HeartBeam, Inc.
For the period ended Jun 30, 2025. Filed Aug 13, 2025.
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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.
Jun 30, 2025 · Filed Aug 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-Q
Period ended 2025-03-31; filed 2025-05-13.
0001628280-25-025064
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001628280-25-040135
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 54 previous paragraphs and 55 current paragraphs.
26 unchanged; 21 reworded; 6 added; 6 removed; 1 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 (6)
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 allowed patent application covers methods of automatically assessing a patient’s risk of an acute cardiac event by evaluating risk factors and generating a diagnostic report.
Current report
The Company’s issued and pending U.S. patent claims are directed to compact electrocardiogram (ECG) systems for remote detection and/or diagnosis of acute myocardial infarction (“AMI”). Outside of the U.S., the pending applications in the European Union, Canada (“CA”), Australia (“AU”), Japan (“JP”), South Korea (“KR”), and China (“CN”) generally correspond to the Company’s U.S. filings.
Current report
At-the-Market Offering
Current report
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 284,338 shares issued under the ATM during the six months ended June 30, 2025, and there was approximately $15.6 million available for issuance as of the financial statement issuance date, potentially subject to other baby shelf limitations.
Current report
Research and development expenses (“R&D”) expenses increased by approximately $1.5 million or 29% during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024. The increase in R&D expense is primarily related to an increase in product development expense of $1.0 million, related to the development of the HeartBeam System, a net increase in headcount of $1.1 million and non-cash stock-based compensation expense amounting to $0.8 million associated with additional awards granted since June 30, 2024, partially offset by a decrease in clinical related cost of $0.6 million driven by completion of clinical study and decrease in consulting expenses of $0.8 million compared to the prior period.
Removed paragraphs (6)
Previous report
February Public Offering under Form S-3
Previous report
During the three months ended March 31, 2025, we entered into an underwriting agreement with Public Ventures, LLC dba MDB Capital (“Public Ventures”) to consummate an offering (the “February Public Offering”) and we have raised approximately $11.5 million in gross proceeds through sales of common stock as listed below:
Previous report
•On February 12, 2025, 5,882,353 shares of common stock sold at an offering price of $1.70 per share, which closed on February 14, 2025. The Company received $8.94 million in net proceeds from the February Public Offering after deducting underwriter discounts and commissions. 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.
Previous report
•On February 21, 2025, Public Ventures exercised the bulk of their over-allotment option (the “Over-allotment Option”) of 864,033 shares of common stock which closed on February 25, 2025. The Company received $1.31 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 Public Ventures.
Previous report
As of March 31, 2025, the Company held two treasury securities with maturity dates of greater than 90 days. These short-term investments have an amortized cost basis of approximately $3.8 million and maturity periods of 94 and 119 days, respectively. When combined with cash and cash equivalents of $4.4 million, the balance for the Company at March 31, 2025 was $8.2 million
Previous report
We had no financing activity during the three months ended March 31, 2024.
Reworded paragraphs (21)
Previous wording
We believe our Products (“Products” or “Product”) and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payors, and will also address the rapidly growing field of ambulatory cardiac health monitoring. We believe that we are uniquely positioned to play a central role in ambulatory cardiac monitoring including high-risk Coronary Artery Disease (“CAD”), 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.
Current wording
We believe our Products (“Products” or “Product”) and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payors, and will also address the rapidly growing field of ambulatory cardiac health monitoring. As part of our long-term vision, we believe that we are uniquely positioned to play a central role in ambulatory cardiac monitoring including high-risk Coronary Artery Disease(“CAD”), 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. The initial product and service offering is expected to be an ambulatory device, carried by patients, which can synthesize a 12L ECG for manual assessment of arrhythmia by physicians.
Previous wording
The HeartBeam System (previously referred to as “AIMIGo TM”) was granted FDA clearance on December 13, 2024. The HeartBeam System is the first U.S. Food and Drug Administration (“FDA”) cleared cable-free, ambulatory 3-D ECG that captures the heart’s electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics for arrhythmia assessment. The HeartBeam System is comprised of a credit card sized 3-Lead ECG recording device, a patient application, a physician portal, and powerful cloud-based algorithms.
