AZIENDA PROVINCIALE PER I SERVIZI SANITARI DELLA PROVINCIA AUTONOMA DI TRENTO

Tensive Reports Positive Pivotal Trial Results for REGENERA™ Bioresorbable Breast Reconstruction Device

- Tensive's REGENERA™ bioresorbable scaffold met its primary safety endpoint in a pivotal trial of 94 patients undergoing lumpectomy, demonstrating strong safety and biocompatibility at six-month follow-up. - The device achieved high levels of patient and surgeon satisfaction while maintaining favorable aesthetics and not interfering with radiotherapy delivery or follow-up imaging during adjuvant treatment. - REGENERA™ addresses a significant unmet need for the 1.6 million women annually who do not receive breast reconstruction after lumpectomy, with first EU regulatory approvals expected in early 2027.