HeartBeam Inc
For the period ended Dec 31, 2024. Filed Mar 13, 2025.
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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.
FY2024 · Filed Mar 13, 2025
BEAT$0.40+1.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-03-20.
0001779372-24-000002
Item 7. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 OperationsThe 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 85 previous paragraphs and 71 current paragraphs.
21 unchanged; 25 reworded; 22 added; 39 removed; 0 previous and 3 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 (22)
Current report
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 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.
Current 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.
Current 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.
Current report
New and Existing Patent Assignments
Current 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.
Current report
Interactions with Industrial Players
Current 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.
Current report
Presentations at AHA
Current 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.
Current report
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 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.
Current report
In order to proceed with the PV Sales Agreement, we terminated the prior Sales Agreement with A.G.P/Alliance Global Partners.
Current 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.
Current 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.
Current 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.
Current report
February Public Offering under Form S-3
Current 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.
Current report
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 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.
Current report
Research and Development: Clinical and Manufacturing Accruals
Current 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.
Removed paragraphs (39)
Previous report
Our Products require FDA clearance and have not been cleared for marketing.
Previous report
We have had productive discussions with the FDA on both products. On the first submission, we are in the substantive review phase of answering questions posed by the FDA. We have clarified the information requested in meetings with FDA representatives and are in the process of preparing our official responses. We currently anticipate clearance by the end of Q2 2024.
Previous report
On March 13, 2024, we enrolled the first patient in the VALID-ECG study. The VALID-ECG study is a prospective single-arm multicenter trial designed with the goal to validate the AIMIGo 12L ECG Synthesis Software by comparing its results with those of a standard FDA-cleared 12L ECG using both quantitative and qualitative assessment methodologies. We plan to enroll a total of approximately198 patients presenting to an outpatient cardiology clinic or arrhythmia center for symptoms suggestive of cardiac arrhythmia or for routine checkup of previously diagnosed arrhythmia. The study is expected to include up to 5 sites. The primary objective is to demonstrate the equivalence of ECG waveforms between AIMIGo Synthesized 12L ECG and Standard 12L ECG, recorded simultaneously in each subject, by assessing intervals and amplitudes.
Previous report
We expect to complete enrollment in the VALID-ECG study in Q2 2024 and submit the second 510(k) application by Q3 2024. We continue to anticipate that our limited launch of AIMIGo will occur by the end of 2024.
Previous report
In 2023, we withdrew the FDA application of our AIMI Product, which is a software-only product designed for use in hospitals. We are exclusively focusing on the large market of ambulatory cardiac monitoring,
Previous report
A landmark clinical study on the HeartBeam technology was published in the August 2023 issue of the journal JACC: Advances. The publication, “Coronary Artery Occlusion Detection Using 3-Lead ECG System Suitable for Credit Card-Size Personal Device Integration” demonstrated that HeartBeam’s VECG technology detects the presence of a coronary occlusion, the cause of heart attacks, with the same accuracy as a standard 12L ECG.
Previous report
The study showed that the automated analysis of the VECG and 12L ECG signals had similar performance in determining whether a coronary artery was occluded. Also in the study, the human interpretation of the 12L ECGs had significant intra- and inter-observer variability, which does not occur with automated readings. The study also showed that the presence of the “normal baseline” recording, a novel feature that is integral to HeartBeam’s VECG technology, dramatically improved the accuracy of interpretation, increasing the Area Under the Curve (“AUC”), a standard measure of diagnostic performance, from 0.72 to 0.95. This is particularly important since physicians who are analyzing 12L ECGs often do not have access to a normal baseline, implying that the HeartBeam system could outperform this approach.
Previous report
The study was a collaboration of Harvard Medical School Faculty at Beth Israel Deaconess Medical Center in Boston, Massachusetts, and Clinical Center of Serbia in Belgrade.
Previous report
Appointment of President
Previous report
In January 2023, our Board of Directors appointed Robert P. Eno as President of the Company effective as of January 18, 2023.
Previous report
Appointment of Board of Directors
Previous report
We increased the size of our Board of Directors (the “Board”) this year to eight, adding individuals that broadened the scope and experience of our then 5-person Board.
Previous report
On June 5, 2023, the Board appointed Mark Strome and Ken Nelson as directors of the Company.
Previous report
•Mr. Strome combines over 40 years of experience in the investment management and securities industry. Mark is the Founder, Chief Investment Officer, and Chairman at Strome Investment Management, L.P. and Strome Group, Inc. Mark earned a Bachelor of Science in Engineering from Old Dominion University and Master of Science in Economics from the University of California at Berkeley.
