The implant is designed to support tissue regrowth following lumpectomy and shows favorable safety and aesthetic outcomes in early results.
Tensive Srl has released positive top-line results from two ongoing trials for its REGENERA (EU)/SOFTAG (US) bioresorbable scaffold, an implant intended for breast reconstruction following lumpectomy procedures. The data suggests the implant is a safe and feasible option for volume replacement in breast-conserving surgery.
The REGENERA/SOFTAG device is a bioresorbable implant with a fine scaffold matrix designed to be inserted in place of a surgically removed tumor. According to the company, the device is gradually absorbed by the body, allowing the patient’s own tissue to regrow into the space, which helps preserve the breast’s original shape and feel. The implant is also designed to be distinct from surrounding tissue on diagnostic imaging to support targeted radiotherapy and monitoring.
Early Clinical Trial Results
In an interim analysis of Tensive’s pivotal trial, the REGENERA device met its primary safety and secondary performance objectives based on a 6-month follow-up of 25 patients receiving adjuvant therapy.
A separate interim analysis of 25 patients who received only adjuvant radiotherapy found the device to be safe, biocompatible, and effective for volume replacement. Investigators also noted high patient satisfaction, favorable aesthetics, and no interference with radiotherapy delivery or follow-up imaging. A sub-study of 15 of these patients showed encouraging preliminary results for using the scaffold to help identify the tumor bed.
“The successful interim analyses of our pivotal trial and additional positive follow-up data continue to demonstrate the potential of REGENERA/SOFTAG. These results add momentum to our progress in bringing the devices to market for patients with breast cancer in Europe and the US…With our team, we are working toward first regulatory approvals as early as Q1 2027,” says Sanjay Kakkar, chief executive officer of Tensive, in a release.
The pivotal trial completed enrollment of 94 patients in March, with final data on primary endpoints expected in late 2025. The company notes that of the 2.1 million lumpectomies performed worldwide annually, an estimated 1.6 million are not reconstructed, representing a significant unmet clinical need.
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