Q1 2026 ClearPoint Neuro Inc Earnings Call
Speaker #2: If anyone should require operator assistance, please press *0 on your telephone keypad. 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.
Speaker #2: These forward-looking statements may include without limitation statements related to company's plans, prospects, and strategies, both preliminary and projected, the size of total addressable markets or the market opportunity for the company's products and services, the company's expectations regarding the integration, performance, and anticipated benefits of its recent acquisition of Eras Holdings, Inc., including operational efficiencies, and the impact on the company's financial condition and results of operations, the company's expectation for future development, regulatory approval, timing, commercialization, and the market for sell and gene therapies, and the anticipated adoption of the company's products and services for use in the delivery of gene and cell therapies.
Operator: 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, the size of total addressable markets or the market opportunity for the company's products and services, the company's expectations regarding the integration, performance, and anticipated benefits of its recent acquisition of IRRAS Holdings, Inc., including operational efficiencies and the impact on the company's financial condition and results of operations, the company's expectation for future development, regulatory approval, timing, commercialization, and the market for cell and gene therapies, and the anticipated adoption of the company's products and services for use in the delivery of gene and cell therapies, and management's expectations, beliefs, estimates, or projections regarding future revenue and results of operations. You are cautioned not to place undue reliance on forward-looking statements which speak only as of the date on which they were made.
Operator: 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, the size of total addressable markets or the market opportunity for the company's products and services, the company's expectations regarding the integration, performance, and anticipated benefits of its recent acquisition of IRRAS Holdings, Inc., including operational efficiencies and the impact on the company's financial condition and results of operations, the company's expectation for future development, regulatory approval, timing, commercialization, and the market for cell and gene therapies, and the anticipated adoption of the company's products and services for use in the delivery of gene and cell therapies, and management's expectations, beliefs, estimates, or projections regarding future revenue and results of operations. You are cautioned not to place undue reliance on forward-looking statements which speak only as of the date on which they were made.
Speaker #2: And management's expectations beliefs, estimates, or projections regarding future revenue and results of operations. You are cautioned not to place undue reliance on forward-looking statements which speak only as of the date on which they were made.
Speaker #2: 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 about the company's risks and uncertainties, please refer to the company's filings with the SEC, including the company's recent filings on Form 8-K, Form 10-K, and Form 10-Q.
Operator: 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 about the company's risks and uncertainties, please refer to the company's filings with the SEC, including the company's recent filings on Form 8-K, Form 10-K, and Form 10-Q. 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 call over to Joe Burnett, Chief Executive Officer. Please go ahead.
Operator: 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 about the company's risks and uncertainties, please refer to the company's filings with the SEC, including the company's recent filings on Form 8-K, Form 10-K, and Form 10-Q. 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 call over to Joe Burnett, Chief Executive Officer. Please go ahead.
Speaker #2: 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 call over to Joe Burnett, Chief Executive Officer.
Speaker #2: Please go ahead. Thank you, Shamali. And as always, thank you to all of the investors, analysts, and biopharma partners listening to today's call. We remain both committed to and focused on developing a complete neuroecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies to the brain.
Joseph M. Burnett: Thank you, Shamali, and as always, thank you to all of the investors, analysts, and biopharma partners listening to today's call. We remain both committed to and focused on developing a complete neuro ecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies to the brain. We believe that this approach will finally unlock hope for the patients and their families who are battling these frightening neurologic disorders and who today have very few options to choose from. This is one of the largest unmet needs in all of medicine, and we at ClearPoint believe we can play a crucial, if not essential, role in this exciting future.
Joe Burnett: Thank you, Shamali, and as always, thank you to all of the investors, analysts, and biopharma partners listening to today's call. We remain both committed to and focused on developing a complete neuro ecosystem capable of delivering various minimally invasive treatments, including cell and gene therapies to the brain. We believe that this approach will finally unlock hope for the patients and their families who are battling these frightening neurologic disorders and who today have very few options to choose from. This is one of the largest unmet needs in all of medicine, and we at ClearPoint believe we can play a crucial, if not essential, role in this exciting future.
Speaker #2: We believe that this approach will finally unlock hope for the patients and their families who are battling these frightening neurologic disorders and who today have very few options to choose from.
Speaker #2: This is one of the largest unmet needs in all of medicine and we at ClearPoint believe we can play a crucial, if not essential, role in this exciting future.
Speaker #2: Our company has started 2026 on a strong note by achieving record revenue of $12.1 million for the quarter driven primarily by organic devices growth of 25%, which includes our historical drug delivery cannulas, navigation disposables, laser ablation applicators, capital systems and software.
Joseph M. Burnett: Our company has started 2026 on a strong note by achieving record revenue of $12.1 million for the quarter, driven primarily by organic devices growth of 25%, which includes our historical drug delivery cannulas, navigation disposables, laser ablation applicators, capital systems, and software. This revenue was complemented by inorganic device growth from our acquisition of the IRRAflow product line, which pushed our overall growth rate to 43% company-wide. We continued to realize meaningful revenue and cost synergies as a result of our new completed acquisition of IRRAS, with the majority of post-merger integration costs now behind us and taking place in Q1. Importantly, we made progress across all four of our growth pillars that are designed to make our unique drug delivery ecosystem more refined and more accessible to biopharma partners, surgeons, and to patients globally.
Joe Burnett: Our company has started 2026 on a strong note by achieving record revenue of $12.1 million for the quarter, driven primarily by organic devices growth of 25%, which includes our historical drug delivery cannulas, navigation disposables, laser ablation applicators, capital systems, and software. This revenue was complemented by inorganic device growth from our acquisition of the IRRAflow product line, which pushed our overall growth rate to 43% company-wide. We continued to realize meaningful revenue and cost synergies as a result of our new completed acquisition of IRRAS, with the majority of post-merger integration costs now behind us and taking place in Q1. Importantly, we made progress across all four of our growth pillars that are designed to make our unique drug delivery ecosystem more refined and more accessible to biopharma partners, surgeons, and to patients globally.
Speaker #2: This revenue was complemented by inorganic device growth from our acquisition of the new Eraflow product line, which pushed our overall growth rate to 43% company-wide.
Speaker #2: We continued to realize meaningful revenue and cost synergies as a result of our newly completed acquisition of Eris, with the majority of post-merger integration costs now behind us and taking place in Q1.
Speaker #2: Importantly, we made progress across all four of our growth pillars that are designed to make our unique drug delivery ecosystem more refined and more accessible to biopharma partners, surgeons, and to patients globally.
Speaker #2: We believe that we are truly a unique, hybrid device biotech enabling company that not only has an existing revenue plan of more than $50 million today, but a completely untapped and expansive opportunity in commercial cell and gene therapy delivery built for tomorrow.
Joseph M. Burnett: We believe that we are truly a unique hybrid device biotech-enabling company that not only has an existing revenue plan of more than $50 million today, but a completely untapped and expansive opportunity in commercial cell and gene therapy delivery built for tomorrow. Our strategy now includes more than 60 active biopharma partners, more than 25 existing clinical trials across more than 15 different disease indications, and more than 10 partner programs that are already under some form of FDA expedited review. That is a significant head start, and through both our team and our investment into this portfolio, we intend to extend our lead. With that, I will turn the call over to Danilo D'Alessandro, our CFO, who will walk through the financial detail after which I will give a more strategic update on our progress. Danilo.
Joe Burnett: We believe that we are truly a unique hybrid device biotech-enabling company that not only has an existing revenue plan of more than $50 million today, but a completely untapped and expansive opportunity in commercial cell and gene therapy delivery built for tomorrow. Our strategy now includes more than 60 active biopharma partners, more than 25 existing clinical trials across more than 15 different disease indications, and more than 10 partner programs that are already under some form of FDA expedited review. That is a significant head start, and through both our team and our investment into this portfolio, we intend to extend our lead. With that, I will turn the call over to Danilo D'Alessandro, our CFO, who will walk through the financial detail after which I will give a more strategic update on our progress. Danilo.
Speaker #2: Our strategy now includes more than 60 active biopharma partners, more than 25 existing clinical trials across more than 15 different disease indications, and more than 10 partner programs that are already under some form of FDA expedited review.
Speaker #2: That is a significant head start and through both our team and our investment into this portfolio, we intend to extend our lead. With that, I will call the turn the call over to Danilo D'Alessandro, our CFO, who will walk through the financial detail after which I will give a more strategic update on our progress.
Speaker #2: Danilo?
Speaker #3: Thank you, Joe. And thank you all for joining us today. Looking at the first quarter 2026 results, total revenue was $12.1 million for the three months ended March 31st, 2026, and $8.5 million for the three months ended March 31st, 2025, which represents 43% growth versus the first quarter of 2025 and 16% organic growth.
Danilo D'Alessandro: Thank you, Joe, and thank you all for joining us today. Looking at the Q1 2026 results, total revenue was $12.1 million for the 3 months ended 31 March 2026, and $8.5 million for the 3 months ended 31 March 2025, which represents 43% growth versus the Q1 2025 and 16% organic growth. Our revenue is made up of three components: Biologics and Drug Delivery, neurosurgery navigation and therapy, and capital equipment and software. Biologics and Drug Delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products. Biologics and Drug Delivery revenue increased 2% to $4.8 million in the Q1, up from $4.7 million in 2025.
Danilo D'Alessandro: Thank you, Joe, and thank you all for joining us today. Looking at the Q1 2026 results, total revenue was $12.1 million for the three months ended 31 March 2026, and $8.5 million for the three months ended 31 March 2025, which represents 43% growth versus the Q1 2025 and 16% organic growth. Our revenue is made up of three components: Biologics and Drug Delivery, neurosurgery navigation and therapy, and capital equipment and software. Biologics and Drug Delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials utilizing our products. Biologics and Drug Delivery revenue increased 2% to $4.8 million in the Q1, up from $4.7 million in 2025.
Speaker #3: Our revenue is made up of three components: biologics and drug delivery, neurosurgery navigation and therapy, and capital equipment and software. Biologics and drug delivery revenue includes sales of disposable products and services related to customer-sponsored preclinical and clinical trials, utilizing our products.
Speaker #3: Biologics and drug delivery revenue increased 2% to $4.8 million in the first quarter, up from $4.7 million in 2025. This increase was mainly due to an increase in product revenue of $0.1 million.
