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Edge14 Aug 2026
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Oncosil Medical
Oncosil Medical (OSL) investor relations material
Oncosil Medical FDA announcement summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.FDA announcement summary17 Aug, 2026
Introduction and purpose
OncoSil device received FDA Humanitarian Device Exemption (HDE) approval for treating distal cholangiocarcinoma (dCCA), completing the regulatory process and granting U.S. marketing authorization.
OncoSil is the first and only FDA-approved Class III device for dCCA, a rare and aggressive bile duct cancer with limited treatment options.
Details of approval or decision
HDE approval allows commercial marketing in the U.S. for unresectable, non-metastatic dCCA as an adjunct to systemic therapy in patients over 21.
Approval restricts initial commercial use to five centers and 30 patients until completion of a post-approval study (PAS).
FDA approval was granted on August 14, 2026.
Impact on industry and stakeholders
Opens a new treatment pathway for dCCA patients, addressing a high unmet medical need.
Estimated total addressable market is AUD 80 million annually, with about 1,000 eligible U.S. patients per year.
Approval enhances partnering opportunities and is expected to attract industry attention.
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Latest events from Oncosil Medical
- Revenue up 40% to $516,632, but net loss widened; $9.8M equity raised for growth.OSL
H2 2024 - Q4 saw revenue up 136% YoY, new market launches, and $9.9 million in equity raised.OSLQ4 2024 TU
- Strong clinical results and regulatory progress drive commercial expansion for OncoSil™.OSLInvestor presentation
- Q1 revenue grew, clinical and regulatory milestones advanced, and new capital was secured.OSLQ1 2025 TU
- Strong clinical results and regulatory progress position OncoSil™ for rapid global market expansion.OSLCompany presentation
- Strong clinical results and regulatory progress position OncoSil™ for rapid commercial growth.OSLAGM 2024 presentation
- Expanded distribution, regulatory wins, and $8M equity raise boost cash and growth outlook.OSLQ2 2025 TU
- Regulatory wins and clinical progress drive expanded access and financial strength.OSLCompany presentation
- Revenue up 422% year-over-year, but net loss widened; cash bolstered by new equity raises.OSLH1 2025
Next Oncosil Medical earnings date
H2 20263 Sep, 2026
Oncosil Medical
Next Oncosil Medical earnings date
H2 20263 Sep, 2026
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