Tulyp Medical Emerges From Sofinnova’s Medtech Accelerator and Announces FDA Submission Following Initial First-in-Human Use

PARIS–(BUSINESS WIRE)–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. This idea comes from a simple but powerful observation: most mammals share a similar blood pressure range.

“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,” said Richard Karas, M.D., Ph.D., Tulyp’s co-founder and retired cardiologist. “Our system is designed to deliver flow at these natural pressure levels, ensuring more effective oxygenation during critical procedures.”

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.

About Tulyp Medical
Tulyp Medical, Inc. (“Tulyp”) is a Paris based privately held, medical device company and part of Sofinnova MD Start, Sofinnova Partners’ medical device accelerator. The company is developing a patented pressure-driven perfusion system for vascular procedures. Based on the fundamental principle that oxygen delivery is governed by vascular pressure rather than flow, Tulyp’s technology is designed to improve tissue oxygenation and reduce complications in patients undergoing major interventions. For more information, visit Tulyp Medical’s LinkedIn page.

About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage.

Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners manages over €4 billion in assets. For more information, please visit: sofinnovapartners.com.