- HeartBeam Enters New Growth Phase Following FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment
- First Commercial Partner ClearCardio™ to Bring HeartBeam’s 3D ECG Technology to High-Growth Preventive Cardiology Market
- First Patients Enrolled in Heart Attack Detection Pilot Study, A Key Step Toward Future FDA Indication Expansion
- Completed the First Working Prototype of an Extended-Wear 12-Lead ECG Patch
- Strategic Collaboration with the
Icahn School of Medicine at Mount Sinai to Accelerate Next-Generation AI-ECG Algorithms - Management to Host Webcast and Conference Call Today at
4:30 p.m. ET
The Company continues to make significant progress entering commercialization while advancing several key initiatives as part of its growth strategy:
Limited Launch:
U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the Company’s groundbreaking 12-lead electrocardiogram (ECG) synthesis software for the assessment of arrhythmias inDecember 2025 .- Company is initiating a limited market release, focusing on select concierge and preventive cardiology groups that have proactively signaled strong interest in adopting HeartBeam’s technology.
- Signed first commercial partnership with ClearCardio™, a rapidly growing preventive cardiology practice with a highly engaged member population. They serve thousands of patients through advanced heart health screening and personalized prevention programs.
- Includes an initial staged rollout to ensure a seamless patient and physician experience, facilitating plans for broader expansion across multiple
U.S. geographies. - Established initial foothold in structured direct pay healthcare segment, representing 5 million patients in the
U.S.
Heart Attack Detection:
- Enrolled first patients in ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection.
- ALIGN-ACS pilot study expected to complete patient enrollment quickly as study is designed to enroll chest pain patients in the emergency department.
- Milestone signifies key step toward future FDA indication expansion for heart attack assessment.
- Future indication expansion would unlock large market with over 20 million patients at risk of a heart attack.
12-lead ECG Extended Wear Patch:
- Completed the first working prototype of an extended-wear ECG patch which the Company believes is the first ECG patch capable of offering 12-lead ECG signals.
- Potential to be a best-in-class offering addressing a significant clinical gap in an existing multi-billion-dollar market with reimbursement.
- Product demonstrations to be provided at the
American College of Cardiology’s annual scientific conferenceMarch 28-30, 2026 , inNew Orleans .
AI Program:
- Announced strategic collaboration with the
Icahn School of Medicine at Mount Sinai to accelerate the joint development and validation of next-generation AI-ECG algorithms. - Combining Mount Sinai’s world-class AI and clinical expertise with HeartBeam’s groundbreaking 3D ECG signal collection technology to develop increasingly personalized algorithms.
HeartBeam is the only platform capable of collecting longitudinal synthesized 12-lead ECG data from patients anytime, anywhere – bringing clinical-grade monitoring into patients’ daily lives.- Positions
HeartBeam to expand from symptom-based cardiac rhythm monitoring into AI-enabled disease assessment and management.
Other Commercialization and Operational Highlights:
- Appointed
Bryan Humbarger as Chief Commercial Officer to lead commercial strategy and execution across the Company’s key growth initiatives. - Cash and cash equivalents totaled
$4.4 million as ofDecember 31, 2025 , with net cash used in operating activities of$2.9 million for the three-month period endedDecember 31, 2025 , resulting in a 30% decrease compared to same quarter in the prior year.
Management Commentary
“The fourth quarter of 2025 and early 2026 were transformational for
“HeartBeam’s technology is a true platform. We believe that our unique and patented technology is the only way for patients to obtain a 12-lead ECG at home or wherever they have symptoms, through a small, easy to use, cable free device.
“Our core technology can be applied to multiple form factors. In the background, we also have been developing a second form factor, an on-demand 12-lead patch. We believe that this can disrupt the long-term continuous monitor and mobile cardiac telemetry, or MCT markets, a combined
“Through our platform, we are creating an ecosystem that will add unique insights and actionable data for both patients and physicians that are unavailable elsewhere and add to the premium offering of
Fourth Quarter and Full Year 2025 Financial Results
Research and development expenses for the fourth quarter of 2025 were
General and administrative expenses for the fourth quarter of 2025 were
Net loss for the fourth quarter of 2025 was
Net cash used in operating activities was
Cash and cash equivalents totaled
Fourth Quarter and Full Year 2025 Results Conference Call
The conference call will be accompanied by a presentation and short video, which can be viewed during the webcast or accessed following the call via the investor relations section of the Company’s website here.
