Tensive has signed a convertible loan agreement of up to €20 million with the European Investment Bank (EIB) to advance REGENERA™, its bioresorbable implant for breast reconstruction following lumpectomy. The financing covers half of the company’s €40 million funding plan, supporting CE Mark approval, manufacturing scale-up and commercialization in Europe and the U.S.
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REGENERA™ is a sponge-like scaffold placed in the cavity created during tumor removal. The biomaterial gradually resorbs as the patient’s own tissue regenerates, aiming to restore breast volume and shape without requiring a second reconstructive procedure. The implant is also designed to remain clearly distinguishable on diagnostic imaging, supporting radiotherapy planning and follow-up.
The EIB commitment follows positive 12-month pivotal trial data from 94 patients, with 94.2% of evaluable cases achieving good-to-excellent cosmetic outcomes. Patient-reported outcomes also improved significantly, while the implant showed no interference with oncologic imaging; five-year follow-up from Tensive’s first-in-human study has additionally shown persistent volume replacement and vascularization with gradual scaffold resorption.
With EU regulatory approval anticipated in early 2027, the financing gives Tensive a significant funding base to move REGENERA™ from clinical development toward commercial launch. The company is seeking an additional €20 million from institutional investors, specialist healthcare investors and strategic partners to complete its financing plan.
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