HeartBeam Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 7, 2024
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-Q
Period ended 2024-06-30; filed 2024-08-14.
0001628280-24-037202
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001628280-24-046250
Item 2. 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 64 previous paragraphs and 68 current paragraphs.
32 unchanged; 28 reworded; 8 added; 4 removed; 0 previous and 0 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 (8)
Current report
On June 20, 2024, we completed patient enrollment in the VALID-ECG Study. A total of 198 patients were enrolled from five clinical sites 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. Efforts were made to enroll patients with a diverse demographic profile reflective of the intended use population in the United States.
Current report
New and Existing Patent Assignments
Current report
Presentations at AHA
Current report
In August 2024, we were notified of the acceptance of two of our pilot studies for presentation at American Heart Association meeting in November 2024. The studies are 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
Appointment of Additional Senior Management Team members
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.
Removed paragraphs (4)
Previous report
On June 20, 2024, we completed patient enrollment 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 enrolled a total of 198 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 included five 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
New Patent Assignments
Previous report
MedTech Breakthrough Award
Previous report
On May 13, 2024, we were selected as the winner of the “Best New ECG Technology Solution” award in the 8th annual MedTech Breakthrough Awards program. This awards program is conducted by MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global digital health and medical technology market.
Reworded paragraphs (28)
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™” or “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 (“CAD”) 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 Myocardial Infarction (“MI”).
Current wording
We believe our Products and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payors. We are developing our telehealth 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 system 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 (3L) X, Y, Z vector VECG. We are in the substantive review phase of answering questions posed by the FDA on this submission. We have clarified the information requested in meetings with FDA representatives and are finalizing our official responses. During the second quarter of 2024 we received additional questions from FDA, have provided answers and additional data, and are engaged in productive discussions to finalize the clearance. If cleared as anticipated, we believe this will be the first patient-held VECG device to be cleared by the FDA and this will be a major milestone for the company.
Current wording
To date, we have developed a working prototype for the HeartBeam System and have filed a 510(k) submission with the FDA. This submission is for the initial Product, a device which is a 3 lead (3L) X, Y, Z vector VECG. We are in the substantive review phase of answering questions posed by the FDA on this submission. We have clarified the information requested in meetings with FDA representatives and are finalizing our official responses. During the second half of 2024 we received additional questions from FDA, have provided answers and additional data, and are engaged in productive discussions to finalize the clearance. If cleared as anticipated, we believe this will be the first patient-held VECG device to be cleared by the FDA and this will be a major milestone for the company.
Previous wording
Following the FDA clearance of the AIMIGo 3L device, we plan to file a submission for the software algorithms that synthesize a 12L ECG from the HeartBeam AIMIGo device. We have held two Pre-submission meetings with FDA on this 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
Following FDA clearance of the HeartBeam System, we plan to file a submission for the software algorithms that synthesize a 12L ECG from the HeartBeam System. We have 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 that is 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, we have designed a prospective multicenter pivotal study, the VALID-ECG Study for clinical validation of the HeartBeam 12 Lead ECG Synthesis Software for Arrhythmia Detection.
Previous wording
We are currently analyzing the data and working on the other components of the second 510(k) application. We anticipate submitting this 510(k) application in the second half of 2024. The result of these two 510(k) submissions, when cleared by the FDA as anticipated, will be an ambulatory device, carried by patients, which can synthesize a 12L ECG for physician review.
Current wording
We are currently analyzing the data and working on the other components of the second 510(k) application. We anticipate submitting this 510(k) application soon after receiving the initial FDA clearance. The result of these two 510(k) submissions, if cleared by the FDA as anticipated, will be an ambulatory device, carried by patients, which can synthesize a 12L ECG for physician review.
Previous wording
We continue to anticipate that our limited launch of AIMIGo will occur by the end of 2024. This limited launch, focused on the AIMIGo 3L system, will provide the company with valuable feedback on the user experience and functionality of the system in a real world setting. We do not anticipate that the AIMIGo 3L system clearance will generate significant revenue before the 12L clearance.
Current wording
We continue to anticipate that our Early Access Program for the HeartBeam System will occur in coming months. This program will provide the company with valuable feedback on the user experience and functionality of the system in a real world setting. We do not anticipate that the HeartBeam System clearance will generate significant revenue before the 12L clearance.
Previous 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 accepted and 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:
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:
Previous wording
•The potential to further enhance user experience and simplify the onboarding process, and
Current wording
•Potentially enhancing user experience and simplify the onboarding process, and
Previous wording
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.
Current wording
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, 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 wording
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.
