Ann: 200th patient treated with the OncoSil device, page-47

Here a summary for the Pancosil Clinicial Trial part of the webinar.
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 Pancosil Clinicial Trial . 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 Pancosil Clinicial Trial part of it :

Pancosil Clinical Trial (Amsterdam)

Ryan Soutar: Nigel, can you explain the significance of the Pancosil clinical trial and its current progress?

Nigel Lange: Certainly, the Pancosil trial being conducted at the University of Amsterdam is a crucial part of our clinical development for the Oncosil device. Here are the key details:

Significance of the Pancosil Trial

Objective:

• The Pancosil trial aims to evaluate the safety and efficacy of the Oncosil device in treating pancreatic cancer. Specifically, it explores the use of Interventional Radiology to deliver the treatment, which can expand our user base and market opportunities.
• Pancosil is an Investigator Initiated Clinical Trial looking at the safety and feasibility of CT-guided percutaneous radionuclide therapy with the OncoSil™ device in patients with non-progressive locally advanced pancreatic cancer.

Trial Progress and Methods

Clinical Progress:

• The Pancosil trial has progressed well. Initially, the first five patients were treated under general anaesthesia to ensure safety. The Ethics Committee has now approved the transition to treating patients under conscious sedation. This transition is crucial as it simplifies the procedure, reduces the need for an anaesthesiology team, and speeds up the treatment process.

Treatment Method:

• Initially, the procedure required general anaesthesia, but with positive safety data from the first five patients, the trial has moved to conscious sedation. This means the treatment can be completed in about 15 to 20 minutes, making it more accessible and efficient.

Expansion and Collaboration

Additional Sites:

• We are nearing the upper limit of the number of sites for this trial. While we may add one or two more sites, the focus remains on maintaining high-quality data and ensuring consistent treatment protocols.

Expert Collaboration:

• The University of Amsterdam team includes leading experts who provide invaluable insights and assistance. Their expertise ensures the trial's success and helps address any medical questions that arise.

Regulatory and Commercial Impact

Data Utilisation:

• The data collected from the Pancosil trial will be critical for regulatory submissions and obtaining broader approvals. If the safety data supports it, we plan to add conscious sedation to our label, enhancing the marketability of the Oncosil device.

Market Expansion:

• Successfully completing the Pancosil trial will strengthen our position in Europe and provide robust data to support our applications in other markets. Using Interventional Radiology for treatment delivery opens up greater market opportunities by accommodating different medical practices across regions.

Timeline and Next Steps

Ethics Committee Review:

• The Ethics Committee's approval to move to conscious sedation is a significant milestone. We expect this approval to speed up patient enrolment and treatment completion.

Completion Target:

• We aim to complete the trial and gather sufficient data to support regulatory submissions and potential label expansions by the end of this calendar year.

Conclusion on Pancosil Trial

Nigel Lange: In summary, the Pancosil trial at the University of Amsterdam is a critical component of our clinical strategy. It allows us to refine our treatment protocols, expand our user base, and gather essential data for regulatory approvals. The transition to conscious sedation is a significant advancement, and we are optimistic about the trial's contribution to our overall goals.