120 German Hospitals Now Authorized to Negotiate OncoSil™ Device Funding
OncoSil Medical has secured authorization for 120 German hospitals to negotiate funding for its pancreatic cancer treatment device, marking a 43% increase from last year and signaling growing acceptance in Germany’s healthcare system.
- 120 German hospitals authorized to negotiate OncoSil™ device funding under NUB program
- 43% increase in hospital participation compared to 2024
- German Ministry of Health approval and Coverage with Evidence Development Study Directive published
- OncoSil™ device recognized for treating locally advanced unresectable pancreatic cancer
- Device already approved and marketed in over 30 countries including EU and UK
Expanding Hospital Access in Germany
OncoSil Medical Limited (ASX:OSL) has announced a significant milestone in its commercial journey with the OncoSil™ brachytherapy device. The German Institute for the Hospital Remuneration System (InEK) has authorized 120 hospitals across Germany to negotiate funding for the OncoSil™ device under the innovation funding (NUB) program. This represents a 43% increase from 84 hospitals in 2024, reflecting growing demand and recognition of the device within the German healthcare landscape.
The NUB program allows hospitals to negotiate additional funding for innovative treatments not yet fully integrated into standard reimbursement schemes. OncoSil’s expanded hospital access signals increasing confidence among German healthcare providers in the clinical potential of this novel pancreatic cancer treatment.
Regulatory Momentum and Clinical Validation
OncoSil’s progress in Germany has been bolstered by key regulatory approvals. In October 2024, the German Federal Joint Committee (G-BA) approved a directive to test the new treatment method involving endoscopic injection of 32P-labeled microparticles into unresectable, locally advanced pancreatic tumors. This was followed by the Ministry of Health’s approval in January 2025 and the publication of the Coverage with Evidence Development Study Directive in the National German Gazette.
These regulatory endorsements not only validate the clinical promise of the OncoSil™ device but also pave the way for broader adoption and reimbursement discussions. The device’s targeted brachytherapy approach, delivering radioactive phosphorus-32 directly into pancreatic tumors alongside chemotherapy, addresses a critical unmet need in a cancer type known for its poor prognosis and limited treatment options.
Commercial Footprint and Future Prospects
Already approved for sale in over 30 countries including the European Union, United Kingdom, Türkiye, and Israel, OncoSil has begun initial commercial treatments in Spain, Italy, and Israel. The device holds breakthrough device designation in major markets, underscoring its innovative status.
CEO Nigel Lange highlighted the importance of the German developments, stating that the expanded hospital authorizations and regulatory approvals reinforce OncoSil’s commitment to delivering life-changing solutions for patients with locally advanced pancreatic cancer. The company’s dual focus on advancing clinical trials and accelerating commercialization efforts positions it well to capitalize on growing market opportunities.
However, while the authorization to negotiate funding is a critical step, the actual outcomes of these negotiations with statutory health insurance companies will ultimately determine the device’s reimbursement landscape and commercial success in Germany.
Bottom Line?
OncoSil’s expanding footprint in Germany sets the stage for critical funding negotiations that will shape its commercial trajectory in Europe’s largest healthcare market.
Questions in the middle?
- What will be the outcome of funding negotiations between hospitals and statutory health insurers for OncoSil™?
- How quickly will German hospitals adopt the OncoSil™ device following reimbursement agreements?
- What impact will ongoing clinical trials have on broader regulatory approvals and market access?
