TENSIVE

Tensive S.r.l. is a clinical-stage advanced biomaterials medical device company founded in 2012 and headquartered in Milan, Italy, focused on regenerative medicine for reconstructive surgery following breast cancer. The company is developing REGENERA™/SOFTAG™, a bioresorbable polymeric scaffold placed in a single surgical step during lumpectomy that naturally regenerates breast tissue while remaining fully compatible with radiotherapy and post-operative MRI/ultrasound imaging. Interim pivotal trial results published in 2026 reported zero device-related adverse events at 90 days, 100% radiotherapy completion, and 88% good-to-excellent cosmetic outcomes across 25 patients. Tensive is targeting CE Mark submission in mid-2026 with first EU approval expected in early 2027.