ClearPoint Neuro (CLPT) - Cuộc họp công bố kết quả kinh doanh Q3 2026: Doanh thu tăng 36%, Hướng tới các động lực tăng trưởng năm 2027

Cuộc họp báo cáo kết quả kinh doanh quý 3/2026 của ClearPoint Neuro (Nasdaq: CLPT) tập trung vào mức tăng trưởng doanh thu 36%, doanh số bán thiết bị kỷ lục, việc tích hợp IRRAflow và sự chuẩn bị cho các thử nghiệm liệu pháp tế bào và gen quy mô lớn hơn.

Những điểm chính

• Doanh thu quý 3/2026 tăng 36% so với cùng kỳ năm trước lên 12,1 triệu USD, dẫn đầu là mức tăng trưởng 59% doanh thu từ điều hướng và điều trị phẫu thuật thần kinh cùng mức tăng 68% doanh thu từ thiết bị và phần mềm.
• Biên lợi nhuận gộp giảm 5 điểm phần trăm xuống 58%, chủ yếu do chi phí quản lý chung tại cơ sở mới ClearPoint Advanced Laboratories và chi phí phân bổ tài sản vô hình đã mua lại.
• Chi phí hoạt động đạt tổng cộng 13,4 triệu USD, giảm từ mức gần 17 triệu USD trong quý 2/2026. Ban quản lý cho rằng sự cải thiện so với quý trước là nhờ tái cơ cấu thương mại và hiệu quả cộng hưởng từ việc tích hợp IRRAflow.
• ClearPoint kết thúc quý với 46,2 triệu USD tiền và các khoản tương đương tiền sau khi thu về 22 triệu USD tiền ròng thông qua chương trình phát hành cổ phiếu theo giá thị trường (ATM).
• Ban quản lý tiếp tục chuẩn bị cho nhiều nghiên cứu Giai đoạn 3 của các đối tác, dự kiến sẽ tuyển bệnh nhân hoặc bắt đầu vào năm 2027. Công ty cũng phác thảo 5 cột mốc lâm sàng và sản phẩm IRRAflow mục tiêu cho năm 2027.
• Ban quản lý cho biết mức tăng trưởng doanh thu cơ sở khoảng 14-16% (mid-teens) vẫn là một giả định sơ bộ hợp lý cho năm 2027, nhưng nhấn mạnh rằng đây không phải là dự báo chính thức.

Dữ liệu tài chính cốt lõi

Kết quả kinh doanh và hoạt động

Sản phẩm sinh học và phân phối thuốc

ClearPoint đang hỗ trợ uniQure nộp hồ sơ xin cấp phép cho AMT-130 điều trị bệnh Huntington, với tài liệu thiết bị của hãng đã được nộp lên FDA. Ban quản lý cho biết, tùy thuộc vào việc FDA chấp thuận BLA (Hồ sơ Xin cấp phép Sinh học), ClearPoint dự kiến sẽ nộp hồ sơ 510(k) đi kèm. Mục tiêu của công ty là thúc đẩy việc xem xét song song cả liệu pháp và thiết bị phân phối.

ClearPoint cũng kỳ vọng việc tuyển bệnh nhân sẽ tiếp tục và khởi động nhiều thử nghiệm Giai đoạn 3 của các đối tác trong năm tới. Ban quản lý lưu ý rằng các nghiên cứu này có thể bao gồm tới 200 bệnh nhân tại khoảng 20 trung tâm, so với dưới 15 bệnh nhân và một vài trung tâm ở một số thử nghiệm Giai đoạn 1.

Công ty đang mở rộng ClearPoint Advanced Laboratories tại Torrey Pines, California. Các năng lực mới và theo kế hoạch bao gồm chất đánh dấu PET và SPECT, dược phẩm phóng xạ và mô học. Doanh thu của CAL đã tăng liên tiếp qua 3 quý, và ban quản lý cho biết công việc đang triển khai trong tháng 10 củng cố kỳ vọng tiếp tục tăng trưởng trong quý 4.

Điều hướng phẫu thuật thần kinh và robot

ClearPoint ghi nhận quý có doanh số bán thiết bị cao nhất từ trước đến nay. Ban quản lý liên kết nhu cầu này với việc các trung tâm nghiên cứu chuẩn bị cho các thử nghiệm phân phối thuốc, cũng như sự quan tâm đến giải pháp điều hướng phòng mổ ICT của công ty dành cho các thủ thuật kích thích não sâu và sinh thiết.