Previous report
•Mr. Nelson is a 20-year digital health, medical device, and remote patient monitoring executive and innovator. Over the past 10 years, Ken has led commercial efforts for disruptive technologies in the digital health, wearables, and cardiac remote patient monitoring industries for 3 of the top 4 market share players in cardiac digital health and remote patient monitoring. Ken earned a Bachelor of Arts in Economics from Vanderbilt University and is a graduate of Phillips Exeter Academy.
Previous report
On July 24, 2023, the Board appointed Dr. Michael R. Jaff as a director of the Company. Dr. Jaff is currently Chief Medical Officer and Vice President of Clinical Affairs, Technology, and Innovation of the Peripheral Interventions division at Boston Scientific Corporation. Dr. Jaff received a B.S. from Dickinson College, a D.O. from Kirksville College of
Previous report
Osteopathic Medicine, a Business degree from Harvard Business School and an honorary Doctorate of Arts from Harvard Medical School.
Previous report
•On August 8, 2023, we announced the appointment of Deborah Castillo, PhD, as Vice President of Regulatory Affairs. Ms. Castillo is an experienced biomedical engineer with extensive knowledge of and background at the FDA, EU, and Health Canada regulations. She has held various roles at the FDA, including overseeing 510(k) submissions encompassing a wide-range of cardiovascular devices.
Previous report
•On September 26, 2023, we announced the appointment of Richa Gujarati as Senior Vice President, Product, and Pooja Chatterjee as Vice President, Clinical. Ms. Gujarati has over 13 years of experience collecting market-level insights and translating them into business needs, driving overall product portfolio and go-to-market strategy. Previously at Apple, as Head of Health Products, Apple Watch, she built and launched applications in the wearable sensor space. Ms. Chatterjee brings over 15 years of extensive clinical leadership experience in the medical device industry and was responsible for multiple FDA approvals in medical technologies including heart failure and cardiac rhythm management. Additionally, while at Abbott Medical Devices her role included focus on obtaining peer reviewed publications in key journals.
Previous report
Expanded the Scientific Advisory Board
Previous report
On November 9, 2023, we announced the expansion of our Scientific Advisory Board (SAB) to include several leading cardiologists. The SAB is led by Peter J. Fitzgerald, MD, PhD, the company’s Chief Medical Officer and C. Michael Gibson, MD. The newly announced members of the HeartBeam SAB are:
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•Charles L. Brown III, MD, CEO of the Piedmont Healthcare Physician Enterprise.
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•Tony Das, MD, a nationally recognized board-certified interventional cardiology specialist, leader, and educator in the field of cardiovascular diseases.
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•Robert Harrington, MD, Dean of Weill Cornell Medicine, and provost for medical affairs of Cornell University.
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•Campbell Rogers, MD, Executive Vice President and Chief Medical Officer at HeartFlow, Inc.
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•Niraj Varma, MD, Ph.D., Professor of Medicine, and consultant electrophysiologist at the Cleveland Clinic.
Previous report
Retirement of Chief Financial Officer
Previous report
On December 29, 2023, Richard Brounstein, informed the Company of his plans to retire from his position as Chief Financial Officer effective as of February 1, 2024. Mr. Brounstein has been an important member of the executive team at HeartBeam since 2015. Mr. Brounstein will provide CFO advisory services as a consultant to the Company to assist with a smooth transition of his former duties.
Previous report
New Patent Assignments
Previous report
•We were granted two patents (US 11,877,853 and US 11,701,049) on mobile cardiac monitoring devices and methods for providing automated diagnosis of cardiac issues to patients, by the United States Patent and Trademark Office. These innovations build on our growing intellectual property portfolio enabling ECG diagnostics outside of a medical setting.
Previous report
•We were also granted a patent (US 11,793,444) on electrocardiogram patch devices and methods by the United States Patent and Trademark Office. This patent further expands our coverage of wearable and patch-based patient monitoring.
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•We now have a total of eleven patents issued as of December 31, 2023.
Previous report
On February 1, 2023, we entered into a sales agreement (the “Sales Agreement”) with AGP pursuant to which we may issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to $13.0 million in at-the-market offerings (“ATM”) sales. At the same time, we filed a prospectus supplement under a shelf registration on Form S-3 relating to the Sales Agreement. The registration statement was declared effective on February 10, 2023. AGP will act as sales agent and will be paid a 3% commission on each sale under the Sales Agreement. Our common stock will be sold at prevailing market prices at the time of the sale, and, as a result, prices will vary. There have been no sale of shares under the ATM since February 2023, nor under the Form S-3 since May 2023. Asof December 31, 2023 there was approximately $11.0 million available for issuance under the ATM.
