Successful CardiAMP Heart Failure Trial
The CardiAMP Heart Failure Trial demonstrated safety and meaningful benefits for heart failure patients, potentially addressing a significant unmet clinical need for approximately 1 million Americans.
New Trial Enrollments and Progress
The CardiAMP Heart Failure II Trial is actively enrolling patients at three clinical sites with plans to be fully enrolled over the next two years, aiming to confirm previous results and enhance enrollment.
Data Safety Monitoring Board Review Success
The CardiALLO allogeneic mesenchymal stem cell therapy for ischemic heart failure passed a Data Safety Monitoring Board review, with no adverse events in the low-dose cohort.
Helix Biotherapeutic Delivery System Advances
Preparation for submission for approval of the Helix biotherapeutic delivery system is underway, with potential to be the first approved transendocardial biotherapeutic delivery system in the U.S.
Approval of Morph DNA Platform
The FDA approved the Morph DNA steerable introducer platform, which is being positively received by physicians.