Công ty cũng đang phát triển một nền tảng robot tập trung vào sọ脑 được thiết kế cho các thủ thuật nhanh chóng, chính xác và đa quỹ đạo. Ban quản lý cho biết nền tảng này nhằm hỗ trợ quy trình phân phối thuốc và siêu âm hội tụ bên ngoài phòng chụp MRI. ClearPoint kỳ vọng một số năng lực này có thể tạo ra doanh thu dịch vụ tiền lâm sàng tại CAL trước khi nhận được sự phê duyệt của FDA cho việc sử dụng thương mại.

Liệu pháp laser Prism và ứng dụng cột sống

ClearPoint đang tham gia vào khoản tài trợ NCI R01 thời hạn 5 năm do Dartmouth Health dẫn đầu nhằm phát triển liệu pháp laser hướng dẫn bằng MRI cho ung thư di căn cột sống. Chương trình dự kiến sẽ tiến triển từ thử nghiệm trong phòng thí nghiệm, qua đánh giá tiền lâm sàng quy mô lớn và đi vào thử nghiệm lâm sàng sử dụng hệ thống Prism.

Ban quản lý nhận định liệu pháp nhiệt laser kẽ cho cột sống là một cơ hội ở giai đoạn đầu có khả năng liên quan đến hơn 10.000 bệnh nhân trên toàn cầu. Prism hiện chưa được phép sử dụng cho cột sống. Phục vụ mục đích mô hình hóa, ban quản lý ước tính doanh thu tiềm năng của ClearPoint đạt từ 13.000 USD đến 20.000 USD cho mỗi thủ thuật, trong đó mức khoảng 15.000 USD được coi là một giả định hợp lý.

IRRAflow

Ban quản lý đã xác định 5 cột mốc IRRAflow mục tiêu cho năm 2027:

1. Ra mắt phần mềm Shoreline.
2. Ra mắt ống thông Dart.
3. Ra mắt ống thông luồn phía trước thế hệ tiếp theo.
4. Trình bày kết quả từ thử nghiệm ARCH ngẫu nhiên.
5. Đẩy mạnh xin chỉ định chính thức (on-label) từ FDA cho điều trị tụ máu dưới màng cứng.

Công ty có kế hoạch mở rộng có tính toán đội ngũ quản lý tài khoản lâm sàng và chuyên gia trước các cột mốc về sản phẩm, dữ liệu và pháp lý này.

Dự báo từ ban quản lý

Ban quản lý cho biết cả ba danh mục doanh thu—thiết bị, sản phẩm dùng một lần và dịch vụ CAL—đều có thể đóng góp vào mức tăng trưởng trong quý 4 đã được đưa vào mức trung vị của dự báo doanh thu năm 2026 khoảng 49 triệu USD được đề cập trong cuộc họp.

Đối với năm 2027, ban quản lý cho biết vẫn thoải mái với mức tăng trưởng doanh thu cơ sở khoảng 14-16% như một giả định kế hoạch ban đầu. Đây không phải là dự báo chính thức. Công ty dự kiến sẽ cung cấp thêm chi tiết sau khi có cái nhìn rõ ràng hơn về tiến trình pháp lý của AMT-130, thời điểm bắt đầu các thử nghiệm Giai đoạn 3, việc lắp đặt thiết bị CAL và 5 chương trình IRRAflow đã lên kế hoạch.

ClearPoint kỳ vọng mức tiêu tốn tiền mặt cho hoạt động sẽ giảm dần qua từng quý trong 4 đến 6 quý tới do tăng trưởng doanh thu vượt tốc độ tăng chi phí hoạt động. Tuy nhiên, ban quản lý cũng dự kiến sẽ có thêm chi phí đầu tư tư bản liên quan đến CAL trong 12 tháng tới.

Rủi ro và các yếu tố cần theo dõi

• Tiến độ của AMT-130 phụ thuộc vào việc FDA chấp thuận và xem xét hồ sơ BLA của uniQure, tiếp theo là hồ sơ 510(k) đi kèm theo kế hoạch của ClearPoint. Ban quản lý mô tả khả năng được phê duyệt vào giữa đến cuối năm 2027 là kịch bản tốt nhất nếu quy trình diễn ra đúng như dự kiến.
• Doanh thu từ thiết bị có thể không đồng đều do việc ghi nhận doanh thu phụ thuộc vào quá trình giao hàng, lắp đặt và thời điểm hệ thống chính thức đi vào hoạt động.
• Biên lợi nhuận gộp chịu áp lực từ chi phí quản lý chung khi khởi chạy CAL và chi phí phân bổ liên quan đến các tài sản vô hình đã mua lại.
• Các năng lực của CAL đòi hỏi phải mua sắm thiết bị và tuyển dụng trước vài tháng so với thời điểm bắt đầu có doanh thu dịch vụ liên quan.
• ClearPoint đã sử dụng công cụ phát hành cổ phiếu ATM để tài trợ cho việc mở rộng, mang về 22 triệu USD tiền ròng trong quý 3.
• Chương trình Prism cho cột sống vẫn đang ở giai đoạn đầu và ban quản lý cho biết quy trình pháp lý chính xác cũng như nhãn sản phẩm trong tương lai vẫn chưa được xác định.

