HEARTBEAM, Inc. See accompanying notes to the condensed unaudited financial statements In February 2023, the Company entered into a sales agreement (the "Sales Agreement") with A.G.P./Alliance Global Partners ("AGP") pursuant to which the Company may issue and sell, from time to time, shares of the Company's common stock having an aggregate offering price of up to $13.0 million in at-the-market offerings ("ATM") sales, which was terminated in May 2024. NET LOSS PER COMMON SHARE In March 2024, the FASB issue ...

HeartBeam (NASDAQ:BEAT) just reported results for the fourth quarter of 2023.HeartBeam reported earnings per share of -13 cents. This met the analyst estimate for EPS of -13 cents.The company did not report any revenue for the quarter.InvestorPlace Earnings is a project that leverages data from TradeSmith to automate coverage of quarterly earnings reports. InvestorPlace Earnings distills key takeaways including earnings per share and revenue, as well as how a company stacks up to analyst estimates. These ar ...

| --- | --- | --- | --- | --- | --- | |--------------------------------------------------------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | The Power of a 12-Lead ECG Always with the patient | | | | | | | | | | | | | | Fourth Quarter & Full Year 2023 Financial Results Conference Call | | | | | | | NASDAQ: BEAT March 20, 2024 | | | | | | Fourth Quarter 2023 Financial Results Conference Call 2 DISCLAIMERS This presentation contai ...

Financial Data and Key Metrics Changes - General and administrative expenses for Q4 2023 were $2.1 million, consistent with Q4 2022, while for the full year, G&A expenses increased to $8.5 million from $7.3 million in 2022, primarily due to non-cash stock-based compensation of $1.6 million [22][23] - Research and development expenses for Q4 2023 were $2 million, up from $1.6 million in Q4 2022, and for the full year, R&D expenses rose to $6.8 million from $5.7 million, attributed to increased headcount and professional services [23] - The net loss for 2023 was $14.6 million compared to $13 million in 2022, with cash and cash equivalents at $16.2 million as of December 31, 2023, up from $3.6 million a year earlier [25][29] Business Line Data and Key Metrics Changes - The AIMIGo system is expected to be the first patient-held 3D VECG device cleared by the FDA, which will serve as a cornerstone for future regulatory submissions and AI applications [9][12] - The company is focusing on developing AI algorithms that leverage the rich data from the AIMIGo device, which is anticipated to enhance diagnostic capabilities [18][19] Market Data and Key Metrics Changes - The U.S. market opportunity for atrial fibrillation (AFib) patients is approximately $2 billion, while the coronary artery disease market is about $12 billion, totaling an estimated $14 billion opportunity in the U.S. [8] Company Strategy and Development Direction - The company aims to finalize the FDA clearance for the AIMIGo system by the end of Q2 2024, which will be foundational for future developments, including a second submission for synthesizing 12-lead ECGs [27][28] - The strategy includes advancing a robust product pipeline that incorporates AI-enabled technologies and patient-friendly devices such as a 12-lead ECG watch and on-demand 12-lead patches [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory process, indicating that the questions from the FDA are typical and manageable, with no significant showstoppers anticipated [31] - The company is optimistic about the potential of its AI initiatives and the unique data set provided by the AIMIGo device, which is expected to enhance predictive and diagnostic capabilities [37] Other Important Information - The company has received two additional U.S. patents, strengthening its intellectual property portfolio, which includes innovations for a 12-lead ECG watch and on-demand 12-lead patches [19][20] - The total cost of the valid ECG study is estimated to be around $700,000, which is considered manageable given the study's design [42] Q&A Session Summary Question: How would you characterize the questions from the FDA regarding the 510(k) submission? - Management indicated that the questions are typical for the 510(k) review process and are being addressed through regulatory tools and engagement with the FDA [31] Question: What is the timeline for future FDA submissions related to AI applications? - The company is currently assessing the schedule for AI submissions but is not ready to share specific timelines [32] Question: When will commercialization efforts ramp up following the second AIMIGo clearance? - The commercialization team will begin ramping up in conjunction with the limited launch planned for the end of 2024 [33] Question: Can you describe the valid ECG study in more detail? - The study aims to demonstrate the similarity between synthesized 12-lead ECGs and standard hospital-based ECGs, with simultaneous recordings taken during patient visits [36] Question: How are cybersecurity aspects being addressed? - The company is confident in its ability to meet regulatory expectations for cybersecurity, working with experts in the field [40][41] Question: What are the costs associated with the valid ECG study? - The total cost is estimated at $700,000, which includes contracts with a clinical research organization and patient enrollment costs [42]

We are applying for 510(k) clearance for the AIMIGo system. To obtain 510(k) clearance, a company must submit a notification to the FDA demonstrating that its proposed device is substantially equivalent to a predicate device (i.e., a device that was in commercial distribution before May 28, 1976, a device that has been reclassified from Class III to Class I or Class II, or a 510(k)-cleared device). The FDA's 510(k) clearance process generally takes from three to 12 months from the date the application is su ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, announced today that it has enrolled the first patients in the VALID-ECG (Clinical Validation of the AIMIGo 12-Lead ECG Synthesis Software for Arrhythmia Detection) pivotal study. The first patients were enrolled at Atlanta Heart Specialists, a top cardiology physician practice in Atlanta, GA. The VALID-ECG study will evaluate ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, announced today that it has received two new patents on its core vectorelectrocardiography (VECG) technology from the United States Patent and Trademark Office. HeartBeam now has 14 issued and allowed US patents and 4 international patents for its VECG technology which collects 3D signals of the heart and converts them into a 12-l ...

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, will hold a conference call on Wednesday March 20, 2024 at 4:30 p.m. Eastern time to discuss its results for the fourth quarter and full fiscal year ended December 31, 2023, and will be providing regulatory updates, reviewing ongoing initiatives, and anticipated 2024 milestones. A press release detailing these results will be issu ...

Addison, TX, Jan. 31, 2024 (GLOBE NEWSWIRE) -- MDB Capital Holdings, LLC, (NASDAQ:MDBH) ("MDB"), a public venture platform with the objective of growing the public venture marketplace and optimizing the way meaningful technologies are financed and built, today released its annual letter to shareholders from its CEO and Co-Founder, Christopher Marlett. To the Shareholders of MDB Capital Holdings, LLC: Welcome to our first annual letter, which I plan to send every January to reflect on the past year and how w ...

HeartBeam, Inc. (NASDAQ:BEAT) Q3 2023 Earnings Conference Call November 14, 2023 4:30 PM ET Company Participants Branislav Vajdic - Chief Executive Officer & Founder Rob Eno - President Rick Brounstein - Chief Financial Officer Conference Call Participants Ben Haynor - Alliance Global Partners Operator Greetings and welcome to the HeartBeam Third Quarter 2023 Financial Results Conference Call. [Operator Instructions] A question-and-answer session will follow the formal presentation. As a reminder, this conf ...