Previous report
Note Purchase Agreement and Security Purchase Agreement
Previous report
On February 28, 2023, we entered into Agreements, each as amended on March 7, 2023, with Maverick. Pursuant to the terms of the Agreements, as amended, we agreed to sell up to $4,000,000 of our common stock at 75% of the average calculated Volume Weighted Average Price (“VWAP”) per share during a Drawdown Pricing Period as defined in the Agreements. We issued a $500,000 Convertible Note to the Investor pursuant to the NPA. On March 9, 2023, the Convertible Note was settled upon the execution of a SPA and related issuance of 0.2 million shares of common stock pursuant to the SPA drawdown notice dated March 7, 2023. These 0.2 million shares of common stock were registered under our registration statement on Form S-3 dated February 10, 2023, and the related prospectus supplement dated March 9, 2023.
Previous report
Public Offerings under Forms S-1 and S-3
Previous report
On April 20, 2023, we entered into a Placement Agency Agreement with Public Ventures, LLC to consummate an offering of 16,666,666 shares of Common Stock at an offering price of $1.50 per share, which closed in accordance with the subscription agreement dated May 2, 2023. The Company received $23.2 million in net proceeds from the offering after deducting placement agent discounts and commission and other estimated offering expenses. In addition, the subscription agreement granted 1,666,666 placement agent warrants as part of this transaction.
Previous report
On May 2, 2023, we completed a Registered Direct Offering of 1,000,000 shares of our common stock at an offering price of $1.50 per share. We received net proceeds of $1.1 million after deducting financial advisory and legal fees as well as other estimated offering expenses.
Previous report
During the year ended December 31, 2023, we raised $24.8 million is primarily the issuance of common stock from the secondary financing in May 2023.
Reworded paragraphs (25)
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 ECG solutions is achieved through the development of our proprietary and patented VECG technology platform. Our VECG technology is capable of capturing 3D vector images of the heart’s electrical activity and synthesizing a 12L ECG from these signals. In early studies, our approach demonstrated equal or superior diagnostic capability than traditional hospital-based 12L ECG systems.
Current 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.
Previous wording
We believe our Products and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payors. We are developing our telehealth Product, HeartBeam AIMIGo, to address the rapidly growing field of ambulatory cardiac health monitoring. HeartBeam AIMIGo 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 patients, because the initial studies have shown that our ischemia detection system may be more accurate than existing ambulatory monitoring solutions. CAD patients are at increased risk for a heart attack or MI.
Current 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”).
Previous wording
To date, we have developed a working prototype for HeartBeam AIMIGo and have filed a 510(k) submission with the FDA. This submission is for the initial Product, a device which is a 3 lead X, Y, Z vector VECG. We expect this to be the first patient-held VECG device to be cleared by the FDA and this will be a major milestone for the company. Following the FDA clearance of the AIMIGo device, we plan to file a submission for the software algorithms that synthesize a 12L ECG from the HeartBeam AIMIGo device. The 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.
Current wording
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 wording
In addition, we have held two Pre-submission meetings with FDA on the 12L synthesis submission. These meetings have been focused primarily on the performance goals of our clinical study that is designed to demonstrate the similarity between our synthesized 12L signal and the output of a standard 12L ECG. Based on feedback from FDA and our clinical experts, we have designed our clinical study, “Clinical Validation of AIMIGo 12 Lead ECG Synthesis Software for Arrhythmia Detection: A Prospective Multicenter Pivotal Study,” (the “VALID-ECG Study”).
Current wording
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 wording
We also have an active AI program underway. Our AI team includes 5 PhDs. The leadership has deep AI expertise, including prior positions at Apple, Microsoft and Google. We have acquired approximately one million 12L ECGs from various sources, a key element in our fast-paced AI development efforts.
Current wording
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.
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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 accepted for presentation at two prestigious Electrophysiology conferences: the European Heart Rhythm Association, to be held in Berlin, Germany in April 2024 and the Heart Rhythm Society, to be held 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 a number of ways, including:
Current wording
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:
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•The potential to further enhance user experience and simplify the onboarding process, and
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• Potentially enhancing user experience and simplify the onboarding process, and
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•In the longer run, we believe that applying deep learning algorithms on top of the rich VECG data, especially with the longitudinal dataset from patients taking repeated readings, may result in unsurpassed predictive and diagnostic capabilities.
Current wording
• 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.
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The custom software and hardware of our Products are classified as Class II medical devices by the FDA, running on an FDA registered Class I software platform. 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 is expected to require clinical data to support FDA clearance.
Current wording
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 wording
HeartBeam has 13 issued and allowed 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, and allowed U.S. patent application no. 18/068,481), and nine pending U.S applications. Outside of the U.S., HeartBeam has four issued patents in Germany, France, Netherlands and United Kingdom and fourteen pending applications in Canada, China, the European Union, Japan, South Korea and Australia. HeartBeam has two pending Patent Cooperation Treaty applications. The issued patents are predicted to expire between April 11, 2036 and April 21, 2042.
