NOVOSTIA’S TRIFLO HEART VALVE COMPLETES FIRST TRIAL PHASE

Novostia’s TRIFLO Heart Valve shows promise in early clinical trials, aiming to replace heart valves without lifelong anticoagulation.

“I believe that in Switzerland we have everything we need to succeed: market maturity, competency and an innovative, entrepreneurial culture.”

Alain Barbel

former CEO of Novostia

Today Novostia, based at Biopôle, a life science campus within Switzerland Innovation Park West EPFL, is advancing the next generation of heart valve prostheses with its TRIFLO Heart Valve, engineered to eliminate the need for lifelong anticoagulation and reduce the discomfort caused by noisy valve operation. The company’s innovation focuses on improving quality of life for patients undergoing aortic valve replacement.

The First-In-Human clinical study, known as PILATUS (NCT06119607), was launched in December 2023 at Vilnius University Hospital Santaros Klinikos. Ten patients received the TRIFLO valve under the care of Prof. Kęstutis Ručinskas, Head of the Heart and Thoracic Surgery Centre. All implantations were completed successfully, and early data show significant post-operative recovery and symptom improvement.

One of the key features of the TRIFLO valve is its potential to function safely with minimal or no anticoagulation therapy—a major differentiator from existing mechanical valves. Patients in the study are expected to stop anticoagulation by September 2024. The trial includes an 18-month follow-up to evaluate mid-term outcomes and a five-year program to assess durability.

To support this development, Novostia raised CHF 5.6 million in September 2024 and appointed Soad El Ghazouani as CEO. With over 20 years of experience in the cardiovascular industry, she will lead the company into the next phase of regulatory and market expansion. Novostia’s progress highlights the potential for truly life-changing innovation in structural heart disease treatment.

Novostia TRIFLO Heart Valve
Copyright: © Novostia

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