Hi, and welcome to BioStock Studio. We are in the midst of report season, and last week, medtech CLS reported their third quarter. The quarter has above all meant advances in the U.S. in the form of an FDA approval. We have CEO Dan Mogren with us to tell us more. Welcome, Dan.
Thank you so much.
Like I said, the biggest advancement during Q3 was definitely the FDA approval for use of your laser ablation system in neurosurgery. How is the U.S. rollout progressing?
It's progressing well. We selected to work with ClearPoint Neuro for the U.S. markets within neurosurgery. We're progressing according to plan. ClearPoint Neuro is a prominent player. They've been on the market for many years, established themselves. They have a fantastic organization with both sales and clinical application specialists supporting the sales. They have today established themselves in more than 70 centers in the U.S. That's forming the basis for the rollout with the neurosurgery in U.S. for the product, which is, again, branded Prism Neuro Laser Therapy System. Yes, it's moving along according to plan.
It is very clear in your report that your focus is now the U.S. market. What does this mean for your other target markets, the European market and Asia Pacific?
U.S. represents approximately 55% of the world market, so obviously is a very important market to us, and 55% is in across border. Both with the neurosurgery as well as the urology market for us, we see it as one of the biggest and most important market to CLS. Obviously our focus is shifting in that direction with the 510 clearance and with the rollout. We will continue working in the European market and towards the Asian Pacific according to the goals and milestones that we set up, but there will be a shift towards the U.S. market based on the clearances and the rollout, yes.
If we then look a little bit to the financial side.
Mm-hmm
What does the U.S. focus and rollout mean in terms of needs financially and in terms of organizational needs for CLS?
If we look at the organizational needs again with ClearPoint Neuro, with their organization, they will manage both sales support on the U.S. market. CLS do not plan to increase its organization within the sales force or in the clinical application specialist force for the neurosurgical market. However, what we're dealing with now is the need within ClearPoint to train their staff, to train their salespeople, to train their clinical application specialists to support the rollout in the U.S. This is what we're doing currently in the U.S. right now. In terms of the other market segments in the urology, we're also seeing that we're ramping up in the U.S. right now with the team that we have in the U.S.
We will look into what that means in terms of organization buildup, both on the sales but also on that supporting side that I mentioned for neurosurgery. We have not exactly the same need in urology but a similar need in urology to build up clinical application support. We're looking into that right now. We're right in the middle of budgeting and planning at this point, so we'll get back to what it means in detail in due time.
With 2022 nearing its end, what are the main goals for 2023?
Uh, main goals for us in '23, 2023, is to make sure that the, the, the market release in the U.S. for the neurosurgical market works as intended. We will certainly focus on that. Also in urology, as we launched early this year, um, our products, our systems for fusion-guided FLA for focal therapy in prostate cancer, we will continue to support that, and we're expecting to see, um, results from, from the, the launch in the U.S. market also in urology. Uh, other than that is to increase the number of market clearances we have. Uh, we have the MR-based system, uh, TRANBERG system for focal therapy, where we are, uh, going ahead, uh, with that towards a, a clearance in the U.S., also a clearance in the, in the Asian Pacific region for that particular product.
We're also expecting to see some early results from our clinical trials that are ongoing, I would say across the world. We do that on both sides of the Atlantic, and to see some of those early results coming out from the clinical trials. We're also expecting to see, either before the end of this year, more likely in the beginning of next year, have additional commercial partnerships within urology. We have the ClearPoint collaboration since a couple of years back in neurosurgery. I think it's been very successful. We're looking at something similar also, as we mentioned before, in urology. We expect to see that early in 2023. Together, we're obviously seeing that, or expecting that our sales revenues will go up in 2023 based on the investments we're doing right now.
Sounds like you have an exciting 2023 ahead of you then.
We certainly do, yes. Thank you.
Thank you so much for tuning into this Q3 update with CLS, and thank you for coming, Dan.
Thank you so much for having me.