Tensive Reports Positive Pivotal Trial Results for REGENERA™ Bioresorbable Breast Reconstruction Device
核心洞察
Tensive's REGENERA™ (搜索) bioresorbable scaffold met its primary safety endpoint in a pivotal trial of 94 patients undergoing lumpectomy, demonstrating strong safety and biocompatibility at six-month follow-up.
The device achieved high levels of patient and surgeon satisfaction while maintaining favorable aesthetics and not interfering with radiotherapy delivery or follow-up imaging during adjuvant treatment.
REGENERA™ (搜索) addresses a significant unmet need for the 1.6 million women annually who do not receive breast reconstruction after lumpectomy, with first EU regulatory approvals expected in early 2027.
Tensive S.r.l (搜索) announced positive top-line results from its pivotal trial evaluating the REGENERA™ (搜索) bioresorbable implant in patients undergoing lumpectomy to treat malignant breast lesions (搜索). The multicenter study demonstrated that the device met its primary safety endpoint while showing encouraging secondary performance outcomes in 94 enrolled patients.
Clinical Trial Results Demonstrate Safety and Efficacy
The ongoing pivotal trial (NCT05941299) achieved its primary safety endpoint, demonstrating a strong safety profile at three and six-month follow-up periods. Secondary performance findings showed consistent scaffold behavior in situ based on six-month follow-up data from 90 patients and 12-month follow-up data from 25 patients receiving adjuvant therapy including radiotherapy, chemotherapy, and targeted therapy.
"Six-month follow-up represents a critical milestone in this patient population in the context of adjuvant cancer therapy," said Manuela Roncella, MD, breast surgeon at the Breast Surgery Unit, Ospedale Santa Chiara, and lead investigator of the pivotal trial. "In routine clinical practice, surgeons have limited options for volume replacement following lumpectomy. What we are seeing at six months is particularly encouraging: the scaffold shows consistent and robust behavior in situ and does not interfere with imaging, alongside strong qualitative feedback from both surgeons and patients."
Device Performance and Patient Outcomes
In the study, REGENERA™ (搜索) demonstrated safety, biocompatibility, and feasibility for volume replacement in breast-conserving surgery across all eligible patients. The device provided high satisfaction levels, favorable aesthetics, and did not compromise radiotherapy delivery or follow-up imaging during the post-surgical or adjuvant treatment period.
A sub-study involving 15 patients showed that the scaffold's use for imaging in identifying the tumor bed supported accurate delivery of adjuvant radiotherapy. Secondary endpoints included surgeon satisfaction, pain assessment, patient satisfaction and quality of life measured using the validated Breast-Q breast cancer (搜索) patient questionnaire, and interference with imaging.
Addressing Significant Unmet Medical Need
The clinical development of REGENERA™ (搜索) targets a substantial gap in breast cancer (搜索) care. Of the 2.1 million lumpectomies performed worldwide annually, 1.6 million are not reconstructed, representing a sizeable unmet clinical need. Despite the psychological impact of breast disfigurement, common cosmetic surgery options are rarely used due to their invasive and complex nature, often failing to achieve desired outcomes because of the irregular sizes and shapes of lumpectomies.
"These positive top-line results from our pivotal trial continue to demonstrate the transformational potential of REGENERA™ (搜索)," said Sanjay Kakkar, MD, Chief Executive Officer of Tensive. "This adds momentum to our progress in bringing the device to market for patients with breast cancer (搜索) in Europe and the U.S. We are working toward first regulatory approvals in early 2027, so that we can improve clinical outcomes and preserve the quality of life for the millions of women who currently have no solution for breast reconstruction after lumpectomy."
Technology and Mechanism of Action
REGENERA™ (搜索)/SOFTAG™ (搜索) is a bioresorbable implant designed to be inserted in place of surgically removed tumor tissue during lumpectomy procedures. The advanced biomaterial resembles a sponge with a fine scaffold matrix that can be rapidly adjusted for size and shape. Its placement during lumpectomy surgery represents a one-step, minimally invasive procedure that is fast and easy for surgeons to adopt.
The biomaterial enables patients' own healthy tissue to regrow in the area it fills while being gradually absorbed by the body. This process results in breast restoration composed of the patient's own natural tissue in their original breast shape. Additionally, the implant is clearly differentiated from surrounding tissue on diagnostic imaging, supporting more targeted radiotherapy delivery and more accurate monitoring for potential recurrence.
Supporting Clinical Evidence
The pivotal trial results build upon previously published positive data from an earlier first-in-human trial involving 15 women who underwent lumpectomy of non-malignant breast lesions (搜索) and received the REGENERA™ (搜索) bioresorbable implant. Follow-up data from this initial study, recently published in a peer-reviewed journal, demonstrated continued excellent safety at two years, no interference with imaging, and high performance levels, with an aesthetic score of 'Excellent' in 85.7% of patients.
Regulatory Timeline and Next Steps
Patients in the pivotal trial will continue to be followed for five years to assess long-term safety outcomes. Full results from the pivotal trial will be submitted for presentation at upcoming scientific conferences and for publication in peer-reviewed medical journals. The company expects first regulatory approvals in the European Union in early 2027.