Danilo D'Alessandro: This increase was mainly due to an increase in product revenue of $0.1 million. BNDD service revenue was in line with prior year. Neurosurgery navigation revenue consists of commercial sales of disposable products and services related to cases utilizing the ClearPoint System, the Prism laser system, and IRRAflow. This revenue segment grew to $5.9 million for Q1 2026, including $2.1 million in IRRAflow disposable revenue. The growth in this segment was primarily due to our increased installation base and the full market release of our Prism laser system and ICT solution.
Danilo D'Alessandro: This increase was mainly due to an increase in product revenue of $0.1 million. BNDD service revenue was in line with prior year. Neurosurgery navigation revenue consists of commercial sales of disposable products and services related to cases utilizing the ClearPoint System, the Prism laser system, and IRRAflow. This revenue segment grew to $5.9 million for Q1 2026, including $2.1 million in IRRAflow disposable revenue. The growth in this segment was primarily due to our increased installation base and the full market release of our Prism laser system and ICT solution.
Speaker #3: BNDD service revenue was in line with prior year. Neurosurgery navigation revenue consists of commercial sales of disposable products and services related to cases utilizing the ClearPoint system, the Prism laser system, and Eraflow.
Speaker #3: This revenue segment grew to $5.9 million for the first quarter of 2026, including $2.1 million in Eraflow disposable revenue. The growth in this segment was primarily due to our increased installation base and the full market release of our Prism laser system and ICT solution.
Speaker #3: Capital equipment and software revenue consisting of sales of our reusable hardware and software and of related services increased 177% to $1.4 million in the quarter, from $0.5 million for the same period in 2025 due to an increase in the placements of ClearPoint navigation system, Prism laser units, and Eraflow control units.
Danilo D'Alessandro: Capital equipment and software revenue, consisting of sales of our reusable hardware and software and related services, increased 177% to $1.4 million in the quarter from $0.5 million for the same period in 2025 due to an increase in the placements of ClearPoint navigation system, ClearPoint Prism units, and IRRAflow control units. Gross margin for Q1 2026 was 64%, an increase of 4% compared to 60% in Q1 2025, mostly related to a decrease in excess and obsolete inventory reserves. Research and development costs were $4.5 million for the three months ended 31 March 2026, compared to $3.4 million for the same period in 2025, an increase of $1.1 million, or 34%.
Danilo D'Alessandro: Capital equipment and software revenue, consisting of sales of our reusable hardware and software and related services, increased 177% to $1.4 million in the quarter from $0.5 million for the same period in 2025 due to an increase in the placements of ClearPoint navigation system, ClearPoint Prism units, and IRRAflow control units. Gross margin for Q1 2026 was 64%, an increase of 4% compared to 60% in Q1 2025, mostly related to a decrease in excess and obsolete inventory reserves. Research and development costs were $4.5 million for the three months ended 31 March 2026, compared to $3.4 million for the same period in 2025, an increase of $1.1 million, or 34%.
Speaker #3: Gross margin for the first quarter 2026 was 64%, an increase of 4% compared to 60% in Q1 2025, mostly related to a decrease in excess and obsolete inventory reserves.
Speaker #3: Research and development costs were $4.5 million for the three months ended March 31st, 2026, compared to $3.4 million for the same period in 2025, an increase of 1.1 million or 34%.
Speaker #3: The increase was due primarily to higher personnel cost of $0.6 million and higher product and software development cost of $0.3 million. Sales and marketing expenses were $6.7 million for Q1 compared to $3.8 million for the same period in 2025, an increase of $2.9 million or 75%.
Danilo D'Alessandro: The increase was due primarily to higher personal costs of $0.6 million and higher product and software development costs of $0.3 million. Sales and marketing expenses were $6.7 million for Q1 compared to $3.8 million for the same period in 2025, an increase of $2.9 million or 75%. This increase was due primarily to additional personal cost of $1.9 million and increase in travel costs of $0.5 million, resulting from the expansion of our clinical and sales teams due to the IRRAS integration, as well as additional amortization expense of acquired intangible assets of $0.2 million. General and administrative expenses were $5 million for Q1, an increase of $0.9 million or 22%.
Danilo D'Alessandro: The increase was due primarily to higher personal costs of $0.6 million and higher product and software development costs of $0.3 million. Sales and marketing expenses were $6.7 million for Q1 compared to $3.8 million for the same period in 2025, an increase of $2.9 million or 75%. This increase was due primarily to additional personal cost of $1.9 million and increase in travel costs of $0.5 million, resulting from the expansion of our clinical and sales teams due to the IRRAS integration, as well as additional amortization expense of acquired intangible assets of $0.2 million. General and administrative expenses were $5 million for Q1, an increase of $0.9 million or 22%.
Speaker #3: This increase was due primarily to additional personnel cost of $1.9 million and an increase in travel cost of $0.5 million, resulting from the expansion of our clinical and sales teams due to the Eris integration.
Speaker #3: As well as additional amortization expense of acquired intangible assets of $0.2 million. General and administrative expenses were $5 million for the first quarter, an increase of $0.9 million or 22%.
Speaker #3: This increase was due primarily to higher occupancy costs of $0.7 million and higher personnel costs of $0.2 million. As of March 31, 2026, we held cash and cash equivalents totaling $35.6 million, as compared to $45.9 million at December 31, 2025.
Danilo D'Alessandro: This increase was due primarily to higher occupancy costs of $0.7 million and higher personal cost of $0.2 million. As of 31 March 2026, we held cash and cash equivalents totaling $35.6 million as compared to $45.9 million at 31 December 2025. The cash reduction was primarily due to the operational cash burn of $8 million in Q1 2026 and $2 million due to payments for taxes related to net share settlement of equity awards. We expect the operational cash burn to decrease in the coming quarters as we complete the IRRAS integration. I'd like now to turn the call back to Joe.
Danilo D'Alessandro: This increase was due primarily to higher occupancy costs of $0.7 million and higher personal cost of $0.2 million. As of 31 March 2026, we held cash and cash equivalents totaling $35.6 million as compared to $45.9 million at 31 December 2025. The cash reduction was primarily due to the operational cash burn of $8 million in Q1 2026 and $2 million due to payments for taxes related to net share settlement of equity awards. We expect the operational cash burn to decrease in the coming quarters as we complete the IRRAS integration. I'd like now to turn the call back to Joe.
Speaker #3: The cash reduction was primarily due to the operational cash burn of $8 million in Q1 2026, and $2 million due to payments for taxes related to net share settlement of equity awards.
Speaker #3: We expect the operational cash burn to decrease in the coming quarters as we complete the Eris integration. I'd like now to turn the call back to Joe.
Speaker #2: Thank you, Danilo. We look to build upon a successful first quarter and continue to expect 2026 revenue to be in the range of $52 to $56 million.
Joseph M. Burnett: Thank you, Danilo. We look to build upon a successful Q1 and continue to expect 2026 revenue to be in the range of $52 to $56 million. We are also pleased to report that our Q1 burn came in on budget from what we were expecting. As a reminder, the Q1 each year has historically been our highest burn quarter, driven by annual employee bonuses, timing of FICA taxes, additional withholdings, and several once-a-year expenses. This year, the Q1 also included a number of one-time events related to post-merger integration costs after the acquisition of the IRRAS assets. Gross margin expanded 64%. Now, although gross margin can fluctuate from quarter to quarter, it is encouraging that our first full quarter with the IRRAS technology came in slightly ahead of our pre-integration projections.
Joe Burnett: Thank you, Danilo. We look to build upon a successful Q1 and continue to expect 2026 revenue to be in the range of $52 to $56 million. We are also pleased to report that our Q1 burn came in on budget from what we were expecting. As a reminder, the Q1 each year has historically been our highest burn quarter, driven by annual employee bonuses, timing of FICA taxes, additional withholdings, and several once-a-year expenses. This year, the Q1 also included a number of one-time events related to post-merger integration costs after the acquisition of the IRRAS assets. Gross margin expanded 64%. Now, although gross margin can fluctuate from quarter to quarter, it is encouraging that our first full quarter with the IRRAS technology came in slightly ahead of our pre-integration projections.
Speaker #2: We are also pleased to report that our first quarter burn came in on budget from what we were expecting. As a reminder, the first quarter each year has historically been our highest burn quarter driven by annual employee bonuses, time in a FICA taxes, additional withholdings, and several once-a-year expenses.
Speaker #2: This year, the first quarter also included a number of one-time events related to post-merger integration costs after the acquisition of the Eris assets. Additionally, gross margin expanded 64%.
Speaker #2: Now, although gross margin can fluctuate from quarter to quarter, it is encouraging that our first full quarter with the Eris technology came in slightly ahead of our pre-integration projections.
Speaker #2: As always, let's now turn to our four-pillar growth strategy for a bit more detail. As a quick reminder, our four pillars consist of the following segments: number one, pre-commercial biologics and drug delivery products and services; number two, neurosurgery navigation and robotics; number three, laser therapy and access; and number four, neurocritical care and active CSF exchange.
Joseph M. Burnett: As always, let's now turn to our four pillar growth strategy for a bit more detail. As a quick reminder, our four pillars consist of the following segments. Number one, Pre-commercial Biologics and Drug Delivery products and services. Number two, Neurosurgery Navigation and Robotics. Number three, Laser Therapy and Access. Number four, Neurocritical Care and Active CSF Exchange. These are the 4 markets that we participate actively in today, and pretty much 100% of our current revenue is coming from these 4 markets. In 2026, we expect all 4 of these segments to each grow double digits. For clarity's sake, this does not include any revenue from the commercial launch of cell and gene therapies, which we expect to start in the years ahead upon appropriate global drug approvals. First, let's start with pillar number one, Pre-commercial Biologics and Drug Delivery.
Joe Burnett: As always, let's now turn to our four pillar growth strategy for a bit more detail. As a quick reminder, our four pillars consist of the following segments. Number one, Pre-commercial Biologics and Drug Delivery products and services. Number two, Neurosurgery Navigation and Robotics. Number three, Laser Therapy and Access. Number four, Neurocritical Care and Active CSF Exchange. These are the four markets that we participate actively in today, and pretty much 100% of our current revenue is coming from these four markets. In 2026, we expect all four of these segments to each grow double digits. For clarity's sake, this does not include any revenue from the commercial launch of cell and gene therapies, which we expect to start in the years ahead upon appropriate global drug approvals. First, let's start with pillar number one, Pre-commercial Biologics and Drug Delivery.
