Tensive S.r.l., a clinical-stage medical device company specializing in advanced biomaterials, has announced encouraging top-line results from its pivotal trial evaluating the REGENERA™ bioresorbable scaffold for breast reconstruction following lumpectomy.
The trial, which enrolled 94 patients with malignant lesions undergoing adjuvant cancer therapy, assessed the safety and performance of the REGENERA™ implant. The device is designed to allow the body to regenerate its own breast tissue, providing a natural, permanent, and minimally invasive reconstruction option for the 1.6 million women worldwide who currently do not receive breast reconstruction after lumpectomy due to limited options.
“Six-month follow-up represents a critical milestone in this patient population undergoing adjuvant therapy,” said Dr. Manuela Roncella, lead investigator and breast surgeon at Ospedale Santa Chiara. “We observed consistent and robust scaffold behavior in situ, no interference with imaging, and strong positive feedback from both surgeons and patients. Combined with 12-month follow-up data in a subset of patients, these results highlight the potential of this approach in post-cancer breast reconstruction.”
REGENERA™ met its primary safety endpoint, demonstrating a favorable safety profile at both three- and six-month follow-ups. Secondary analyses showed consistent scaffold performance in situ. The interim analysis included six-month follow-up for 90 patients and 12-month follow-up for 25 patients receiving adjuvant therapy, including radiotherapy, chemotherapy, or targeted therapy.
“The positive outcomes from this pivotal trial underscore the transformational potential of REGENERA™,” said Dr. Sanjay Kakkar, CEO of Tensive. “We are progressing toward regulatory approvals in early 2027, aiming to improve clinical outcomes and preserve quality of life for women who currently have no solution for breast reconstruction after lumpectomy.”
In the trial, REGENERA™ was safe, biocompatible, and effective for volume replacement in all eligible patients. The device delivered high patient satisfaction, favorable aesthetic outcomes, and did not interfere with radiotherapy or follow-up imaging. A sub-study in 15 patients further confirmed the scaffold’s utility in accurately identifying tumor beds for targeted radiotherapy.
The ongoing multicenter pivotal trial (NCT05941299) has completed enrollment. Patients will continue to be followed for five years, with secondary endpoints including surgeon satisfaction, pain, patient quality of life (measured by the Breast-Q questionnaire), and interference with imaging.
REGENERA™ builds on positive outcomes from an earlier first-in-human trial of 15 women with non-malignant breast lesions, which showed excellent safety at two years, high aesthetic scores, and strong patient and investigator satisfaction.
Globally, of the 2.1 million lumpectomies performed each year, 1.6 million patients do not undergo reconstruction, highlighting a significant unmet clinical need. Traditional reconstruction procedures are often invasive, complex, and may fail to achieve the desired outcome.
REGENERA™/SOFTAG™ is a bioresorbable implant designed to be inserted during lumpectomy. Its sponge-like scaffold allows surgeons to adjust the size and shape for a one-step, minimally invasive procedure. The device supports regrowth of the patient’s own tissue and is gradually absorbed by the body, resulting in natural breast restoration. It is also clearly differentiated on diagnostic imaging, facilitating precise radiotherapy and accurate monitoring for recurrence.
Full results from the pivotal trial will be submitted for presentation at scientific conferences and peer-reviewed publication. Tensive will also participate in the JP Morgan Healthcare Conference in San Francisco in January 2026, highlighting its ongoing progress in advancing breast reconstruction solutions.
Tensive S.r.l. is dedicated to improving clinical outcomes and quality of life for breast cancer patients worldwide through innovative, accessible, and sustainable solutions.
