ClearPoint Neuro, Inc. (CLPT) Q2 2021 Earnings Call Transcript

ClearPoint Neuro, Inc. (CLPT -3.27%)
Q2 2021 Earnings Call
Aug 10, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Greetings. Welcome to the ClearPoint Neuro second-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] Please note 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 March 31, 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 June 30, 2021, which the company intends to file with the Securities and Exchange Commission on or before August 16, 2021. All the company's filings may be obtained from the SEC or the company's website at www.clearpoint neuro.com. I will now turn the conference over to your host, Joe Burnett, chief executive officer.

Thank you. You may begin.

Joe Burnett -- Chief Executive Officer

Thank you, Diego, and thank you to all of the investors and analysts on today's call for being a part of the ClearPoint vision and journey. We are here 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 second quarter of 2021, we made substantial progress across all four of our pillars of growth, including functional neurosurgery navigation, biologics, and drug delivery, ClearPoint therapeutic products, and achieving global scale. Importantly, we made this progress while seeing a return to pre-pandemic case volumes for a new quarterly record of 249 procedures covered, as well as adding multiple new biologics partners to our active list, bringing our total from 30 to approximately 35 today.

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 detail to our four-pillar growth strategy. Danilo?

Danilo D'Alessandro -- Chief Financial Officer

Thank you, Joe, and thank you all for joining us today. Looking at the second-quarter 2021 results, total revenue was $3.4 million for the three months ended June 30, 2021, and $2.5 million for the three months ended June 30, 2020, which represents an increase in revenue of $0.9 million or 38%. Our revenue is made from $1.1 million for the same period in 2020. This increase reflects the resumptions in the three months ended June 30, 2021, of elective surgical procedures, which were postponed or canceled during the same period in 2020 due to the COVID-19 pandemic.

Biologics and drug delivery revenue include sales of product -- of disposable products and services related to customer-sponsored clinical trials utilizing our products. Biologics and drug delivery sales increased 19% to $1.4 million for the three months ended June 30, 2021, from $1.2 million for the same period in 2020. This increase is attributable to increases in both biologic and drug delivery product revenue and service revenue as our biologic and drug delivery customers reestablished their estimated timelines for initiation or resumption of their clinical trials. Capital equipment and software revenue, consisting of sales of ClearPoint reusable hardware and software and of related services were $0.2 million for each of the three-month periods ended June 30, 2021, and 2020.

Revenue from this product line historically has varied from quarter to quarter. While interest in the ClearPoint system remains strong, capital headwinds and delayed evaluations due to COVID and IT ransomware concerns continue to slow new site activations. Gross margin for the three months ended June 30, 2021, was 67%, compared to 68% for the same period in 2020. This decrease was due primarily to a decreased contribution in the second quarter of 2021 to total sales of service revenue, which bear higher gross margins in comparison to other -- to our product lines.

This decrease was substantially offset by an increased contribution from functional neurosurgery navigation disposable product sales, which carry a higher gross margin relative to other product lines. Research and development costs were $2.1 million for the three months ended June 30, 2021, compared to $0.8 million for the same period in 2020, an increase of $1.3 million or 177%. Sales and marketing expenses were $1.6 million for the three months ended June 30, 2021, compared to $1.1 million for the same period in 2020, an increase of $0.5 million or 42%. Both these increases reflect additions in key areas to our team as we invest in expanding our product line, launching indications, and comply with global standards as installations take place around the world.

General and administrative expenses were $2 million for the three months ended June 30, 2021, compared to $1.2 million for the same period in 2020, an increase of $0.8 million or 63%. This increase was due primarily to increases in state franchise taxes, insurance expenses, occupancy costs, and share-based compensation. As a benefit of our last round of financing, we have hired 50 new employees across the organization since the beginning of the year in order to accelerate product development efforts, commercial support, and global expansion. At June 30, 2021, we had cash and cash equivalents totaling $61.5 million as compared to $20.1 million at December 31, 2020, with the increase resulting primarily from the completion of a public offering of our common stock in February of this year.

I would like to turn now the call back to Joe.