Speaker #2: These are the four markets that we participate actively in today and pretty much 100% of our current revenue is coming from these four markets.
Speaker #2: In 2026, we expect all four of these segments to each grow double digits. For clarity's sake, this does not include any revenue from the commercial launch of cell and gene therapies, which we expect to start in the years ahead upon appropriate global drug approvals.
Speaker #2: First, let's start with pillar number one, pre-commercial biologics and drug delivery. The team has made substantial progress building out the ClearPoint Advanced Laboratories facility in Torrey Pines, California, affectionately known as the CAL.
Joseph M. Burnett: The team has made substantial progress building out the ClearPoint Advanced Laboratories facility in Torrey Pines, California, affectionately known as the CAL. This new facility will become a common starting point for our relationship with biopharma partners to perform benchtop and preclinical studies, as well as troubleshoot workflows to build custom devices and software that are drug and target specific. Despite the fact that the facility was significantly limited for most of the month of March for planned construction projects, we were still able to perform numerous studies in the Q1, which included multiple new routes of administration, which were tested for the very first time by the ClearPoint team.
Joe Burnett: The team has made substantial progress building out the ClearPoint Advanced Laboratories facility in Torrey Pines, California, affectionately known as the CAL. This new facility will become a common starting point for our relationship with biopharma partners to perform benchtop and preclinical studies, as well as troubleshoot workflows to build custom devices and software that are drug and target specific. Despite the fact that the facility was significantly limited for most of the month of March for planned construction projects, we were still able to perform numerous studies in the Q1, which included multiple new routes of administration, which were tested for the very first time by the ClearPoint team.
Speaker #2: This new facility will become a common starting point for our relationship with biopharma partners to perform benchtop and preclinical studies as well as troubleshoot workflows to build custom devices and software that are drug and target-specific.
Speaker #2: Despite the fact that the facility was significantly limited for most of the month of March for planned construction projects, we were still able to perform numerous studies in the first quarter, which included multiple new routes of administration which were tested for the very first time by the ClearPoint team.
Speaker #2: This demonstrates not only our ability to co-develop new products with partners but also shows how we expect our drug delivery portfolio will continue to grow in the future, often with new techniques and new intellectual property that we are building alongside of our partners.
Joseph M. Burnett: This demonstrates not only our ability to co-develop new products with partners, but also shows how we expect our drug delivery portfolio will continue to grow in the future, often with new techniques and new intellectual property that we are building alongside of our partners. Additional progress was made globally, evidenced by a record number of clinical trial patients enrolled across numerous indications. We also performed our first ever commercial drug delivery procedure using ClearPoint technology in the Asia Pacific region. Our biopharma partners need to know that their therapies can reach patients anywhere in the world, and our commitment to global availability of our ecosystem delivers on exactly that. It's a costly investment, but also a key competitive advantage that reinforces the significant head start we've built in the space. As planned, we have begun to integrate the IRRAflow product line into our portfolio.
Joe Burnett: This demonstrates not only our ability to co-develop new products with partners, but also shows how we expect our drug delivery portfolio will continue to grow in the future, often with new techniques and new intellectual property that we are building alongside of our partners. Additional progress was made globally, evidenced by a record number of clinical trial patients enrolled across numerous indications. We also performed our first ever commercial drug delivery procedure using ClearPoint technology in the Asia Pacific region. Our biopharma partners need to know that their therapies can reach patients anywhere in the world, and our commitment to global availability of our ecosystem delivers on exactly that. It's a costly investment, but also a key competitive advantage that reinforces the significant head start we've built in the space. As planned, we have begun to integrate the IRRAflow product line into our portfolio.
Speaker #2: Additional progress was made globally evidenced by a record number of clinical trial patients enrolled across numerous indications. We also performed our first-ever commercial drug delivery procedure using ClearPoint technology in the Asia-Pacific region.
Speaker #2: Our biopharma partners need to know that their therapies can reach patients anywhere in the world, and our commitment to global availability of our ecosystem delivers on exactly that.
Speaker #2: It's a costly investment but also a key competitive advantage that reinforces the significant headstart we've built in the space. And as planned, we have begun to integrate the Eraflow product line into our portfolio.
Speaker #2: The Eraflow dual-lumen catheter is a flexible, multi-day placement catheter that we expect to address a gap in our drug delivery offerings by providing extended access to the brain, a capability that we did not have in our portfolio until now.
Joseph M. Burnett: The IRRAflow dual-lumen catheter is a flexible multi-day placement catheter that we expect to address a gap in our drug delivery offerings by providing extended access to the brain, a capability that we did not have in our portfolio until now. I can say that we have already had multiple meetings with interested researchers and plan to provide updates later this year on this new option for our partners. Moving on to pillar number 2, which is neuro navigation and robotics, where we have made some tremendous progress recently as well. Our successful launch of the 3.X platform continues in the US, and that expanded to Europe with the very first 3.X case performed there in Q1.
Joe Burnett: The IRRAflow dual-lumen catheter is a flexible multi-day placement catheter that we expect to address a gap in our drug delivery offerings by providing extended access to the brain, a capability that we did not have in our portfolio until now. I can say that we have already had multiple meetings with interested researchers and plan to provide updates later this year on this new option for our partners. Moving on to pillar number 2, which is neuro navigation and robotics, where we have made some tremendous progress recently as well. Our successful launch of the 3.X platform continues in the US, and that expanded to Europe with the very first 3.X case performed there in Q1.
Speaker #2: I can say that we have already had multiple meetings with interested researchers and plan to provide updates later this year on this new option for our partners.
Speaker #2: Moving on to pillar number two, which is neuronavigation and robotics, where we have made some tremendous progress recently as well. Our successful launch of the 3.x platform continues in the United States, and that has expanded to Europe, with the very first 3.x case performed there in Q1.
Speaker #2: The subsequent approval in Canada has also yielded multiple interested parties and our first clinical cases ever performed in Canada are expected here in the near future.
Joseph M. Burnett: The subsequent approval in Canada has also yielded multiple interested parties. Our first clinical cases ever performed in Canada are expected here in the near future. Numerous demonstrations of our prototyped ClearPoint robotic platform, which prioritizes cranial procedures, have been extremely well received and have repeatedly highlighted our unique understanding of the cranial drug delivery space. It is important to remember that we are leveraging more than 15 years of software development focused on the brain. This historical investment into our best-in-class cranial segmentation and navigation workflow allows us to jump out of the starting gate, especially when paired with an established robotic arm provider using the KUKA LBR Med robotic arm. One highlight to share is that we recently performed our first ever preclinical drug delivery case at our CAL facility using this robotic platform. The results were better than expected.
Joe Burnett: The subsequent approval in Canada has also yielded multiple interested parties. Our first clinical cases ever performed in Canada are expected here in the near future. Numerous demonstrations of our prototyped ClearPoint robotic platform, which prioritizes cranial procedures, have been extremely well received and have repeatedly highlighted our unique understanding of the cranial drug delivery space. It is important to remember that we are leveraging more than 15 years of software development focused on the brain. This historical investment into our best-in-class cranial segmentation and navigation workflow allows us to jump out of the starting gate, especially when paired with an established robotic arm provider using the KUKA LBR Med robotic arm. One highlight to share is that we recently performed our first ever preclinical drug delivery case at our CAL facility using this robotic platform. The results were better than expected.
Speaker #2: Numerous demonstrations of our prototyped ClearPoint robotic platform, which prioritizes cranial procedures, have been extremely well received, and have repeatedly highlighted our unique understanding of the cranial drug delivery space.
Speaker #2: It is important to remember that we are leveraging more than 15 years of software development focused on the brain. This historical investment into our best-in-class cranial segmentation and navigation workflow allows us to jump out of the starting gate especially when paired with an established robotic arm provider using the KUKA LBR MedRobotic arm.
Speaker #2: One highlight to share is that we recently performed our first-ever preclinical drug delivery case at our CAL facility using this robotic platform, and the results were better than expected.
Speaker #2: We plan to offer this system for use in preclinical biopharma studies at the CAL facility to our more than 60 active partners. For pillar number three, laser therapy and access, our biggest highlight of the quarter was the FDA clearance of the Velocity Alpha MR high-speed surgical drill system, manufactured by our partner Adior Medical AG.
Joseph M. Burnett: We plan to offer this system for use in preclinical biopharma studies at the CAL facility to our more than 60 active partners. For pillar number 3, laser therapy and access, our biggest highlight of the quarter was the FDA clearance of the Velocity Alpha MR high-speed surgical drill system manufactured by our partner, adeor medical AG. We believe this drill will be an attractive solution for surgeons compared to our historical hand-operated twist drill. This device operates at more than 75,000 RPM, and when using our custom drill bits, we expect to meaningfully reduce procedure times. These efficiency gains were already evident during the very first ever clinical procedure performed with the drill just a couple of weeks ago for one of our partner's cell therapy clinical trial.
Joe Burnett: We plan to offer this system for use in preclinical biopharma studies at the CAL facility to our more than 60 active partners. For pillar number 3, laser therapy and access, our biggest highlight of the quarter was the FDA clearance of the Velocity Alpha MR high-speed surgical drill system manufactured by our partner, adeor medical AG. We believe this drill will be an attractive solution for surgeons compared to our historical hand-operated twist drill. This device operates at more than 75,000 RPM, and when using our custom drill bits, we expect to meaningfully reduce procedure times. These efficiency gains were already evident during the very first ever clinical procedure performed with the drill just a couple of weeks ago for one of our partner's cell therapy clinical trial.
Speaker #2: We believe this drill will be an attractive solution for surgeons compared to our historical hand-operated twist drill. This device operates at more than 75,000 RPM, and when using our custom drill bits, we expect to meaningfully reduce procedure times.
Speaker #2: These efficiency gains were already evident during the very first-ever clinical procedure performed with the drill just a couple of weeks ago for one of our partners' cell therapy clinical trial.
Speaker #2: Additionally, we were pleased to announce just today that the drill has now received CE marking in Europe as well, which expands the system's availability beyond the United States and provides a scalable pathway to support neurosurgical procedures and therapy adoption globally, including across our European partnered biologic programs.
