HeartBeam reports Q4 and full year 2023 financial results

HeartBeam, Inc. has reported its financial and operational results for the fourth quarter and full year ended December 31, 2023.

Fourth quarter & subsequent 2024 operational highlights
The company made steady progress toward key clinical and regulatory milestones on its AIMIGo™ 3D VECG system.

AIMIGo 510(k) submission:

• The 510(k) submission for the AIMIGo system is currently being reviewed by the FDA.
• The initial AIMIGo 510(k) submission is focused on the credit card-sized 3D VECG device, patient application, physician portal and wireless communication among the elements. This is the cornerstone submission for HeartBeam and will be the basis of future submissions.
• The company currently anticipates clearance by the end of Q2 2024.

12 Lead Synthesis Software submission:

• HeartBeam has held two pre-submission meetings with FDA on the planned second AIMIGo 510(k) submission, which is focused on the algorithms that synthesize a 12 lead ECG from the 3D VECG signals. This application will be submitted after the initial clearance of the 3D VECG System. The emphasis of the pre-submission meetings was on the performance goals of the VALID-ECG clinical study (Clinical Validation of the AIMIGo 12-Lead ECG Synthesis Software for Arrhythmia Detection) that will demonstrate the similarity between the synthesized 12L ECG and a standard 12L ECG.
• The company enrolled the first patients in the VALID-ECG pivotal study, with enrollment expected to be completed in Q2 2024.
• Prior to initiating the VALID-ECG study, HeartBeam completed an 80-patient pilot study using the same protocol as the VALID-ECG study.

Management commentary
“We have continued to make steady progress on regulatory and clinical milestones for the AIMIGo 3D VECG technology platform,” said Branislav Vajdic, PhD, Chief Executive Officer and Founder of HeartBeam. “We have filed a 510(k) submission to the FDA for our AIMIGo VECG device system. When cleared, this will be a major milestone for the company, as we expect this to be the first patient-held 3D VECG to be cleared by the FDA. Additionally, this clearance is the cornerstone of our regulatory efforts as it will be the basis for future FDA submissions, including our planned second FDA application on the system’s ability to synthesize a 12L ECG. We continue to anticipate that our limited launch of AIMIGo will occur by the end of 2024.

“Based on feedback from the FDA and our clinical experts, we designed the VALID-ECG clinical study, a prospective single-arm multicenter trial 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 recently enrolled the first patients, with a plan to enroll a total of approximately 198 adult patients. We anticipate completion of enrollment in the VALID-ECG study in Q2 2024 and submission of the second 510(k) application by Q3 2024. We also previously completed an 80-patient pilot study using the same protocol as the VALID-ECG study. Based on the pilot results, we initiated the VALID-ECG study.

“During the fourth quarter, we announced significant developments related to the use of artificial intelligence (AI) applied to our VECG technology. By leveraging AI to analyze our data-rich signals, we believe we will be able to improve diagnostic accuracy and extract unique information that today’s ambulatory ECGs are unable to detect, such as complex heart rhythms, subtle signs of deteriorating heart health and cardiac events that may have previously been missed. This presents a unique opportunity to create a comprehensive repository of data that could unlock personalized AI-driven insights to improve cardiac care. Our team includes world class AI experts in previous positions with Google, Apple and Microsoft. In addition, two abstracts on our deep learning algorithm have been accepted for presentation at scientific meetings in April and May of this year. Importantly, we continued expanding our intellectual property footprint, recently receiving two new patents on our VECG technology.”

“We ended the fourth quarter of 2023 with approximately $16.2 million in cash and cash equivalents. We are using cash at a lower rate than anticipated, and believe we are in a strong position as we carefully manage spending, which we believe will extend our cash runway into early 2025. We look forward to providing updates on our progress in the months ahead,” concluded Dr. Vajdic.

Fourth quarter & full year 2023 financial results
Research and development expenses for the fourth quarter of 2023 were $2.0 million, compared to $1.6 million for the fourth quarter of 2022. For the year ended December 31, 2023, Research and development expenses increased to $6.8 million compared to $5.7 million in the same period of 2022.

General and administrative expenses for the fourth quarter of 2023 were $2.1 million compared to $2.1 million for the fourth quarter of 2022. For the year ended December 31, 2023, G&A expense increased to $8.5 million compared to $7.4 million in the same period of 2022.

Net loss for the fourth quarter of 2023 was $3.9 million, compared to a net loss of $3.7 million for the fourth quarter of 2022, and $14.6 million for the full year 2023 compared to $13.0 million in the same period of 2022.

Cash and cash equivalents totaled $16.2 million as of December 31, 2023, compared to $3.6 million as of December 31, 2022. Net cash used in operations was $12.1 million for the year ended December 31, 2023.
MB Bureau