Điểm nổi bật trong phần Hỏi & Đáp với chuyên viên phân tích

Các chuyên viên phân tích tập trung vào yếu tố thúc đẩy từ đối tác, mức tiêu tốn tiền mặt, hiệu quả kinh tế của liệu pháp laser cột sống và triển vọng tăng trưởng năm 2027.

Về AMT-130, ban quản lý cho biết FDA có thể đưa ra quyết định chấp nhận, từ chối hoặc trì hoãn BLA trong thời gian tới. Nếu được chấp nhận và quy trình diễn ra không có sự chậm trễ, ban quản lý ước tính quyết định cuối cùng có thể có sau 6 đến 8 tháng kể từ khi chấp nhận. ClearPoint đang tuyển dụng và đào tạo nhân sự để hỗ trợ cho các ca bệnh thương mại hoặc các nghiên cứu xác nhận và Giai đoạn 3 quy mô lớn hơn.

Về chi tiêu, ban quản lý đã phân biệt giữa các sản phẩm đã trưởng thành đòi hỏi đầu tư hạn chế, các sản phẩm tăng trưởng hiện tại như Prism và IRRAflow, cùng các cơ hội ở giai đoạn sớm hơn như CAL, liệu pháp laser cột sống, tụ máu dưới màng cứng và phân phối thuốc thương mại. Công ty kỳ vọng chi phí tích hợp IRRAS sẽ giảm bớt trong khi chi tiêu đầu tư tư bản liên quan đến CAL vẫn tiếp tục.

Về doanh thu quý 4, ban quản lý đã dẫn chứng phễu bán thiết bị kỷ lục, nhu cầu sản phẩm dùng một lần từ các hệ thống mới lắp đặt và sự tăng trưởng tiếp tục của dịch vụ CAL. Công ty lưu ý rằng thời điểm chính xác của việc lắp đặt thiết bị có thể làm di chuyển doanh thu giữa các quý.

Toàn văn biên bản cuộc họp báo cáo kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

Operator

Greetings, and welcome to ClearPoint Neuro Third Quarter 2026 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

Comments made on this call may include statements that are forward-looking within the meaning of the securities laws. These forward-looking statements may include, without limitation, statements related to anticipated industry trends, the company's plans, prospects and strategies, both preliminary and projected, the size of total addressable markets or the market opportunity for the company's products and services; 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. 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.

I would now like to turn the conference over to your host, Mr. Joe Burnett, Chief Executive Officer. Thank you. You may begin.

Joseph Burnett

Thank you, Rob, and good evening to all the investors, analysts and partners joining us for today's ClearPoint Neuro third quarter earnings call. Our company remains dedicated to developing therapies that can help restore function and improve outcomes for millions of patients worldwide living with serious neurological disorders. We are thrilled to have your continued interest and support as a part of this journey.

In the third quarter, we continued to make substantial progress with our neuro drug delivery strategy, focused on establishing ClearPoint as the gold standard for cell and gene therapy delivery. We have spent more than a decade building a leadership position in this market, and we are committed to maintaining and expanding that lead. This strategic progress includes pipeline development for our comprehensive and uniquely positioned drug delivery ecosystem, including AI segmentation and modeling tools, periprocedural navigation software and frames, surgical robotics, laser therapy and access drills, cannulas and new routes of administration, focus ultrasound and confirmatory drug infusion software.

In addition to our investment in this product portfolio, we continue to expand our ClearPoint Advanced Laboratories drug discovery facility in Torrey Pines, California, adding capacity, new capabilities and services. We also stand ready to support our more than 60 active biopharma partners who continue to announce both data readouts and global clinical trial initiations, including multiple Phase III studies that are either enrolling or expected to initiate in 2027. We look forward to the next regulatory milestones for our partner, uniQure's BLA submission to the FDA for AMT-130 to treat Huntington's disease during the weeks and months ahead, which could result in the very first FDA-approved gene therapy for this terrible disease.

To complement the strategic progress, we have made financial progress as well in the quarter. growing overall revenue by 36% compared to operating expenses, which grew 23%, a result that reflects the scalability. This result was possible due to our continued integration activities post the IRRAS acquisition and the reorganization of our clinical field team to get ready for Phase III trials and eventual drug delivery commercialization.

In order to fund these hiring activities in support of our clinical field team expansion and the start-up costs of our CAL expansion, we used our existing ATM facility for the first time, generating net proceeds of $22 million and ended the quarter with cash and cash equivalents of $46.2 million. This gives us the balance sheet flexibility to continue advancing our comprehensive drug delivery ecosystem, including robotics and focused ultrasound and to prepare our field team for new commercial product launches that we expect in 2027.

