FDA has granted Humanitarian Device Exemption (HDE) approval to OncoSil Medical’s OncoSil™ device for the treatment of unresectable, non-metastatic distal cholangiocarcinoma (dCCA). OncoSil Medical announced it in a recent press release.
The approval covers patients over 21 years of age with dCCA that is unresectable because the disease is locally advanced and/or the patient is not a candidate for surgery, and is non-metastatic. OncoSil is intended to be used as an adjunct to systemic therapy.
According to OncoSil Medical, the device is the first and only FDA-approved Class III medical device specifically indicated for the treatment of dCCA in the United States.
About the OncoSil Device
OncoSil is an implantable targeted radiation device that delivers phosphorus-32 (32P) microparticles directly into the tumor through an endoscopic ultrasound-guided intratumoral injection. The treatment delivers localized beta radiation while aiming to limit radiation exposure to surrounding healthy tissue.
Distal cholangiocarcinoma is a rare and aggressive cancer arising in the distal common bile duct. More than half of patients are reportedly unable to undergo potentially curative surgery, while median overall survival for patients with unresectable, non-metastatic disease has been reported at approximately 6.7 months.
U.S. Rollout and Post-Approval Study
As part of the HDE approval, the initial U.S. rollout of OncoSil will be restricted to a maximum of five treatment centers with appropriately trained practitioners participating in an FDA-required post-approval study.
The prospective, multicenter study is expected to include up to 30 patients and evaluate the safety and probable benefit of the device, with participants followed for up to 24 months.
OncoSil Medical expects to launch the device in the United States during the second half of FY2027, while working to establish treatment sites, clinician training, reimbursement and market-access pathways.
Nigel Lange, CEO and Managing Director of OncoSil Medical, described the FDA decision as a major milestone for the company and said:
“Our attention now turns to successfully launching OncoSil™ in the United States.”
Dr. Juan Valle, Chief Medical Officer of the Cholangiocarcinoma Foundation, also welcomed the approval, highlighting the opportunity for U.S. specialist centers to gain experience with the device and better understand its potential role in multidisciplinary care for eligible patients with dCCA.
Read further on OncoDaily: FDA Lists More Than 1,500 AI-Enabled Medical Devices as Oncology Applications Expand
