News and Announcements
OncoSil Financial Report – Preliminary Final Report; $10m Private Placement; Advanced Manufacturing and Supply Chain Processes
- Published September 02, 2016 11:24AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
30th August 2016, ASX Announcement
OncoSil Medical Ltd (ASX:OSL) (Oncosil or the Company), a late stage medical devices company focused on localised treatments with pancreatic and liver cancer, is pleased to report its financial results to the full year ended 30 June 2016 (the Financial Report) and its Appendix 4E. All financial results are in Australian dollars and are audited.
Highlights – Operational
- The Company completed a number of milestones during the year, with the key focus being the CE Mark application in the European Union and Investigational Device Exemption (IDE) with the Food and Drug Administration (FDA) to commence the OncoPac-1 pivotal clinical study. The highlights included the following:
- CE Mark dossier submitted to BSI and subsequently granted fast track review status
- Submissions responding to all questions requested from BSI have been made
- IDE application submitted to the FDA
- Q-Submission meeting with relevant Divisional Heads at the FDA followed by IDE Amendment filing with the U.S. FDA addressing all matters raised
- Commenced marketing efforts to introduce the OncoSil device to potential, key opinion leaders, commercial and trial centres
- Advanced the manufacturing and supply chain processes necessary to support both regulatory filings and planned launch of the OncoPac-1 study and commercial launch
- Completed key hires for the Company’s leadership team including Tom Milicevic, CFO; Charles Rowland, President U.S. Operations; and Michael Warrener, Sales and Marketing Director
- Commenced a process of Board regeneration with the appointment of Dr Chris Roberts as a Non-Executive Director and Chairman-elect.
Subsequent to the year, the Company was very pleased to report the IDE approval from the EDA enabling the commencement of the OncoPac-1 Pivotal study for the treatment of patients with pancreatic cancer this year.
To read the full announcement, please click on the button below.
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