Current wording
The HeartBeam System (previously referred to as “AIMIGOTM”) was granted FDA clearance on December 13, 2024. The HeartBeam System is the first U.S. Food and Drug Administration (“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 for arrhythmia assessment. The HeartBeam System is comprised of a credit card sized 3-Lead ECG recording device, a patient application, a physician portal, and powerful cloud-based algorithms.
Previous wording
The Company held two pre-submission meetings with the FDA ahead of the 12L ECG synthesis software submission. These meetings focused primarily on the performance goals of our clinical study designed to demonstrate the similarity between our synthesized 12L ECG signal and the output of a standard 12L ECG for the arrhythmia assessment.. 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 12L ECG synthesis software for arrhythmia assessment.
Current wording
The Company held two pre-submission meetings with the FDA ahead of the 12L ECG synthesis software submission. These meetings focused primarily on the performance goals of our clinical study designed to demonstrate the similarity between our synthesized 12L ECG signal and the output of a standard 12L ECG for arrhythmia assessment. 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 12L ECG synthesis software for arrhythmia assessment.
Previous wording
In April 2025, the Company announced that the VALID-ECG pivotal study successfully met its clinical endpoints. The study evaluated the mean difference in ECG intervals and amplitudes between HeartBeam’s synthesized 12L ECG and a simultaneously collected standard 12L ECG. Intervals and amplitudes are important in assessing non-life-threatening arrhythmias. Data showed a 93.4% overall diagnostic agreement, indicating that HeartBeam’s synthesized 12-lead ECG can support diagnosis of arrhythmias in a manner consistent with standard 12L ECGs.
Current wording
In April 2025, the Company announced that the VALID-ECG pivotal study successfully met its clinical endpoints. The study evaluated the mean difference in ECG intervals and amplitudes between HeartBeam’s synthesized 12L ECG and a simultaneously collected standard 12L ECG. Intervals and amplitudes are important in assessing non-life-threatening arrhythmias. Data showed a 93.4% overall diagnostic agreement, indicating that HeartBeam’s synthesized 12-lead ECG can support diagnosis of arrhythmias in a manner consistent with standard 12L ECGs. The VALID-ECG pivotal study was a multicenter trial that enrolled 198 patients across five clinical sites in the US, including Allegheny Health Network, Atlanta Heart Specialists, Mount Sinai Hospital, Northwell Health and Piedmont Heart Institute. Efforts were made to enroll patients with a diverse demographic profile reflective of the intended use population in the United States.
Previous wording
During the first quarter of 2025 and ensuing period, the Company continued its efforts with commercial readiness activities, in advance of an anticipated commercial launch that will occur once we receive FDA clearance for our 12L synthesis software.
Current wording
During the first half of 2025 and ensuing period, the Company continued commercial readiness activities, in advance of an anticipated commercial launch that will occur once we receive FDA clearance for our 12L synthesis software.
Previous wording
In April 2025, HeartBeam announced a strategic collaboration with AccurKardia to potentially add their FDA-cleared, automated ECG interpretation platform to our Product. Adding AccurKardia’s FDA-cleared, device-agnostic automated ECG interpretation platform to HeartBeam’s device will enhance HeartBeam’s commercial offering for arrhythmia assessment by enabling patients and physicians to get an automated rhythm assessment which will facilitate a quicker diagnosis and faster access to clinical care when needed. The strategic collaboration is expected to expedite HeartBeam’s product development efforts, reducing both costs and timelines.
Current wording
In April 2025, HeartBeam announced a strategic collaboration with AccurKardia to potentially add their FDA-cleared, automated ECG interpretation platform to our Product. Adding AccurKardia’s FDA-cleared, automated ECG interpretation platform to HeartBeam’s device will enhance HeartBeam’s commercial offering for arrhythmia assessment by enabling patients and physicians to get an automated rhythm assessment, which will facilitate a quicker diagnosis and faster access to clinical care when needed. The strategic collaboration is expected to expedite HeartBeam’s product development efforts, reducing both costs and timelines.
