Tensive, a company specializing in regenerative medical devices, has secured a €20 million convertible loan from the European Investment Bank. This funding covers half of the firm's €40 million financing plan intended to support the development and launch of its REGENERA product in the European and US markets.
The loan is structured in two tranches of €8 million and €12 million, with a maturity period of 20 years from each drawdown date. The financing is supported by the InvestEU program. Tensive is currently in negotiations with institutional and strategic investors to raise the remaining €20 million required for its operations.
REGENERA is a bioresorbable scaffold designed for breast reconstruction following lumpectomy. The material is replaced by the patient's own tissue over time. According to the company, the product integrates into existing surgical workflows and allows for clear diagnostic imaging, which aids in radiotherapy and follow-up procedures.
Clinical data from a pivotal trial involving 94 patients showed positive cosmetic outcomes in 94.2% of cases at the 12-month mark. Additionally, five-year follow-up data from an earlier study indicated persistent volume replacement and vascularization at the implant site. Tensive expects to receive EU regulatory approval for the product as early as 2027.