Tensive, an Italian clinical-stage medical device company, has reported topline results from two ongoing trials for its bioresorbable scaffold device, Regenera (EU)/Softag (US), aimed at transforming breast reconstruction for patients undergoing lumpectomy.
Results from two ongoing trials demonstrate that the device met its primary safety and secondary performance objectives, reinforcing its potential as a minimally invasive, natural, and durable alternative to traditional reconstructive options.
“The successful interim analyses of our pivotal trial and additional positive follow-up data continue to demonstrate the transformational potential of Regenera/Softag,” said Sanjay Kakkar, CEO of Tensive. “We are working toward first regulatory approvals as early as Q1 2027, with the goal of providing a safe and lasting solution for millions of women worldwide who currently lack viable reconstruction options after lumpectomy.”
Strong Interim Data
The interim analysis, which included 25 patients receiving adjuvant therapies such as radiotherapy, chemotherapy, or targeted therapy, confirmed a strong safety profile and favorable performance outcomes. Patients and surgeons reported high levels of satisfaction with aesthetic results and overall tolerability.
A separate analysis of 25 patients who received only radiotherapy further underscored the device’s promise. Investigators found Regenera to be safe, biocompatible, and effective in replacing lost breast volume while maintaining compatibility with imaging and radiotherapy.
In a sub-study involving 15 patients, the implant also proved useful in helping clinicians identify the tumor bed, an important factor in guiding radiotherapy planning and improving long-term monitoring.
The new findings build on earlier results from Tensive’s first-in-human study, published in Updates in Surgery in April 2025. That trial followed 15 women who underwent lumpectomy for benign breast lesions and received Regenera implants.
“The implant demonstrated consistent performance over two years, with preserved breast contour and no significant complications,” the study authors noted. “This underlines the potential of bioresorbable scaffolds as an effective alternative to conventional reconstructive surgery.”
Looking Ahead
Regenera offers a one-step, minimally invasive procedure. The implant resembles a fine sponge-like scaffold and is inserted during lumpectomy surgery. Over time, it is naturally absorbed by the body while allowing the patient’s own tissue to regenerate in its place. The result is a restored breast shape and feel composed of natural tissue.
Another differentiating advantage of Regenera is its visibility on diagnostic imaging. This feature supports precise delivery of radiotherapy and more accurate long-term surveillance for potential recurrence, addressing a key clinical challenge.
Tensive has completed enrollment of its pivotal trial, which includes 94 patients with malignant lesions who are receiving adjuvant therapy. Final results on primary endpoints are expected later in 2025, with patients to be followed for up to five years.
If successful, the company anticipates first regulatory approvals in Europe and the US by early 2027.
