Greetings and welcome to the ClearPoint Neuro Inc. Third Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. Comments made on this call may include statements that are forward-looking within the meaning of securities laws. These forward-looking statements may include, without limitation, statements related to anticipated industry trends; the company’s plans, prospects, and strategies, both preliminary and projected; and management’s expectations, beliefs, estimates, or projections regarding future results of operations. Actual results or trends could differ materially. The company undertakes no obligation to revise forward-looking statements for new information or future events. For more information, please refer to the company’s Annual Report on Form 10-K for the year ended December 31, 2020, and the company's quarterly report on Form 10-Q for the quarter ended June 30, 2021 both of which have been filed with the Securities and Exchange Commission, and the company’s quarterly report on Form 10-Q for the quarter ended September 30, 2021, which the company intends to file with the Securities and Exchange Commission on or before November 15, 2021. All the company’s filings may be obtained from the SEC or the company’s website at www.clearpointneuro.com. At this time, I would like to turn the floor over to Mr. Joe Burnett, Chief Executive Officer. Thank you, sir. Please go ahead.

Thank you, Kate, and thank you to all of the investors and analysts on today's call for being a part of the ClearPoint vision and journey. Our mission and our priority is to help restore quality of life to patients and their families who are suffering from some of the most debilitating neurological disorders imaginable. In the third quarter of 2021, we have continued to make progress against our four pillars of growth, including functional neurosurgery navigation, biologics & drug delivery therapy and access products, and achieving global scale. While elective case volume was once again impacted this time by the Delta variant in August and September, we still achieved record revenue overall. We also added new partners, both on our medical device navigation portfolio and in our biologics and drug delivery portfolio. These two distinct market categories are both served by the same ClearPoint platform, and we estimate that they each have total annual addressable markets of more than $1 billion each in the years ahead. I will now turn the call over to Danilo, our CFO, to review our financial performance in the quarter after which I will add some details to our four pillar growth strategy. Danilo? Danilo D’Alessandro: Thank you, Joe and thank you all for joining us today. Looking at the third quarter 2021 results, total revenue was $4.6 million in the third quarter of 2021 compared to $3.5 million in the third quarter of 2020, an increase of $1.1 million or 30%. Our revenue is made up of three components, functional neurosurgery navigation therapy, biologics & drug delivery, and capital equipment and software. Functional Neurosurgery Navigation revenue consists of commercial sales of disposable products and services related to cases utilizing the ClearPoint system to deliver medical device therapy to the proper target. This revenue…

Thanks Danilo. The third quarter was a successful quarter for our team across our four pillar growth strategy, headlined by record revenue of $4.6 million for the quarter, new partnerships in both our medical device and drug delivery businesses, and the successful hiring of talented new employees across product development, quality, clinical support, and even a new board member has just announced last week. Let's break that progress down into our four pillars of growth. Starting with functional neurosurgery navigation. We achieved record revenue of $2.2 million during the quarter and 227 cases supported by our clinical team. While case volume declined slightly versus our record second quarter, we did see disposable purchasing increase to replenish inventory and to prepare for future procedures that have been scheduled here in the fourth quarter. The Delta variant did impact elective procedures at about 20% of our hospitals in August and September. However, in October, we saw the majority of those impacted hospitals resume elective procedures. The new and somewhat unforeseen symptom of COVID has been hospital staffing shortages at hospitals across the country, where a hospital may have plenty of ICU beds available for elective procedures, that same hospital may not have enough nurses and other staff members to support the procedure and the recovery of that patient. Now, speaking of patients. In the third quarter, we launched our first program designed to educate patients and their families about their options for deep brain stimulation treatment. Our first patient testimonial video featured Susan O'Rourke DBS journey with an MRI guided DBS placement under general anesthesia, otherwise known as a sleep DBS. At ClearPoint, we always put the patient first. So, we would encourage each patient to speak directly with their physician about DBS treatment options, which could be an awake MER guided…

Thank you. The floor is now open for questions. [Operator Instructions] Our first question comes from Frank Takkinen. Please state your question.

Joe, Danilo, thanks for taking my questions. Congrats on a solid quarter. For starters, can you give …

Hi, Frank.