Joe Burnett -- Chief Executive Officer

Thank you, Danilo. As mentioned earlier, our clinical specialist team enjoyed a record quarter for procedures supported. We added multiple new biologics partners and new services to our active list and portfolio and two exciting new partnerships with Blackrock Neurotech and adeor were announced, showing our progress in reaching further and further into the operating room to complement our MRI guidance strategy. Let's break down that progress into our four growth pillars.

First, functional neurosurgery navigation continued to rebound with 249 cases covered by our specialist team in the quarter versus 126 a year ago during COVID, a growth of about 98%. We had previously communicated that we believe the case volume would return to these levels in the second half of 2022. So on the positive side, we see that this return happened about a few months early. We are not fully out of the woods yet, however, as we are aware of a number of hospitals in states like Texas, Kansas, Louisiana, Florida, and Georgia, that have communicated that elective procedures may once again be put on hold due to the COVID Delta variant.

And the number -- and the growing number of hospitalizations. At this point, at least one hospital has halted elective procedures and one hospital has limited them. All other communications to this point has been a warning so far. From a development standpoint, we continued progress across our portfolio and solidified budgets, schedules, and team members using the significant capital infusion in the first quarter of this year.

As mentioned on the last call, we did receive FDA clearance for the SmartFrame Array, which is meant to streamline workflows and help ClearPoint to cross over into the operating room. We will continue our limited market release through the second half of 2021 and remain on track for a full market release in the first half of 2022. We have continued development across the rest of our pipeline as well, including the 2.1 ClearPoint software, the Maestro Brain Model, the Orchestra multi trajectory head frame, our co-developed MER system in collaboration with Blackrock, and our robotic-assisted system called ClearPoint Revolution in partnership with D&K engineering. We feel that we have an exciting cadence of new and improved products over the next few years, which will continue to demonstrate ClearPoint as one of the true innovative companies in the neurosurgery space.

All of our previous timelines remain intact and after completing our first clinical cases with SmartFrame Array, which was accomplished in the second quarter, we continue to expect first cases of ClearPoint 2.1 and the Maestro in 2022 and Orchestra, MER, and Revolution in 2023. Our recent announcement to enter the Brain-Computer Interface Navigation segment with Blackrock Neurotech is a very exciting one. There is tremendous potential around the future of BCIs, both for medical and communication purposes, as you can tell by the significant investment taking place in this space. Blackrock is one of the first and most experienced BCI implant companies with 29 cortical implants completed to date in human subjects.

Their recent infusion of capital is designed to accelerate the clinical and commercial launches of their pipeline of BCI tools. Under this agreement, we are leveraging our existing ClearPoint platform to build a custom SmartFrame solution and software to make the BCI implementation faster, more precise, and more repeatable across multiple surgeons and hospital sites. I think of this partnership as very similar to the work we do with our pharma partners, where we provide a system, disposables, and clinical support during the infusion of a drug. In this example, we are placing the BCI as a target instead of the infusion cannula, but the business relationship is very similar.

Our intention is to sell this navigation system directly to hospitals through our commercial channel and see this as another disposable spoke on the ClearPoint Hub platform. Importantly, while MRI images are used for many, if not all BCI applications, the surgery itself is designed to take place in the operating room. So this is another application that we are focused on that is not reliant on MRI access, but rather an additional crossover technology for ClearPoint into the operating room. We also just announced yesterday an agreement with adeor, a leader in surgical drill solutions based in Germany.

This partnership has two important elements, first, a distribution agreement allowing ClearPoint to sell and support the adeor portfolio of power drills designed for the operating room here in the United States. This is an impressive portfolio of products that has been quite successful across Europe and just recently gained FDA clearance. We expect training and limited market release activities to begin in the fourth quarter of 2021 with a full market release in the first half of 2022. The second element of our agreement with adeor is that adeor will build an MRI conditional device based on their current Velocity Alpha design and upon this successful development, ClearPoint will be the worldwide exclusive distributor of the MRI conditional drill.

This drill is an important addition to our portfolio as it is designed to eliminate the need for a slower hand-twist drill and could save anywhere from 15 minutes to more than an hour of surgical time during each procedure, depending on the numbers of trajectories. This is especially relevant for our drug delivery partners as multiple trajectories and infusions are quite common. Like in the Blackrock agreement, this also provides yet another crossover technology for ClearPoint to help penetrate the operating room as well. Second, our biologics and drug delivery team continued to add additional partners and services in the second quarter.

