NuPulseCV

Executive Summary

NuPulseCV is a private medical device company developing the NuPulse Voyage, a minimally invasive long-term cardiac assist device for patients with chronic heart failure. Unlike traditional left ventricular assist devices (LVADs) that require major surgery and tethered power sources, the NuPulse Voyage leverages counterpulsation therapy via a small, percutaneously placed pump that can be delivered through the subclavian artery. This design allows patients to be ambulatory and potentially discharged home, addressing a critical unmet need for a less invasive, durable support option. The device's physiological approach aims to reduce ventricular workload while improving coronary perfusion, similar to intra-aortic balloon pumps but designed for extended use. Founded in 2015 and headquartered in Durham, North Carolina, the company is advancing toward clinical validation of this novel technology. The company is currently preparing for a pivotal trial to support market approval from the FDA. Given the significant market opportunity in heart failure—affecting over 6 million Americans—and the potential to offer a less invasive alternative to surgical LVADs, NuPulseCV's success could transform the standard of care. The pivotal trial will likely evaluate safety and efficacy endpoints such as survival, quality of life, and adverse events. While still private and without disclosed funding or valuation, the company's progress toward a pivotal study positions it for potential regulatory submission within the next 2-3 years. Key risks include the challenges of device durability, infection, and thromboembolism, as well as the need to demonstrate clear superiority or non-inferiority to existing therapies.

Upcoming Catalysts (preview)

• Q2 2026IDE Approval for Pivotal Trial90% success
• Q3 2026First Patient Enrollment in Pivotal Trial80% success