Starlight Cardiovascular

Executive Summary

Starlight Cardiovascular is a privately held medical device company dedicated to developing pediatric-specific devices for babies born with congenital heart disease (CHD). Founded in 2019 and based in San Carlos, CA, the company addresses a critical gap in cardiac care: most existing devices are adapted from adult cardiology, often leading to suboptimal outcomes for pediatric patients. Starlight's mission is to improve morbidity, mortality, and access to care for this vulnerable population by designing tools tailored to the unique anatomy and physiology of infants and children. The company's portfolio focuses on interventional and surgical devices that aim to provide safer, more effective treatment options for CHD, a condition affecting nearly 1% of live births worldwide. Despite the significant unmet need, Starlight remains in early development stages with no disclosed funding rounds or regulatory milestones. The company's progress is likely dependent on raising capital to advance prototype development and preclinical testing. Given the complexity of pediatric device development and the stringent regulatory pathway, near-term catalysts are expected to center around financing and initial clinical validation. Starlight's success hinges on demonstrating safety and efficacy in a niche but high-need market, where specialized competitors are scarce but regulatory and clinical hurdles are substantial.

Upcoming Catalysts (preview)

• Q3 2026Series A Funding Round70% success
• Q4 2026FDA Breakthrough Device Designation60% success
• Q1 2027First Preclinical Study Results55% success