Medtech startup co-founded by cardiologist seeks FDA clearance for new-look perfusion device

Tulyp Medical, a French medtech startup, has emerged from stealth and announced its intention to secure U.S. Food and Drug Administration (FDA) clearance for a patented perfusion device designed to manage blood flow during vascular procedures.

The company’s technology was developed with help from veteran cardiologists. It provides support during a variety of procedures by ensuring the patient’s blood pressure stays in a predetermined range. According to Tulyp Medical, using the device should improve patient access to complex procedures that require the oxygenation of tissue.

“Almost all mammals, from mice to humans to whales, have the same vascular pressure, between 80-120 mmHg,” Richard Karas, MD, PhD, Tulyp Medical’s co-founder and a retired cardiologist, said in a statement. “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 approach is unique because it applies a fundamental physiologic principle to perfusion,” added Tim Lenihan, Tulyp Medical co-founder and chief operating officer. “By controlling pressure rather than flow, we aim to optimize oxygen delivery, reduce complications, and bring meaningful innovation to vascular procedures.”