New Proactive Investor Article, page-7

'OncoSil Medical initiated a US FDA gap analysis in early August of 2013, and is an important step in defining the regulatory pathway to a pre Investigational Device Exemption “IDE” meeting with the US Food and Drug Administration. This follows in the footsteps of highly successful and commercialised precedents for Investigational Device Exemptions granted by the FDA for localised radiation treatments of hepatic and prostate cancers.  

OncoSil Medical has contracted with regulatory consultancy Emergo Group as experts to support both the US FDA IDE submission and the European submission. The firm has extensive experience in the support of global and US medical device submissions. Emergo will initially compile an FDA Regulatory Pathway report that is based on current data that is applicable to the development of OncoSil™.

The IDE submission includes manufacturing data, protocol, investigators brochure, and clinical safety and efficacy data that have been generated to this date. OncoSil will then determine if a simple reference device comparison / 510(k) submission, or a Pre Marketing Authorisation is appropriate.

The Company is also planning a global clinical study in 2014 that is designed to provide data on the safety and efficacy of the OncoSil™ device. '