Form 8-K

8-K — Lucid Diagnostics Inc.

Accession: 0001493152-26-043659

Filed: 2026-09-22

Period: 2026-09-22

CIK: 0001799011

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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EX-99.1 (ex99-1.htm)

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

DC 20549

FORM

8-K

CURRENT

REPORT

PURSUANT

TO SECTION 13 OR 15(d) OF THE

SECURITIES

EXCHANGE ACT OF 1934

Date

of Report (Date of earliest event reported): September 22, 2026

LUCID

DIAGNOSTICS INC.

(Exact

Name of Registrant as Specified in Charter)

Delaware

001-40901

82-5488042

(State

or Other Jurisdiction

Incorporation)

(Commission

File

Number)

(IRS

Employer

Identification

No.)

360

Madison Avenue, 25th Floor,

New York,

New York

10017

(Address

of Principal Executive Offices)

(Zip

Code)

Registrant’s

telephone number, including area code: (917) 813-1828

N/A

(Former

Name or Former Address, if Changed Since Last Report)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under

any of the following provisions (see General Instruction A.2. below):

☐

Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).

☐

Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).

☐

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).

☐

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)).

Securities

registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common

Stock, Par Value $0.001 Per Share

LUCD

The

Nasdaq Stock Market LLC

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405

of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ☒

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01.

Regulation FD Disclosure.

September 22, 2026, Lucid Diagnostics Inc. (the “Company”) issued a press release announcing advances in multiple

payment, billing, and coding pathways for its EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device,

following three public meetings held last week. A copy of the press release is attached to this report as Exhibit 99.1 and is incorporated

herein by reference.

The

information furnished under Item 7.01, including the exhibit related thereto, shall not be deemed “filed” for purposes of

Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any disclosure document of the

Company, except as shall be expressly set forth by specific reference in such document.

Item 9.01. Financial

Statements and Exhibits.

(d)

Exhibits:

Exhibit

No.

Description

99.1

Press

release.

104

Cover Page Interactive

Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

Dated:

September 22, 2026

LUCID

DIAGNOSTICS INC.

By:

/s/

Dennis McGrath

Dennis

McGrath

Chief

Financial Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

Lucid

Diagnostics Advances Multiple EsoGuard® and EsoCheck® Payment, Billing and Coding Pathways

Medicare

Advisory Panel recommends maintaining EsoGuard’s original gapfill payment basis under the Clinical Laboratory Fee Schedule

AMA

CPT Editorial Panel approves a new Category III CPT code for non-endoscopic cell collection procedures performed with EsoCheck

Proposal

for a new ICD-10-CM diagnosis code identifying positive EsoGuard results draws a favorable response from the CDC/NCHS ICD-10 Coordination

and Maintenance Committee

NEW

YORK, September 22, 2026 - Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid” or the “Company”), a commercial-stage,

cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced advances in multiple payment,

billing, and coding pathways for its EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell

Collection Device, following three public meetings held last week.

The

Centers for Medicare & Medicaid Services (CMS) held a special Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests

(CDLT) Meeting on September 15-16 to make recommendations on Medicare payment methodologies for certain CDLTs paid under the Clinical

Laboratory Fee Schedule (CLFS), including EsoGuard. CMS convened the meeting in response to recent legislation resuming the reporting

and payment update cycle under the Protecting Access to Medicare Act (PAMA) after repeated postponements. The panel recommended maintaining

the original gapfill payment basis for EsoGuard (PLA code 0114U), whose payment rate took effect in the CY2021 CLFS Update. CMS

has posted a consent agenda reflecting this recommendation and is expected to issue final determinations in November following

a public comment period.

The

American Medical Association (AMA) held its September 2026 Hybrid CPT® Editorial Panel Meeting on September 17-19.

