The ongoing trial is a marketing exercise designed to get a CE approval (after the company failed to get one circa 2015).
It is not designed to, or really able to, demonstrate effectiveness. To do that, you need a much larger, properly controlled trial and this costs serious money (tens or hundreds of millions of dollars).
Look at the development timeline of Sirtex for comparison. They got their marketing approvals, then had to spend a small fortune on real clinical studies before they had any significant sales. After that they still needed to build regulatory, production and sales capacity in ~28 different countries with different systems.
Management have been misrepresenting the value of a CE mark approval since before 2015. I don’t hold this company and don’t intend to, but if you do I seriously suggest reading up on what a CE mark actually means for the product.
Read about Avita Medical for another example of how CE marks can be misrepresented - certainly didn’t lead to success for them.
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