Tulyp Medical Announces FDA Submission Following Initial First-In-Human Use

Tulyp Medical, a Paris-based startup developing a medical device for intelligent pressure-driven perfusion, emerged from stealth and announced it has submitted its 510(k) application to the U.S. Food and Drug Administration (FDA). The company’s debut follows positive results from its initial first-in-human study.

Tulyp is led by Mano Iyer, Partner at Sofinnova Partners and a serial medtech entrepreneur, who serves as Chief Executive Officer. 

Tim Lenihan, co-founder and Chief Operating Officer, joins cardiologists Dr. Navin Kapur and Dr. Richard Karas in developing the company’s technology. The same team previously co-founded preCARDIA, another Sofinnova MD Start company acquired in 2021 by Abiomed, a Johnson & Johnson company, following the successful development of a device for treating Acute Decompensated Heart Failure (ADHF).

“Tulyp’s approach is unique because it applies a fundamental physiologic principle to perfusion,” said Iyer. “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.”

Tulyp’s patented technology has been developed by a team of experienced cardiologists, engineers, and entrepreneurs to support various procedures that require appropriate oxygenation of tissue that may otherwise be obstructed and lead to severe complications, including amputations or death. 

Unlike traditional methods that focus on how much blood is flowing, Tulyp’s approach is based on maintaining the right pressure, which is a key factor in delivering oxygen to the body.

The technology was recently used during a routine leg artery bypass surgery, where it helped stabilize blood pressure and improve oxygenation. Results in the initial procedures demonstrated safety and functionality, with pressure-driven perfusion maintaining stable vascular pressure and improving tissue oxygenation. Tulyp has filed a 510(k) application with the FDA seeking clearance for broad clinical use.