Current wording
The study was a collaboration of Harvard Medical School Faculty at Beth Israel Deaconess Medical Center in Boston, MA, and Clinical Center of Serbia in Belgrade.
Previous wording
As of June 30, 2024, 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 September 30, 2024, we had 20 employees. We intend to hire or engage additional full-time professionals, employees, and / or consultants to align 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.
Previous 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. 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. The other patent covers methods and apparatuses around HeartBeam’s wrist-based ECG system.
Previous wording
•We now have 13 issued U.S. patents and ten pending U.S applications. Outside of the U.S., we have four issued patents in Germany, France, Netherlands and United Kingdom and nineteen pending applications in Canada, China, the European Union, Japan, South Korea and Australia. We also have one pending Patent Cooperation Treaty application. The issued patents are predicted to expire between April 11, 2036 and March 4, 2044.
Current wording
•We now have 17 issued patents worldwide, with 13 issued patents in the U.S. and four issued patents in Germany, France, Netherlands and United Kingdom. Additionally, we have ten pending U.S applications and twenty-one pending applications in Canada, China, the European Union, Japan, South Korea and Australia. We also have one pending Patent Cooperation Treaty application. The issued patents are predicted to expire between April 11, 2036 and March 4, 2044.
Previous wording
Summary of Statements of Operations for the three and six months ended June 30, 2024 compared with the three and six months ended June 30, 2023:
Current wording
Summary of Statements of Operations for the three and nine months ended September 30, 2024 compared with the three and nine months ended September 30, 2023:
Previous wording
General and administrative (“G&A”) expenses increased by approximately $0.4 million or 23% during the three months ended June 30, 2024 as compared to the three months ended June 30, 2023. The increase in G&A expense is primarily related to non-cash stock-based compensation expense amounting to $0.1 million associated with additional awards granted since June 30, 2023, higher consultants costs of $0.3 million primarily offset by lower legal costs in this quarter compared to the prior period.
Current wording
General and administrative (“G&A”) expenses increased by approximately $0.06 million or 3% during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023. The increase in G&A expense is primarily related to increase in headcount amounting to $0.02 million, higher consultants costs of $0.07 million primarily offset by lower legal costs in this quarter compared to the prior period.
Previous wording
General and administrative (“G&A”) expenses increased by approximately $0.3 million or 7% during the six months ended June 30, 2024. The increase in G&A expense is primarily related to non-cash stock-based compensation expense amounting to $0.7 million associated with additional awards granted since June 30, 2023, higher consulting costs of $0.3 million related to finance consultants, primarily offset by decrease in payroll cost of $0.5 million related to lower costs associated with transitioning our commercial team, decrease in lower investor relation costs, and legal costs incurred in this period compared to the prior period.
Current wording
General and administrative (“G&A”) expenses increased by approximately $0.4 million or 6% during the nine months ended September 30, 2024. The increase in G&A expense is primarily related to non-cash stock-based compensation expense amounting to $0.7 million associated with additional awards granted since September 30, 2023, higher consulting costs of $0.4 million related to finance consultants, primarily offset by decrease in payroll cost of $0.4 million related to lower costs associated with restructuring of G&A headcount, decrease of $0.5 million comprising of lower investor relation costs, and legal costs incurred in this period compared to the prior period.
Previous wording
Research and development expenses (“R&D”) expenses increased by approximately $1.4 million or 92% during the three months ended June 30, 2024 as compared to the three months ended June 30, 2023. The increase in R&D expense is primarily related to increase in headcount of $0.4 million, increase of clinical and AI related costs of $0.7 million, increase in consulting spend of $0.3 million offset by decrease in product development consulting cost of $0.4 million primarily driven by completion of milestone projects in prior period.
Current wording
Research and development expenses (“R&D”) expenses increased by approximately $1.3 million or 78% during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023. The increase in R&D expense is primarily related to increase in headcount of $0.3 million and non-cash stock-based compensation expense amounting to $0.1 million associated with additional awards granted since September 30, 2023, increase of clinical and AI related costs of $0.5 million, increase in consulting spend of $0.6 million offset by decrease in product development consulting cost of $0.1 million primarily driven by completion of milestone projects in prior period.
Previous wording
Research and development expenses (“R&D”) expenses increased by approximately $2.1 million or 67% during the six months ended June 30, 2024 as compared to the six months ended June 30, 2023. The increase in R&D expense is primarily related to increase in headcount of $0.9 million and non-cash stock-based compensation expense amounting to $0.4 million associated with additional awards granted since June 30, 2023, increase of clinical and AI related costs of $1.2 million, increase in consulting spend of $0.2 million offset by decrease in product development consulting cost of $0.9 million primarily driven by completion of milestone projects in prior period.