Previous wording
In addition, the Company also has an active AI program underway. We have acquired approximately one million standard 12L ECGs from various sources, a key element in our fast-paced AI development efforts. We believe that, when combined with our Products, these deep learning algorithms will provide additional value to patients and physicians in several ways.
Current wording
In addition, the Company also has an active AI program underway. We have acquired approximately five million standard 12L ECGs from various sources, a key element in our fast-paced AI development efforts. We believe that, when combined with our Products, these deep learning algorithms will provide additional value to patients and physicians in several ways.
Previous wording
HeartBeam has 15 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, U.S. 11,969,251, U.S. US 12,207,908 and U.S. 12,290,368) Outside of the U.S., HeartBeam has five issued patents in South Korea, Germany, France, Netherlands and the United Kingdom
Current wording
HeartBeam has 16 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, U.S. 11,969,251, U.S. US 12,207,908, U.S. 12,290,368 and allowed U.S. app. no. 18/324,111). Outside of the U.S., HeartBeam holds six issued patents across Japan, South Korea, Germany, France, the Netherlands, and the United Kingdom, as well as two allowed patent applications, one in the European Union and one in Australia.
Previous wording
Thus far in 2025, we have been granted two new U.S. patents related to HeartBeam’s compact, mobile three-lead cardiac monitoring devices and detection of atrial fibrillation.
Current wording
Thus far in 2025, we have been granted two new U.S. patents relating to its compact, mobile three-lead cardiac monitoring technologies and methods for atrial fibrillation detection. Furthermore, the company has received a Notice of Allowance for an additional U.S. patent application directed to hand-held devices for automated cardiac risk assessment and diagnostic analysis.
Previous wording
The Company now has 20 issued patents worldwide, including fifteen (15) issued U.S. patents and eleven (11) pending U.S applications. Outside of the U.S., we have five (5) issued patents in South Korea, Germany, France, Netherlands and United Kingdom, two (2) allowed patents and twenty-one (21) 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 wording
In addition, HeartBeam continues to expand its intellectual property portfolio and has recently filed two non-provisional and one provisional U.S. patent applications intended to further strengthen the protection of its proprietary technologies. The Company now holds a total of twenty-one (21) issued patents worldwide, including fifteen (15) issued U.S. patents. Within the United States, the Company has one (1) allowed U.S. patent application and eleven (11) pending U.S. patent applications (including the allowed case). Outside of the U.S., the Company owns six (6) issued patents across Japan, South Korea, Germany, France, the Netherlands, and the United Kingdom. In addition, there are two (2) allowed foreign patent applications and twenty-four (24) pending applications (including the two allowed cases) in jurisdictions including Canada, China, the European Union, Japan, South Korea, and Australia. The issued patents are expected to expire between April 11, 2036, and April 21, 2042.
Previous wording
Summary of Statements of Operations for the three months ended March 31, 2025 compared with the three months ended March 31, 2024:
Current wording
Summary of Statements of Operations for the three and six months ended June 30, 2025 compared with the three and six months ended June 30, 2024:
Previous wording
General and administrative (“G&A”) expenses decreased by approximately $0.3 million or 15% during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. The decrease in G&A expense is primarily related to decrease in non-cash stock-based compensation expense amounting to $0.5 million driven by change in estimate for recognition of milestone options offset by an increase in insurance expense of $0.1 million and commercial readiness expenses for $0.1 million.
Current wording
General and administrative (“G&A”) expenses decreased by approximately $0.6 million or 25% during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024. The decrease in G&A expense is primarily related to non-cash stock-based compensation expense amounting to $0.2 million primarily driven by change in estimate for recognition of milestone options, and lower consultant costs of $0.2 million.
Previous wording
Research and development expenses (“R&D”) expenses increased by approximately $1.1 million or 44% during the three months ended March 31, 2025 as compared to the three months ended March 31, 2024. The increase in R&D expense is primarily related to increase in headcount of $0.6 million and non-cash stock-based compensation expense amounting to $0.4 million associated with additional awards granted since March 31, 2024, increase in product development expense of $0.5 million, offset by a decrease in clinical related costs of $0.4 million.
