OncoSil Medical enters final FDA review stage for HDE

OncoSil Medical (ASX:OSL) announced that its Humanitarian Device Exemption application for the OncoSil device has entered the final stage in the U.S. Food and Drug Administration review process.

The device is being evaluated for the treatment of distal cholangiocarcinoma, a rare form of bile duct cancer, marking the most advanced phase reached by the company’s U.S. regulatory programme to date.

The progress follows formal communication from the FDA confirming that all outstanding substantive questions regarding the HDE application have been resolved.

To finalise the administrative process, the FDA has requested that OncoSil submit its final device labelling and any necessary modifications to its proposed post-market study within the next 30 days.

Once these final details are submitted, the FDA intends to complete its review and grant the HDE approval within 45 days.

The anticipated clearance represents a crucial step forward for the Sydney-based company, which specialises in developing localised treatments for unresectable, locally advanced cancers.

The upcoming FDA decision could expand treatment options for dCCA patients in the United States.