Joseph M. Burnett: Additionally, we were pleased to announce just today that the drill has now received CE marking in Europe as well, which expands the system's availability beyond the United States and provides a scalable pathway to support neurosurgical procedures and therapy adoption globally, including across our European partnered biologic programs. Our Prism laser therapy system continues to be a highly competitive solution in the market, with multiple installs, evaluations, and purchases completed in Q1. As a quick reminder, our newly expanded labeling now includes both 3.0 and 1.5 Tesla scanners, which has significantly expanded our potential customer base compared to where we were a year ago.
Joe Burnett: Additionally, we were pleased to announce just today that the drill has now received CE marking in Europe as well, which expands the system's availability beyond the United States and provides a scalable pathway to support neurosurgical procedures and therapy adoption globally, including across our European partnered biologic programs. Our Prism laser therapy system continues to be a highly competitive solution in the market, with multiple installs, evaluations, and purchases completed in Q1. As a quick reminder, our newly expanded labeling now includes both 3.0 and 1.5 Tesla scanners, which has significantly expanded our potential customer base compared to where we were a year ago.
Speaker #2: Our Prism laser therapy system continues to be a highly competitive solution in the market with multiple installs, evaluations, and purchases completed in the first quarter.
Speaker #2: As a quick reminder, our newly expanded labeling now includes both 3.0 and 1.5 Tesla scanners, which has significantly expanded our potential customer base compared to where we were a year ago.
Speaker #2: And last but not least, pillar number four, which is neurocritical care and active CSF exchange, is made up of the various EraFlow assets, included in the acquisition of the ERIS at the end of 2025.
Joseph M. Burnett: Last but not least, pillar 4, which is neuro critical care and active CSF exchange, is made up of the various IRRAflow assets included in the acquisition of IRRAS at the end of 2025. This is a completely new market for ClearPoint Neuro, but an important one as it fits into our 2-phase strategy perfectly. 1, it allows us to participate today in an existing $500 million market opportunity with a unique and differentiated product supported by growing clinical evidence. 2, it adds a flexible indwelling catheter to our Biologics and Drug Delivery portfolio, a capability we've historically lacked, opening up a new potential pathway for drug delivery to the brain. In Q1, we have successfully merged our commercial teams together, including initial cross-training on the devices.
Joe Burnett: Last but not least, pillar 4, which is neuro critical care and active CSF exchange, is made up of the various IRRAflow assets included in the acquisition of IRRAS at the end of 2025. This is a completely new market for ClearPoint Neuro, but an important one as it fits into our 2-phase strategy perfectly. Number 1, it allows us to participate today in an existing $500 million market opportunity with a unique and differentiated product supported by growing clinical evidence. 2, it adds a flexible indwelling catheter to our Biologics and Drug Delivery portfolio, a capability we've historically lacked, opening up a new potential pathway for drug delivery to the brain. In Q1, we have successfully merged our commercial teams together, including initial cross-training on the devices.
Speaker #2: This is a completely new market for ClearPoint, but an important one as it fits into our two-phase strategy perfectly. Number one, it allows us to participate today in an existing 500-million-dollar market opportunity with a unique and differentiated product supported by growing clinical evidence.
Speaker #2: And number two, it adds a flexible indwelling catheter to our biologics and drug delivery portfolio, a capability we've historically lacked, opening up a new potential pathway for drug delivery to the brain.
Speaker #2: In the first quarter, we have successfully merged our commercial teams together, including initial cross-training on the devices. With the sales integration now behind us, we expect to continue to grow this business in 2026 and in the years ahead.
Joseph M. Burnett: With the sales integration now behind us, we expect to continue to grow this business in 2026 and in the years ahead. Having mapped out multiple revenue and cost synergies, we believe that the addition of the IRRAflow assets could potentially be cash neutral for ClearPoint as early as 2027 or next year. Globally, we now have more than 175 active sites using some form of ClearPoint technology and expect that number to surpass 200 by the end of 2026. This site expansion not only allows ClearPoint technology to be available to more hospitals and patients worldwide, but it also enables the scaling of our business model, including the expert clinical support for which we are very well respected in the neurosurgical community. With that, I would like to open up the call to any questions.
Joe Burnett: With the sales integration now behind us, we expect to continue to grow this business in 2026 and in the years ahead. Having mapped out multiple revenue and cost synergies, we believe that the addition of the IRRAflow assets could potentially be cash neutral for ClearPoint as early as 2027 or next year. Globally, we now have more than 175 active sites using some form of ClearPoint technology and expect that number to surpass 200 by the end of 2026. This site expansion not only allows ClearPoint technology to be available to more hospitals and patients worldwide, but it also enables the scaling of our business model, including the expert clinical support for which we are very well respected in the neurosurgical community. With that, I would like to open up the call to any questions.
Speaker #2: Having mapped out multiple revenue and cost synergies, we believe that the addition of the Eraflow assets could potentially be cash-neutral for ClearPoint as early as 2027, or next year.
Speaker #2: Globally, we now have more than 175 active sites using some form of ClearPoint technology and expect that number to surpass 200 by the end of 2026.
Speaker #2: This site expansion not only allows ClearPoint technology to be available to more hospitals and patients worldwide, but it also enables the scaling of our business model, including the expert clinical support for which we are very well respected in the neurosurgical community.
Speaker #2: With that, I would like to open up the call to any questions.
Speaker #3: Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press *1 on your telephone keypad.
Operator 2: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing these star keys. One moment please while we poll for questions. Our first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed with your question.
Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing these star keys. One moment please while we poll for questions. Our first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please proceed with your question.
Speaker #3: A confirmation tone will indicate your line is in the question queue. You may press *2 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the *keys.
Speaker #3: One moment, please, while we pull for questions. Our first question comes from the line of Frank Takinen with Lakestream Capital Market. Please proceed with your question.
Speaker #4: Great. Thank you for taking the questions. I was hoping to start with one in pillar one, in kind of a two-part question and a little unrelated, so sorry if it's a little lengthy.
Frank Takkinen: Great. Thank you for taking the questions. I was hoping to start with one in pillar one, and kind of a two-part question and a little unrelated, so sorry if it's a little lengthy. Part one would be related to can you just give us a update from, ClearPoint's standpoint, the current state of affairs or clinical backdrop at the FDA? Obviously, there's been some headlines around some leadership changes, and I'm just curious how this has impacted some of your interactions. Do you foresee maybe some of those conversations becoming a little bit more efficient in the future with different leadership and, anything else that's important there? That's part one. Part two, one of your partners was acquired by UCB or pending acquisition.
Frank Takkinen: Great. Thank you for taking the questions. I was hoping to start with one in pillar one, and kind of a two-part question and a little unrelated, so sorry if it's a little lengthy. Part one would be related to can you just give us a update from, ClearPoint's standpoint, the current state of affairs or clinical backdrop at the FDA? Obviously, there's been some headlines around some leadership changes, and I'm just curious how this has impacted some of your interactions. Do you foresee maybe some of those conversations becoming a little bit more efficient in the future with different leadership and, anything else that's important there? That's part one. Part two, one of your partners was acquired by UCB or pending acquisition.
Speaker #4: But part one would be related to, can you just give us an update from ClearPoint's standpoint—the current state of affairs or clinical backdrop at the FDA?
Speaker #4: Obviously, there have been some headlines around leadership changes, and I'm just curious how this has impacted some of your interactions. Do you foresee some of those conversations becoming a little bit more efficient in the future with different leadership?
Speaker #4: And anything else that's important there as part one? And then, part two: one of your partners was acquired by UCB, or is pending acquisition. Just was curious if you could provide any updates related to your partner activities ongoing there that you're able to discuss?
Frank Takkinen: Just was curious if you could provide any updates related to your partner activities, ongoing there that you're able to discuss. Thanks, and sorry again for the lengthy question.
Frank Takkinen: Just was curious if you could provide any updates related to your partner activities, ongoing there that you're able to discuss. Thanks, and sorry again for the lengthy question.
Speaker #4: Thanks. And sorry again for the lengthy question.
Speaker #5: Frank, I expect nothing less than multi-part questions from you, so thanks for asking. So the first one: relative to the FDA, there are two different groups of the FDA that we generally work with—one part on the devices side, and then part on the combination devices side, which definitely has a component of biologics to it.
Joseph M. Burnett: Frank, I expect nothing less than multi-part questions for you from. Thanks for asking. The first one relative to the FDA, you know, there's two different groups at the FDA that we generally work with, which, you know, part on the devices side and then part on the combination devices side, which definitely has a component of biologics to it. On the devices side, we've seen very little change. We've seen incredible cooperation. We've hosted multiple pre-submission meetings with a team that's been pretty well intact. You know, we haven't seen anything negative at all on that side. It's been very positive, you know, for really years now at this point, and that includes conversations we've had with the newly acquired IRRAS assets as well.
Joe Burnett: Frank, I expect nothing less than multi-part questions for you from. Thanks for asking. The first one relative to the FDA, you know, there's two different groups at the FDA that we generally work with, which, you know, part on the devices side and then part on the combination devices side, which definitely has a component of biologics to it. On the devices side, we've seen very little change. We've seen incredible cooperation. We've hosted multiple pre-submission meetings with a team that's been pretty well intact. You know, we haven't seen anything negative at all on that side. It's been very positive, you know, for really years now at this point, and that includes conversations we've had with the newly acquired IRRAS assets as well.
Speaker #5: On the devices side, we've seen very little change. We've seen incredible cooperation. We've hosted multiple pre-submission meetings with a team that's been pretty well intact, so we haven't seen anything negative at all on that side.
Speaker #5: It's been very positive for really years now at this point. And that includes conversations we've had with the newly acquired ERIS assets as well.
Speaker #5: So if you think about the traditional device part of the business, we have not seen very much difference, if anything. I think it's going smooth.
Joseph M. Burnett: If you think about the traditional device part of the business, we have not seen very much difference. If anything, I think it's going smooth. On the biologics side, you know, we're not always privy to each and every one of these questions, but obviously you can't read a headline today without, you know, understanding that there's been incredible confusion at the FDA, and confusion on some of the feedback that had been provided across multiple ClearPoint partners, and I'm sure likely others as well. I think everyone is looking for really that confusion, I think, to halt more than anything else as the first step.
