Description du projet
LifeMatrix is active in the fast-growing field of medical biomimetics and has developed a unique bio-engineering technology to grow human replacement tissues in the laboratory as next generation implants for the treatment of cardiovascular diseases. The patented LifeMatrix tissues can be manufactured as heart valves, blood vessels and other cardiovascular structures. When implanted, the patient’s own cells will vitalize and transform the LifeMatrixTM tissue into living heart valves and blood vessels which can grow and regenerate with the patient. The LifeMatrix technology has the objective of overcoming the significant limitations of existing implants.
The LifeMatrixTM Vascular Graft has been developed according to the compliance requirements of the Medical Device Regulation (MDR) and ISO-13485 and has been designed to meet the requirements for several indications in congenital heart surgery. In this regard, the LifeMatrixTM Vascular Graft has been tested extensively in in-vitro bench testing and in-vivo biocompatibility and performance testing which demonstrated clinical grade, long-term, safety and performance in translational GLP animal trials. Within this project we will perform additional in vivo studies to validate the LifeMatrixTM Vascular Graft in other relevant congenital indications (e.g. pulmonary artery reconstruction and right ventricular outflow tract reconstruction). If proven successful, this will allow LifeMatrix to expand the clinical development, strengthen the data for interactions with regulatory authorities, significantly increase the value proposition of the first product in discussions with potential investors and strategic partners and consequently boost the time to market.
To date, the full study protocol for the preclinical assessment of the LifeMatrixTM Vascular Graft has been developed together with a CRO and the LifeMatrixTM Vascular Grafts have been successfully manufactured using LifeMatrix’ proprietary bioengineering process. Following this, the LifeMatrixTM Vascular Grafts were successfully implanted into lambs as per protocoland the animals are now being followed up to assess the safety and efficacy of the LifeMatrixTM Vascular Graft.
Personnes participant au projet
Dernière mise à jour de cette présentation du projet 21.09.2022