Yeah, absolutely. Can you give a little bit more color into the guidance range? I'm looking at the results. And from low end to top end, can mean both sequentially down as well as sequentially up for Q4 revenue? So maybe give us some assumptions around the guide as well as what type of COVID-related impacts, whether that be a shortage of staffing at hospitals is baked into the guidance for the full year.

Yeah. Frank, thanks for the question. And I think you said it right there. One of the reasons we're hesitant to go a little deeper in the revenue forecasting is that, COVID could in fact rear its ugly head yet again. But your math is absolutely right. And I think it certainly assumes that we would be doing somewhere between $4 million and $5.5 million for the rest of the year or in the fourth quarter. I think it's fair to expect that, assuming COVID does not have a significant impact, we probably expect something in the $4.5 million range or so given where we are today, given our forecast.

Got it. That's helpful. And just thought I'd try to give a little bit more color on how you're thinking about 2022. I realized there's no guidance out there yet, but maybe speak to how you're thinking about the growth profile of the company. As we look into 2022, obviously COVID is a large variable in this situation, but maybe just give us some thoughts on how we should start to think about 2022 growth.

Yeah. Without going too far into the numbers, let's kind of talk pillar by pillar. We would expect really all four of our pillars to experience growth in 2022. Starting with functional neurosurgery, I think there's been some pent-up demand. And certainly some patients who have been put on hold for their surgery that have not been able to go in whether it was from the Delta variant in August, in September or from some of these staffing shortages that you see here. But we do hear from a number of our customers, that there is a significant backlog of patients that are waiting to be treated. So, we certainly expected those to start to flow out in 2022. Not to mention the backlog of interested parties that have not been able to purchase the ClearPoint system. So we really have not placed many systems this year at all. And we do expect that placement that start to accelerate here in the fourth quarter, as well as throughout 2022. Now in the fourth quarter, I don't know that that much capital will come in, given the typical timing around an evaluation, but certainly we see capital as a significant opportunity for growth in 2022 as well. And then, on the biologic side of things, we do expect that to continue to grow. We've added, I believe, 15 additional partnerships this year already, and we do have a number of additional ones in the queue. And each partnership generally starts with a smaller investment in consulting services and benchtop testing with any one of our pharma partners. And then as the -- let's say, the partnership begins to mature and the regulatory process starts to unfold for our partner, then they start purchasing more devices for preclinical studies for Phase 1, Phase 2 trials, and in some cases for inventory security and things like that. So, whereas we do have a number of new partners that are just getting started with us. We also have many other partners that are much more advanced that we're expecting to have additional development services and revenue coming from Phase 1, Phase 2 and even Phase 3 trials next year. And I think the last point I think I didn't touch on was, was the therapy side of things where I don't expect therapy and access to be a huge contributor in 2022. Although, if our timeline stay intact for our own laser system, then in the second half of next year, we would expect to start seeing our first sales, and our partnership with adeor is something that we're pretty excited about as well that we should be able to start seeing sales throughout 2022. So, whereas that therapy number I believe was zero here in the third quarter, in 2022 we'll be really collecting our first revenue in that segment.

Got it. That's helpful. That's great color, a lot of different growth opportunities there. Last one for me. I think on the last call, there was some reference to PTC, isn't the only partner that has a potential 2022 FDA approval. One, was that correct? And two, can you maybe frame up just how many of your partners could be submitting for approval in 2022? Just trying to get a sense for shots on goal?

Yeah. I would say there's two or three in there, that could fall into the category as you describe it that are using either a cannula or a navigation system or both. And they actually stretch across a few different disorders. So, it's three different indications that are potential ones. I believe PTC is still the most mature. I believe they've recently mentioned that their BLA is expected to go here in the U.S. early in Q1 of next year. I believe the most recent information, which could still have them on track for 2022 FDA clearance. It's also likely they could have a European or a CMR clearance in 2022 ahead of the FDA clearance too. So, we still think that's the most advanced one. However, there are a couple others that could go in. And again, in these -- in all three of these situations, these are very rare childhood genetic disorders where there's really no alternative for these patients. So, any of the regulatory bodies want to feel like we've got a shot to help these folks. And because the number of patients is relatively small compared to massive opportunities like Parkinson's disease and tumor and essential tremor, it's easier to track these patients even in a commercial setting and just do it through market surveillance instead of a clinical trial. So, that's why we think there is the potential for some of that flexibility. However, a lot of the examinations and inspections that the FDA or notified bodies will have to do of the manufacturing processes of these sites still have to go very well. So, there's a lot of work still left to do.

