5 million increase in compensation related costs, including stock-based compensation of approximately $0.2 million with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc.
−Removed: 2018 Equity Plan to
−Removed: Lucid Diagnostics and PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase
−Removed: in the number of employees principally related to an increase in headcount;
+Added: $0.7 million increase in compensation related costs, including stock-based
+Added: compensation of approximately $0.2 million with respect to RSA grants under the Lucid Diagnostics Inc.
+Added: 2018 Equity Plan to Lucid Diagnostics
+Added: and PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase in headcount;
approximately
−Removed: $2.1 million increase in consulting services related to patents, regulatory compliance, legal processes for contract review,
−Removed: transition of public relations and investor relations firms, and public company expenses;
−Removed: approximately $0.6 million of amortization expense related to our intangible
−Removed: approximately $0.3 million
−Removed: increase in the MSA fees, after allocation, from PAVmed related to the growth and expansion of our business and the services incurred
−Removed: through PAVmed;
−Removed: approximately $0.7 million
−Removed: increase in general business expenses.
+Added: $0.5 million increase in consulting services related to patents, regulatory compliance, legal processes for contract review, transition
+Added: of public relations and investor relations firms, and public company expenses;
+Added: approximately
+Added: $0.6 million increase in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services
+Added: incurred through PAVmed;
+Added: approximately
+Added: $0.4 million increase in general business expenses.
+Added: of Operations - continued
+Added: months ended September 30, 2022 as compared to three months ended September 30, 2021 - continued
and development expenses
−Removed: the three months ended June 30, 2022, research and development costs were approximately $3.4 million, compared to $1.9 million for the
−Removed: corresponding period in the prior year.
+Added: the three months ended September 30, 2022, research and development costs were approximately $2.7 million, compared to $2.2 million for
+Added: the corresponding period in the prior year.
The net increase of $0.5 million was principally related to:
2 unchanged sentences
with respect to EsoCheck, EsoCure and EsoGuard;
−Removed: approximately $0.1 million
−Removed: increase in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred
−Removed: through PAVmed.
+Added: approximately
+Added: $0.2 million increase in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services
+Added: incurred through PAVmed.
our accompanying unaudited condensed consolidated financial statements for each of:
Note 4 , Related Party Transactions, for a
−Removed: discussion of the consulting fee expense and stock based compensation expense recognized with respect to the Physician Inventors consulting
−Removed: agreements and stock options and restricted stock awards;
−Removed: and the MSA between Lucid Diagnostics and PAVmed;
−Removed: and Note 11 , Stock-Based
−Removed: Compensation , for information regarding each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed Inc.
+Added: discussion of the consulting fee expense and stock based compensation expense recognized with respect to the Physician Inventors
+Added: consulting agreements and stock options and restricted stock awards and for a discussion of the MSA between Lucid Diagnostics and
+Added: and Note 10 , Stock-Based Compensation , for information regarding each of the Lucid Diagnostics 2018 Equity Plan and
+Added: the PAVmed Inc.
2014 Equity Plan.
−Removed: of Operations - continued
−Removed: months ended June 30, 2022 as compared to six months ended June 30, 2021
−Removed: In the six months ended June
−Removed: 30, 2022, revenue was $0.2 million as compared to no revenue in the corresponding period in the prior year.
−Removed: The $0.2 million increase
−Removed: relates to our EsoGuard Commercialization Agreement, dated August 1, 2021, which resulted in revenue recognition of $0.1 million per month
−Removed: commencing August 2021 and ending February 2022 upon the February 25, 2022 termination date of such agreement.
−Removed: the six months ended June 30, 2022, cost of revenue was approximately $0.4 million, compared to no cost of revenue in the corresponding
+Added: months ended September 30, 2022 as compared to nine months ended September 30, 2021
+Added: the nine months ended September 30, 2022, revenue was $0.3 million as compared to $0.2 million in the corresponding period in the prior
+Added: The $0.1 million increase principally relates to revenue for laboratory services rendered for our EsoGuard Esophageal DNA
+Added: Test performed in our own CLIA laboratory.
