Clinical TrialsAfter twelve cell and gene therapy clinical studies, including CardiAMP and CardiALLO trials, demonstrating a high safety standard, the company plans to submit the Helix biotherapeutic delivery system for approval to the FDA.
Patient OutcomesPatients experienced an average increase in exercise tolerance of 80 seconds and an average of 82% reduction in angina episodes vs. baseline.
Regulatory ProgressPotential approval of proprietary biotherapeutic delivery device should strengthen financial position and support clinical progress.