On August 17, 2026, OncoSil Medical announced that the U.S. Food and Drug Administration (FDA) granted Humanitarian Device Exemption (HDE) approval to the OncoSil device for the treatment of distal cholangiocarcinoma (dCCA) in the United States.
The approval provides U.S. marketing authorization for OncoSil under the HDE framework and completes the company’s HDE regulatory process for this indication. OncoSil Medical describes the device as the first and only U.S. FDA-approved Class III device for the treatment of dCCA.
Nigel Lange, CEO & Managing Director of OncoSil Medical, said:
“FDA approval of the OncoSil™ device under the HDE pathway represents the most significant milestone in
OncoSil Medical’s history and a transformational moment for our Company. Most importantly, it provides a
pathway making OncoSil™ available for patients with dCCA in the United States, where there remains
significant unmet clinical need.”
“Our attention now turns to successfully launching OncoSil™ in the United States. We will work with leading
cancer centres and clinical teams to establish treatment sites, advance reimbursement and market access, and
build the foundations for sustainable adoption. This approval marks the beginning of an exciting new chapter
for OncoSil Medical as we work to make a meaningful difference to patients facing this challenging cancer.”
What Does HDE Approval Mean?
The FDA’s Humanitarian Device Exemption pathway provides a regulatory route for medical devices intended to treat or diagnose rare diseases or conditions affecting no more than 8,000 individuals annually in the United States.
Unlike the traditional Premarket Approval pathway, an HDE does not require demonstration of reasonable assurance of effectiveness. Instead, the FDA must determine that the device does not pose an unreasonable or significant risk and that its probable benefit outweighs the risks of its use.
This distinction is important when interpreting the approval: under the HDE framework, approval does not require the same demonstration of reasonable assurance of effectiveness as the traditional Premarket Approval pathway.
Approximately 8,000 people are diagnosed with cholangiocarcinoma in the United States each year, with dCCA estimated to account for around 30%–40% of cases. Within this population, OncoSil Medical estimates that approximately 1,000 patients annually could meet the FDA-approved indication for OncoSil.
How Does OncoSil Work?
OncoSil™ is a single-use brachytherapy device composed of phosphorus-32 (32P) microparticles suspended in a specially formulated diluent. The microparticles form a permanent intratumoral implant and contain 32P, a pure beta-emitting radioisotope with a physical half-life of 14.27 days.
Approximately 98% of the radiation is delivered within 81 days, corresponding to an absorbed dose equivalent to 100 Gy. The device is implanted directly into the tumor under endoscopic ultrasound guidance, enabling targeted intratumoral radiation delivery while sparing surrounding critical organs.
Who Is Eligible for OncoSil?
The FDA-approved indication covers patients over 21 years of age with distal cholangiocarcinoma that is both unresectable and non-metastatic, including those with locally advanced disease and/or patients considered unfit for surgery.
OncoSil is indicated as an adjunct to systemic therapy. The device is intended for intratumoral implantation into a solid tumor through injection under endoscopic ultrasound guidance. Its implantable components are supplied sterile and are intended for single-patient, single-use.
Distal cholangiocarcinoma is a rare and aggressive cancer arising from the distal common bile duct. More than 50% of patients are unable to undergo potentially curative resection. Among patients with unresectable, non-metastatic dCCA, reported median overall survival is approximately 6.7 months.
Treatment options remain limited and typically include biliary stenting to maintain bile duct patency together with systemic therapy and, in selected patients, radiation therapy. Disease progression may lead to recurrent biliary obstruction, stent occlusion, cholangitis, hospitalization, and interruption of systemic treatment, highlighting the need for additional treatment options aimed at improving local tumor control and clinical outcomes.
FDA Requires a Post-Approval Study
As a condition of approval, initial use and distribution of OncoSil in the United States will be restricted to a maximum of five treatment centers with appropriately trained practitioners. An FDA-required post-approval study will further evaluate the device in the approved patient population.
The multicenter, prospective study is expected to enroll 30 patients and evaluate the safety and probable benefit of OncoSil in the approved patient population. Patients will be followed for up to 24 months. The final study protocol and associated requirements are expected to be confirmed with the FDA.
Juan Valle, Chief Medical Officer at the Cholangiocarcinoma Foundation, said:
“Distal cholangiocarcinoma is a rare and aggressive cancer with a significant need for new therapeutic
approaches. The FDA’s HDE approval of this device is an important development, providing eligible U.S. patients
and clinicians with an additional treatment option through targeted radiation delivered directly within the
tumour. I welcome the opportunity for U.S. specialist centres to gain experience with OncoSil™ and further
understand its role in the multidisciplinary treatment pathway for eligible patients with dCCA.”
Previous Clinical Evidence With OncoSil
Previous clinical evidence with OncoSil has been generated in unresectable locally advanced pancreatic adenocarcinoma (LAPC). Results from the PanCO study (NCT03003078) were published in February 2022 in ESMO Open.
PanCO was an international, multicenter, single-arm, open-label pilot study evaluating endoscopic ultrasound-guided implantation of phosphorus-32 (32P) microparticles in combination with either gemcitabine/nab-paclitaxel or FOLFIRINOX. Fifty patients were enrolled and received chemotherapy, while 42 underwent 32P microparticle implantation.
At 16 weeks, the local disease control rate was 82.0% in the intention-to-treat population and 90.5% among implanted patients. Ten implanted patients (23.8%) subsequently underwent surgical resection, with R0 margins achieved in 8 of 10 patients. Median overall survival was 15.2 months in the intention-to-treat population and 15.5 months among implanted patients.
Regarding safety, 41 treatment-emergent adverse events in 16 of 42 implanted patients (38.1%) were considered possibly or probably related to the 32P microparticles or implantation procedure, including 8 grade 3 events in 3 patients (7.1%). No radiation-related serious treatment-emergent adverse events were reported.
The study was limited by its small sample size, single-arm design, and absence of a comparator group. These findings were generated in patients with LAPC and should therefore not be interpreted as evidence of efficacy in distal cholangiocarcinoma.
What Comes Next?
Following the HDE approval, OncoSil Medical plans a focused U.S. commercialization strategy targeting leading academic cancer centers and specialist hepatobiliary oncology teams. The company expects to launch OncoSil in the United States during the second half of FY27.
Preparations will include establishing and activating treatment centers, engaging multidisciplinary clinical teams, advancing reimbursement and market-access pathways, and expanding clinician education and training programs.
The approval introduces an additional device-based treatment option for eligible patients over 21 years of age with unresectable, non-metastatic distal cholangiocarcinoma, used as an adjunct to systemic therapy. The required prospective post-approval study will further evaluate the safety and probable benefit of OncoSil in the approved patient population, while experience at U.S. specialist centers may help clinicians further understand its role within the multidisciplinary treatment pathway for eligible patients with dCCA.
Read the full announcement on the OncoSil Medical website.