Business
HeartBeam Reports Second Quarter 2024 Results
Continued Clinical and Regulatory Progress on the HeartBeam AIMIGo™ System Enrollment Complete in VALID-ECG Clinical Study That Will Be the Basis of the
About this update from Heartbeam, Inc.
[{"type":"text","content":"\nContinued Clinical and Regulatory Progress on the HeartBeam AIMIGo™ System\n\n\nEnrollment Complete in VALID-ECG Clinical Study That Will Be the Basis of the Upcoming FDA Submission on the 12-Lead Synthesis Software\n\n\nManagement to Host Webcast and Conference Call Today at 4:30 p.m. ET\n\n\n SANTA CLARA, Calif.--(BUSINESS WIRE)--\nHeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, has reported its financial and operational results for the second quarter ended June 30, 2024.\n\n\nSecond Quarter & Subsequent 2024 Operational Highlights\n\n\nThe Company made steady progress toward key clinical and regulatory milestones on its HeartBeam AIMIGo™ System.\n\n\nAIMIGo 510(k) Submission:\n\n\n\nThe 510(k) submission for the HeartBeam AIMIGo System is currently being reviewed by the FDA.\n\n\n\nAIMIGo is a credit card-sized, cable-free cardiac monitoring device that will be capable of producing a 12-lead ECG by leveraging the Company’s core vector technology, which captures 360-degree signals of the heart’s electrical activity. The Company owns patents supporting the underlying technology.\n\n\n\nThis is the cornerstone submission for HeartBeam and will be the basis of future submissions.\n\n\n\nThe Company has successfully resolved the vast majority of the questions the FDA has asked. During the second quarter of 2024 the FDA requested additional information, which the Company is in the process of providing. The Company is working with the FDA to address the small number of remaining questions.\n\n\n\nThe Company continues to plan for a limited launch of AIMIGo by the end of 2024.\n\n\n\n12-Lead Synthesis Software Submission:\n\n\n\nHeartBeam has completed two pre-submission meetings with the FDA on the planned second 510(k) submission, which will be submitted after the initial clearance of the AIMIGo System.\n\n\n\nThe second submission is focused on the algorithms that convert the 360-degree signals captured by the AIMIGo System into a synthesized 12-lead ECG.\n\n\n\nA key component of the submission will be the results of the VALID-ECG pivotal study, which is designed to demonstrate the similarity between the synthesized 12-lead ECG and a standard 12-lead ECG.\n\n\n\nPatient enrollment for VALID-ECG was completed on June 20, 2024.\n\n\n\nTh...