Joe Burnett: If you think about the traditional device part of the business, we have not seen very much difference. If anything, I think it's going smooth. On the biologics side, you know, we're not always privy to each and every one of these questions, but obviously you can't read a headline today without, you know, understanding that there's been incredible confusion at the FDA, and confusion on some of the feedback that had been provided across multiple ClearPoint partners, and I'm sure likely others as well. I think everyone is looking for really that confusion, I think, to halt more than anything else as the first step.
Speaker #5: On the biologics side, we're not always privy to each and every one of these questions, but obviously, you can't read a headline today without understanding that there's been incredible confusion at the FDA.
Speaker #5: Confusion on some of the feedback that had been provided across multiple ClearPoint partners. And I'm sure likely others as well. And I think everyone is looking for really that confusion, I think, to halt more than anything else as the first step.
Speaker #5: And my understanding is where we are with the newly selection or for both the head of SIBRA as well as the head of the FDA itself, we're still a little bit in a waiting mode here to see what that final decision is.
Joseph M. Burnett: My understanding is where we are with the newly selection or for both the head of CBER as well as the head of the FDA itself, we're still a little bit in a waiting mode here to see what that final decision is. Now certainly, any appointment to either one of those roles from someone who, you know, is not only incredibly competent in the device, I'm sorry, the biologic space, statistical clinical trial design, et cetera, that would be very, very welcome. Then, of course, anyone who's, you know, gone through the gauntlet of how difficult it is to enroll these incredibly complex clinical trials, I think would also be viewed as a positive, not just by ClearPoint, but the entire community as well.
Joe Burnett: My understanding is where we are with the newly selection or for both the head of CBER as well as the head of the FDA itself, we're still a little bit in a waiting mode here to see what that final decision is. Now certainly, any appointment to either one of those roles from someone who, you know, is not only incredibly competent in the device, I'm sorry, the biologic space, statistical clinical trial design, et cetera, that would be very, very welcome. Then, of course, anyone who's, you know, gone through the gauntlet of how difficult it is to enroll these incredibly complex clinical trials, I think would also be viewed as a positive, not just by ClearPoint, but the entire community as well.
Speaker #5: Now, certainly, any appointment to either one of those roles from someone who is not only incredibly competent in the device I'm sorry, the biologic space, statistical clinical trial design, etc., that would be very, very welcome.
Speaker #5: And then, of course, anyone who's gone through the gauntlet of how difficult it is to enroll these incredibly complex clinical trials, I think, would also be viewed as a positive, not just by ClearPoint but the entire community as well.
Speaker #5: So we're anxiously awaiting as well to see what those final decisions look like and the sort of the ability to get started. On the second question relative to, I believe you're talking about the neurona acquisition by UCB, again, that was, I think, a very, very positive.
Joseph M. Burnett: You know, we're anxiously awaiting as well to see what those final decisions look like and the sort of the ability to get started. On the second question relative to, I believe you're talking about the Neurona acquisition by UCB. Again, that was, I think, a very positive. The Neurona team is still very much intact, very much working alongside us. From our standpoint, we've had a wonderful relationship with UCB for many years now as well. It's kind of two of our partners sort of coming together and getting the benefits of both teams at that time. We expect to continue to support the Neurona asset as it moves into their phase III pivotal trial as we speak.
Joe Burnett: You know, we're anxiously awaiting as well to see what those final decisions look like and the sort of the ability to get started. On the second question relative to, I believe you're talking about the Neurona acquisition by UCB. Again, that was, I think, a very positive. The Neurona team is still very much intact, very much working alongside us. From our standpoint, we've had a wonderful relationship with UCB for many years now as well. It's kind of two of our partners sort of coming together and getting the benefits of both teams at that time. We expect to continue to support the Neurona asset as it moves into their phase III pivotal trial as we speak.
Speaker #5: The neurona team is still very much intact, very much working alongside us. And from our standpoint, we've had a wonderful relationship with UCB for many years now as well.
Speaker #5: So it's kind of two of our partners sort of coming together and getting the benefits of both teams at that time. So we expect to continue to support the neurona asset as it moves into their phase three pivotal trial as we speak.
Joseph M. Burnett: Just one quick thing I would bring up, Frank, 'cause it's a really important question too. It's kind of getting back to the FDA side of things. We need to remember that, you know, not to bucket everything together. There's sort of the rare disease side of things, which are things like Huntington's disease and, you know, a number of these very, very rare conditions that sit on sort of one side. Then there's the much higher volume, higher prevalence diseases like epilepsy, Parkinson's, et cetera. When the FDA had given guidance in the past to provide expedited review for these programs to try to accelerate their pathway to market, the larger market opportunities were always in a position where they were going to be doing some form of a pivotal phase III study.
Joe Burnett: Just one quick thing I would bring up, Frank, 'cause it's a really important question too. It's kind of getting back to the FDA side of things. We need to remember that, you know, not to bucket everything together. There's sort of the rare disease side of things, which are things like Huntington's disease and, you know, a number of these very, very rare conditions that sit on sort of one side. Then there's the much higher volume, higher prevalence diseases like epilepsy, Parkinson's, et cetera. When the FDA had given guidance in the past to provide expedited review for these programs to try to accelerate their pathway to market, the larger market opportunities were always in a position where they were going to be doing some form of a pivotal phase III study.
Speaker #5: Just one quick thing I would bring up, Frank, because it's a really important question, too. It's kind of getting back to the FDA side of things.
Speaker #5: We need to remember that not to bucket everything together. There's sort of the rare disease side of things, which are things like Huntington's disease and a number of these very, very rare conditions that sit on sort of one side.
Speaker #5: And then there's the much higher volume, higher prevalence diseases like epilepsy, Parkinson's, etc. So when the FDA had given guidance in the past to provide expedited review for these programs to try to accelerate their pathway to market, the larger market opportunities were always in a position where they were going to be doing some form of a pivotal phase three study.
Speaker #5: So, when this sort of confusion arose to some extent, where it was argued that some of the decisions had been changed, or some of the guidance had been changed, I don't personally believe that that's impacted disorders like Parkinson's, or epilepsy, or Alzheimer's disease, or dementias, or things like that, because the plan was always to do that pivotal trial.
Joseph M. Burnett: When this sort of confusion arose to some extent where it was argued that, you know, it, some of the decisions had been changed or some of the guidance had been changed, I don't personally believe that that's impacted disorders like Parkinson's or epilepsy or Alzheimer's disease or dementias or things like that because the plan was always to do that pivotal trial. I think the bigger question was on the other side with these rare diseases where it's just incredibly difficult to do one of these randomized sham studies because surgeons are not necessarily comfortable enrolling patients, and patients themselves might feel like they're missing a chance to experiment with other studies if they're waiting for one in a situation where they don't even get the experimental drug. They were just given a placebo.
Joe Burnett: When this sort of confusion arose to some extent where it was argued that, you know, it, some of the decisions had been changed or some of the guidance had been changed, I don't personally believe that that's impacted disorders like Parkinson's or epilepsy or Alzheimer's disease or dementias or things like that because the plan was always to do that pivotal trial. I think the bigger question was on the other side with these rare diseases where it's just incredibly difficult to do one of these randomized sham studies because surgeons are not necessarily comfortable enrolling patients, and patients themselves might feel like they're missing a chance to experiment with other studies if they're waiting for one in a situation where they don't even get the experimental drug. They were just given a placebo.
Speaker #5: I think the bigger question was on the other side with these rare diseases, where it's just incredibly difficult to do one of these randomized sham studies, because surgeons are not necessarily comfortable enrolling patients, and patients themselves might feel like they're missing a chance to experiment with other studies if they're waiting for one in a situation where they don't even get the experimental drug.
Speaker #5: They were just given a placebo. So just the practicality of some of these rare disease studies is really the thing that was the biggest question that we had seen.
Joseph M. Burnett: The practicality of some of these rare disease studies is really the thing that was the biggest question that we had seen.
Joe Burnett: The practicality of some of these rare disease studies is really the thing that was the biggest question that we had seen.
Speaker #4: Got it. Very helpful. And then maybe for my second one, just help us through kind of low-end versus high-end of guidance. What are some of the key variables you're tracking that might push you towards one of those two ends?
Frank Takkinen: Got it. Very helpful. Maybe for my second one, just help us through kind of low end versus high end of guidance. What are some of the key variables you're tracking that might push you towards one of those two ends?
Frank Takkinen: Got it. Very helpful. Maybe for my second one, just help us through kind of low end versus high end of guidance. What are some of the key variables you're tracking that might push you towards one of those two ends?
Speaker #5: Yeah, I mean, I would say the largest factor there is really the continued investment and preparation of the preclinical services that we're providing at the new CAL facility.
Joseph M. Burnett: Yeah, I mean, I would say the largest factor there is really the continued investment and preparation of the preclinical services that we're providing at the new CAL facility. You know, as you've seen, you know, throughout our history, there's always choppiness from quarter-to-quarter. The thing I would point out there is that we're still very much not fully operational yet and under capacity. I view that as kind of a positive. In Danilo's comments he made, he mentioned that our preclinical services, our Biologics and Drug Delivery services were flat year-over-year. What I would point out is sort of twofold. If you think about our new facility, think of it this way. This is not a perfect analogy, but at least gives you some context.
Joe Burnett: Yeah, I mean, I would say the largest factor there is really the continued investment and preparation of the preclinical services that we're providing at the new CAL facility. You know, as you've seen, you know, throughout our history, there's always choppiness from quarter-to-quarter. The thing I would point out there is that we're still very much not fully operational yet and under capacity. I view that as kind of a positive. In Danilo's comments he made, he mentioned that our preclinical services, our Biologics and Drug Delivery services were flat year-over-year. What I would point out is sort of twofold. If you think about our new facility, think of it this way. This is not a perfect analogy, but at least gives you some context.
Speaker #5: As you've seen throughout our history, there's always choppiness from quarter to quarter. But the thing I would point out there is that we're still very much not fully operational yet and under capacity.
Speaker #5: And I view that as kind of a positive in Danilo's comments. He mentioned that our preclinical services, our biologics and drug delivery services, were flat year over year.
Speaker #5: What I would point out is sort of twofold. If you think about our new facility, think of it this way. This is not a perfect analogy, but at least gives you some context.
