News and Announcements
OncoSil Medical Receives IDE Approval from the U.S. FDA
- Published August 05, 2016 11:22AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
2nd August 2016, ASX Announcement
OncoSil Medical Limited (ASX: OSL) (OncoSil Medical or the Company) a late stage medical devices company focused on localised treatments for subjects with pancreatic and liver cancer, is pleased to announce that it has recieved Invesigarional Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). The Company will now initiate a pivotal clinical investigation for OncoSil™ for the treatment of eligible subjects with pancreatic cancer.
OncoPac-1 U.S. and International Clinical Study
As previously advised, the Company had filed an IDE Amendment with the FDA for its planned global clinical study of OncoSil™ for the treatment of pancreatic cancer (OncoPac-1). This followed an intensive eight month process of submissions and interactions with the FDA.
The Company has received notification from the FDA that the IDE Amendment submission has been approved thereby clearing the way for the Company to initiate its planned global clinical study, OncoPac-1
To view the full announcement, please click on the button below.
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