Tensive has signed a convertible loan agreement with the European Investment Bank for up to €20 million to advance development, regulatory approval, manufacturing scale-up and commercialization of its REGENERA bioresorbable breast implant.
The EIB financing covers approximately half of Tensive’s €40 million financing plan for bringing REGENERA through CE Mark approval and into commercial launch in Europe. The company is pursuing additional equity financing to fund the remaining amount and support development and launch activities in Europe and the U.S.
The financing is structured as a convertible loan available in two tranches of €8 million and €12 million, with each tranche carrying a 20-year maturity from its respective drawdown date.
Proceeds will support research and development, clinical studies, CE marking, manufacturing scale-up and commercialization readiness. Drawdowns are subject to financial and contractual conditions.
The financing is supported under the European Commission’s InvestEU program and is intended to provide Tensive with a less dilutive source of capital while helping catalyze additional investment from institutional and strategic investors.
Tensive is a Milan-based clinical-stage medical device company developing REGENERA and SOFTAG bioresorbable scaffolds for breast reconstruction and tissue marking.
REGENERA is designed for placement during breast-conserving lumpectomy surgery in the space created by removal of a tumor. The sponge-like scaffold gradually resorbs as the patient’s own tissue grows into the area, with the goal of restoring breast volume and shape without requiring a permanent implant or additional reconstructive surgery.
The financing follows positive 12-month data reported in July from Tensive’s ongoing pivotal clinical trial involving 94 patients. Of those patients, 87 had exceeded 12 months of follow-up and 30 had reached 24 months.
Tensive reported good-to-excellent cosmetic outcomes in 94.2% of evaluable cases at 12 months, along with high surgeon satisfaction and statistically significant improvements in patient-reported Satisfaction with Breast and Cancer Worry measures. The company also said REGENERA did not interfere with oncologic imaging.
Five-year follow-up from Tensive’s first-in-human study has also shown persistent volume replacement and vascularization at the implant site, gradual scaffold resorption and no capsule formation.
Tensive expects the first European regulatory approval for REGENERA as early as early 2027.
The company estimates approximately 1.6 million women annually lack viable reconstruction options following lumpectomy. Tensive is positioning REGENERA as a one-step solution that can be incorporated into existing surgical workflows while avoiding some of the complexity associated with conventional breast reconstruction approaches.
KEY QUOTES:
“The EIB has examined our clinical evidence and our regulatory file in detail and has committed €20 million to enable us to take REGENERA™ from our recently reported positive pivotal clinical results to a product in the hands of European surgeons. This commitment anchors and catalyzes our ongoing equity financing. We are one step closer to offering the first natural, lasting solution to women who today have no viable options for reconstruction after breast cancer lumpectomy.”
Sanjay Kakkar, MD, Chief Executive Officer of Tensive
“Supporting European innovation in health, and in women’s health in particular, is central to the EIB Group’s mission. This financing will help Tensive advance its promising regenerative technology with the potential to address important unmet medical needs in breast cancer care. Backed by InvestEU, the operation also strengthens Europe’s capacity to develop high value medical technologies and create highly skilled jobs.”
Gelsomina Vigliotti, Vice President of the European Investment Bank