Current wording
Research and development expenses (“R&D”) expenses increased by approximately $0.5 million or 17% during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024. The increase in R&D expense is primarily related to an increase in product development expense of $0.6 million related to the development of the HeartBeam System, a net increase in headcount of $0.5 million and non-cash stock-based compensation expense amounting to $0.4 million associated with additional awards granted since June 30, 2024, partially offset by a decrease in clinical related cost of $0.4 million driven by completion of clinical study and a decrease in consulting expenses of $0.6 million compared to the prior period.
Previous wording
We have incurred losses each year since inception and have experienced negative cash flows from operations in each year since inception. As of March 31, 2025, we have cash and short-term investments of approximately $8.2 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 have experienced negative cash flows from operations in each year since inception. As of June 30, 2025, we have cash and short-term investments of approximately $5.1 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
As of March 31, 2025, we had approximately $4.4 million in cash and cash equivalents, an increase of $2.0 million from $2.4 million as of December 31, 2024.In addition, the Company held, short-term investments of $3.8 million as treasury securities at the balance sheet date. When combined with cash and cash equivalents of $4.4 million, the balance for the Company as at March 31, 2025 was $8.2 million.
Current wording
As of June 30, 2025, we had approximately $3.3 million in cash and cash equivalents, an increase of $0.9 million from $2.4 million as of December 31, 2024. In addition, the Company held, short-term investments of $1.8 million as treasury securities at the balance sheet date. When combined with cash and cash equivalents of $3.3 million, the balance for the Company as at June 30, 2025 was $5.1 million.
Previous wording
Cash flows for the three months ended March 31, 2025 and 2024 (in thousands):
Current wording
Cash flows for the six months ended June 30, 2025 and 2024 (in thousands):
Previous wording
Net cash used in our operating activities of $4.5 million during the three months ended March 31, 2025, is primarily due to our net loss of $5.5 million less $1.1 million in non-cash expenses and $0.1 million of net changes in operating assets and liabilities.
Current wording
Net cash used in our operating activities of $7.9 million during the six months ended June 30, 2025 is primarily due to our net loss of $10.4 million less $2.3 million in non-cash expenses and $0.2 million of net changes in operating assets and liabilities.
Previous wording
Net cash used in our operating activities of $3.5 million during the three months ended March 31, 2024, is primarily due to our net loss of $4.6 million less $1.2 million in non-cash expenses and $0.1 million of net changes in operating assets and liabilities.
Current 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.
Previous wording
Net cash used in investing activities during the three months ended March 31, 2025, of $3.8 million is from the purchase of short-term investments.
Current wording
Net cash used in investing activities during the six months ended June 30, 2025, of $0.1 million is from the purchase of property and equipment, $3.8 million is from the gross purchase of short term investments and offset by the maturities of short term investments of $2.0 million.
Previous wording
Net cash used in investing activities during the three months ended March 31, 2024 of $0.1 million, is from the purchase of equipment.
Current 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.
Previous wording
During the three months ended March 31, 2025, net cash provided by financing activities of $10.3 million is primarily from net proceeds from sale of common stock, net of issuance costs.
Current wording
During the six months ended June 30, 2025, net cash provided by financing activities of $10.7 million is primarily from net proceeds from sale of common stock, net of issuance costs.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
General and administrative (“G&A”) expenses decreased by approximately $0.9 million or 19% during the six months ended June 30, 2025 as compared to six months ended June 30, 2024. The decrease in G&A expense is primarily related to non-cash stock-based compensation expense amounting to $0.8 million primarily driven by change in estimate for recognition of milestone options, and lower consultant costs of $0.2 million.
Current report — wording carried from elsewhere
During the six months ended June 30, 2024, net cash provided by financing activities of $0.1 million is primarily from net proceeds from sale of equity, net of issuance costs.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The VALID-ECG pivotal study was a multicenter trial that enrolled 198 patients across five clinical sites in the US, including Allegheny Health Network, Atlanta Heart Specialists, Mount Sinai Hospital, Northwell Health and Piedmont Heart Institute. Efforts were made to enroll patients with a diverse demographic profile reflective of the intended use population in the United States.