(RTTNews) – OncoSil Medical Limited (OSL.AX) announced the completion of its Humanitarian Device Exemption (HDE) application to the U.S. Food and Drug Administration for the OncoSil device, designed to treat distal cholangiocarcinoma (dCCA).
dCCA is a rare and aggressive bile duct cancer with poor prognosis and limited treatment options. Patients with untreated disease often face survival measured only in months, underscoring the urgent need for innovative therapies.
The submission marks the next stage in OncoSil’s HDE process, moving the application into the FDA’s review phase. If approved, the OncoSil device would become the first and only FDA-approved Class III medical device specifically indicated for the treatment of distal cholangiocarcinoma in the United States.
The FDA has advised the company that it expects to complete its review within approximately 45 days, with the potential to grant the HDE approval.
OSL.AX was trading at A$0.9850 up A$0.1750 or 21.60%.
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