Tensive S.r.l., a clinical-stage medical device company focused on advanced biomaterials, has released top-line results from a pivotal clinical trial of its REGENERA™ bioresorbable implant in women undergoing lumpectomy for breast cancer, highlighting encouraging safety, imaging compatibility and patient-reported outcomes.
The study evaluated REGENERA™, a sponge-like scaffold designed to be placed in the cavity left after tumor removal, where it supports the regrowth of the patient’s own tissue and is gradually absorbed by the body. The technology is intended to address a major gap in breast-conserving surgery, as an estimated 1.6 million of the 2.1 million women who undergo lumpectomy globally each year receive no form of reconstruction.
According to interim data from the multicenter trial, the device met its primary safety endpoint at three and six months, demonstrating a strong safety profile. Secondary analyses showed consistent and robust scaffold behavior in situ, with no interference in follow-up imaging or delivery of radiotherapy. The results are based on six-month follow-up data from 90 patients and 12-month data from 25 patients who were also receiving adjuvant treatments such as radiotherapy, chemotherapy or targeted therapy.
“Six-month follow-up represents a critical milestone in this patient population, particularly in the context of adjuvant cancer therapy,” said Dr. Manuela Roncella, lead investigator of the trial and breast surgeon at Ospedale Santa Chiara in Italy. “What we are seeing is particularly encouraging: the scaffold behaves consistently in the body, does not interfere with imaging, and has received strong qualitative feedback from both surgeons and patients. Together with the longer-term data, this supports the potential of this approach in post-cancer breast reconstruction.”
Investigators reported that REGENERA™ was safe, biocompatible and feasible for volume replacement in all eligible patients, while delivering high levels of patient and surgeon satisfaction and favorable aesthetic outcomes. A sub-study involving 15 participants also found that the implant helped accurately identify the tumor bed on imaging, supporting more precise delivery of adjuvant radiotherapy.
Tensive’s Chief Executive Officer, Dr. Sanjay Kakkar, said the findings move the company closer to commercialization. “These positive top-line results continue to demonstrate the transformational potential of REGENERA™ and add momentum to our plans to bring the device to patients in Europe and the U.S.,” he said. “We are working toward first regulatory approvals in early 2027 so we can improve clinical outcomes and preserve quality of life for millions of women who currently have no solution after lumpectomy.”
The ongoing pivotal trial (NCT05941299) completed enrollment of 94 women with malignant breast lesions in March. Participants will be followed for up to five years, with secondary endpoints including pain, quality of life and cosmetic satisfaction measured using the validated Breast-Q questionnaire, as well as any impact on diagnostic imaging.
The latest results build on earlier data from this study and from a first-in-human trial in 15 women with non-malignant breast lesions. Recently published two-year follow-up data from that initial study showed continued excellent safety, no interference with imaging and high performance, with 85.7% of patients rated as having “excellent” aesthetic outcomes.
REGENERA™/SOFTAG™ is designed to be inserted during lumpectomy as a one-step, minimally invasive procedure. The adjustable, bioresorbable scaffold allows healthy tissue to regrow into the space left by the removed tumor, restoring the breast with the patient’s own natural tissue while remaining clearly visible on imaging to support targeted radiotherapy and ongoing monitoring.
Full results from the pivotal trial will be submitted for presentation at upcoming scientific conferences and for publication in a peer-reviewed journal. Tensive is also set to present its technology to investors and industry partners during the JP Morgan Healthcare Conference in San Francisco in mid-January 2026, where Dr. Kakkar will appear on a panel discussing the future of medical devices in surgery and patient care.
