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HeartBeam, Inc.

For the period ended Dec 31, 2025. Filed Mar 12, 2026.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2025 · Filed Mar 12, 2026

BEAT$0.40+1.8%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-K

Period ended 2024-12-31; filed 2025-03-13.

0001628280-25-012614

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-K

Period ended 2025-12-31; filed 2026-03-12.

0001193125-26-104080

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 71 previous paragraphs and 66 current paragraphs.

24 unchanged; 14 reworded; 26 added; 33 removed; 0 previous and 2 current paragraphs rearranged.

Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (26)

Current report

HeartBeam’s credit card sized 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025.

Current report

We are focused on advancing several key initiatives as part of our growth strategy:

Current report

Limited Launch: On the back of our recent FDA Clearance for the HeartBeam System, we are initiating a market introduction in early 2026, focusing on select concierge and preventive cardiology groups that have proactively signaled strong interest in adopting HeartBeam’s technology. This limited market release will enable the Company to validate real-world performance and establish reference sites for broader commercialization.

Current report

Heart Attack Detection: We are pursuing an expansion of our cleared indications through a heart attack detection indication, supported by compelling proof-of-concept data and representing a major expansion opportunity to tens of millions of patients in the U.S.

Current report

Extended Wear Patch: We are making significant advancements with an on-demand 12L ECG extended wear monitor. The Company has developed a working prototype of its novel 12L patch, which has the potential to be a best-in-class offering in an existing multi-billion-dollar market with reimbursement.

Current report

Longitudinal Data and AI: The Company believes it has the ability to unlock the power of the unique data-rich repository generated from our 3D ECG platform and deep learning algorithms. As adoption grows, the ability for patients to record synthesized 12L ECGs over time will create the opportunity to build AI-based screening and prediction algorithms that go beyond what is possible with single-timepoint ECGs or traditional wearables.

Current report

As of December 31, 2025, we had 16 employees. In January 2026, the Company hired a Chief Commercial Officer, Bryan Humbarger, bringing total headcount to 17 employees. Mr. Humbarger brings more than 25 years of experience in building and scaling groundbreaking medical technologies. While initially focused on launching the Company’s FDA-cleared 12L system for arrhythmia assessment, he will lead the Company’s broader commercialization strategy across key growth initiatives, including heart attack detection and the 12L ECG extended wear patch.

Current report

We believe our intellectual property (“IP”) protects our innovations, and our goal is to become a leader in the ambulatory ECG sector. For some aspects of our proprietary technology, we rely on trade secret protection, while for others we pursue patent protection. It is our view that the combination of these two methods of IP protection maximizes our chances for success.

Current report

The Company’s patent portfolio includes twenty-five (25) issued patents worldwide, consisting of seventeen (17) issued patents in the United States and eight (8) issued patents outside of the United States, including one (1) European patent granted with unitary effect under the Unitary Patent system.

Current report

In the United States, the Company also has thirteen (13) additional pending patent applications. Outside the United States, the Company has twenty-two (22) pending patent applications in jurisdictions including Canada, China, the European Union, Japan, South Korea, and Australia.

Current report

The issued patents are expected to expire between April 11, 2036, and April 21, 2042. The pending applications, regardless of publication status, are projected to expire between April 11, 2036, and February 20, 2045.

Current report

Over the course of 2025 and into early 2026, we were granted a total of eight (8) new patents relating to its compact, mobile three-lead cardiac monitoring technologies and automated diagnostics, methods for atrial fibrillation detection, photoplethysmogram data analysis and presentation, and electrocardiogram patch devices and methods. These patents significantly strengthen HeartBeam’s intellectual property position surrounding its credit card–sized ECG device, reinforcing both the defensive and offensive moats around the company’s core technology. They also expand the application of risk-based diagnostic algorithms across HeartBeam’s wearable device portfolio and cover methods for automatically assessing a patient’s risk of an acute cardiac event by evaluating clinical risk factors and generating a diagnostic report.