We currently have approximately 35 individual pharma and academic partnerships across multiple indications, up from approximately 30 a quarter ago. As a reminder, it is common that each customer or partner has a drug platform of their own, meaning they are not planning to use their drug or vector for only one indication. Our decision to expand into Europe has already helped us win additional European-based pharma business and academic researchers. We plan to continue adding partners and still believe that initial -- an initial commercial gene therapy approval for neuro could take place in the year 2022.

As you have likely seen from recent press releases, the enrollment of patients into these trials has restarted after COVID, and we fully expect multiple partners to continue enrollment and initiate new trials here in the second half of 2021. It is also important to note that the majority of our investment into the navigation system mentioned in pillar one applies also to biologics and drug delivery. That is the beauty of our platform strategy as much of the investment is applied across many indications in both biologics and medical device navigation. This is crucial from a training standpoint as well.

Every biopsy case, laser ablation case, or deep brain stimulation case a hospital does with ClearPoint today is, in fact, training and preparing them to do biologics cases in the future. For our third pillar, therapeutic devices, we have continued our development progress and remain on schedule for our previously communicated timeline. The ClearPoint exclusive laser ablation system that is in development with CLS in Sweden and IGT in France continues to make progress and collect data, and we are still planning for a submission in the second half of 2021 to the FDA despite some COVID related delays. We did announce an installation and clinical partnership in Paris at Rothschild Hospital a couple of weeks ago.

The primary clinical data that will be collected will be on pediatric tumors using the complete ClearPoint CLS IGT laser solution, with the expectation of the first patients being enrolled in the first half of 2022. Our biopsy platform, similarly, is planned for first human cases in 2022 and remains on track today. Finally, our fourth pillar of achieving global scale has made progress as well. Our quality system has been successfully updated to be compliant with the new European MDR rules that went into effect in May of this year.

This is not a small task and has been daunting enough to some companies that they have decided not to sell certain products in Europe under these new regulations. Although compliance is challenging, we believe our investment is the right one and the simple fact that we have one of our clinical specialists present at our procedures helps us with that compliance and market surveillance. We have also relocated key personnel to Europe and are preparing to do additional installations like the one that was just announced in Paris later this year. Based on the second-quarter results, we are continuing to stand by our prior forecast of between $16 million and $17.5 million in revenue for the year and a range of 900 to 1,000 cases covered by our clinical team.

The last comment I would like to make is about our team. We have successfully added about 15 exceptional team members across clinical, development, quality, legal, finance, and production over the past six months, and I want to make sure I underline how special this team is. We have a vision of where we want to go. We are well-capitalized, and we have a motivated and very capable team that knows these patients and their families are depending on us.

In my experience, this has always been a recipe for success. With that, I would like to open up the call to any questions.

Questions & Answers:

Operator

Thank you. And at this time, we will be conducting our question-and-answer session. [Operator instructions] Our first question comes from Frank Takkinen with Lake Street Capital Markets. Please state your question.

Frank Takkinen -- Lake Street Capital Markets -- Analyst

Hey, guys. Thanks for taking my questions. I wanted to first ask on the fiscal-year '21 guidance reaffirmed. Where should we expect the reacceleration to come to drive the sequential growth through year-end? With the report here, it's modeled in to be growing through the end of the year.

So I was just hoping you can give us a little bit more color on the drivers to drive the sequential growth through the back half of the year?

Joe Burnett -- Chief Executive Officer

Yeah, happy to. And thanks for the question, Frank. So as you mentioned, we have reiterated our forecast. And obviously, that does imply that the second half of this year has significantly more revenue than the first half.

So we are expecting to see that and see that pick up in the third quarter. Again, when you're growing things off of a smaller revenue base, even a week of a delay of a delivery to a biologics customer or, for example, we had a very large number of cases in the last two weeks of June. So a lot of those replenishment orders took place in the first two weeks of July. So really just timing at where the quarter happened to end, I think, maybe brought the revenue numbers for Q2 down, but it's certainly been replenished here in Q3.

