News and Announcements
OncoSil US FDA Investigational Device Exemption Submitted
- Published December 14, 2015 12:32PM UTC
- Publisher Wholesale Investor
- Categories Company Updates
14th December 2015, ASX Announcement
OncoSil Medical Lmited (ASX: OSL) (OncoSil Medical, the Company) is pleased to announce that it has filed an Investigational Device Exemption (IDE) with the US Food and Drug Administration (FDA) for its lead product candidate, the OncoSilTM localised radiation treatment for cancer.
This is a significant milestone in the development pathway for OncoSilTM in pancreatic cancer and is the firsts step towards securing FDA commercial approval for OncoSilTM under a Pre-market Appoval (PMA).
Subject to an IDE being granted, OncoSil Medical will commence a clinical study under the FDA to support the PMA. A PMA will allow the Company to commercially market OncoSilTM in the USA.
The company formally filed its IDE submission on 10th December 2015 after successfully completing a lengthy pre-IDE process. The pre-IDE process involved an FDA review of the proposed Clinical Investigational plan including the endorsement of clinical endpoints and outcomes measure.
To read the full announcement, please click here.
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