Current report

In addition, HeartBeam continues to expand its intellectual property portfolio and filed two (2) non-provisional, three (3) provisional and three (3) continuing patent applications throughout 2025, further strengthening the protection of its proprietary technologies.

Current report

HeartBeam Appoints Bryan Humbarger as Chief Commercial Officer

Current report

In January 2026, the Company hired Bryan Humbarger as Chief Commercial Officer. Mr. Humbarger brings more than 25 years of commercial leadership experience spanning large medical device organizations and high-growth MedTech companies. Most recently, he served as Chief Commercial Officer at the venture-backed surgical guidance company Proprio, where he led the go-to-market strategy and market development while establishing the company's sales and clinical support infrastructure. His background also includes senior commercial leadership roles at innovative cardiovascular and digital health companies Heartflow, AliveCor, and Eko Health—organizations that share important parallels with HeartBeam’s technology-driven, patient-centric approach.

Current report

While initially focused on launching the Company’s FDA-cleared 12L system for arrhythmia assessment, he will lead the Company’s broader commercialization strategy across key growth initiatives, including heart attack detection and the 12L ECG extended wear patch.

Current report

On March 4, 2026, the Company announced ClearCardio as its first commercial customer. ClearCardio is a leading preventive cardiology practice that has served thousands of patients through advanced heart health screening and personalized prevention programs. The partnership includes an initial staged rollout to ensure a seamless patient and physician experience and plans for broader expansion to thousands of highly engaged members across multiple U.S. geographies.

Current report

The initial agreement with ClearCardio is structured as a Letter of Intent (LOI), outlining the commercial terms and a collaborative rollout plan, including a subscription fee per patient. During the initial deployment phase, HeartBeam and ClearCardio intend to negotiate and execute a definitive agreement.

Current report

First Patients Enrolled in Heart Attack Detection Pilot Study:

Current report

On March 5, 2026, the Company announced it enrolled the first patients in the ALIGN-ACS study. HeartBeam’s technology is uniquely capable of assessing possible heart attacks outside of traditional clinical settings and this milestone signifies a key step toward a future FDA indication expansion for heart attack assessment.

Current report

The ALIGN-ACS pilot study is designed to enroll 100 patients presenting with chest pain in the emergency room (ER). Patients will be evaluated with both a standard 12-lead ECG and the HeartBeam device and both results will be compared with each patient’s final diagnosis at discharge. As the study is designed to enroll chest pain patients in the ER, enrollment is expected to progress quickly.

Current report

On March 10, 2026, the Company and the Icahn School of Medicine at Mount Sinai in New York (“Mount Sinai”) entered into strategic AI collaboration to bring clinical-grade heart monitoring into the home. This collaboration will aim to accelerate development of personalized cardiac AI on the HeartBeam platform for wellness and clinical applications, including assessing heart attack risk. It combines Mount Sinai’s world-class AI and clinical expertise with HeartBeam’s groundbreaking 3D ECG signal collection technology. The partnership marks a significant milestone in the Company’s long-term strategy to build an ecosystem around its platform and strengthen its leadership in AI-enabled cardiac monitoring.

Current report

Results of operations for the years ended December 31, 2025 and 2024
Removed paragraphs (33)

Previous report

In January 2025, the Company filed a 510(k) notification for the software algorithms that synthesize a 12L ECG from the HeartBeam System. This latest submission builds on HeartBeam’s recent FDA clearance for its patented technology, which captures the heart’s electrical signals from three distinct directions. The software synthesizes these signals into a familiar 12-lead ECG using a personalized transformation matrix.

Previous report

The cumulative result of these two 510(k) submissions, once cleared by the FDA, will be an ambulatory device, carried by patients, which can synthesize a 12L ECG for physician review for arrhythmia assessment.

Previous report

In support of this recent submission, the Company held two pre-submission meetings with the FDA on this 12L synthesis submission. These meetings focused primarily on the performance goals of our clinical study designed to demonstrate the similarity between our synthesized 12L signal and the output of a standard 12L ECG for the intended use. Based on feedback from FDA and our clinical experts, the Company designed a prospective multicenter pivotal study, the VALID-ECG pivotal study, for clinical validation of the HeartBeam 12 Lead ECG Synthesis Software for Arrhythmia Detection.