And in fact, to date, July has been our most successful month ever, from a biologics and from a case volume standpoint. So we do expect that acceleration to start back up in Q3 here.

Frank Takkinen -- Lake Street Capital Markets -- Analyst

Got it. That's helpful. Thank you. Moving over to Array.

Maybe speak to the opportunity you guys see with this product in your 60 established sites. Do you feel this is something all 60 sites would benefit from implementing at their practice? Is that a portion of those? Is it more than 60? Just trying to get a feel for the opportunity to sell into the established market right now.

Joe Burnett -- Chief Executive Officer

Yeah. I believe it is an opportunity for not only existing customers but maybe even more for new customers that would like to use some of ClearPoint's technology, especially when our laser is available and our MER system is available, but simply can't do that today because we're still waiting for that solution. But I do think it's something that applies broadly. I don't think it's specific to a hospital, and I think it becomes more specific to the timing to an indication.

So what I mean by that is if you're doing a laser ablation procedure, using the Array system makes a lot of sense because it's faster, it's simpler, it's a little bit easier to make adjustments. And if you're doing multiple trajectories in the same patients, which is very common for tumors, it makes that workflow a little bit simpler. So I think the adoption of Array into laser procedures will be sooner. If you wanted to use the Array for a procedure like a deep brain stimulation case, this is really required to use something like microelectric recording or MER in the operating room.

So what I mean by that is the timing of Array adoption for deep brain stimulation might have to wait until our MER system is available closer to 2023. So it really depends on what it is the site is looking to use our technology for.

Frank Takkinen -- Lake Street Capital Markets -- Analyst

Got it. OK. And then last one for me. I wanted to ask on -- I heard your commentary about you still are expecting your first biologic approval this year that is using the ClearPoint system.

Can you speak to this approval? I want to say it's PTC-AADC and European market, but I wanted to say that they also may have pushed out the U.S. BLA submission. So could you just update us on this partner, one, if that's the correct partner, and two, their latest development timeline that they're expecting?

Joe Burnett -- Chief Executive Officer

Yes. So I believe what they've communicated is that they're still expecting to submit their BLA here in 2021 with a potential approval in 2022. So I do believe that that commentary from PTC is effectively what we're presenting here today. There is the potential for a European commercial approval to take place sooner than 2022 or sooner than the United States.

But whether it happens in the second half of this year or the first half of this year -- or the first half of next year, I think it kind of remains to be seen. We need to remember that it's going to be a very significant milestone whenever it takes place because it will be the very first gene therapy approved for a neuro indication. However, being the first is always challenging when the FDA notified bodies are continuing to work through all of those different requirements. We know many of the challenging requirements that have been taking place related to manufacturing and replication of the drugs themselves since many of these facilities are set up for the first time.

But we're still -- we'll be ready whenever that clearance is available. One other thing I'd build on that comment, however, is that there are also some other opportunities for orphan disorders that could take place in 2022 as well. So while PTC is one of the partners we work with, where we've announced the name, and we're doing a lot of pre-launch activities and planning for them, it does not mean that that's necessarily always going to be the first one. There are other opportunities in 2022.

Frank Takkinen -- Lake Street Capital Markets -- Analyst

Got it. OK. That's helpful. That's all for me.

Thanks for taking my questions.

Joe Burnett -- Chief Executive Officer

All right. Thanks, Frank.

Operator

That's next question comes from Andrew D'Silva with B. Riley Securities. Please state your question.

Andrew D'Silva -- B. RIley Financial -- Analyst

Hey, good afternoon. Thanks for taking my questions. Apologies if you answered any of these, I was jumping between calls. So the first question for me is about Europe.

Just curious how things are progressing from a site activation or the ability to get into sites from a sales and marketing standpoint faster? I just see a couple of installs year to date, which looks good. But obviously, Europe seems like it could be approved from a commercial standpoint first, and the majority of the navigation potentially is domestic. So I'm just trying to get a sense of how support there from ClearPoint will look once approvals and launches start happening?

Joe Burnett -- Chief Executive Officer

OK. Now, thanks for the question, Andrew. And, yes, so Europe is starting to open up again. However, there's obviously some additional challenges worldwide with the Delta variant that we're seeing.