To access the call, please use the following information:
Date: | ||
Time: | ||
Dial-in: | 1-844-826-3035 | |
International Dial-in: | 1-412-317-5195 | |
Conference Code: | 10206235 | |
Webcast: |
A telephone replay will be available approximately three hours after the call and will run through
About
Forward-Looking Statements
All statements in this release that are not based on historical fact are "forward-looking statements." While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the
1Cleared Indications for Use |
The HeartBeam System with 12-Lead ECG synthesis software for arrhythmia assessment received FDA clearance in |
Balance Sheets | ||||||||
(In thousands, except share data) | ||||||||
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| 2025 |
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| 2024 |
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Assets |
|
|
|
|
|
| ||
Current Assets: |
|
|
|
|
|
| ||
Cash and cash equivalents |
| $ | 4,380 |
|
| $ | 2,377 |
|
Prepaid expenses and other current assets |
|
| 202 |
|
|
| 393 |
|
Inventory |
|
| 103 |
|
|
| - |
|
Total Current Assets |
| $ | 4,685 |
|
| $ | 2,770 |
|
Property and equipment, net |
|
| 1,102 |
|
|
| 450 |
|
Other assets |
|
| 56 |
|
|
| 56 |
|
Total Assets |
| $ | 5,843 |
|
| $ | 3,276 |
|
Liabilities and Stockholders’ Equity |
|
|
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|
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| ||
Current Liabilities: |
|
|
|
|
|
| ||
Accounts payable (includes related party |
|
| 1,053 |
|
|
| 531 |
|
Accrued expenses |
|
| 2,187 |
|
|
| 1,091 |
|
Total Liabilities |
|
| 3,240 |
|
|
| 1,622 |
|
Commitments |
|
|
|
|
|
| ||
Stockholders’ Equity |
|
|
|
|
|
| ||
Preferred Stock - |
|
| — |
|
|
| — |
|
Common stock - |
|
| 4 |
|
|
| 3 |
|
Additional paid in capital |
|
| 79,887 |
|
|
| 57,924 |
|
Accumulated deficit |
|
| (77,288 | ) |
|
| (56,273 | ) |
Total Stockholders’ Equity |
| $ | 2,603 |
|
| $ | 1,654 |
|
Total Liabilities and Stockholders’ Equity |
| $ | 5,843 |
|
| $ | 3,276 |
|
Statements of Operations | ||||||||
(In thousands, except share and per share data) | ||||||||
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|
| ||||||
|
| 2025 |
|
| 2024 |
| ||
Operating Expenses: |
|
|
|
|
|
| ||
General and administrative |
| $ | 7,689 |
|
| $ | 8,836 |
|
Research and development |
|
| 13,450 |
|
|
| 11,051 |
|
Total operating expenses |
|
| 21,139 |
|
|
| 19,887 |
|
Loss from operations |
|
| (21,139 | ) |
|
| (19,887 | ) |
Other Income |
|
|
|
|
|
| ||
Interest income |
|
| 122 |
|
|
| 446 |
|
Other income and expense (net) |
|
| 2 |
|
|
| (7 | ) |
Total other income |
|
| 124 |
|
|
| 439 |
|
Loss before provision for income taxes |
|
| (21,015 | ) |
|
| (19,448 | ) |
Income tax provision |
|
| — |
|
|
| — |
|
Net Loss |
| $ | (21,015 | ) |
| $ | (19,448 | ) |
Net loss per share, basic and diluted |
| $ | (0.62 | ) |
| $ | (0.73 | ) |
Weighted average common shares outstanding, basic and diluted |
|
| 33,710,095 |
|
|
| 26,645,228 |
|
Statements of Cash Flows | ||||||||
(In thousands) | ||||||||
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|
| ||||||
|
| 2025 |
|
| 2024 |
| ||
Cash Flows From Operating Activities |
|
|
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|
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Net loss |
| $ | (21,015 | ) |
| $ | (19,448 | ) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
|
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| ||
Depreciation |
|
| 40 |
|
|
| 7 |
|
Stock based compensation expense |
|
| 5,147 |
|
|
| 4,299 |
|
Stock issuance for services |
|
| 226 |
|
|
| - |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
| ||
Prepaid expenses and other current assets |
|
| 191 |
|
|
| 243 |
|
Inventory |
|
| (103 | ) |
|
| - |
|
Accounts payable and accrued expenses |
|
| 1,526 |
|
|
| 428 |
|
Net cash used in operating activities |
|
| (13,988 | ) |
|
| (14,471 | ) |
Cash Flows From Investing Activities |
|
|
|
|
|
| ||
Purchase of property and equipment |
|
| (600 | ) |
|
| (201 | ) |
Purchase of short-term investments |
|
| 3,760 |
|
|
| - |
|
Maturities of short-term investments |
|
| (3,760 | ) |
|
| - |
|
Net cash used in investing activities |
|
| (600 | ) |
|
| (201 | ) |
Cash Flows From Financing Activities |
|
|
|
|
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Proceeds from sale of equity, net of issuance costs |
|
| 10,250 |
|
|
| 730 |
|
Proceeds from sale of equity under ATM, net of issuance costs |
|
| 6,328 |
|
|
| - |
|
Proceeds from exercise of stock options |
|
| 13 |
|
|
| 136 |
|
Net cash provided by financing activities |
|
| 16,591 |
|
|
| 866 |
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|
|
|
|
|
|
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Net increase (decrease) in cash and restricted cash |
|
| 2,003 |
|
|
| (13,806 | ) |
Cash, cash equivalents and restricted cash - beginning of the year |
|
| 2,433 |
|
|
| 16,239 |
|
|
|
|
|
|
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Cash, cash equivalents and restricted cash - at end of the year |
| $ | 4,436 |
|
| $ | 2,433 |
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|
|
|
|
|
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Reconciliation of cash, cash equivalents and restricted cash: |
|
|
|
|
|
| ||
Cash and cash equivalents |
|
| 4,380 |
|
|
| 2,377 |
|
Restricted cash (included in other assets) |
|
| 56 |
|
|
| 56 |
|
Total cash, cash equivalents and restricted cash |
|
| 4,436 |
|
|
| 2,433 |
|
|
|
|
|
|
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Supplemental Disclosures of Cash Flow Information: |
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Purchase of property and equipment in accounts payable |
| $ | 92 |
|
| $ | — |
|
Taxes paid |
| $ | — |
|
| $ | — |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20260312059838/en/
Media Contact:
media@heartbeam.com
Investor Relations Contact:
Executive Vice President
Direct: 949-491-8235
BEAT@mzgroup.us
www.mzgroup.us
Source: