A 24-month follow-up study found the implant maintained positive outcomes, a strong safety profile, and high patient satisfaction following lumpectomy.
Tensive Srl announced the publication of a positive interim analysis from a long-term study of its REGENERA/SOFTAG bioresorbable scaffold in the journal Breast Cancer. The data show that positive outcomes were maintained 24 months after the device was placed during breast-conserving lumpectomy surgery. Findings also showed high levels of investigator and patient satisfaction, a strong safety profile, no interference with imaging, and evidence of implant resorption in all patients.
The REGENERA/SOFTAG device is a bioresorbable implant designed to be placed where a tumor is surgically removed during a lumpectomy. The scaffold allows a patient’s own tissue to regrow in its place, restoring natural tissue and preserving the breast’s original shape and feel. Because it is gradually absorbed by the body, the implant does not require surgical removal. It also helps demarcate the lumpectomy boundaries on diagnostic imaging, supporting more targeted radiotherapy and monitoring for potential recurrence.
“The publication of these encouraging data in Breast Cancer strengthens our confidence in the transformative potential of Tensive’s implants. The gradual maturation of soft tissue, replacing the scaffold with newly grown tissue, highlights a truly lasting regenerative process,” says Alberto Cantaluppi, chief medical officer at Tensive, in a release. “We’re expecting to submit the product for regulatory approvals as early as spring 2026, a crucial step to fulfill our mission of improving clinical outcomes and quality of life for breast cancer patients.”
The ongoing long-term observational study followed 14 women who received the implant after a lumpectomy for benign lesions. Patients were evaluated for safety, device performance including changes in breast appearance and imaging interference, and satisfaction. Further interim results are planned for 36 and 48 months, with final results expected after 60 months of follow-up.
Separately, Tensive’s multi-center pivotal trial finished enrollment of 94 patients with malignant lesions in March, and final data on primary endpoints are expected in late 2025. According to the company, of the 2.1 million lumpectomies performed worldwide annually, 1.6 million are not reconstructed.
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