Tulyp Medical, a Paris-based medtech startup, has emerged from stealth and submitted a 510(k) application to the US Food and Drug Administration (FDA) for its patented pressure-driven perfusion device. The company’s announcement follows positive results from its initial first-in-human procedures.

The device is designed to maintain healthy blood flow during vascular procedures by controlling pressure rather than flow, a principle aimed at improving oxygen delivery and reducing complications. Tulyp’s technology was recently used during a routine leg artery bypass surgery, where it stabilised blood pressure and improved tissue oxygenation. Early results demonstrated both safety and functionality, supporting broader clinical evaluation.

Tulyp is led by Mano Iyer, partner at Sofinnova Partners and serial medtech entrepreneur, who serves as chief executive officer. Tim Lenihan, co-founder and chief operating officer, works alongside cardiologists Dr Navin Kapur and Dr. Richard Karas. The team previously co-founded preCARDIA, another Sofinnova MD Start company acquired by Abiomed, a Johnson & Johnson company, in 2021 following the successful development of a device for acute decompensated heart failure.

Tulyp’s approach applies a fundamental physiological principle to perfusion. “By controlling pressure rather than flow, we aim to optimize oxygen delivery, reduce complications, and bring meaningful innovation to vascular procedures. From an investor perspective, Tulyp represents the kind of transformational innovation we seek, with a proven team addressing a significant unmet clinical need, and a clear path to patient impact and commercial success,” Iyer said.

Richard Karas, MD, co-founder and retired cardiologist, explained the science behind the device: “Almost all mammals, from mice to humans to whales, have the same vascular pressure, between 80-120mmHg. Therefore, our biologic systems know how to deliver oxygen into tissue based on pressure, as opposed to flow. Our system is designed to deliver flow at these natural pressure levels, ensuring more effective oxygenation during critical procedures.”

Tulyp’s patented system has been developed by a team of cardiologists, engineers, and entrepreneurs to support procedures where tissue oxygenation may be obstructed, potentially preventing severe complications such as amputations or death. The company’s FDA 510(k) filing seeks clearance for broad clinical use, with plans to expand applications across a range of vascular interventions.