Current wording
Research and development expenses (“R&D”) expenses increased by approximately $3.4 million or 71% during the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023. The increase in R&D expense is primarily related to increase in headcount of $0.9 million and non-cash stock-based compensation expense amounting to $0.5 million associated with additional awards granted since September 30, 2023, increase of clinical and AI related costs of $2.0 million, increase in consulting spend of $1.0 million offset by decrease in product development consulting cost of $0.8 million primarily driven by completion of milestone projects in prior period.
Previous wording
Other income during the three and six months ended June 30, 2024 and 2023 is related to interest earned on our cash balances.
Current wording
Other income during the three and nine months ended September 30, 2024 and 2024 is related to interest earned on our cash balances.
Previous wording
We have incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of June 30, 2024, we have cash and cash equivalents balance of approximately $9.2 million. Based on our current business plan assumptions and expected cash burn rate, we believe 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 our ability to continue as a going concern.
Current wording
We have incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of September 30, 2024, we have cash and cash equivalents balance of approximately $5.8 million. Based on our current business plan assumptions and expected cash burn rate, we believe 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 our ability to continue as a going concern.
Previous wording
Our continued operations will depend on the ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships until sufficient revenue can be generated to achieve positive cash flow from operations. We expect no material commercial revenue in 2024 nor can we provide assurance that a financing or strategic relationships will be available on acceptable terms.
Current wording
Our continued operations and our commercialization plan will depend on the ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships until sufficient revenue can be generated to achieve positive cash flow from operations. We expect no material commercial revenue in 2024 nor can we provide assurance that a financing or strategic relationships will be available on acceptable terms.
Previous wording
As of June 30, 2024, we had approximately $9.2 million in cash, a decrease of $7.0 million from $16.2 million as of December 31, 2023.
Current wording
As of September 30, 2024, we had approximately $5.8 million in cash, a decrease of $10.4 million from $16.2 million as of December 31, 2023.
Previous wording
Cash flows for the six months ended June 30, 2024 and 2023 (in thousands):
Current wording
Cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):
Previous wording
Net cash used in our operating activities of $7.0 million during the six months ended June 30, 2024, is primarily due to our net loss of $9.5 million less $2.2 million in non-cash expenses and $0.3 million of net changes in operating assets and liabilities.
Current wording
Net cash used in our operating activities of $10.3 million during the nine months ended September 30, 2024, is primarily due to our net loss of $14.5 million less $3.3 million in non-cash expenses and $0.9 million of net changes in operating assets and liabilities.
Previous wording
Net cash used by our operating activities of $7.1 million during the six months ended June 30, 2023, is primarily due to our net loss of $7.3 million less $1.1 million in non-cash expenses, offset by $0.9 million of net changes in operating assets and liabilities.
Current wording
Net cash used by our operating activities of $9.2 million during the nine months ended September 30, 2023, is primarily due to our net loss of $10.8 million less $2.0 million in non-cash expenses and $0.4 million of net changes in operating assets and liabilities.
Previous wording
Net cash used in investing activities during the six months ended June 30, 2024 of $0.1 million, is from the purchase of property and equipment.
Current wording
Net cash used in investing activities during the nine months ended September 30, 2024 of $0.2 million, is from the purchase of property and equipment.
Previous wording
Net cash used in investing activities during the six months ended June 30, 2023, of $3.9 million, is from the purchase of short-term investments.
Current wording
Net cash used in investing activities during the nine months ended September 30, 2023, of $0.1 million, is primarily due to purchase of property and equipment.
Previous wording
During the six months ended June 30, 2024, net cash provided by financing activities during the six months ended June 30, 2024, of $0.1 million is primarily from net proceeds from sale of equity, net of issuance costs.
Current wording
During the nine months ended September 30, 2024, net cash provided by financing activities during the nine months ended September 30, 2024, of $0.1 million is primarily from net proceeds from sale of equity, net of issuance costs.
Previous wording
Net cash provided by financing activities during the six months ended June 30, 2023, of $24.9 million, is primarily from net proceeds of $23.2 million from the issuance of common stock under the Placement Agency Agreement, $1.1 million net proceeds from the issuance of common stock under a registered direct offering and $0.5 million from the issuance of common stock under the SPA.
Current wording
Net cash provided by financing activities during the nine months ended September 30, 2023, of $24.9 million, is primarily from the issuance of common stock, net of issuance costs.