Previous report

This latest FDA submission is backed by robust data from the VALID-ECG study, which enrolled 198 patients across five clinical sites. The Company believes the study's findings support the clinical equivalence of HeartBeam's synthesized 12-lead ECG where the leads are similar to standard 12-lead ECGs for rhythm and arrhythmia assessment. Efforts were made to enroll patients with a diverse demographic profile reflective of the intended use population in the United States. The primary objective was to demonstrate the equivalence of ECG waveforms between the HeartBeam System Synthesized 12L ECG and Standard 12L ECG, recorded simultaneously in each subject, by assessing relevant ECG characteristics, i.e. intervals and amplitudes.

Previous report

The Company is in the process of initiating an Early Access Program for the HeartBeam System. This program will provide the company with valuable feedback on the user experience, overall workflow and functionality of the system in a real-world setting. The Early Access Program will also help prepare the Company to commercialize the technology once we receive FDA clearance for our 12L synthesis algorithm. We do not anticipate that the HeartBeam System clearance will generate significant revenue before the clearance of the synthesized 12L algorithm.

Previous report

We also have an active AI program underway. We have acquired approximately one million 12L ECGs from various sources, a key element in our fast-paced AI development efforts.

Previous report

We have developed initial deep learning algorithms, focused on the ability to detect various cardiac arrhythmias. HeartBeam has had data on its deep learning algorithm presented at two prestigious Electrophysiology conferences. Data were presented at the European Heart Rhythm Association in Berlin, Germany in April 2024 and at the Heart Rhythm Society, in Boston, MA in May 2024. We believe that, when combined with our Products, HeartBeam’s AI will provide additional value to patients and physicians in several ways, including:

Previous report

• Providing automated classification of cardiac conditions, including common arrhythmias,

Previous report

• Potentially enhancing user experience and simplify the onboarding process, and

Previous report

• In the longer run, we believe that applying deep learning algorithms on top of the rich data, especially with the longitudinal dataset from patients taking repeated readings, may result in unsurpassed predictive and diagnostic capabilities.

Previous report

The custom software and hardware of our Products are classified as Class II medical devices by the FDA. Premarket review and clearance by the FDA for Class II devices is generally accomplished through the 510(k) premarket notification process or De Novo process. Given the proposed intended use of our device, the 510(k) submission or De Novo process is expected to require clinical data to support FDA clearance.

Previous report

HeartBeam has 14 issued U.S. patents (U.S. 10,433,744, U.S. 10,117,592, U.S. 11,071,490, U.S. 11,419,538, U.S. 11,445,963, U.S. 11,701,049, U.S. 11,529,085, U.S. 10,980,433, U.S. 11,412,972, U.S. 11,234,658, U.S. 11,793,444, U.S. 11,877,853, U.S. 11,969,251 and U.S. US 12,207,908), and nine pending U.S applications. Outside of the U.S., HeartBeam has four issued patents in Germany, France, Netherlands and the United Kingdom and twenty-four pending applications in Canada, China, the European Union, Japan, South Korea and Australia. The issued patents are predicted to expire between April 11, 2036, and April 21, 2042.

Previous report

•One patent covers apparatuses and methods that facilitate the comparison of cardiac signals over time for the automated or assisted detection of heart attacks.

Previous report

•The other covers methods and apparatuses around HeartBeam’s wrist-based ECG system.

Previous report

Thus far in 2025, we have been granted one new U.S. patent related to HeartBeam’s compact, mobile three-lead cardiac monitoring devices.

Previous report

We now have fourteen (14) issued U.S. patents and nine (9) pending U.S applications. Outside of the U.S., we have four (4) issued patents in Germany, France, Netherlands and United Kingdom and twenty-four (24) pending applications in Canada, China, the European Union, Japan, South Korea and Australia. The issued patents are predicted to expire between April 11, 2036 and April 21, 2042.

