Tensive reports positive pivotal trial top-line results showing REGENERA™ bioresorbable device may transform breast reconstructionMilan, Italy – January 8, 2026 – Tensive S.r.l, a clinical-stage advanced biomaterials medical device company developing REGENERA™/SOFTAG™ bioresorbable scaffolds for breast reconstruction and tissue marking, today announced top-line results from a pivotal trial evaluating the REGENERA™ implant in patients undergoing lumpectomy to treat malignant lesions.
Tensive publishes positive long-term clinical follow-up data in Breast Cancer on REGENERA™ / SOFTAG™ breast implantMilan, Italy – 9 October, 2025 – Tensive S.r.l, a clinical-stage advanced biomaterials medical device company developing REGENERA™ (EU) / SOFTAG™ (U.S.) bioresorbable scaffolds for breast reconstruction and tissue marking, today announces the publication of a positive interim analysis in a long-term study with its REGENERA™ / SOFTAG™ implants in the leading peer-reviewed journal Breast Cancer. The data show that positive outcomes were maintained after 24 months of follow-up following placement of the device in breast-conserving lumpectomy surgery. The data also continue to show high levels of investigator and patient satisfaction, an excellent safety profile, and no interference with imaging. The study also showed that resorption of the implant is taking place in all patients.
Tensive provides positive clinical updates highlighting potential of REGENERA™ / SOFTAG™ device to transform post-cancer breast reconstructionMilan, Italy – September 5, 2025 – Tensive S.r.l, a clinical-stage advanced biomaterials medical device company developing REGENERA™ (EU) / SOFTAG™ (U.S.) bioresorbable scaffolds for breast reconstruction and tissue marking, today provides top-line results from two ongoing trials in patients undergoing lumpectomy to treat benign and malignant lesions respectively. The new data underscore the device’s potential to provide a natural, minimally invasive, permanent and safe solution for the 1.6 million patients per year who do not receive reconstruction after lumpectomy because of the lack of viable options.
Tensive appoints medical device veteran Bill Hunter Chairman as its bioresorbable scaffold for breast reconstruction after cancer approaches marketMilan, Italy – August 5, 2025 – Tensive S.r.l, a clinical-stage advanced biomaterials medical device company, and the developer of REGENERA™ and SOFTAG™ bioresorbable scaffolds for breast reconstruction and tissue marking, has appointed Bill Hunter, MD, as Chairman of its Board of Directors. Dr. Hunter brings more than 30 years of leadership in the medical technology and life sciences sectors. His appointment reflects Tensive’s focus on strengthening its governance and expanding its global network as it accelerates toward pivotal clinical milestones and commercialization in the U.S. and Europe.