Speaker #5: We pretty much have three floors of that facility. So of those three floors, we have only taken control of one of them. And these are all three revenue-generating floors for benchtop testing, for analytics, for histology, you name it.
Joseph M. Burnett: We pretty much have three floors of that facility. Of those three floors, we have only taken control of one of them. These are all three revenue-generating floors for benchtop testing, for analytics, for histology, you know, you name it. To even start the quarter, we only had 1/3 of that revenue-generating space, if you will. Even if you look at the 1/3 we had, there was an entire month of March where we weren't doing studies because we were finishing completion of some of the construction there as too.
Joe Burnett: We pretty much have three floors of that facility. Of those three floors, we have only taken control of one of them. These are all three revenue-generating floors for benchtop testing, for analytics, for histology, you know, you name it. To even start the quarter, we only had 1/3 of that revenue-generating space, if you will. Even if you look at the 1/3 we had, there was an entire month of March where we weren't doing studies because we were finishing completion of some of the construction there as too.
Speaker #5: So to even start the quarter, we only had one-third of that revenue-generating space, if you will. And then even if you look at the one-third we had, there was an entire month of March where we weren't doing studies because we were finishing completion of some of the construction there as too.
Speaker #5: So if you think about estimating capacity of what that facility could do for us, we still came in in the millions of dollars, but you could argue we were like two-ninths or 20% of what the actual capacity is.
Joseph M. Burnett: If you think about estimating capacity of what that facility could do for us, you know, we still came in, you know, in the millions of dollars, but you could argue we were like two-ninths or 20% of, you know, what our actual capacity is. We're significantly subscale on that as well. You know, we expect if you think by the end of Q2, early Q3, we should be getting close to taking the first floor over, the second or the second floor, if you think of it in my analogy. By Q1 of 2027, we'd have the full facility completed. It's gonna be this kind of, sort of, stable, but increase over the next year or so, maybe in the next 18 months.
Joe Burnett: If you think about estimating capacity of what that facility could do for us, you know, we still came in, you know, in the millions of dollars, but you could argue we were like two-ninths or 20% of, you know, what our actual capacity is. We're significantly subscale on that as well. You know, we expect if you think by the end of Q2, early Q3, we should be getting close to taking the first floor over, the second or the second floor, if you think of it in my analogy. By Q1 of 2027, we'd have the full facility completed. It's gonna be this kind of, sort of, stable, but increase over the next year or so, maybe in the next 18 months.
Speaker #5: So we're significantly subscale on that as well. And we expect, if you think by the end of Q2, early Q3, we should be getting close to taking the first floor over, the second floor, if you think of it in my analogy.
Speaker #5: And then by Q1 of 2027, we'd have the full facility completed. So it's going to be this kind of, sort of stable but increase over the next year or so, maybe in the next 18 months.
Speaker #5: And to answer your question, when those facilities and studies get booked is really the biggest driver of that range in guidance.
Joseph M. Burnett: You know, to answer your question, when those facilities and studies get booked is really the biggest driver of that range and guidance.
Joe Burnett: You know, to answer your question, when those facilities and studies get booked is really the biggest driver of that range and guidance.
Speaker #4: Got it. Okay. Very helpful. Thank you.
Frank Takkinen: Got it. Okay. Very helpful. Thank you.
Frank Takkinen: Got it. Okay. Very helpful. Thank you.
Speaker #5: Sure.
Joseph M. Burnett: Sure.
Joe Burnett: Sure.
Speaker #4: Thank you. Our next question comes from the line of Tom Steffen with Stifel. Please proceed with your question.
Operator 2: Thank you. Our next question comes from the line of Tom Stephan with Stifel. Please proceed with your question.
Operator: Thank you. Our next question comes from the line of Tom Stephan with Stifel. Please proceed with your question.
Speaker #6: Great. Hey, guys. Thanks for taking the questions. Maybe as a follow-up to Frank's prior question, Danilo, maybe for you, can you talk a bit about revenue cadence for the year as we think about the guide?
Tom Stephan: Great. Hey, guys. Thanks for taking the questions. Maybe as a follow-up to Frank's prior question, Danilo, maybe for you, can you talk a bit about revenue cadence for the year as we think about the guide, and notably as we consider, I'd say, IRRAflow synergies that you've talked about. And then as a tack on, can you give us a sense for, you know, within your range, how much of the mix is kind of base business versus IRRAflow? And then I'll have a follow-up.
Tom Stephan: Great. Hey, guys. Thanks for taking the questions. Maybe as a follow-up to Frank's prior question, Danilo, maybe for you, can you talk a bit about revenue cadence for the year as we think about the guide, and notably as we consider, I'd say, IRRAflow synergies that you've talked about. And then as a tack on, can you give us a sense for, you know, within your range, how much of the mix is kind of base business versus IRRAflow? And then I'll have a follow-up.
Speaker #6: And notably, as we consider I'd say Euroflow synergies that you've talked about. And then as a tack-on, can you give us a sense for within your range, how much of the mix is kind of base business versus Euroflow?
Speaker #6: And then I'll have a follow-up.
Speaker #5: Yeah, the way I would think about it is with sequential growth, potentially quarter over quarter, for the remainder of the year, so it would be gradual.
Danilo D'Alessandro: Yeah. The way I would think about it is with sequential growth potentially quarter over quarter for the remainder of the year. It will be gradual, but we expect it to be somewhat consistent over the next three quarters. With regard to the IRRAflow side of things, we expect it to grow, and it still accounts for that 20% to 25% of our total business. That's what we expect between now and the end of the year.
Danilo D'Alessandro: Yeah. The way I would think about it is with sequential growth potentially quarter-over-quarter for the remainder of the year. It will be gradual, but we expect it to be somewhat consistent over the next three quarters. With regard to the IRRAflow side of things, we expect it to grow, and it still accounts for that 20% to 25% of our total business. That's what we expect between now and the end of the year.
Speaker #5: But we expect it to be somewhat consistent over the next three quarters. With regard to the Euroflow side of things, we expect it to grow, and it's still accounts for that 20 to 20 in that 20 to 25 percent of our total business.
Speaker #5: That's what we expect between now and the end of the year.
Speaker #6: Got it. That's great.
Tom Stephan: Got it. That's great.
Tom Stephan: Got it. That's great.
Joseph M. Burnett: Yeah. Tom, the only thing maybe I'd add there as well is that, you know, as we mentioned at the beginning, in the H1 of the year, our European and OUS strategy for IRRAflow has changed a little bit, where we've moved on from certain distributors, and we're going direct in different markets as well. That sort of paused our European growth to some extent, while the US continues to kind of fire here in the H1. There could be a little bit of a lag there relative to when, sort of outside of the US IRRAflow, kicks in because of some of these changes. Again, it, you know, it's I wouldn't say it's just noise.
Joe Burnett: Yeah. Tom, the only thing maybe I'd add there as well is that, you know, as we mentioned at the beginning, in the H1 of the year, our European and OUS strategy for IRRAflow has changed a little bit, where we've moved on from certain distributors, and we're going direct in different markets as well. That sort of paused our European growth to some extent, while the US continues to kind of fire here in the H1. There could be a little bit of a lag there relative to when, sort of outside of the US IRRAflow, kicks in because of some of these changes. Again, it, you know, it's I wouldn't say it's just noise.
Speaker #5: Yeah. Tom, the only thing maybe that I'd add there as well is that as we mentioned at the beginning, then the first half of the year, our European and OUS strategy for Euroflow has changed a little bit, where we've moved on from certain distributors, and we're going direct in different markets as well.
Speaker #5: So that sort of paused our European growth to some extent, while the U.S. continues to kind of fire here in the first half. So there could be a little bit of a lag there, relative to when, sort of outside of the U.S., Euroflow kicks in because of some of these changes.
Speaker #5: But again, it's I wouldn't say it's just noise. I mean, I think it's real, but it's not something that's going to change the map of our revenue for the year.
Joseph M. Burnett: I mean, I think it's real, but it's not something that's gonna change the math of our revenue for the year.
Joe Burnett: I mean, I think it's real, but it's not something that's gonna change the math of our revenue for the year.
Speaker #6: Got it. That's great. Appreciate that. And then I guess moving down the P&L, if you will, sort of a two-parter again, but gross margin really nice step up in one Q.
Tom Stephan: Got it. That's great. Appreciate that. Then I guess moving down the P&L, if you will, sort of a two-parter again. Gross margin, really nice step up in Q1. Joe, can you talk about kind of puts and takes specifically around IRRAflow? And I know you mentioned it can fluctuate, but is this mid-60% range potentially sustainable moving forward? Then sort of similarly on OpEx, Joe, you mentioned some one-timers. How much were those, and what's kind of the right OpEx run rate moving forward for 2026? Thanks.
Tom Stephan: Got it. That's great. Appreciate that. Then I guess moving down the P&L, if you will, sort of a two-parter again. Gross margin, really nice step up in Q1. Joe, can you talk about kind of puts and takes specifically around IRRAflow? And I know you mentioned it can fluctuate, but is this mid-60% range potentially sustainable moving forward? Then sort of similarly on OpEx, Joe, you mentioned some one-timers. How much were those, and what's kind of the right OpEx run rate moving forward for 2026? Thanks.
Speaker #6: Joe, can you talk about kind of puts and takes specifically around Euroflow? And I know you mentioned it can fluctuate, but is this mid-60% range potentially sustainable moving forward?
Speaker #6: And then sort of similarly on OPEX, Joe, you mentioned some one-timers. How much were those, and what's kind of the right OPEX run rate moving forward for '26?
Speaker #6: Thanks.
Joseph M. Burnett: Yeah. You know, quarter to quarter it's there's definitely gonna be some fluctuations. I mean, it could be down next quarter and then up the one after that. It's nice to get a good one under our belt for Q1. We are still very much subscale in just about everything that we do, including IRRAflow. If you think about what took place in Q1, we shut down the IRRAflow factory that was in San Diego, and we moved all of their operations and employees over to our Carlsbad facility.
Speaker #5: Yeah. Quarter to quarter, there's definitely going to be some fluctuation. So I mean, it could be down next quarter and then up the one after that.