Previous report

We believe that our ECG technology has the potential to be the most advanced ambulatory cardiac monitoring solution and is applicable in a number of form factors. In anticipation of FDA clearance, we are refining our go-to-market strategy and are encouraged by our early discussions with industry players and their interest in our technology.

Previous report

In November 2024, two of our pilot studies were presented at American Heart Association meeting. The studies were designed to show early evidence of (1) clinical equivalence of the HeartBeam Synthesized 12L ECG to a standard 12L ECG for diagnosis of arrhythmia and (2) the use of the technology for heart attack detection.

Previous report

Any Shares to be offered and sold under the PV Sales Agreement will be issued and sold pursuant to our Registration Statement on Form S-3 (File No. 333-269520), filed with the Securities and Exchange Commission on February 1, 2023 and the prospectus supplement included therein, relating to the Offering, by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if specified by us, by any other method permitted by law.

Previous report

In order to proceed with the PV Sales Agreement, we terminated the prior Sales Agreement with A.G.P/Alliance Global Partners.

Previous report

On September 10, 2024, we announced the appointment of Timothy Cruickshank as Chief Financial Officer (CFO). Mr. Cruickshank brings more than 15 years of public company experience with a focus on growing businesses with disruptive technologies through authentic leadership, strategic focus, data-driven decisions, and strong risk management and governance. He succeeds long-time CFO Richard Brounstein, who has been serving in an advisory capacity since retiring in February 2024.

Previous report

On September 24, 2024, we announced the appointment of Lance Myers, PhD, a pioneer in digital health data analytics and body-worn biosensor technologies, as Chief Artificial Intelligence (AI) Scientist. In this newly created position, Dr. Myers will play a pivotal role in guiding how AI is applied to the Company’s core technology. Most recently, Dr. Myers served as AI Advisor to HeartBeam until September 23, 2024.

Previous report

On October 17, 2024, we announced the appointment of Robert Eno as Chief Executive Officer (CEO). Mr. Eno joined HeartBeam as President in January 2023 and will lead as the Company continues to work towards securing the foundational FDA 510(k) clearance for its vector-based technology and prepares for commercialization and growth. As part of a long-planned transition, Mr. Eno succeeds long-time CEO and founder, Branislav Vajdic, Ph.D. Dr. Vajdic will continue as President of HeartBeam, focused on innovating on the Company’s groundbreaking vector-based technology, driving research and development efforts, and advancing artificial intelligence (AI) applications.

Previous report

On February 12, 2025, we entered into an Underwriting Agreement with Public Ventures, LLC to consummate an offering of 5,882,353 shares of Common Stock at an offering price of $1.70 per share, which closed on February 14, 2025 (the “February Public Offering”). The Company received $9.08 million in net proceeds from the February Public Offering after deducting underwriter discounts and commission. In addition, pursuant to the Underwriting Agreement, as partial compensation for its service, we granted 588,235 underwriter warrants with an exercise price of $2.13 to Public Ventures, LLC. On February 21, 2025, the Underwriter exercised the bulk of the Over-allotment Option of 864,033 which closed on February 25, 2025. The Company received $1.3 million in net proceeds from the Over-allotment Option after deducting underwriter discounts and commission and we granted an additional 86,403 underwriter warrants with an exercise price of $2.13 as compensation to the Underwriter.

Previous report

Subsequent to year end, the Company raised $11.5 million (before costs) via a $10 million underwritten Public Offering and a $1.5 million exercise of the Underwriter’s over-allotment option from the Public Offering.

