Project description
Innovative resorbable implants for breast reconstruction surgery
Breast tissue modifications and restorations utilise silicone implants, which are associated with significant risks and need replacement every 10-15 years. The alternative fat grafting technique requires multiple interventions for large reconstructions, has been linked to carcinogenic risks and does not promote vascularisation. Italian-based company Tensive has developed a bioabsorbable scaffold based on highly biocompatible polyurethane ester. The patented scaffold provides a synthetic microvascular network that supports adipocyte colonisation in vivo. The unique design enables vascularisation, and the scaffold degrades over time to be replaced by the patient´s fat tissue. The EU-funded REGENERA project aims to bring to market this innovative mammary prosthesis by conducting the first-in-human trial and completing the regulatory requirements for commercialisation.
Objective
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
Fields of science
Programme(s)
Funding Scheme
SME-2 - SME instrument phase 2Coordinator
20124 Milano
Italy
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.