Helping cancer survivors restoring their natural breast with resorbable implants inducing self‐tissue regeneration

Description du projet

Des implants résorbables innovants pour la chirurgie de reconstruction mammaire

Les modifications et reconstitutions des tissus mammaires font appel à des implants en silicone, qui s’accompagnent de risques notoires et doivent être remplacés tous les 10 à 15 ans. La technique alternative de greffe de graisse implique de nombreuses interventions pour les grandes reconstructions, a été liée à des risques cancérigènes et ne favorise pas la vascularisation. La société Tensive, basée en Italie, a développé un échafaudage bioabsorbable à base de polyuréthane ester hautement biocompatible. L’échafaudage breveté apporte un réseau microvasculaire synthétique qui favorise la colonisation des adipocytes in vivo. Cette conception unique favorise la vascularisation, et l’échafaudage se dégrade avec le temps pour être remplacé par le tissu adipeux du patient. Le projet REGENERA, financé par l’UE, a pour objectif de mettre cette prothèse mammaire innovante sur le marché en réalisant le tout premier essai sur un être humain et en remplissant les exigences réglementaires pour sa commercialisation.

Objectif

Tensive was founded in 2012 to address the challenge of developing better biomaterials for regenerative medicine. We developed a bio absorbable scaffold based on highly biocompatible polyurethaneester. Our patented scaffolds provide a synthetic micro-vascular network that enables adipocytes colonization in vivo. This unique design leads to vascularization, fat integration and volume maintaining after implantation. Based on these unique properties, we will bring to the market REGENERA, an innovative mammary prosthesis that is degraded over time and replaced by the patient´s fat. Silicone implants, the most currently used breast tissue modifications, have important risks and need replacement every 10-15 years. Fat grafting, the best alternative nowadays, has been linked to carcinogenic risks and does not promote vascularization (leading to necrosis) with multiple interventions needed for large reconstructions. REGENERA, which only requires one surgical intervention, will meet the need to develop biomaterials able to promote new blood vessels formation that perpetuate the reconstructed tissue. REGENERA will have a significant impact on various levels: (i) Healthcare system: it will save the cost of additional surgeries (more than €241M yearly in the EU), helping to the sustainability of the Healthcare system. (ii) breast cancer patients: it will offer a solution to lumpectomy patients, for whom there are no good solutions yet; a better alternative for mastectomy and breast augmentation patients; a permanent solution by a single surgery for all patients, improving their quality of life. (iii) company: it will increase Tensive’s revenues (cumulative profit of €257M with a ROI of 19.37 by 2025) (iv) society: it will highly benefit 230,000 women needing reconstructive surgery after breast cancer, together with the 1.35M women undergoing breast augmentation for personal reasons