Previous report

Research and Development: Clinical and Manufacturing Accruals

Previous report

We record accruals for estimated costs of research, preclinical studies and clinical trials, and manufacturing development, which are a significant component of research and development expenses. A substantial portion of our ongoing research and development activities are conducted by one CRO. Our contract with this CRO include pass-through fees such as regulatory expenses, investigator fees, travel costs and other miscellaneous costs. We accrue the costs incurred under agreements with CRO based on estimates of actual work completed in accordance with the CRO agreement. We determine the estimated costs based on actual services performed by the CRO and clinical sites as at each period end. As actual costs become known, we adjust our accruals. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in our reporting amounts that are too high or too low in any particular period.
Reworded paragraphs (14)

Previous wording

We are a medical technology company focused on transforming cardiac care through the power of personalized insights. Our aim is to deliver innovative, higher resolution ambulatory cardiac monitoring solutions that can be used by patients anywhere to enable the detection and monitoring of cardiac disease outside of a healthcare facility. Our ability to develop higher resolution Electrocardiogram (“ECG”) solutions is achieved through the development of our proprietary and patented technology platform that allows us to collect heart’s electrical activity from three distinct directions and synthesize a 12-Lead (12L) ECG from these signals. Our approach has demonstrated comparable diagnostic capability to a traditional hospital-based 12L ECG system in recent studies. The data from these studies was also submitted to FDA as part of our recent FDA submission.

Current wording

HeartBeam is a medical technology company focused on transforming cardiac care through the power of personalized insights. Our aim is to deliver innovative, higher resolution ambulatory cardiac monitoring solutions that can be used by patients anywhere to enable the detection and monitoring of cardiac disease outside of a healthcare facility. Our ability to develop higher resolution Electrocardiogram (“ECG”) solutions is achieved through the development of our proprietary and patented technology platform that allows us to collect the heart’s electrical activity from three dimensions and synthesize a 12-Lead (“12L”) ECG from these signals.

Previous wording

We believe our Products and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payors. We are developing our Product, (the “HeartBeam System”, previously referred to as “AIMIGo™”), to address the rapidly growing field of ambulatory cardiac health monitoring. The HeartBeam System is comprised of a credit card sized electrocardiogram device, a patient application, a physician portal, and powerful cloud-based algorithms. We believe that we are uniquely positioned to play a central role in ambulatory cardiac monitoring including high-risk Coronary Artery Disease (“CAD”) patients, because the initial studies have shown that our ischemia detection tool may be more accurate than existing ambulatory monitoring solutions. CAD patients are at increased risk for a heart attack or Myocardial Infarction (“MI”).

Current wording

We believe our Products (“Products” or “Product”) and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payers, and will also address the rapidly growing field of ambulatory cardiac monitoring. As part of our long-term vision, we believe that we are uniquely positioned to play a central role in high-risk Coronary Artery Disease (“CAD”) monitoring, given positive, proof-of-concept data from the initial feasibility studies that demonstrated comparable performance of the HeartBeam System and the standard 12L ECG in ischemia detection. CAD patients are at increased risk for a heart attack or Myocardial Infarction (“MI”). Additionally, our unique portable form-factor will make high-fidelity insights easily accessible, wherever patients are, compared to a standard 12L ECG, which is typically limited to a healthcare setting.

Previous wording

Our Products (“Product” or “Products”) require U.S. Food and Drug Administration (“FDA”) clearance. The HeartBeam System (defined below) was granted FDA clearance on December 13, 2024. We believe the HeartBeam System is the first FDA cleared cable-free, ambulatory ECG that captures the heart’s electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics.

Current wording

Our initial product and service offering is the HeartBeam System. The HeartBeam System is the first U.S. Food and Drug Administration (“FDA”) cleared cable-free, ambulatory 12L ECG that captures the heart’s electrical signals from three dimensions for high-fidelity data collection and advanced diagnostics for arrhythmia assessment. The HeartBeam System is comprised of a credit card sized 3D ECG recording device, a patient application, a physician portal, and powerful cloud-based algorithms. Unlike any single-lead or 6-lead consumer device, HeartBeam’s patented cable-free technology captures the heart’s electrical signals in three non-coplanar dimensions and synthesizes them into a familiar 12L ECG display, using a personalized transformation matrix. This allows patients to obtain a 12L ECG reading for their arrhythmia from the comfort of home, or wherever they happen to be, representing a new level of convenience and peace of mind. The synthesized 12-lead ECG is promptly reviewed by an on-demand, board-certified cardiologist.

