Ann: 200th patient treated with the OncoSil device, page-41

Now the same for MDR and TGA

Have used the aid of Ai to extract some transcript from the Webinar, and then more Ai to create a summary of that with particular focus on MDR and TGA applications. What is printed below is not word for word what the CEO said, it is rather an Ai summary which is quite accurate I believe - but DYOR, do not rely on this Ai generated webinar summary to make investment decisions, best you listen to the Youtube recording instead.

here is the Ai summarised MDR and TGA applications part of it :

European Medical Device Regulation (MDR) and Australian Therapeutic Goods Administration (TGA) Application

Ryan Sudo: Could you explain the significance of the European MDR approval and how it impacts the subsequent TGA application in Australia?

Nigel Lange: Certainly, the European Medical Device Regulation (MDR) approval process is a critical step for us, not just for maintaining our CE Mark in Europe, but also for facilitating our entry into the Australian market through the Therapeutic Goods Administration (TGA). Here’s a detailed breakdown of both processes and their significance:

European Medical Device Regulation (MDR)

Importance of MDR:

• The MDR is a stringent regulatory framework designed to ensure the safety and efficacy of medical devices within the European Union. Every medical device, whether it’s a syringe or a complex implant like the Oncosil device, must comply with MDR to maintain the CE Mark.
• The MDR process involves comprehensive documentation and rigorous testing to demonstrate that a device meets high safety and performance standards.

Current Status:

• We have filed our MDR application some time ago and anticipate receiving approval by August or September of this year. The process has been extensive, requiring us to address over 330 questions from the regulatory body to satisfy their stringent requirements.

Impact of MDR Approval:

• Securing MDR approval is not just about compliance; it significantly bolsters our credibility and marketability in Europe. It assures healthcare providers and patients that our device meets the highest safety and performance standards.
• MDR approval is also a precursor to regulatory submissions in other jurisdictions. Many countries outside Europe view the CE Mark under MDR as a benchmark for quality and safety.

Australian Therapeutic Goods Administration (TGA) Application

Link to MDR:

• The TGA in Australia recognizes the rigor of the European MDR process. If a company has MDR approval, the TGA is more likely to consider that data favorably, which can streamline the approval process in Australia.
• This mutual recognition means that once we achieve MDR approval, we can use the same comprehensive data package for our TGA application.

Application Process:

• After receiving MDR approval, we plan to submit our TGA application promptly. The TGA process typically has a turnaround time of 4 to 6 weeks if we are not selected for an audit. However, if an audit is required, the process could extend to six months.

Current Expectations:

• Given the substantial work we’ve already done for the MDR, including answering hundreds of detailed questions, we are optimistic about the TGA process. The rigorous scrutiny we’ve undergone for MDR should position us well for a smooth approval process in Australia.

Strategic Importance:

• Achieving TGA approval is crucial for our strategic expansion into the Australian market. Australia has a robust healthcare system, and TGA approval will allow us to offer our device to Australian patients, tapping into a new and significant market.
• Moreover, having TGA approval will further enhance our global reputation, as Australia’s regulatory standards are highly regarded internationally.

Conclusion on MDR and TGA Processes

Nigel Lange: To summarise, the European MDR approval is a critical milestone for Oncosil. It not only ensures our continued presence in the European market but also paves the way for a streamlined TGA application in Australia. The rigorous MDR process has prepared us well, and we anticipate a favorable and efficient approval process with the TGA, allowing us to expand our market reach and offer our innovative treatment to more patients globally.