Milan-based MedTech startup Tensive, the developer of REGENERA/SOFTAG bioresorbable scaffolds for breast reconstruction and tissue marking, has recieved a loan of €20 million in order to fund research and development, clinical studies, CE marking, manufacturing scale-up and commercialisation readiness.
The convertible loan agreement was made with the European Investment Bank (EIB) – covering half of the company’s €40 million financing plan. The financing is supported under the Commission’s InvestEU programme.
“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,” says Sanjay Kakkar, MD, Chief Executive Officer of Tensive. “This commitment anchors and catalyses 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.”
While implants for breast cancer is a relatively niche market, Tensive’s loan comes amid relevant financing activity in European medical devices and regenerative technologies throughout 2026.
EU-Startups has reported approximately €151 million across adjacent announcements, including €20.5 million for Dutch-US Xeltis, whose vascular implants are gradually replaced by patients’ own tissue, €83 million in private capital and grants for French implantable cardiac-device developer FineHeart, €20 million in EIB financing for Belgian surgical-imaging startup SamanTree Medical, and €13.6 million for breast-cancer detection company ScreenPoint Medical.
In Italy, Pisa-based Wearable Robotics raised €5 million for rehabilitation robotics, while Bologna-based Cellply secured €7.15 million for cancer and cell-therapy analytical tools.
“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,” adds Gelsomina Vigliotti, EIB Vice President.
Founded in 2012, is a clinical-stage advanced biomaterials medical device company developing bioresorbable, biomimetic polymeric scaffolds for breast reconstruction and tissue marking for patients recovering from lumpectomy or undergoing cosmetic procedures.
Their offering REGENERA addresses the post-surgery challenge of cosmetic solutions; the sponge-like bioresorbable scaffold is placed during lumpectomy, fitting within surgical workflows. It is bioresorbable (gradually replaced by the patient’s own natural tissue).
Because REGENERA is a material similar in consistency to adipose tissue, it adapts to the surgical cavity without the need for any manual size adjustments and thereby offers surgeons a fast, convenient, and low-risk solution during the initial lumpectomy surgery. Furthermore, as it is bioresorbable, it eliminates the risks, costs, and inconvenience of further surgical intervention to reconstruct the breast or remove the device.
The patient’s own healthy tissue regrows in the area initially filled by the biomaterial and gradually absorbs it. The result is breast restoration composed of the patient’s own natural tissue while preserving the patient’s original breast shape and feel from the time of surgery.
Importantly, the implant is clearly differentiated from surrounding tissue on diagnostic imaging, facilitating precisely targeted delivery of radiotherapy and more accurate surveillance and follow-up.
Under today’s agreement, the EIB will make available up to €20 million to Tensive in the form of a convertible loan, drawable in two tranches of €8 million (Tranche A) and €12 million (Tranche B), with a maturity of 20 years from each drawdown date.
The EIB facility acts as a catalyst providing a less dilutive source of financing for about half of the €40 million required to complete development and launch REGENERA in EU and U.S.
Tensive says they are in active discussions with institutional investors, leading global specialist investors and potential strategic partners who may invest the remaining amount.
On 28 July 2026, Tensive reported 12-month follow-up data from its ongoing pivotal trial (NCT05941299), covering all 94 patients enrolled, of whom 87 have exceeded twelve months and 30 have now completed 24 months of follow-up. Good-to-excellent cosmetic outcomes were recorded in 94.2% of evaluable cases at twelve months, surgeon satisfaction remained high, patient-reported outcomes (BREAST-Q) improved significantly versus baseline in the Satisfaction with Breast and Cancer Worry domains (p<0.001), and REGENERA caused no interference with oncologic imaging.
Separately, Tensive recently announced five-year follow-up from the company’s first-in-human study continues to show persistent volume replacement and vascularisation of the implant site, with gradual resorption of the scaffold and no capsule formation.
The company anticipates EU regulatory approval of REGENERA as soon as early 2027.
Source: EU-Startups
