Imagine a temporary sponge made of safe, dissolvable material that is placed in the breast after a tumor is removed. Instead of a permanent silicone bag, this sponge acts as a guide for the body to grow its own natural tissue. Once the body has rebuilt the breast, the sponge simply disappears on its own.
Lumpectomy patients lack effective reconstruction options, as traditional implants are unsuitable and autologous transfers are too painful and costly. Current solutions often require multiple follow-up surgeries and carry risks like rupture or leakage.
A cell-free porous scaffold made of resorbable biocompatible poly(urethane-ester-ether) with a biomimetic architecture. The project also developed the automated shaping process and toxicological risk assessments.
If you are a medical device company dealing with the risks of silicone rupture and leakage — this project developed a resorbable poly(urethane-ester-ether) scaffold that eliminates these risks by promoting tissue self-regeneration.
If you are a clinic dealing with the high cost and pain of multiple follow-up surgeries for lumpectomy patients — this project developed a cell-free porous scaffold that avoids follow-up surgeries and reduces patient pain.
If you are a materials firm dealing with the challenge of creating biomimetic architectures for tissue growth — this project developed a specific poly(urethane-ester-ether) composition that is fully resorbable and biocompatible.
Based on available project data, specific pricing or cost per unit is not mentioned.
Yes, the project studied shaping automation with positive results and planned a cleanroom revamping in 2025 to achieve GMP and MDR compliance.
Based on available project data, specific patent numbers or licensing terms are not provided, though the technology is developed by TENSIVE SRL.
The project performed chemical characterization of leachables and extractables and a toxicological risk assessment according to ISO 10993-17:2009.
The company is accelerating the CE mark achievement, with a manufacturing facility setup postponed to 2026.
The project is led by a single Italian SME, TENSIVE SRL, representing a 100% industry ratio. This lean structure suggests a fast-track commercialization path, focusing heavily on manufacturing optimization and regulatory compliance rather than academic research.
Contact TENSIVE SRL in Italy regarding the REGENERA scaffold
Contact us to explore licensing opportunities for resorbable breast implants.