The panel approved the addition of a new Category III CPT code for reporting nonendoscopic esophageal cell collection. Once effective,

the code will allow physicians and health systems to report and track office-based esophageal cell collection procedures performed with

EsoCheck, supporting systematic evaluation of utilization and clinical outcomes. The AMA is expected to publish the meeting’s Summary

of Panel Actions in the coming weeks.

The

Centers for Disease Control and Prevention’s National Center for Health Statistics (CDC/NCHS) hosted the diagnosis code portion

of the ICD-10 Coordination and Maintenance Committee Meeting on September 15-16. The committee considered a proposed new ICD-10-CM

diagnosis code (R85.83) to report positive results for the two methylated DNA biomarkers targeted by EsoGuard. The proposal, submitted

by Lucid and supported by the American Foregut Society (AFS), would provide a dedicated code for reporting positive EsoGuard results

on claims for subsequent confirmatory upper endoscopy. Once implemented, the code will help physicians document the clinical rationale

for the endoscopy and enhance EsoGuard’s clinical value as a triage tool. AFS President Felice Schnoll-Sussman, M.D., M.Sc., Professor

of Clinical Medicine at Weill Cornell Medicine, presented the proposal, which was positively received by the committee. The Company expects

the proposed code to be finalized following a public comment period.

These

meetings addressed payment, billing and coding for EsoCheck cell collection, EsoGuard laboratory testing, and confirmatory endoscopy,

including for Medicare beneficiaries. Lucid owns and operates two CLIA-certified laboratories in Lake Forest, California and Irving,

Texas, where it performs EsoGuard testing on samples collected with EsoCheck. Medicare claims for each laboratory are processed by the

Medicare Administrative Contractor (MAC) for its jurisdiction under applicable coverage policies. The MolDX program coordinates coverage

determinations on behalf of a subset of participating MACs.

The

California laboratory is located within a MolDX-participating MAC’s jurisdiction. Lucid will begin submitting Medicare claims under

EsoGuard’s PLA code, 0114U, for tests performed at its California laboratory once a final revised EsoGuard Local Coverage Determination

(LCD) resulting from Lucid’s pending reconsideration request is effective.

The

Texas laboratory is located within the jurisdiction of a MAC that does not participate in the MolDX program. Lucid will begin submitting

Medicare claims this month under EsoGuard’s PLA code, 0114U, for tests performed at its Texas laboratory.

“These

three public meetings mark important positive milestones in advancing payment, billing and coding for EsoGuard esophageal precancer testing,”

said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. “We are encouraged by the near-term commercial

opportunities to expand access to EsoGuard through both of our CLIA-certified laboratories, including for Medicare beneficiaries.”

About

Lucid Diagnostics

Lucid

Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM).

Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at

risk of developing esophageal precancer and cancer. Lucid’s EsoGuard® Esophageal DNA Test, performed on samples

collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device, represent

the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early

detection of esophageal precancer in at-risk patients.

For

more information, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com.

Forward-Looking

Statements

This

press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements

that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid Diagnostics’

management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks

and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid Diagnostics’ common

stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required

to advance Lucid Diagnostics’ products to regulatory submission; whether regulatory authorities will be satisfied with the design

of and results from Lucid Diagnostics’ clinical and preclinical studies; whether and when Lucid Diagnostics’ products are

cleared by regulatory authorities; market acceptance of Lucid Diagnostics’ products once cleared and commercialized; Lucid Diagnostics’

ability to raise additional funding as needed; and other competitive developments. These factors are difficult or impossible to predict

accurately and many of them are beyond Lucid Diagnostics’ control. In addition, new risks and uncertainties may arise from time

to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may

affect Lucid Diagnostics’ future operations, see Part I, Item 1A, “Risk Factors,” in Lucid Diagnostics’ most

recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A,

“Risk Factors” in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. Lucid

Diagnostics disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in

its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood

that actual results will differ from those contained in the forward-looking statements.

Investor

and Media Contact:

Matt

Riley

PAVmed and Lucid Diagnostics

mjr@pavmed.com

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