Joe Burnett: Yeah. You know, quarter-to-quarter it's there's definitely gonna be some fluctuations. I mean, it could be down next quarter and then up the one after that. It's nice to get a good one under our belt for Q1. We are still very much subscale in just about everything that we do, including IRRAflow. If you think about what took place in Q1, we shut down the IRRAflow factory that was in San Diego, and we moved all of their operations and employees over to our Carlsbad facility.
Speaker #5: It's nice to get a good one under our belt for the first quarter. But we are still very much subscale in just about everything that we do.
Speaker #5: Including Euroflow. So if you think about what took place in Q1, we shut down the Euroflow factory that was in San Diego, and we moved all of their operations and employees over to our Carlsbad facility.
Speaker #5: So if you think of it as something that showed up on the G&A, for example, as an increase, we have an empty building right now that we're in the process of subleasing.
Joseph M. Burnett: If you think of it something that showed up on the G&A, for example, as an increase, you know, we have an empty building right now that we're in the process of subleasing, to go ahead and, you know, to over. That's one of those very obvious cost synergies that we've already done all the work to move everything over, and now it's just finding a tenant to take over the lease. Those are the types of things. You know, multiply that times 10 or 15 different opportunities with redundant vendors, with the ability to have some sort of negotiating power with our vendors of just, you know, raw materials, putting more and more products through our factory.
Joe Burnett: If you think of it something that showed up on the G&A, for example, as an increase, you know, we have an empty building right now that we're in the process of subleasing, to go ahead and, you know, to over. That's one of those very obvious cost synergies that we've already done all the work to move everything over, and now it's just finding a tenant to take over the lease. Those are the types of things. You know, multiply that times 10 or 15 different opportunities with redundant vendors, with the ability to have some sort of negotiating power with our vendors of just, you know, raw materials, putting more and more products through our factory.
Speaker #5: To go ahead and to over that's one of those very obvious cost synergies that we've already done all the work to move everything over, and now it's just finding a tenant to take over the lease.
Speaker #5: So those are the types of things. If you multiply that times 10 or 15 different opportunities with redundant vendors, with the ability to have some sort of negotiating power with our vendors of just raw materials, putting more and more products through our factory, and then even on the sales and marketing side, to be able to have our clinicals travel less because the volume has increased across our portfolio in different cities with gas prices where they are and travel expenses where they are.
Joseph M. Burnett: Then even on the sales and marketing side, to be able to have our clinicals travel less because the volume has increased across our portfolio in different cities. You know, with gas prices where they are and travel expenses where they are, that's a very, very meaningful part of the strategy too. That doesn't hit our gross margin, but it helps, it's definitely gonna help us on the sell X side of things. Got it. Thanks, guys.
Joe Burnett: Then even on the sales and marketing side, to be able to have our clinicals travel less because the volume has increased across our portfolio in different cities. You know, with gas prices where they are and travel expenses where they are, that's a very, very meaningful part of the strategy too. That doesn't hit our gross margin, but it helps, it's definitely gonna help us on the sell X side of things. Got it. Thanks, guys.
Speaker #5: That's a very, very meaningful part of the strategy too that doesn't hit our gross margin, but it's definitely going to help us on the sell-ex side of things.
Speaker #6: Got it. Thanks, guys.
Speaker #5: Thank you.
Danilo D'Alessandro: Thank you.
Danilo D'Alessandro: Thank you.
Speaker #4: Thank you. Our next question comes from the line of Matthew Blackman with TD Cowen. Please proceed with your question.
Operator 2: Thank you. Our next question comes from the line of Mathew Blackman with TD Cowen. Please proceed with your questioning.
Operator: Thank you. Our next question comes from the line of Mathew Blackman with TD Cowen. Please proceed with your questioning.
Mathew Blackman: Hey, Joe, Danilo. Thanks for taking my questions. Can you hear me okay?
Speaker #7: Hey, Joe. Danilo, thanks for taking my questions. Can you hear me okay?
Mathew Blackman: Hey, Joe, Danilo. Thanks for taking my questions. Can you hear me okay?
Speaker #5: Yeah. It's loud and clear.
Danilo D'Alessandro: Yes.
Danilo D'Alessandro: Yes.
Joseph M. Burnett: Yes, loud and clear.
Joe Burnett: Yes, loud and clear.
Speaker #7: Oh, great. Well, good to hear your voices. Clearly, a lot has happened since I last had the opportunity to be on a ClearPoint call. And so on that theme—sort of a big-picture question—you are now more evolved with the four-phase, five-growth pillar strategy.
Mathew Blackman: Oh, great. Well, good to hear your voices. Clearly a lot has happened since I last had the opportunity to be on a ClearPoint Neuro call. On that theme, sort of a big picture question, you're now more evolved, four phase, five growth pillar strategy, I think with a combined $500 million long-term revenue target. Here's another multi-part question for you. Question one, do you have all the key pieces in place today to hit that $500 million number some, you know, time in the future? Are there still platforms or services you need to roll in to make that number achievable? Part two is there a way to get to that $500 million target faster inorganically?
Mathew Blackman: Oh, great. Well, good to hear your voices. Clearly a lot has happened since I last had the opportunity to be on a ClearPoint Neuro call. On that theme, sort of a big picture question, you're now more evolved, four phase, five growth pillar strategy, I think with a combined $500 million long-term revenue target. Here's another multi-part question for you. Question one, do you have all the key pieces in place today to hit that $500 million number some, you know, time in the future? Are there still platforms or services you need to roll in to make that number achievable? Part two is there a way to get to that $500 million target faster inorganically?
Speaker #7: I think with a combined 500 million dollar long-term revenue target. Here's another multi-part question for you. Question one, do you have all the key pieces in place today to hit that 500 million dollar number?
Speaker #7: Some time in the future, or are there still platforms or services you need to roll in to make that number achievable? And part two is, is there a way to get to that $500 million target faster inorganically, or are there assets out there that have technology and revenue bases that could help accelerate your pathway?
Mathew Blackman: Are there assets out there that have technology and revenue bases that could help accelerate your pathway? How do you evaluate that pathway versus getting there organically? Then I do have one follow-up question.
Mathew Blackman: Are there assets out there that have technology and revenue bases that could help accelerate your pathway? How do you evaluate that pathway versus getting there organically? Then I do have one follow-up question.
Speaker #7: And how do you evaluate that pathway versus getting there organically? And then I do have one follow-up question.
Speaker #5: Yeah. So the first question was around, do we have all the parts to build this spaceship and get to our destination here? And I think the answer is yes.
Joseph M. Burnett: Yeah. You know, do we have all the parts to build this spaceship and get to our destination here? I think the answer is yes. I would say it in the way that there's still refinements in our portfolio, but we have control of the portfolio. I'll give you a perfect example of that is our robotics platform. You know, we do not have an FDA-cleared robot today. We have one that we are doing preclinical cases with for pharma partners, so it's functional in the preclinical setting. We have every confidence in this program because of the development that KUKA has put into the robotic arm development and parallel to what we have done over 15 years for our software development.
Joe Burnett: Yeah. You know, do we have all the parts to build this spaceship and get to our destination here? I think the answer is yes. I would say it in the way that there's still refinements in our portfolio, but we have control of the portfolio. I'll give you a perfect example of that is our robotics platform. You know, we do not have an FDA-cleared robot today. We have one that we are doing preclinical cases with for pharma partners, so it's functional in the preclinical setting. We have every confidence in this program because of the development that KUKA has put into the robotic arm development and parallel to what we have done over 15 years for our software development.
Speaker #5: I would say it in the way that there's still refinements in our portfolio, but we have control of the portfolio. So I'll give you a perfect example of that—our robotics platform.
Speaker #5: We do not have an FDA-cleared robot today. We have one that we are doing preclinical cases with for pharma partners. So it's functional in the preclinical setting.
Speaker #5: We have every confidence in this program because of the development that KUKA has put into the robotic arm development and parallel to what we have done over 15 years for our software development.
Speaker #5: So it's not that we're dependent on something inorganic or dependent on something that requires invention or luck. These are things that I think are execution.
Joseph M. Burnett: It's not that we're dependent on something inorganic or dependent on something that requires invention or luck. You know, these are things that I think are execution. Once we have a robotic platform and arguably become the only company where you have one software that can be done in the MRI, using the same frame and ICT and then also with a robot as well, you know, I think that's something that, especially if our pharma partners support it as their robot of choice, I think that's gonna differentiate us and give us a right to win.
Joe Burnett: It's not that we're dependent on something inorganic or dependent on something that requires invention or luck. You know, these are things that I think are execution. Once we have a robotic platform and arguably become the only company where you have one software that can be done in the MRI, using the same frame and ICT and then also with a robot as well, you know, I think that's something that, especially if our pharma partners support it as their robot of choice, I think that's gonna differentiate us and give us a right to win.
Speaker #5: But once we have a robotic platform and arguably become the only company where you have one software that can be done in the MRI using the same frame and ICT, and then also with a robot as well, I think that's something that, especially if our pharma partners support it as their robot of choice, I think that's going to differentiate us and give us a right to win.
Speaker #5: If you think about other things that are out there inorganically, it's interesting. If we're not going to cross into neurovascular and we're not going to go out of the brain or implant something into the brain, which dramatically increased sort of complexity and costs and patient outreach and neurology call points and things like that, there aren't that many assets that are out there.
Joseph M. Burnett: If you think about other things that are out there inorganically, you know, it's interesting, if we're not gonna cross into neurovascular, and we're not gonna go out of the brain or implant something into the brain, which dramatically increase sort of complexity and costs and patient outreach and, neurology call points and things like that, you know, there aren't that many assets that are out there. It's, it's interesting because the reason for that is so few patients go through with surgery compared to the sheer number of patients that are out there that need help.
Joe Burnett: If you think about other things that are out there inorganically, you know, it's interesting, if we're not gonna cross into neurovascular, and we're not gonna go out of the brain or implant something into the brain, which dramatically increase sort of complexity and costs and patient outreach and, neurology call points and things like that, you know, there aren't that many assets that are out there. It's, it's interesting because the reason for that is so few patients go through with surgery compared to the sheer number of patients that are out there that need help.
Speaker #5: And it's interesting because the reason for that is so few patients go through with surgery compared to the sheer number of patients that are out there that need help.
