PARIS, France — Tulyp Medical, a Paris-based medical device startup developing an intelligent pressure-driven perfusion system, announced its emergence from Sofinnova Partners’ Medtech Accelerator, Sofinnova MD Start, and the submission of 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 demonstrating the safety and functionality of its patented technology.
Tulyp Medical is led by Mano Iyer, Partner at Sofinnova Partners and a serial medtech entrepreneur, who serves as Chief Executive Officer. He is joined by co-founder and Chief Operating Officer Tim Lenihan, along with cardiologists Dr. Navin Kapur and Dr. Richard Karas. The team previously co-founded preCARDIA, another Sofinnova MD Start company acquired in 2021 by Abiomed, a Johnson & Johnson company, after successfully developing a device to treat 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—one with a proven team, a significant unmet clinical need, and a clear path to patient impact and commercial success.”
Tulyp’s patented technology is designed to maintain healthy blood pressure during vascular procedures by focusing on pressure-driven rather than flow-driven perfusion. Developed by a team of cardiologists, engineers, and medtech innovators, the device supports procedures that require continuous oxygenation of tissues at risk of obstruction, which can otherwise lead to severe complications such as amputation or death.
“Almost all mammals, from mice to humans to whales, have the same vascular pressure—between 80 and 120 mmHg,” said Richard Karas, M.D., Ph.D., Tulyp co-founder and retired cardiologist. “Our biologic systems deliver oxygen into tissue based on pressure rather than flow. Tulyp’s system is designed to maintain these natural pressure levels, ensuring more effective oxygenation during critical procedures.”
Tulyp’s technology was recently used in a routine leg artery bypass surgery, where it successfully stabilized blood pressure and improved oxygenation. The early results validated the safety and potential of pressure-driven perfusion in maintaining vascular stability and supporting tissue recovery.
With its FDA submission now filed, Tulyp Medical is advancing toward clinical clearance and broader adoption, aiming to redefine perfusion management and improve outcomes across a range of vascular interventions.