Previous wording

As of December 31, 2024, we had 21 employees. We intend to strike a balance of managing our headcount in line with cash resources, while also, at the appropriate time, hiring or engaging additional full-time professionals, employees, and / or consultants in alignment with our growth strategy. Although the market is highly competitive for attracting and retaining highly qualified professionals in our industry, we continue our endeavor to find such candidates for our Company. Our management team and additional personnel that we may hire in the future will be primarily responsible for executing and implementing growth opportunities, making tactical decisions related to our strategy and pursuing opportunities to invest in new technologies through strategic partnerships and acquisitions.

Current wording

Although the market is highly competitive for attracting and retaining highly qualified professionals in our industry, we continue our endeavor to find such candidates for our Company. Our management team and additional personnel that we may hire in the future will be primarily responsible for executing and implementing growth opportunities, making tactical decisions related to our strategy and pursuing opportunities to invest in new technologies through strategic partnerships and acquisitions.

Previous wording

On May 2, 2024, we entered into the PV Sales Agreement with Public Ventures, pursuant to which we may offer and sell from time to time, at our option, through or to Public Ventures, up to an aggregate of approximately $17 million of shares of the Company’s common stock, $0.0001 par value per share (the “Shares”). We will pay Public Ventures a commission at a fixed rate of 3.0% of the aggregate gross proceeds from each sale of the Shares under the PV Sales Agreement. There were 309,634 Shares issued under the ATM during the year ended December 31, 2024. As of December 31, 2024, there was approximately $16.2 million available for issuance under the ATM following the use of the shelf registration on Form S-3 for the Agreements and the ATM during the year.

Current wording

The Company has an At-the-Market (ATM) sales agreement with Public Ventures, pursuant to which we may offer and sell from time to time, at our option, shares of the Company’s common stock, $0.0001 par value per share (the “Shares”). We will pay Public Ventures a commission at a fixed rate of 3.0% of the aggregate gross proceeds from each sale of the Shares under the PV Sales Agreement. pursuant to which the Company may sell up to an aggregate of $17.0 million shares of the Company’s common stock. There were 5,859,704 shares issued under the ATM during the twelve months ended December 31, 2025, and 970,467 shares issued under the ATM after December 31, 2025. As of March 11, 2026, there was approximately $8.1 million available for issuance as of the financial statement issuance date, potentially subject to other baby shelf limitations.

Previous wording

General and administrative expenses (“G&A”) are largely related to personnel and professional services. G&A expense increased $0.3 million or 4% when compared to the same period in 2023. The $0.3 million increase is related to non-cash stock-based compensation expense amounting to $0.5 million associated with additional awards granted since December 31, 2023, higher consulting costs of $0.4 million related to finance consultants, higher board of director’s fees of $0.1 million related to new committees, primarily offset by decrease in payroll cost of $0.5 million related to lower costs associated with restructuring of G&A headcount, and a decrease of $0.3 million from lower investor relation costs, and legal costs incurred in this period compared to the prior period.

Current wording

General and administrative expenses (“G&A”) are largely related to personnel and professional services. G&A expense decreased $1.1 million or 13% when compared to the same period in 2024. The $1.1 million decrease in G&A expense is primarily related to non-cash stock-based compensation expense amounting to $0.6 million driven by change in estimate for recognition of milestone options, from December 2024 to December 2025, lower consulting costs of $0.4 million related to finance consultants, lower employee cost of $0.3 million, offset by an increase of $0.2 million of consulting costs related to commercial readiness during current year compared to the prior year.

Previous wording

Research and development expenses (“R&D”) are primarily from software development and hardware related to our credit-card sized collection device for the HeartBeam System. R&D expense increased $4.3 million or 63% when compared with the same period in 2023. The $4.3 million increase is primarily related to increase in headcount of $1.8 million and non-cash stock-based compensation expense amounting to $0.6 million associated with additional awards granted since December 31, 2023, increase of clinical related costs of $0.7 million, increase in consulting and patent expense spend of $1.0 million, and a increase of $0.1 million in product development costs when compared to the prior year.