Speaker #5: And that's really the promise of improvements with DVS, improvements to laser systems and awareness and access, improvements to reimbursement. And arguably, most importantly, availability, final commercial availability of cell and gene therapies and other drugs that can be restorative and not ablative or not be an implant, which I think patients are very likely from what we understand to pursue first.
Joseph M. Burnett: That's really the promise of improvements with DBS, improvements to laser systems and awareness and access, improvements to reimbursement, and arguably most importantly, availability, you know, final commercial availability of cell and gene therapies and other drugs that can be restorative and not ablative or not be an implant, which I think patients are very likely, from what we understand, to pursue first. You know, our focus is really getting these therapies across the finish line and then working alongside 50 or 60 pharma partners to educate neurologists, educate patients that they're available, which is something that I think will scale us quite a bit. That's why I'm saying I don't think we're dependent on something inorganic to get there.
Joe Burnett: That's really the promise of improvements with DBS, improvements to laser systems and awareness and access, improvements to reimbursement, and arguably most importantly, availability, you know, final commercial availability of cell and gene therapies and other drugs that can be restorative and not ablative or not be an implant, which I think patients are very likely, from what we understand, to pursue first. You know, our focus is really getting these therapies across the finish line and then working alongside 50 or 60 pharma partners to educate neurologists, educate patients that they're available, which is something that I think will scale us quite a bit. That's why I'm saying I don't think we're dependent on something inorganic to get there.
Speaker #5: So our focus is really getting these therapies across the finish line and then working alongside 50 or 60 pharma partners to educate neurologists, educate patients that they're available, which is something that I think will scale us quite a bit.
Speaker #5: So that's why I'm saying I don't think we're dependent on something inorganic to get there.
Speaker #7: Got it. That really helpful. And then the follow-up for you as well, Joe. Some of the Euroflow catheter, look, I appreciate it's still very early days, but feeling any interest from current or even potentially new biopharma partners in using the indwelling delivery option?
Mathew Blackman: Got it. That's really helpful. The follow-up for you as well, Joe. Some of the IRRAflow catheter look, I appreciate it's still very early days, but showing any interest from current or even potentially new biopharma partners in using the indwelling delivery option? Maybe Danilo, if you could, just how would the IRRAflow catheter, even if just in the roughest terms, differ from a business model or economic standpoint if it, in the future, was co-labeled with a drug versus what you have in place with the SmartFlow cannula? Any help there? Thanks, guys.
Mathew Blackman: Got it. That's really helpful. The follow-up for you as well, Joe. Some of the IRRAflow catheter look, I appreciate it's still very early days, but showing any interest from current or even potentially new biopharma partners in using the indwelling delivery option? Maybe Danilo, if you could, just how would the IRRAflow catheter, even if just in the roughest terms, differ from a business model or economic standpoint if it, in the future, was co-labeled with a drug versus what you have in place with the SmartFlow cannula? Any help there? Thanks, guys.
Speaker #7: And maybe Danilo, if you could just, how would the Euroflow catheter, even if just in the roughest terms, differ from a business model or economic standpoint if it in the future was co-labeled with a drug versus what you have in place with the SmartFlow cannula?
Speaker #7: Any help there? Thanks, guys.
Speaker #5: Yeah. I think I'd say yes, we've absolutely had discussions with partners and research centers we host a meeting called Ignite every year. And we had a number of different research ideas that came out of that where they the researcher themselves was already planning to execute a study using an off-the-shelf device called an EVD or an external ventricular drain, which is a very, very common procedure.
Joseph M. Burnett: Yeah, I think, I'd say yes, we've absolutely had discussions with partners and research centers. We host a meeting called IGNITE every year, and, you know, we had a number of different research ideas that came out of that where they, the researcher themselves, was already planning to execute a study using an off-the-shelf device called an EVD or an external ventricular drain, which is a very, very common procedure. You know, IRRAflow is arguably a next generation EVD because it's dual lumen, and it allows you to actually put some sort of fluid as directed by a surgeon into the brain while it naturally drains instead of just draining and doing a sort of a bolus shot into there.
Joe Burnett: Yeah, I think, I'd say yes, we've absolutely had discussions with partners and research centers. We host a meeting called IGNITE every year, and, you know, we had a number of different research ideas that came out of that where they, the researcher themselves, was already planning to execute a study using an off-the-shelf device called an EVD or an external ventricular drain, which is a very, very common procedure. You know, IRRAflow is arguably a next generation EVD because it's dual lumen, and it allows you to actually put some sort of fluid as directed by a surgeon into the brain while it naturally drains instead of just draining and doing a sort of a bolus shot into there.
Speaker #5: Euroflow is arguably a next-generation EVD because it's dual lumen. And it allows you to actually put some sort of fluid as directed by a surgeon into the brain while it naturally drains instead of just draining and doing a sort of a bolus shot into there.
Speaker #5: So the product arguably for these in-path, very simple EVD studies is kind of an obvious choice to switch to this as quickly as possible.
Joseph M. Burnett: You know, the, the product arguably for these in-path, very simple EVD studies is kind of an obvious choice to switch to this as quickly as possible. It's really an education standpoint. As you pointed out, luckily, ClearPoint has spent the last, you know, 10 plus years building relationships, not just with researchers, but the biopharma companies that are interested in either funding their own study, or licensing these ideas and these technologies out of universities and academic centers. You know, there is a product out there today, in our current IRRAflow product line, that could absolutely become an immediate substitute in some of these studies, and I think that's a very likely case.
Joe Burnett: You know, the, the product arguably for these in-path, very simple EVD studies is kind of an obvious choice to switch to this as quickly as possible. It's really an education standpoint. As you pointed out, luckily, ClearPoint has spent the last, you know, 10 plus years building relationships, not just with researchers, but the biopharma companies that are interested in either funding their own study, or licensing these ideas and these technologies out of universities and academic centers. You know, there is a product out there today, in our current IRRAflow product line, that could absolutely become an immediate substitute in some of these studies, and I think that's a very likely case.
Speaker #5: So it's really an education standpoint. And as you pointed out, luckily, ClearPoint has spent the last 10-plus years building relationships not just with researchers, but the biopharma companies that are interested in either funding their own study or licensing these ideas and these technologies out of universities and academic centers.
Speaker #5: So there is a product out there today that could absolutely, in our current EuroFlow product line, that could absolutely become an immediate substitute in some of these studies.
Speaker #5: And I think that's a very likely case.
Speaker #7: Great. And then Danilo, anything? Yeah.
Mathew Blackman: Great. Thank you. Danilo, anything-
Mathew Blackman: Great. Thank you. Danilo, anything-
Danilo D'Alessandro: Yeah.
Danilo D'Alessandro: Yeah.
Speaker #5: Yeah. Yeah. And on the economics side, we expect Euroflow margins to still be very healthy. Like Joe mentioned earlier, we're still pretty sub-scale. As it grows, we think the margins will keep expanding in that product portfolio.
Mathew Blackman: Yeah.
Mathew Blackman: Yeah.
Danilo D'Alessandro: On the economic side, we expect IRRAflow margins to still be very healthy. Like Joe mentioned earlier, we're still pretty subscale. As it grows, we think the margins will keep expanding in that product portfolio. I think they already are, if you look at even 2026, just given the fact that we've consolidated facilities. From a business model perspective, we're gonna, you know, work with our partners. It's still very early, but we'd like to, of course, pursue similar ways of working that we've had with our, we would retest and explore with our existing partners.
Danilo D'Alessandro: On the economic side, we expect IRRAflow margins to still be very healthy. Like Joe mentioned earlier, we're still pretty subscale. As it grows, we think the margins will keep expanding in that product portfolio. I think they already are, if you look at even 2026, just given the fact that we've consolidated facilities. From a business model perspective, we're gonna, you know, work with our partners. It's still very early, but we'd like to, of course, pursue similar ways of working that we've had with our, we would retest and explore with our existing partners.
Speaker #5: I think there already are, if you look at even 2026, just given the fact that we've consolidated facilities. From a business model perspective, we're going to work with our partners.
Speaker #5: It's still very, very, very early, but we'd like to, of course, pursue similar ways of working that we've had with our we were already tested and explored with our existing partners.
Speaker #7: Got it. Thank you, guys. Appreciate it.
Mathew Blackman: Got it. Thank you, guys. Appreciate it.
Mathew Blackman: Got it. Thank you, guys. Appreciate it.
Speaker #5: Okay. Sure thing, man.
Joseph M. Burnett: Yeah. Thanks for having me.
Joe Burnett: Yeah. Thanks for having me.
Speaker #1: Thank you. And we have reached the end of the question-and-answer session. And therefore, I would like to turn the floor back over to CEO Joe Burnett for a closing remarks.
Operator 2: Thank you. We have reached the end of the question and answer session, and therefore, I would like to turn the floor back over to CEO Joseph M. Burnett for closing remarks.
Operator: Thank you. We have reached the end of the question and answer session, and therefore, I would like to turn the floor back over to CEO Joseph M. Burnett for closing remarks.
Speaker #8: Thanks again for joining our call today. Our team feels like we have built an incredible foundation on these four pillars today, which will support an exciting future of global commercial drug delivery.
Joseph M. Burnett: Thanks again for joining our call today. Our team feels like we have built an incredible foundation on these four pillars today, which will support an exciting future of global commercial drug delivery, which our 60-plus biopharma partners are making progress towards each and every day. We are on a path to helping treat tens of thousands of patients a year who suffer from many of the most frightening neurological diseases imaginable. We are thrilled to have you on our team supporting this vision and supporting us on the road ahead. Good night, everyone.
Joe Burnett: Thanks again for joining our call today. Our team feels like we have built an incredible foundation on these four pillars today, which will support an exciting future of global commercial drug delivery, which our 60-plus biopharma partners are making progress towards each and every day. We are on a path to helping treat tens of thousands of patients a year who suffer from many of the most frightening neurological diseases imaginable. We are thrilled to have you on our team supporting this vision and supporting us on the road ahead. Good night, everyone.
Speaker #8: Which are 60-plus biopharma partners are making progress towards each and every day. We are on a path to helping treat tens of thousands of patients a year who suffer from many of the most frightening neurological diseases imaginable.
Speaker #8: We are thrilled to have you on our team supporting this vision and supporting us on the road ahead. Good night, everyone.
Operator 2: Thank you. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.
Operator: Thank you. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.