However, the installation process seems to have resumed. As I think you pointed out, we've had three installations in Europe that have taken place so far this year in Denmark, in Poland, and in France. I would say by the end of the year, we expect to have at least two or three additional installations take place as we prepare not only to do laser ablation procedures or potentially deep brain stimulation procedures but also prepare to do some of the drug delivery cases either under some sort of commercial approval, as you pointed out, or as we extend into clinical trials with some of our partners that are starting to enroll in European sites. So I think it's the ability to have some support from the pharmaceutical side of things for clinical trials to get our equipment in, certainly helps us to accelerate the process of installation because we generally have a champion at each one of these centers that's really, really interested in being the first in their country or certainly the first in their city to be able to participate in this kind of exciting new procedure.

Andrew D'Silva -- B. RIley Financial -- Analyst

OK. Great context. Thank you very much for that. Last question is just related to the direct-to-patient marketing potential for the asleep DBS procedure in the MRI suite.

Just where are we on that or what should we think about as next steps?

Joe Burnett -- Chief Executive Officer

Yes. I think we're actually making quite a bit of progress there. In fact, there was an article just published this week out of the Brigham and Women's Institute that talks about the accuracy of asleep DBS placement. And some of the materials from different DBS companies are starting to indicate more and more usage of really leaving it up to the physician as to whether the patient should be awake or asleep for these procedures.

We continue to gather this data and organize it in a fashion and expect to start doing some basic education directly with neurologists, as well as physician providers on some techniques on how the ClearPoint procedure is used. And again, whether that patient needs to be awake or asleep for those procedures at the physician's discretion. So I think things are absolutely looking positive there.

Andrew D'Silva -- B. RIley Financial -- Analyst

Great. Thanks for taking all my questions. Congrats on the progress and good luck going forward.

Joe Burnett -- Chief Executive Officer

OK. Thanks, Andrew.

Operator

Our next question comes from Bjorn Ng with 10X Capital. Please go ahead.

Bjorn Ng -- 10X Capital Pte Ltd. -- Analyst

Hey, Joe, we have been following the progress of ClearPoint, and it's really exciting to see how the story is unfolding, and I continue to be a strong supporter of what you do. So I just want to touch on the recent partnership that ClearPoint formed with adeor Medical, and it's definitely great news. Could you share with us on how you feel this will be complementary to ClearPoint existing solutions? And how would this partnership value-add to ClearPoint's current offering, as well as for both the functional neurosurgery and the biologics and drug delivery partners? Thank you.

Joe Burnett -- Chief Executive Officer

Thanks for the question, Bjorn. And I'll cover the part -- the second part first, which is really the strategic rationale for this, which heavily relies on our ambition in the biologics and drug delivery space. And we truly want to be a leader there and continue to be a leader and not relinquish that lead once we have it. So what the drill solution will allow us to do, the one that is currently in development, is it will allow us to replace our twist drill, which is currently in our kit and is used during these clinical trials.

So if you can imagine the difference of drilling inside of an MRI environment. So remember, you can't have any heavy metals there. You have to use titanium drill bits and things like that. So the primary solution that's used in that MRI environment today for these drug delivery cases is putting a hand drill.

So effectively, like moving your arm in a circle to actually rotate the drill bit and drill through the skull. And if you have kind of middle-aged patients with very fixed skulls and certain disorders actually generally lend themselves to thicker skulls as well. Every single one of those drill holes can take you 15 to 20 minutes. And you could actually have to do what's called -- described as bone work at the end to make sure you don't push into the skull itself, but be able to scrape around the holes and give yourself a clean entry or a clean purchase under the skull.

So in some clinical trials, you can imagine, you're not only doing two holes, you could be doing four, you could be doing six, you might even want to do more than that. So the thought of 10 to 15 minutes for each one of those holes can be a pretty daunting one. It can also be tiresome for the surgical team that's doing the procedure. So having an automated version that's similar to the ones available in the operating room today, you could effectively do that same exact work in less than a minute for each one of those holes.