Current wording
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 wording
As of December 31, 2023, we had 15 employees. We intend to hire or engage 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
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.
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During 2023, we were granted three U.S. patents:
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In 2024, we were granted two new U.S. patents:
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•Subsequently in 2024 we received two additional patents on our core VECG technology. One patent covers apparatuses and methods that facilitate the comparison of cardiac signals over time for the automated or assisted detection of heart attacks, The other covers methods and apparatuses around HeartBeam’s wrist-based ECG system.
Current wording
•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 wording
General and administrative expenses (“G&A”) are largely related to personnel and professional services. G&A expense increased $1.2 million or 16% when compared to the same period in 2022. The $1.2 million increase is primarily related to non-cash stock-based compensation expense amounting to $1.6 million associated with additional awards granted since December 31, 2022, primarily offset by costs associated with our commercial team during the year ended December 31, 2022, and lower investor relation costs, marketing costs and legal costs incurred in this year compared to the prior year.
Current 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.
Previous wording
Research and development expenses (“R&D”) are primarily from software development and hardware related to our credit-card sized collection device for HeartBeam AIMIGo. R&D expense increased $1.1 million or 20% when compared with the same period in 2022. The $1.0 million increase is primarily due to non-cash stock-based compensation expense amounting to $0.5 million associated with additional awards granted since December 31, 2022 as well as the increase in headcount and professional services supporting the FDA clearance process, primarily offset by completion of the initial development costs of the AIMIGo platform when compared to December 31, 2022.
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. 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.
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Other income is primarily interest income. The increase is primarily related to our increased cash balance coupled with higher interest rates following the $26.5 million financing in May 2023.
Current wording
Other income is primarily interest income. The decrease is primarily related to our decreased cash balance used in operations.
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 FDA clearance of our AIMIGo device, 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 significant capital resources to R&D and following the proper FDA clearance for our HeartBeam System, our commercialization go to market strategies.
Previous wording
As of December 31, 2023, we had approximately $16.2 million in cash and cash equivalents, an increase of $12.6 million from $3.6 million as of December 31, 2022.
Current 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.
Previous 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.
Current 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.
Previous wording
Net cash used in our operating activities of $9.9 million during the year ended December 31, 2022, is primarily due to our net loss of $12.9 million less $1.1 million in stock-based compensation expense and $1.9 million from changes in operating assets and liabilities.
Current wording
Net cash used in our operating activities of $14.5 million during the year ended December 31, 2024, was primarily due to our net loss of $19.5 million less $4.3 million in stock-based compensation expense and $0.7 million of net changes from changes in operating assets and liabilities.
Previous wording
Net cash used in our operating activities of $12.1 million during the year ended December 31, 2023, is 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 $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.
Previous wording
Net cash used in investing activities during the year ended December 31, 2023, of $0.3 million, is primarily due to the purchase of property and equipment.
Current 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.
Previous wording
During the year ended December 31, 2022, net cash provided by financing activities of $0.3 million, is primarily from the issuance of common stock under the February Stock Purchase Agreement.
Current wording
During the year ended December 31, 2024, net cash provided by financing activities of $0.9 million, was primarily from net proceeds from sale of equity, net of issuance costs.
Previous wording
During the year ended December 31, 2023, net cash provided by financing activities of $24.9 million, is primarily the issuance of common stock from the secondary financing in May 2023.
Current 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.
Previous wording
The compensation cost for all stock-based awards is measured at the grant date, based on the fair value of the award, determined using a Black-Scholes option pricing model for stock options and fair value on the date of grant for non-vested restricted stock, and is recognized as an expense over the employee’s requisite service period (generally the vesting period of the equity award). Determining the fair value of stock-based awards at the grant date requires significant estimates and judgments. Management has determined the fair value and vesting period of stock-based compensation to be a critical accounting estimate due to certain options containing performance-based vesting condition.
Current wording
The compensation cost for all stock-based awards is measured at the grant date, based on the fair value of the award, determined using a Black-Scholes option pricing model for stock options and fair value on the date of grant for non-vested restricted stock, and is recognized as an expense over the employee’s requisite service period (generally the vesting period of the equity award). Determining the fair value of stock-based awards at the grant date requires significant estimates and judgments. Management has determined the vesting period of stock-based compensation to be a critical accounting estimate due to certain options containing performance-based vesting condition related to a milestone achievement date. Quarterly, the management performs its probability assessment regarding the achievement of the key milestone related to these awards. Based on this review, management modifies the vesting period if the expected regulatory approval date changes.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
•The other covers methods and apparatuses around HeartBeam’s wrist-based ECG system.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
Net cash used in investing activities during the year ended December 31, 2024, of $0.2 million, was primarily due to the purchase of property and equipment.