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.
Company Updates
Capital Is Flowing – Just Not to Everyone: Inside Australia’s $1.8 Billion Q1 2026
Australia’s startup ecosystem opened 2026 with a number that demanded attention. In the first three months of the year, $1.8 billion was raised across 81 venture deals and 26 accelerator rounds. That makes Q1 2026 the strongest start to a year since the 2022 boom, up 63% on Q1 2025, and more than double the […]
The control layer for the electrified home
THE MARKET SHIFT Australian households have been pulled into a real-time energy market they never knowingly signed up for. Flat electricity tariffs are disappearing. In their place: dynamic, time-of-use pricing that changes depending on when power is consumed. Electricity is now cheapest when solar floods the grid in the middle of the day — and […]
500 Million Episodes, Limited Treatment: How Patrys is Bridging the Gap in an Underserved Market
In the clinical vocabulary of the Intensive Care Unit, there is perhaps no word that carries as much quiet dread as delirium. It is a “chemical storm” of the brain—an acute dysfunction where the delicate balance between calming and activating signals is scrambled. For the patient, it can be a waking nightmare of hallucinations and […]
Backed By Leading Investment Groups and Family Offices
