Tulyp Medical came out of stealth on November 3, 2025 with a 510(k) already filed. The Paris company built its pressure-driven perfusion system inside Sofinnova's MD Start accelerator and used it in a first-in-human case during a routine leg artery bypass, where the company reported stable vascular pressure and better tissue oxygenation.
The premise is that oxygen delivery tracks pressure rather than flow volume, so the system holds vascular pressure in the 80 to 120 mmHg band during procedures that would otherwise obstruct blood supply. The target indication is acute limb ischemia, where the alternative outcomes are amputation or death. The device is investigational.
Mano Iyer, a Sofinnova partner, was CEO at launch alongside co-founders Tim Lenihan, Navin Kapur and Richard Karas. The same core team built preCARDIA, which Abiomed bought in 2021. Steve Motes, previously at Abbott, Medtronic and Edwards Lifesciences, took over as CEO on May 17, 2026 while Iyer moved to the board, with operations added in Dallas.
Coming out of stealth on the day of a 510(k) filing rather than on a funding round is a deliberate order of operations. It puts the regulatory clock, not the raise, in the headline.