Got it. That's helpful. Appreciate all the color. Thanks.

Sure.

Okay. Our next question comes from Bjorn Ng. Please state your question.

Hey, Joe, it is good to hear voice again. Congratulations on an outstanding quarter and by the way, congrats on the grand opening of the CarePoint Global Training & Innovation Center in Solana Beach. I love the coast Mueller and the story behind it.

Thank you, Bjorn.

Yeah. Thanks Joe. In an earlier call, you shared that laser ablation cases two to three times revenue opportunity and that it makes up about 35% of our total cases. So, do you see an opportunity of laser ablation cases to make up a higher percentage of total cases taking into account the partnership with CLS and IGT SLSP [ph] cranial and spine opportunities?

I do. I think it does have a very good opportunity to grow as a percentage of our cases. And the reason I say that is I believe the laser ablation procedure or the overall market seems to be growing a bit faster than the DBS market today. Now it's a much smaller market than DBS. There's many fewer procedures, but from what we can tell that market seems to be growing anywhere from 15% to 20% plus versus the DBS market is closer to the 5% to 10% range. So, as that grows and as we launch more advanced products to participate in that market and the share of those cases as a percentage of overall ClearPoint cases should also grow. Now that being said, we're also very excited about a number of the new clinical trial work that's being done for deep brain stimulation. There's more and more epilepsy cases that are being done with a Medtronic system, as well as with neuro pace and a few more that are on the horizon. And many of these DBS systems are also going after much larger potential markets as well, including Alzheimer's disease, chronic drug resistant depression, things like that too. So, whereas those are going to take some time to develop, they have to go through the clinical trial process. It's great to see the research community embracing DBS as a very real potential solution.

Got it. So, in terms of the expansion to Europe, could you share some colors on the pipeline for installation CLS enrollment of clinical trials in U.K. sites for next year? I remember you shared that you expect to have another two to three installations this year as well.

That's correct. Yeah. So, we are continuing to push evaluation agreements and install agreements. Again, our strategy in Europe is not to try to place a ClearPoint system at every local hospital, but really to focus again on the centers of excellence. So maybe two or three per country is the direction that we're going today. So where it's hard to commit to the exact month that an install takes place, because of sometimes some construction is needed for air circulation. Sometimes there's additional anesthesia equipment that's required for the MRI suite. So, those things -- just have typical vendor delays, but I would expect that by the end of next year, we have anywhere from five to 10 installations across Europe and Israel.

Thanks. That's helpful. So, the last question I have is I think it's super that Dr. Linda Liau joined ClearPoint's Board of Directors. It's definitely a sign on validation of ClearPoint solutions. So, how has she help to increase adoption and use ClearPoint solution amongst neurosurgeons?

Well, I think she's going to be able to do a number of things for us. Number one is provide some excellent input on training and how to get the attention of a neurosurgical team. Again, she's not only speaking from the arena of being a neurosurgeon, but also responsible for the training of a series of fellows as well. So, being able to understand the individual surgeon's needs as well as the needs of the department, I think is something it's nice to have someone on the inside that that can share that perspective. Similarly, she's been involved and spoken with a number of researchers around the world, working on biologics and drug delivery, primarily on the tumor side of things, but she also has experienced beyond tumors into functional disease too. And I think some of the introductions that she is able to make, and really helps to connect the dots of what drug partners out there would really be able to benefit from our navigation, from our cannulas, or even from some new routes of administration that we're developing to reach different parts of the central nervous system. I think her being able to work with our biologics team and sort of circle and highlight the company that will absolutely benefit from ClearPoint technology.

Got it. Thanks, Joe. There's all the questions I have and I would just like to commend you and your team on your efforts over the quarter. It must not be easy to navigate the impact of the Delta variant. Looking forward to continuing on this journey together with you for the long-term.

That's great. Thank you, Bjorn.

That was our final question. I'll turn it back over to Joe for closing remarks.

All right. Well, once again, thank you everyone for being interested and being a part of our team's story here at ClearPoint. We believe that we're all doing very important work and we'll continue to put the patients and their family first, as we take on greater and greater responsibility for the treatment across our portfolio. Good night everyone.

Thank you. This concludes today's conference call. We thank you for your participation. You may disconnect your lines at this time and have a great day.