So anything we can do to shorten the procedure time to take up less time in the MRI magnet itself and to ensure that when the patient is asleep under general anesthesia, we're not keeping them under anesthesia too long. These are crucial, crucial elements to all of our drug and pharma partners. So it's a very, very important project, and we feel we've partnered with the best company to kind of deliver on this ambition. So that's the strategic part of the development partnership.

The first part, which is the more immediate opportunity is the U.S. opportunity to distribute this Alpha -- this Velocity Alpha, which is the high-end precision surgical drill that adeor makes and distributes throughout Europe. So this is a tool. It's an existing $200-plus million market here in the United States.

If you look across all the indications, including orthopedics and spine and cranial, intracranial for neuro, dentistry, and things like that. Obviously, our channel is not focused on things like dentistry today, but our presence in the hospital and this intimate relationship we have with the neurosurgery community, certainly gives us a chance to go after cranial and spine immediately and actually potentially play in orthopedics as well. So our focus is going to be on the customers that we know and the relationships that we have today. However, we are going to explore the ability to expand into some of these new markets as well.

But even if you just look at the existing U.S. market for cranial and spine, so the neurosurgery applications that our customers are using today, that's at least a $50 million opportunity from the data that we have.

Bjorn Ng -- 10X Capital Pte Ltd. -- Analyst

All right. Thank you. That sounds really exciting. So I just got one more question relating to our biologics and drug delivery partners.

It's great to hear that we added another five partners in this quarter. So do you expect that we will continue adding partners at a similar pace? And could you share with us some color on how our biologics and drug delivery business will make up for any potential impact due to the COVID Delta variant? Thanks, Joe.

Joe Burnett -- Chief Executive Officer

Yeah, I'm happy to. I think we enjoyed a very nice pace here in, I'll say, the second quarter, but I'm including sort of the recent news from this week. So it's really the month of July as well. I think Voyager made an announcement today where they were discontinuing their surgical approach relative to their drug delivery platform.

So obviously, that's the subtraction of one of those partners, at least temporarily. It still remains to be seen if they're interested or willing to sell off that asset to another partner and restart some of the clinical work. But the way that we think about counting these partners is, there's some addition that takes place, and there's also some subtraction. So if we think about what took place in the last three to four months, effectively, we added about seven partners and then subtracted two relative to the Voyager and Neurocrine departure from this space.

It was a net of five, and that's how we continue to make this count. I would say that that's more on the high-end of what I would expect to bring on seven new partners in just three or four months. But I think maintaining a pace of about one a month or one every two months is certainly something that's available. We still believe there's another 100 partners out there across intracranial and spine that would benefit from ClearPoint technology.

And I'd say we have active conversations with 20 to 30 of them at this point, but they haven't matured to the point where we would say, OK, that's an official partner at this point. So similar to the way we think about capital equipment placements where we've got a funnel of potential customers, and then we look to install one or two a quarter. Similarly, on the pharma side of things, we're trying to do the same thing. We're starting with a very large base of potential users that would benefit from ClearPoint and looking to convert them into formal partners on a steady cadence.

Bjorn Ng -- 10X Capital Pte Ltd. -- Analyst

All right. Thanks a lot, Joe. It's a privilege to be your shareholder and to be on the new journey with ClearPoint. Thank you for all the hard work, to you and your team, and have a great day ahead.

Joe Burnett -- Chief Executive Officer

OK. Thank you, Bjorn.

Operator

[Operator instructions] Our next question comes from JH Tan with JH Capital. Please go ahead.

Unknown speaker

Hey, Joe, I would like to also congratulate you on the quarter. And I'm really happy to see how ClearPoint has been progressing so far under your leadership. 

Joe Burnett -- Chief Executive Officer

OK. 

Unknown speaker

So the first question I would like to ask about is the global expansion. So in terms of Europe, we have seen trials such as PTC and also the recent announcement with the hospital foundation Rothschild in Paris. So do you see any interest accelerate the interest in terms of new partnerships in the pipeline? And if possible, can you also walk me through how you are planning to scale up your global expansion to cater to this pipeline? Thank you.