Current wording

Research and development expenses (“R&D”) are primarily from software development and hardware related to our credit-card sized collection device for the HeartBeam System, as well as the development of a 12L patch monitor. R&D expense increased $2.4 million or 22% when compared with the same period in 2024. The $2.4 million increase is primarily related an increase of $1.5 million in product development costs related to the development of the HeartBeam System, an increase $1.2 million in headcount related costs resulting from reallocation of existing headcount into AI and R&D and of $1.4 million in non-cash stock-based compensation expense associated with additional awards granted compared to 2024, primarily offset by an decrease of $0.7 million related to clinical related cost driven by completion of clinical study and a decrease of $1.0 million of consulting expenses related to foundational clearance.

Previous wording

Our cash requirements are and will continue to be, dependent upon a variety of factors. We expect to continue devoting significant capital resources to R&D and following the proper FDA clearance for our HeartBeam System, our commercialization go to market strategies.

Current wording

Our cash requirements are, and will continue to be, dependent upon a variety of factors. We expect to continue devoting capital resources to R&D for the development of software and hardware products and to sales & marketing for the limited launch and commercial strategy of our HeartBeam system.

Previous wording

As of December 31, 2024, we had approximately $2.4 million in cash and cash equivalents, a decrease of $13.8 million from $16.2 million as of December 31, 2023.

Current wording

As of December 31, 2025, we had approximately $4.4 million in cash and cash equivalents, a increase of $2.0 million from $2.4 million as of December 31, 2024.

Previous wording

During the year ended December 31, 2024, we raised $0.7 million from the sale of common stock under the ATM and $0.1 from the proceeds from exercise of stock options.

Current wording

During the year ended December 31, 2025, we raised $16.6 million from the net proceeds from sale of common stock. Subsequent to December 31, 2025, we have raised $1.5 million from the net proceeds under the ATM with Public Ventures.

Previous wording

Based on its current business plan assumptions, proceeds from the February Public Offering and expected cash burn rate, the Company believes that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.

Current wording

Based on its current business plan assumptions and expected cash burn rate, the Company believes that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.

Previous wording

Net cash used in our operating activities of $12.1 million during the year ended December 31, 2023, was primarily due to our net loss of $14.6 million less $3.2 million in stock based compensation expense and $0.7 million of net changes from changes in operating assets and liabilities.

Current wording

Net cash used in our operating activities of $14.0 million during the year ended December 31, 2025, was primarily due to our net loss of $21.0 million less $5.1 million in stock-based compensation expense, $0.2 million in stock issuance for services, $0.1 million in depreciation expense and $1.6 million of net changes from changes in operating assets and liabilities.

Previous wording

Net cash used in investing activities during the year ended December 31, 2023, of $0.3 million, was primarily due to the purchase of property and equipment.

Current wording

Net cash used in investing activities during the year ended December 31, 2025, of $0.6 million, was primarily due to the purchase of property and equipment.

Previous wording

During the year ended December 31, 2023, net cash provided by financing activities of $24.9 million, was primarily from the issuance of common stock from the secondary financing in May 2023.

Current wording

During the year ended December 31, 2025, net cash provided by financing activities of $16.6 million, was primarily from the net proceeds from sale from sale of equity, net of issuance costs.
Rearranged current paragraphs (2)

Current report — wording carried from elsewhere

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Current report — wording carried from elsewhere

We intend to strike a balance of managing our headcount in line with cash resources, while also, at the appropriate time, hiring or engaging additional full-time professionals, employees, and/or consultants in alignment with our growth strategy. To that end, the Company does not anticipate the need to hire a large sales force during the initial launch of its HeartBeam System. We believe that a few well-placed resources will help provide the data points required to effectively invest into a broader launch based around a path to profitable growth.