+Added: The increase was partially offset by the termination of the EsoGuard Commercialization Agreement,
+Added: with RDx as the Company transitioned to its own laboratory operations effective February 25, 2022.
+Added: the nine months ended September 30, 2022, cost of revenue was approximately $2.0 million as compared to $0.1 million for the corresponding
period in the prior year.
−Removed: The $0.4 million increase principally relates to costs associated with the EsoGuard Commercialization Agreement
+Added: The $1.9 million increase principally related to:
+Added: approximately
+Added: $0.4 million increase in compensation related costs as a result of an increase in headcount;
+Added: approximately
+Added: $0.6 million increase in EsoCheck and EsoGuard supplies usage costs;
+Added: approximately
+Added: $0.9 million increase in laboratory operations costs.
and marketing expenses
−Removed: the six months ended June 30, 2022, sales and marketing costs were approximately $7.2 million, compared to $1.7 million for the corresponding
−Removed: period in the prior year.
+Added: the nine months ended September 30, 2022, sales and marketing costs were approximately $11.1 million, compared to $2.6 million for the
+Added: corresponding period in the prior year.
The net increase of $8.5 million was principally related to:
approximately
−Removed: $4.8 million increase in compensation related costs, including stock-based compensation of approximately $0.8 million in stock based
−Removed: compensation with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc.
−Removed: 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees,
−Removed: and an increase in stock options granted corresponding with the increase in the number of employees principally related to an increase
−Removed: in headcount;
−Removed: approximately $0.9 million
−Removed: increase in outside professional services related to EsoCheck, EsoGuard and consulting and professional services fees;
−Removed: approximately $0.2 million
−Removed: decrease in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services incurred
−Removed: through PAVmed.
+Added: $7.7 million increase in compensation related costs, including stock-based compensation of approximately $1.2 million with respect
+Added: to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc.
+Added: 2018 Equity Plan to Lucid Diagnostics and
+Added: PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase in headcount;
+Added: approximately
+Added: $1.0 million increase in consulting and outside professional services fees and for EsoCheck and EsoGuard;
+Added: approximately
+Added: $0.2 million decrease in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services
+Added: incurred through PAVmed.
and administrative expenses
−Removed: the six months ended June 30, 2022, general and administrative costs were approximately $13.2 million, compared to $4.3 million for the
−Removed: corresponding period in the prior year.
+Added: the nine months ended September 30, 2022, general and administrative costs were approximately $18.2 million, compared to $7.8 million
+Added: for the corresponding period in the prior year.
The net increase of $10.4 million was principally related to:
approximately
−Removed: $2.0 million increase in compensation related costs, including stock-based compensation of approximately $1.6 million in stock based
−Removed: compensation with respect to restricted stock awards (“RSA”) grants under the Lucid Diagnostics Inc.
−Removed: 2018 Equity Plan to Lucid Diagnostics and PAVmed employees and non-employees,
−Removed: and an increase in stock options granted corresponding with the increase in the number of employees principally related to an increase
−Removed: in headcount;
−Removed: approximately $4.1 million
−Removed: increase in consulting services related to patents, regulatory compliance, legal processes for contract review, transition of public
−Removed: relations and investor relations firms, and public company expenses;
−Removed: approximately $0.6 million of amortization expense related to our intangible
−Removed: approximately $0.7 million
−Removed: increase in the MSA fees, after allocation, from PAVmed related to the growth and expansion of our business and the services incurred
−Removed: through PAVmed;
−Removed: approximately $1.5 million
−Removed: increase general business expenses.
−Removed: Results of Operations - continued
−Removed: Six months ended June 30, 2022 as compared to six months ended June
−Removed: 30, 2021 - continued
+Added: $2.7 million increase in compensation related costs, including stock-based
+Added: compensation of approximately $1.8 million with respect to RSA grants under the Lucid Diagnostics Inc.
+Added: 2018 Equity Plan to Lucid Diagnostics
+Added: and PAVmed employees and non-employees, and an increase in stock options granted corresponding with the increase in headcount;
+Added: approximately
+Added: $4.8 million increase in consulting services related to patents, regulatory compliance, legal processes for contract review, transition
+Added: of public relations and investor relations firms, and public company expenses;
+Added: approximately
+Added: $1.3 million increase in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services
+Added: incurred through PAVmed;
+Added: approximately
+Added: $1.6 million increase general business expenses.
