PORTEFEUILLE

Valve-sparing aortic root replacement (called David procedure) involves repairing the aortic valve and replacing the aortic root with a prosthetic graft while the heart is stopped. However, there exists no method to accurately assess the operative result (tightness of the valve) during the surgery. Instead, the current state-of-the-art requires surgeons to perform a visual assessment of valve tightness during the surgery while the final assessment is done by ultrasound only after everything is closed up and the heart is restarted. Approximately 20% of all cases result in unsatisfactory tightness (excessive valve leakage), necessitating reintervention of the valve, which significantly increases surgical risk, hospital costs, and patient burden. Consequently, surgeons often opt for valve replacement despite the potential benefits of repair. TightValve solves this unmet clinical need with “the first device to quantify aortic valve leakage during cardiac surgery”. This will allow the surgeon to fix leaky valves on the spot during surgery before closing up and restarting the heart. TightValve offers an easy and quick to use device which will significantly lower the risk for reintervention, reduces patient burden, improves patient outcome, reduces operation time and reduces costs for the healthcare system. Further, this reduced risk of valve re-assessment might enable more patients to receive the best treatment option by keeping their own valve instead of getting their valve replaced.

TightValve is in the transition from research into business, and we are just about to incorporate as a spin-off from the University of Bern and University Hospital Bern. We have an ex-vivo validated prototype, and we are just about to start our first in-human proof-of-concept study to generate key results to industrialize our product and convince investors and key-opinion leaders. This will lay the foundation for the first investor seeding round and all regulatory steps ahead to bring our medical device to the market. The project goals of this InnoBooster project are (1) to prove that our device is capable of measuring valve leakage intraoperatively in the first-in-human feasibility study, (2) to refine the prototype design based on feedback from the feasibility study, (3) to further develop the software application and (4) to document and prepare for the next stages towards medical certification and market launch.