Tensive to receive €20 million from EIB to commercialize bioresorbable breast implant

• European Investment Bank (EIB) convertible loan will help fund REGENERA™ development, CE marking, manufacturing scale-up and commercialization
• Follows positive 12-month pivotal trial data in July
• First EU regulatory approval anticipated in early 2027

Milan, Italy – September 3, 2026 – Tensive S.r.l., a clinical-stage advanced biomaterials medical device company, and the developer of REGENERA™/SOFTAG™ bioresorbable scaffolds for breast reconstruction and tissue marking, today announced that it has signed a convertible loan agreement with the European Investment Bank (EIB) for up to €20 million. The financing covers half of the Company’s €40 million financing plan to carry REGENERA™ through CE Mark approval, manufacturing scale-up and EU product launch.

“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,” said Sanjay Kakkar, MD, Chief Executive Officer of Tensive. “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.”

“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,” said Gelsomina Vigliotti, EIB Vice President.

Terms of the financing

Under the 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. Proceeds will fund research and development, clinical studies, CE marking, manufacturing scale-up and commercialization readiness for REGENERA™. Drawdown of each tranche is subject to financial and contractual conditions set out in the agreement.

The EIB financing is supported under the European Commission's InvestEU programme and is aligned with its objective of promoting research, development and innovation.

Ongoing financing

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 is in active discussions with institutional investors, leading global specialist investors and potential strategic partners who may invest the remaining amount.

Built on a maturing clinical evidence base

The financing follows a series of positive clinical read-outs. 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 vascularization of the implant site, with gradual resorption of the scaffold and no capsule formation [3,4]. Positive interim six-month results from the pivotal trial were published in April 2026 in the peer-reviewed journal Updates in Surgery [2]. Tensive anticipates EU regulatory approval of Regenera™ as soon as early 2027.

Breast conserving surgery (BCS) is the gold standard for early-stage breast cancer, yet cosmetic outcomes remain a significant clinical challenge: deformity risk is substantial when tumor-to-breast ratios are high or lesions are centrally located. and deformity is associated with poor psychosocial outcomes and increased fear of recurrence [1]. Conventional volume replacement options carry autologous tissue rejection risk, longer operative times, and significant technical demands, leaving an estimated 1.6 million women per year without viable options for reconstruction after lumpectomy [1,2].

REGENERA™ addresses this directly; the sponge-like bioresorbable scaffold is placed during lumpectomy, fitting seamlessly 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.

REGENERA™/SOFTAG™ advanced biomaterial is a bioresorbable implant designed to be inserted in place of the surgically removed tumor during a lumpectomy procedure. The biomaterial used in REGENERA™ resembles a sponge with a fine scaffold matrix; it can be rapidly placed during the lumpectomy surgery in a fast one-step, minimally invasive, easy-to-adopt procedure for surgeons. 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.

References

[1] J.F. Waljee et al. Plast Reconstr Surg 2008. Analysis of unreconstructed lumpectomies based on estimates from ISAPS, BCRF, ACS, WHO and Global Market Insights.
[2] M. Ghilli et al. Safety of the use of an absorbable implant in breast-conserving surgery followed by radiotherapy: preplanned interim results from a prospective study. Updates in Surgery 2026. https://link.springer.com/article/10.1007/s13304-026-02629-3
[3] Mariniello et al. Breast Cancer 2023. https://doi.org/10.1007/s12282-023-01446-5
[4] Mariniello et al. Breast Cancer 2025. https://doi.org/10.1007/s12282-025-01780-w

Background information: The European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States. It finances investments that support EU policy objectives. The InvestEU program brings together under one roof the EU financial instruments available to support investment in the European Union, mobilizing public and private funds through an EU budget guarantee of €26.2 billion, expected to trigger at least €372 billion in additional investment.

Tensive S.r.l. (www.tensive.com) 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. Tensive’s mission is to improve clinical outcomes and the quality of life for breast cancer patients worldwide through accessible, innovative, and sustainable solutions.

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