+Added: of Operations - continued
+Added: months ended September 30, 2022 as compared to nine months ended September 30, 2021 - continued
and development expenses
−Removed: the six months ended June 30, 2022, research and development costs were approximately $6.3 million, compared to $3.6 million for the
−Removed: corresponding period in the prior year.
+Added: the nine months ended September 30, 2022, research and development costs were approximately $9.0 million, compared to $5.8 million for
+Added: the corresponding period in the prior year.
The net increase of $3.2 million was principally related to:
2 unchanged sentences
with respect to EsoCheck, EsoCure and EsoGuard;
−Removed: approximately $0.2 million
−Removed: increase in compensation related costs and related to expanded clinical and engineering staff;
−Removed: approximately $0.3 million
−Removed: increase in the MSA fee allocation from PAVmed related to the growth and expansion of Lucid’s business and the services incurred
−Removed: through PAVmed.
+Added: approximately
+Added: $0.2 million increase in compensation related costs and related to expanded clinical and engineering staff;
+Added: approximately
+Added: $0.5 million increase in the MSA fee allocation from PAVmed related to the growth and expansion of our business and the services
+Added: incurred through PAVmed.
our accompanying unaudited condensed consolidated financial statements for each of:
Note 4 , Related Party Transactions, for a
−Removed: discussion of the consulting fee expense and stock based compensation expense recognized with respect to the Physician Inventors consulting
−Removed: agreements and stock options and restricted stock awards;
−Removed: and the MSA between Lucid Diagnostics and PAVmed;
−Removed: and Note 11 , Stock-Based
−Removed: Compensation , for information regarding each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed Inc.
+Added: discussion of the consulting fee expense and stock based compensation expense recognized with respect to the Physician Inventors
+Added: consulting agreements and stock options and restricted stock awards and for a discussion of the MSA between Lucid Diagnostics and
+Added: and Note 10 , Stock-Based Compensation , for information regarding each of the Lucid Diagnostics 2018 Equity Plan and
+Added: the PAVmed Inc.
2014 Equity Plan.
and Capital Resources
−Removed: current operational activities are principally focused on the commercialization of EsoGuard.
−Removed: We are presently focused on expanding commercialization
−Removed: across multiple sales channels, including:
−Removed: the communication and education of medical practitioners and clinicians of the EsoGuard LDT;
−Removed: and establishing “Lucid Diagnostics Test Centers” for the collection of cell samples using EsoCheck.
−Removed: Additionally, we are
−Removed: developing expanded clinical evidence to support recommendation of our products in professional society guidelines and insurance reimbursement
−Removed: adoption by government and private insurers.
−Removed: Further, the Company is also pursuing development of other products and services, including
−Removed: EsoCure™, an esophageal ablation device.
−Removed: ability of the Company to generate revenue depends upon the Company’s ability to successfully advance the commercialization of
−Removed: EsoGuard, while also completing the clinical studies, its product and service development, and the necessary regulatory approval thereof.
−Removed: There are no assurances, however, the Company will be able to obtain an adequate level of financial resources required for the long-term
−Removed: commercialization and development of its products and services.
−Removed: to our initial public offering (“IPO”) of our common stock in October 2021, our operations were funded by PAVmed Inc., inclusive
−Removed: of providing working capital cash advances and the payment of certain operating expenses on-our-behalf.
−Removed: Additionally, certain operations
−Removed: of Lucid Diagnostics Inc.
−Removed: continue to be managed by personnel of PAVmed Inc., for which we incur expense according to the provisions
−Removed: of a Management Services Agreement between us and PAVmed Inc.
−Removed: are subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially
−Removed: all of their efforts to the commercialization of their initial product and services and ongoing research and development activities and
−Removed: conducting clinical trials.
−Removed: We expect to continue to experience recurring losses from operations and will continue to fund our operations
−Removed: with debt and equity financing transactions.
