Tensive reported positive 12-month pivotal trial results for REGENERA after lumpectomy, showing durable cosmetic outcomes, favorable safety, and CE Mark plans for 2027.
Written By: Nalam Karthik, PharmD
Reviewed By: Pharmacally Editorial Team
Tensive has reported positive 12-month interim results from its ongoing pivotal clinical trial (NCT05941299) evaluating the REGENERA™ bioresorbable implant in women undergoing lumpectomy for breast-conserving surgery. The data showed sustained cosmetic benefits, high surgeon satisfaction, significant improvements in patient-reported breast satisfaction and cancer-related anxiety, and no evidence that the implant interfered with routine cancer imaging.
The latest findings also coincide with new five-year follow-up data from the company’s first-in-human study, demonstrating long-term scaffold resorption, natural tissue replacement, and the absence of capsule formation.
REGENERA Supports Natural Breast Tissue Regeneration
REGENERA is a bioresorbable polymer scaffold implanted into the surgical cavity immediately after tumor removal during lumpectomy. The sponge-like structure acts as a temporary framework that gradually becomes replaced by the patient’s own tissue as the scaffold resorbs over time.
Unlike permanent implants or complex autologous tissue reconstruction, the scaffold integrates into the surgical procedure without requiring additional reconstructive surgery. It also remains distinguishable from surrounding tissue on ultrasound, MRI, and mammography, allowing accurate postoperative imaging and radiotherapy planning.
Breast-conserving surgery remains the standard treatment for early-stage breast cancer, but many women experience cosmetic deformities after tumor removal. Current reconstruction options often involve longer operations, greater surgical complexity, or donor-site complications, leaving many patients without practical reconstruction choices.
Pivotal Trial Shows Durable Cosmetic and Quality-of-Life Benefits
The ongoing pivotal study enrolled 94 patients, with 87 patients completing at least 12 months of follow-up and 30 patients reaching 24 months.
Investigators reported only one procedure-related adverse event, involving persistent redness and wound retraction following radiotherapy. Even with this event, the rate of potentially device-related complications remained well below the trial’s predefined 5% safety threshold.
Cosmetic outcomes remained consistently favorable throughout follow-up. Good-to-excellent cosmetic results were observed in 94.5% of evaluable patients immediately after implantation, 96.5% at six months, and 94.2% at 12 months.
Surgeon satisfaction also remained high. Mean investigator satisfaction scores increased from 8.4 at implantation to 9.0 at six months, remaining strong at 8.6 after one year on a 10-point visual analogue scale. Device usability reached 58 out of 60, reflecting consistent ease of implantation.
Patient-reported outcomes measured using the BREAST-Q® questionnaire demonstrated statistically significant improvements in both Satisfaction with Breast and Cancer Worry domains compared with baseline (p<0.001), with benefits maintained through 12 months.
Importantly, REGENERA showed no interference with oncologic surveillance, including ultrasound, magnetic resonance imaging, or mammography.
Long-Term Study Confirms Scaffold Resorption
Separately, Tensive reported five-year follow-up results from its first-in-human study.
The long-term analysis demonstrated persistent restoration of breast volume, continued vascularization of regenerated tissue on ultrasound, gradual bioresorption of the scaffold, and no capsule formation. These findings support the implant’s ability to facilitate durable reconstruction using the patient’s own natural tissue.
Regulatory Path Advances Toward European Commercialization
Chief Executive Officer Dr. Sanjay Kakkar said the one-year results reinforce the consistent safety and long-term clinical benefits observed throughout the REGENERA development program. He noted that sustained cosmetic outcomes, durable patient satisfaction, and preserved imaging compatibility strengthen the clinical evidence supporting commercialization.
Tensive expects to complete its CE Mark regulatory process with the first European approval anticipated in early 2027. The company also plans to publish the complete pivotal trial dataset in a peer-reviewed scientific journal as patient follow-up continues.
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About the Writer
Nalam Karthik (LinkedIn) is a healthcare writer and PharmD graduate with interests in pharmacovigilance, drug safety, clinical data analysis, and quality assurance. He is passionate about translating clinical and pharmaceutical knowledge into accessible healthcare content while staying engaged with advancements in drug development and patient safety initiatives.