InvestSMART

Oncosil Medical Limited (ASX:OSL)

ALERT: Price-sensitive ASX Announcement for OSL
Current share price for OSL : $1.090 0.28 (34.57%)+
Announcement
Release
3 Jul 2026 8:27AM
Price at Release
$0.810
Full Release
download
Summary
OncoSil Medical Limited has announced its submission of the Humanitarian Device Exemption (HDE) application to the U.S. Food and Drug Administration (FDA) for their OncoSil™ device, targeting the treatment of distal cholangiocarcinoma (dCCA). This submission marks the commencement of the FDA review phase, which is anticipated to be completed within 45 days. If approved, the OncoSil™ device would be the first FDA-approved Class III medical device specifically for dCCA treatment, providing a new localized treatment option for this challenging cancer. The approval would allow OncoSil Medical to commercialize the device in the U.S., marking their first regulatory approval in the country and potentially opening the world's largest medical device market for the company.
Key Points
  • Completion of HDE application submission to the FDA.
  • OncoSil™ would be the first FDA-approved Class III device for dCCA.
  • FDA review expected within 45 days post submission.
  • Approval allows U.S. commercialization, marking first U.S. regulatory approval.
  • OncoSil™ provides a new treatment option for distal cholangiocarcinoma.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.