Novostia is excited to announce that it has secured an additional CHF 5.6 million in funding to advance its clinical trials and that it has appointed Mrs. Soad El Ghazouani as the new CEO. With her extensive experience in the cardiovascular field, Mrs. El Ghazouani will lead Novostia's mission to revolutionize aortic valve replacement with the innovative TRIFLO Heart Valve.
Novostia has announced the successful implantation of the 10th patient in its First-In-Human clinical study of the TRIFLO Heart Valve (ClinicalTrials ID: NCT06119607). Conducted between December 2023 and May 2024, all surgeries were successful, showing promising early results and significant improvements in patient recovery and well-being. The patients will be monitored for 18 months, with long-term performance evaluated over five years.
Promising experimental flow visualization (PIV) results have been presented by Lorenzo Ferrari during the Heart Valve Society (HVS) Annual Meeting 2024 in Boston, USA. Comparison with mechanical and biological commercially available prostheses emphases the potential superiority of the TRIFLO regarding flow patterns.
In the frame of its First-In-Human Clinical study PILATUS (ClinicalTrials ID: NCT06119607), the company has successfully implanted in December 2023 its groundbreaking TRIFLO Heart Valve in a human patient for the first time, marking a momentous achievement in the field of valve replacement. This FIH was performed in the context of a prospective, single-arm, exploratory clinical investigation to assess preliminary safety and collect performance and effectiveness data of the TRIFLO Heart Valve. The surgery was performed by Prof. K. Ručinskas and its team at the Vilnius University Hospital Santaros Klinikos, Lithuania.
Novostia has received approval from the Lithuanian State Health Care Accreditation Agency to launch First-in-Human implantations (FIH) of its groundbreaking aortic heart valve prosthesis, the TRIFLO.❤️
The Series A round that pave the way to the launch of First-in-Human (FIH) has just been closed. Series B will be opened this summer, after re-evaluation of the company.
Novostia is in the process of increasing its Share Capital to CHF 203,000 with a new injection of funds of one million. This new investment is linked to the reaching of a strategic milestone: the confirmation of the safety and performance of the TRIFLO valve on animals.
The private and public (EC/H2020) funds raised since the foundation of the company in April 2017 now amount to about 7.5 million. Subsidies from the SPEI and the Biopôle are not included in these funds. Although modest, they have nevertheless enabled the recruitment of key employees, the launch of valve experiments and the participation in international conferences that have all contributed in a positive way to the progress of the TRIFLO project.
Two new fundraisings are open: the first one of 2 million for the one-year follow-up of the first 10 patients who will be implanted with our valve in less than 12 months; the second one of 10 million to launch the pilot study as soon as possible (50 patients, 3 valve sizes and 3/4 centres).
Dr Iman Borazjani's group (Texas A&M) presented the results of the fluid dynamic simulations at the 75th Annual Meeting of the Division of Fluid Dynamics, Indianapolis. The abstract entitled "Computational assessment of the hemodynamics and platelet activation potential of a Trileaflet Mechanical Heart Valve and their comparison with a Bioprosthetic and a Bileaflet Mechanical Heart Valve" brings proofs of the superiority of the TRIFLO valve over commercially available bi-leaflet mechanical valves.
Novostia attended the EACTS (European Association of Cardio-Thoracic Surgery) Congress held in Milan this October 2022. During this event, one of our key partners for preclinical in vivo studies, the University of Leuven represented by Professors Bart Meuris and Tom Langenaeken, presented the latest results of animal studies with the TRIFLO valve. In the sidelines of this congress, Novostia convened its pool of Medical Advisors, a team of eight internationally renowned surgeons, all very active in the quest for premium cardiac valves and fervent supporters of the TRIFLO, to pave the way for the FIHs that will start in a dozen months.
