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- Documentation submitted to FDA completing next step in HDE application
- Application enters FDA’s review phase for commercial approval in US
- OncoSil device provides treatment of distal cholangiocarcinoma
- Approval would provide access to the world’s largest medical device market
OncoSil Medical (ASX:OSL) has hit a key milestone in its plans to commercialise its unique OncoSil device for the treatment of distal cholangiocarcinoma (dCCA).
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The company has completed the submission of its Humanitarian Device Exemption (HDE) application to the US Food and Drug Administration (FDA) for the device for the treatment of dCCA.
Completion of the submission marks the next stage of the company’s HDE application process and places the application into the FDA’s review phase.
Subject to FDA approval, 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 and grant the HDE.
MD and CEO, Nigel Lange, said approval under the HDE pathway would allow OncoSil Medical to commence commercialisation of the OncoSil device in the US for this indication. It would also represent the company’s first regulatory approval in the US, a significant strategic milestone that would establish an important commercial platform for future growth.
“This is one of the most important milestones in OncoSil Medical’s journey to date. Completing our FDA submission reflects years of dedication from our team and our clinical partners and brings us to the final stage of the regulatory process in the United States,” Mr Lange said.
“For patients with distal cholangiocarcinoma, treatment options remain extremely limited. If approved, the OncoSil device has the potential to provide clinicians with a new localised treatment option for this challenging disease while establishing our first commercial presence in the US
“We recognise that the FDA review process remains ongoing and we look forward to working closely with the agency as it completes its assessment.
“Reaching this stage is a testament to the quality of the clinical evidence, the strength of our regulatory strategy and the commitment of everyone who has contributed to the development of the OncoSilTM device.”
The Humanitarian Device Exemption (HDE) pathway is designed to facilitate approval of medical devices intended to treat or diagnose diseases affecting fewer than 8,000 patients annually in the US.
If approved, the HDE would authorise commercial marketing of the OncoSil device in the United States for the treatment of dCCA, subject to the regulatory requirements applicable to HDE-approved devices.
dCCA is a rare and aggressive form of bile duct cancer associated with poor prognosis and limited treatment options. Patients with untreated disease have a median survival measured in months, highlighting the significant unmet need for new treatment options.
OSL was up 17.9% to 95.5¢. Mkt cap $2.013M.
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