−Removed: Notwithstanding, however, with the cash on-hand as of the date hereof and committed equity
−Removed: sources of financing, the Company expects to be able to fund its operations and meet its financial obligations as they become due for
−Removed: the one year period from the date of the issue of the Company’s unaudited condensed consolidated financial statements, as included
−Removed: herein in this Quarterly Report on Form 10-Q for the period ended June 30, 2022.
+Added: current operational activities are principally focused on the commercialization
+Added: We are expanding commercialization across multiple sales channels, including:
+Added: the communication to and education of medical
+Added: practitioners and clinicians regarding EsoGuard;
+Added: and the establishment of Lucid Diagnostics Test Centers for the collection of cell samples
+Added: using EsoCheck.
+Added: Additionally, we are developing expanded clinical evidence to support insurance reimbursement adoption by government and
+Added: private insurers.
+Added: Further, the Company is also pursuing development of other products and services, including EsoCure, an Esophageal Ablation
+Added: ability to generate revenue depends upon our ability to successfully advance
+Added: the commercialization of EsoGuard, while also completing the clinical studies, product and service development, and necessary regulatory
+Added: approval thereof.
+Added: There are no assurances, however, we will be able to obtain an adequate level of financial resources required for the
+Added: long-term commercialization and development of our products and services.
+Added: to our initial public offering (“IPO”) of our common stock
+Added: in October 2021, our operations were funded by PAVmed, inclusive of providing working capital cash advances and the payment of certain
+Added: operating expenses on our behalf.
+Added: Additionally, certain of our operations continue to be managed by PAVmed personnel, for which we incur
+Added: expense according to the provisions of a MSA between us and PAVmed.
+Added: See Note 4 , Related Party Transactions, for a discussion of
+Added: are subject to all of the risks and uncertainties typically faced by medical
+Added: device and diagnostic companies that devote substantially all of their efforts to the commercialization of their initial product and services
+Added: and ongoing research and development activities and conducting clinical trials.
+Added: We expect to continue to experience recurring losses from
+Added: operations and will continue to fund our operations with debt and equity financing transactions.
+Added: Notwithstanding, however, with our cash
+Added: on-hand as of the date hereof and committed equity sources of financing, the Company expects to be able to fund its operations and meet
+Added: its financial obligations as they become due for the one year period from the date of the issue of the Company’s unaudited condensed
+Added: consolidated financial statements, as included herein in this Form 10-Q.
Equity Facility - March 28, 2022
−Removed: March 28, 2022, we entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”).
−Removed: terms of the committed equity facility, Cantor has committed to purchase up to $50 million of our common stock from time to time at our
−Removed: While there are distinct differences, the committed equity facility is structured similarly to a traditional at-the-market equity
−Removed: facility, insofar as it allows us to raise primary equity capital on a periodic basis at prices based on the existing market price.
−Removed: of June 30, 2022, there were no shares of common stock issued under the committed equity facility.
−Removed: Subsequent to June 30, 2022, as of
−Removed: August 10, 2022, under the committed equity facility, a total of 308,152 shares of common stock of the Company were issued for proceeds
−Removed: of approximately $927.
−Removed: our inception in May 2018 through our IPO in October 2021, our operations were funded by PAVmed providing working capital cash advances
−Removed: and the payment by PAVmed of certain operating expenses on-our-behalf.
−Removed: Additionally, our daily operations have been and continue to be
−Removed: principally managed by personnel employed by PAVmed, for which we incur a MSA Fee expense according to the provisions of the MSA discussed
−Removed: of June 30, 2022, we had a Due To:
−Removed: payment obligation liability of an aggregate of approximately $2.4 million payable for
−Removed: the transfer of CapNostics LLC, and for reimbursement of employee related costs and certain operating expenses paid by PAVmed Inc.
−Removed: See our accompanying unaudited condensed consolidated financial statements Note 5, Due To PAVmed Inc.
+Added: On March 28, 2022, we entered into a committed equity facility with Cantor.
+Added: Under the terms of the committed equity facility, Cantor has committed to purchase up to $50 million of our common stock from time to
+Added: time at our request.