Joe Burnett -- Chief Executive Officer

It's a great question, JH, and thank you for your support as well. The global expansion we have focused on initially has been in Europe. And to answer your question directly, we absolutely, as a result of this investment and this communication and not just communication, but achievements of starting these installations, we have already been able to win multiple European-based pharmaceutical partners which we saw added here over the past three to four months. So the message of going to these customers who had always been sort of interested in ClearPoint, but simply wanted to do their pre-clinical work and their clinical work sort of on their home turf across Europe and the U.K., for them to now have the opportunity to work with ClearPoint, it's something that absolutely is opening the doors.

And that combined with our very broad indication for not just our navigation system, but for our SmartFlow cannula on the delivery of fluids to the brain, gives quite a bit of confidence into our partners to say, hey, I'm thrilled to be using the SmartFlow and the ClearPoint system because it's been tried and tested through thousands of cases at this point. It's by no means purely experimental. So I think that's been very positive, and we've certainly seen that in Europe. We have also generated interest from partners in Asia as well.

And we are looking at evaluating the right partnerships and ways to pursue there. Again, we don't want to spread ourselves too thin, and we also recognize that the technical complexity and the benefit of having a ClearPoint personnel in the room for the procedure is certainly something we don't want to walk away from just yet. It's something that we want to continue to build on. So we're going to be very careful as to how far we spread ourselves thin, but it wouldn't surprise me in the next 12 to 18 months that you would see one to two installations in Europe for that same reason of being able to help Asia-based pharmaceutical companies install closer to home.

Unknown speaker

OK. OK. And thank you for that. That was really insightful.

And I have just one last question for you. It's good to see that the elective procedures are starting to rebound. Can I just ask how many partners or hospitals are you seeing that have already resumed the trials? And do you see any new clinical trials being initiated? And if there is any advancement on existing clinical trials that you see. Thank you.

Joe Burnett -- Chief Executive Officer

Sure. Thanks. Yes. So the vast majority of hospitals have absolutely resumed work as a result of COVID.

Now as I mentioned, there's five or six states here in the United States that are struggling with the Delta variant more and have issued warnings. So if they are sites that would be enrolling clinical patients, it's possible that trials would be impacted. However, generally, trials that are being performed here in the United States are spread across multiple sites. So even if a site in Texas, for example, had to pause for a period of time to deal with COVID, I don't know that that same issue is present in the Northeast or in California necessarily where a lot of these other patients would be initiated.

So whereas I could see some slowdown potentially in trial enrollment in some areas, I don't see the same halt in trials like we saw over the past 18 months. So that's, I think, one thing to think about. Further, I do expect -- if I were to tell you, based on what I know today, looking across the 35 active relationships that we have, I would say that at present, the schedules I've seen involve us continuing enrollment and initiating patients in the second half of this year across phase 1, phase 2, and phase 3 trials. So there's quite a bit of demand.

A lot of these -- no one wants to go faster than our biotech partners want to go. They're absolutely moving as quickly as they possibly can because their incentives are to do that as well, to get these patients enrolled and show the benefit of their therapy. So like I said, we're trying to be there for each one of our partners and make sure we're ready as soon as they and the hospital are as well.

Unknown speaker

OK. OK. Thanks a lot, Joe. So I have no more questions from my side.

And I would just want to say that I'm confident that ClearPoint can be an even bigger company than it is today under your leadership. And as a shareholder, I'm looking forward to being on this journey with you. Have a great day.

Joe Burnett -- Chief Executive Officer

OK. Thank you, JH.

Operator

Thank you. There are no further questions at this time. I'll turn it back to management for closing remarks. Thank you.

Joe Burnett -- Chief Executive Officer

All right. Well, once again, thank you to everyone interested in being a part of this team's story here at ClearPoint. We believe that we are doing very important work and will continue to put the patient and their family first as we take on greater and greater responsibility for their treatment across our entire portfolio. Thank you, and have a good night.

Operator

[Operator signoff]

Duration: 44 minutes

Call participants:

Joe Burnett -- Chief Executive Officer

Danilo D'Alessandro -- Chief Financial Officer

Frank Takkinen -- Lake Street Capital Markets -- Analyst

Andrew D'Silva -- B. RIley Financial -- Analyst

Bjorn Ng -- 10X Capital Pte Ltd. -- Analyst

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