OUR PIPELINE
Tensive’s candidate device (REGENERA™/SOFTAG™) consists of a proprietary resorbable biopolymer under development as a tissue scaffold and a tumor bed marker. In Europe, REGENERA™ is in development under the CE Mark pathway for breast reconstruction and tissue marking in patients with breast cancer undergoing lumpectomy. In the U.S., SOFTAG™ is in development for the tissue marking indication first. We expect regulatory approval for both programs in 2027.
The same technology is potentially applicable for breast augmentation and Tensive is exploring this additional application.
REGENERA™ pivotal trial
REGENERA™ is in a multi-center pivotal trial in 94 patients undergoing lumpectomy to remove malignant lesions, followed by adjuvant radiotherapy, chemotherapy, and/or targeted therapy. Preliminary data from the first 16 patients were published in Updates in Surgery in April 2025, with investigators writing: “In conclusion, we are convinced that REGENERA could represent a great innovation in breast oncological surgery, representing a possible alternative to volume replacement with faster operative time, faster recovery, less morbidity, and good patient satisfaction. (A.V.E. Lisa et al. Updates in Surgery Apr 2025 — https://doi.org/10.1007/s13304-025-02212-2).
Interim data from 25 patients treated with adjuvant radiotherapy with 6 months of follow- up, currently in preparation for publication, show that REGENERA™ is safe, biocompatible, and feasible for volume replacement in breast-conserving surgery (BCS). The candidate device achieved high surgeon and patient satisfaction, favorable aesthetics, and does not compromise radiotherapy delivery or follow-up imaging.
The pivotal trial completed enrollment in March. Final data on the primary safety and secondary performance endpoints are expected in late 2025. Secondary endpoints include surgeon satisfaction, pain, patient satisfaction and quality of life measured using the validated Breast-Q Breast Cancer patient questionnaire, and interference with imaging. Patients will continue to be followed for five years.
First-in-Human study
The first-in-human (FIH) trial of REGENERA™ in 15 patients who underwent lumpectomy to remove benign tumors demonstrated positive safety and outstanding performance.
REGENERA™ achieved high investigator and patient satisfaction. Imaging data confirmed volume replacement and ingrowth of cellular, hydrated, and vascularized tissue.
“REGENERA™ could represent a great innovation in breast oncological surgery, representing a possible alternative to volume replacement with faster operative time, faster recovery, less morbidity, and good patient satisfaction” – investigators on preliminary data from first 16 patients in pivotal study – Updates in Surgery, April 2025.
These results followed the publication in Breast Cancer in 2023 of six-month follow-up data from five patients that demonstrated positive outcomes in terms of both safety and performance, leading the authors to conclude that the data were “paving the way to an innovative approach with a potential remarkable impact on clinical application of tissue engineering. (Mariniello et al. Breast Cancer 2023 — https://doi.org/10.1007/s12282-023-01446-5).
SOFTAG™
In the U.S., SOFTAG™ is being developed for tissue marking after lumpectomy. The application will include data from an ongoing preclinical study designed to demonstrate its marking efficacy, as well as human safety data from the FIH and pivotal trials of REGENERA™ for breast reconstruction.
BREAST AUGMENTATION
Tensive is currently conducting preclinical studies to support a European FIH trial of REGENERA™ for breast augmentation. The FIH study is planned to begin in 2026.