+Added: While there are distinct differences, the committed equity facility is structured similarly to a traditional at-the-market
+Added: equity facility, insofar as it allows us to raise primary equity capital on a periodic basis at prices based on the existing market price.
+Added: As of September 30, 2022, under the committed equity facility, a total of 680,263 shares of common stock of the Company were issued
+Added: for proceeds of approximately $1.8 million.
+Added: Since our inception in May 2018
+Added: through our IPO in October 2021, our operations were funded by PAVmed providing working capital cash advances and the payment by PAVmed
+Added: of certain operating expenses on our behalf.
+Added: Additionally, our daily operations have been and continue to be principally managed by personnel
+Added: employed by PAVmed, for which we incur a MSA Fee expense.
+Added: The MSA Fee is charged on a monthly basis and is subject-to periodic adjustment
+Added: corresponding with changes in the services provided by PAVmed Inc.
+Added: personnel to the Company, with any such change in the MSA Fee being
+Added: subject to approval of the Lucid Diagnostics Inc.
+Added: and PAVmed Inc.
+Added: boards of directors.
+Added: In this regard, in August 2022, the boards of directors
+Added: of Lucid Diagnostics Inc.
+Added: and PAVmed Inc.
+Added: approved a sixth amendment to the MSA to increase the MSA Fee to $550 per month from $390 per
+Added: month, with such increase effective on a prospective basis commencing July 1, 2022.
+Added: Pursuant to the sixth amendment, the parties agreed
+Added: may elect to receive payment of the monthly MSA Fee in cash or in shares of our common stock, with such shares valued at the
+Added: volume weighted average price (“VWAP”) during the final ten trading days of the applicable month (subject to a floor price
+Added: of $0.70 per share).
+Added: However, in no event will PAVmed Inc.
+Added: be entitled to receive under the MSA, as amended, more than 7,709,836 shares
+Added: of our common stock (representing 19.99% of our outstanding shares of common stock as of immediately prior to the execution of the sixth
+Added: The shares that may be issued under the MSA, as amended, are being offered and sold in transactions exempt from registration
+Added: under the Securities Act of 1933, as amended, in reliance on the exemption afforded under Section 4(a)(2) thereof.
+Added: As of September 30, 2022,
+Added: we had a Due To:
+Added: payment obligation liability of an aggregate of approximately $6.6 million payable for the transfer of CapNostics,
+Added: LLC, and for reimbursement of employee related costs and certain operating expenses paid by PAVmed on our behalf.
+Added: See our accompanying
+Added: unaudited condensed consolidated financial statements Note 5 , Due To PAVmed Inc.
Accounting Policies and Significant Judgments and Estimates
−Removed: discussion and analysis of our (unaudited) 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
−Removed: statements requires us to make estimates and assumptions affecting the reported amounts of assets, liabilities, and equity, along
−Removed: with the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements
−Removed: and the reported amounts 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.
−Removed: GAAP, we base our estimates on
−Removed: historical experience and on various other assumptions we believe are reasonable under the circumstances.
−Removed: Actual results may differ
−Removed: from these estimates under different assumptions or conditions.
−Removed: Our critical accounting policies are as disclosed in the
−Removed: Company’s annual report on Form 10-K for the year ended December 31, 2021 as filed with the SEC on April 6, 2022, except as
−Removed: otherwise noted in Note 2, Summary of Significant Accounting Policies and Recent Accounting Standards Updates , of our
−Removed: unaudited condensed consolidated financial statements included herein in this Form 10-Q.
+Added: GAAP, we base our estimates on historical experience and on various
+Added: other assumptions we believe are reasonable under the circumstances.
+Added: Actual results may differ from these estimates under different assumptions
+Added: or conditions.
+Added: Our critical accounting policies are as disclosed in the Company’s annual report on Form 10-K for the year ended
+Added: December 31, 2021 as filed with the SEC on April 6, 2022, except as otherwise noted in Note 2, Summary of Significant Accounting Policies
+Added: and Recent Accounting Standards Updates , of our unaudited condensed consolidated financial statements included herein in this Form
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.