Company unveils patented technology designed to help maintain healthy blood flow during vascular procedures

Tulyp Medical, a Paris-based startup specializing in intelligent pressure-driven perfusion technology, has officially emerged from stealth mode and announced that it has submitted its 510(k) application to the U.S. Food and Drug Administration (FDA). The company’s launch follows encouraging results from its first-in-human clinical use, marking an important milestone in its mission to improve oxygen delivery during vascular procedures.

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Led by Chief Executive Officer Mano Iyer, a Partner at Sofinnova Partners and an experienced medtech entrepreneur, Tulyp Medical brings together an accomplished team that includes co-founder and Chief Operating Officer Tim Lenihan and cardiologists Dr. Navin Kapur and Dr. Richard Karas. This leadership group previously co-founded preCARDIA, another Sofinnova MD Start venture that developed a treatment for Acute Decompensated Heart Failure and was later acquired by Abiomed, a Johnson & Johnson company, in 2021.

Mano Iyer explained that Tulyp’s technology takes a new approach to perfusion by focusing on pressure rather than flow. He said that by controlling pressure, Tulyp aims to optimize oxygen delivery, reduce complications, and provide innovation that enhances patient outcomes. He added that the company represents the type of transformative advancement Sofinnova seeks, combining a strong clinical foundation, an experienced team, and a clear path toward commercial impact.

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Tulyp’s patented system was designed by a team of cardiologists, engineers, and entrepreneurs to support medical procedures requiring adequate tissue oxygenation, particularly in cases where blood flow is restricted. Unlike traditional perfusion systems that measure success by flow volume, Tulyp’s method is based on maintaining natural vascular pressure, a key factor in delivering oxygen efficiently. Dr. Richard Karas, co-founder and retired cardiologist, explained that almost all mammals—from mice to humans—maintain similar vascular pressures between 80 and 120 mmHg. This shared biological consistency supports the principle behind Tulyp’s system, which replicates natural pressure levels to enhance oxygenation during procedures.

Tulyp’s technology was recently used during a leg artery bypass surgery, where it helped maintain stable vascular pressure and improve oxygen delivery to tissues. Initial outcomes demonstrated both safety and performance, confirming that pressure-based perfusion can provide consistent oxygenation during critical interventions. The company’s 510(k) submission to the FDA seeks clearance for broader clinical use, a step that positions Tulyp Medical to advance its technology toward widespread adoption in vascular and surgical care.

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