Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- HeartBeam Inc (BEAT, Financial) is developing AIMIGo, a credit card-sized, cable-free cardiac monitoring device capable of producing a 12-Lead ECG.
- The company has broad IP protection on its core technology, including novel form factors like extended wear cardiac monitors and mobile cardiac telemetry devices.
- HeartBeam Inc (BEAT) is making steady progress on regulatory milestones, with the initial 510(k) submission for AIMIGo under active FDA review.
- The company has completed enrollment in the VALID-ECG study, which will support further FDA submissions.
- HeartBeam Inc (BEAT) has presented positive data on its AI algorithms, demonstrating superior performance in detecting atrial flutter compared to traditional methods.
Negative Points
- General and administrative expenses increased to $2.2 million in Q2 2024 from $1.8 million in Q2 2023, primarily due to noncash stock-based compensation and higher consulting costs.
- Research and development expenses rose to $2.8 million in Q2 2024 from $1.5 million in Q2 2023, driven by increased headcount and clinical and AI-related costs.
- Net loss for Q2 2024 was $5 million, up from $3.2 million in Q2 2023.
- The company is still in the process of addressing a small number of remaining questions from the FDA for AIMIGo's 510(k) submission.
- HeartBeam Inc (BEAT) anticipates a limited launch of AIMIGo by the end of 2024, which may delay broader market adoption and revenue generation.
Q & A Highlights
Q: Can you provide more detail on the timing of the FDA clearance?
A: Branislav Vajdic, CEO: We are under active review with the FDA and cannot provide more details beyond what was shared in the call and earnings materials. We have resolved most of the FDA's questions and are in the process of providing additional requested information. We anticipate a limited launch before the end of the year, which will give us valuable feedback on user experience and functionality.
Q: You showed market sizes for HeartBeam's technology. Can you explain where you're going with those?
A: Robert Eno, President: The main point is to show the wide range of applications for HeartBeam's technology, starting with symptom-driven diagnosis (arrhythmia), moving to ischemia and heart attack detection, and eventually incorporating into extended wear patch monitors for chronic conditions like heart failure and chronic kidney disease. Ultimately, frequent 12-lead ECGs combined with AI algorithms could enable prevention and screening for a large number of patients.
Q: You mentioned that the VALID-ECG study has completed enrollment. What are the results of the study?
A: Robert Eno, President: VALID-ECG was designed to demonstrate the similarity between standard 12-lead ECG signals and our synthesized 12-lead signals. Enrollment was completed in June, and the data is currently being analyzed. Results are not yet available, but we plan to submit the findings to the FDA shortly. An 80-patient pilot study with the same protocol has been accepted for presentation at the American Heart Association meeting in November.
Q: If the 12-lead ECG is being evaluated by a physician, why do you need AI?
A: Branislav Vajdic, CEO: HeartBeam AI will provide automated arrhythmia classification immediately after each use. For symptomatic users, the ECG will be sent to a physician for evaluation. For asymptomatic users, the ECG will not automatically go to a physician but can be sent if desired. AI will play a key role in informing patients and aiding physicians in diagnosis.
Q: Will the initial AIMIGo product be able to detect heart attacks from the start, or will further R&D be needed?
A: Branislav Vajdic, CEO: We have conducted significant research and studies related to heart attack detection. While some development work remains, we believe our technology will provide leading insights for patients with chest pain. Initially, we are focusing on arrhythmia detection, with plans to enable heart attack detection as soon as the arrhythmia product is in the market.
Q: Is it possible to speak to pursuing FDA approval for atrial flutter versus atrial fibrillation?
A: Robert Eno, President: We are taking a stepwise approach with the FDA. The initial indications cover a range of arrhythmias, including atrial flutter and atrial fibrillation. We will have clinical data to support these indications within the scope of the initial clearance.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