I will now turn the call over to Danilo D'Alessandro to discuss our financial results, after which I will provide a bit more detail on our 4-pillar growth strategy. Danilo?

Danilo D’Alessandro

Thank you, Joe, and thank you all for joining us today. Looking at the third quarter 2026 results. Total revenue was $12.1 million for the 3 months ended September 30, 2026, and $8.9 million for the 3 months ended September 30, 2025, which represents 36% growth versus the third quarter of 2025. Our revenue is made up of 3 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. Biologics and drug delivery revenue increased 11% to $4.9 million in the third quarter, up from $4.4 million for the same period in 2025. This increase is primarily attributable to higher service revenue performed at ClearPoint Advanced Laboratories.

Neurosurgery navigation revenue consists of commercial sales of disposable products related to cases utilizing the ClearPoint system, the Prism laser system and IRRAflow. This revenue grew 59% to $5.4 million in the third quarter of 2026 from $3.4 million for the same period in 2025, driven primarily by additional revenues due to sales of the IRRAflow product, which we acquired in connection with our acquisition of IRRAS in the fourth quarter of 2025 and in conjunction with growth of our legacy neurosurgery products.

Capital equipment and software revenue, consisting of sales of our reusable hardware and software and related services increased 68% to $1.7 million in the quarter from $1 million for the same period in 2025 due to an increase in the placements of ClearPoint navigation systems, Prism laser units and IRRAflow control units.

Gross margin for the third quarter of 2026 was 58%, a decrease of 5 percentage points compared to 63% in Q3 2025, primarily due to overhead costs at the new CAL facility and additional amortization expense of acquired intangible assets, partially offset by a decrease in other cost of revenue.

Research and development costs were $4 million for the 3 months ended September 30, 2026, compared to $3.5 million for the same period in 2025, an increase of $0.6 million or 16%. The increase was due primarily to higher personnel costs of $0.6 million.

Sales and marketing expenses were $5.5 million for Q3 compared to $3.8 million for the same period in 2025, an increase of $1.7 million or 44%. This increase was due primarily to additional personnel costs of $1.2 million, an increase in travel costs of $0.2 million, resulting from the expansion of our clinical and sales team and additional amortization expense of acquired intangible assets of $0.2 million.

General and administrative expenses were $3.8 million for the third quarter, an increase of $0.3 million or 7%. This increase was due primarily to increases in occupancy costs of $0.5 million, information technology and software costs of $0.2 million and general corporate costs of $0.1 million. These were partially offset by a decrease in bad debt expense of $0.6 million.

In the aggregate, our operating expenses in Q3 were $13.4 million, a meaningful decrease from the nearly $17 million in OpEx last quarter. As of September 30, 2026, we had cash and cash equivalents totaling $46.2 million as compared to $45.9 million at December 31, 2025. The cash increase was primarily due to the net proceeds of $22 million from the at-the-market equity offering program, partially offset by the operational cash burn of $20.1 million through Q3 2026.

I'd like now to turn the call back to Joe.

Joseph Burnett

Thank you, Danilo. I will now provide some further details organized by our continued 4-pillar growth strategy. Starting with pillar #1, biologics and drug delivery, the most noteworthy headline has been the BLA regulatory submission by one of our partners, uniQure for their AMT-130 program to treat Huntington's disease. We continue to support uniQure on the device-related aspects of the submission and our device documentation is now on file with the agency.

Subject to the FDA's review, we expect the next 2 regulatory steps would be: first, that the FDA would formally accept the AMT-130 submission for review; and second, that ClearPoint would submit a companion 510(k) for our product to address its specific use with AMT-130. This is the same pathway we pursued for KEBILIDI, the only other neuro gene therapy that has received FDA approval for administration directly to the brain. The duration of these 2 regulatory pathways would likely take place in parallel with the goal of a simultaneous approval of both the drug and for our device that enables the delivery of the drug.

In addition, we expect continued enrollment as well as the initiation of multiple Phase III partner trials in the next year. As a reminder, Phase III and confirmatory trials are often substantially larger from a site initiation and patient enrollment perspective. While Phase I studies may take place in under 15 patients and only at a handful of sites, these larger randomized trials may include up to 200 patients and around 20 sites. As previously mentioned, we have reorganized and invested in a strong clinical support commercial organization, which we are training to be ready for this increase in cell and gene therapy patients.

As I will mention later, demand for our navigation systems and capital equipment increased during the quarter, reflecting the growing recognition among neurosurgery departments that ClearPoint is a critical enabling technology for participation in the rapidly expanding cell and gene therapy clinical trial market.

Revenue and services directly performed at the CAL facility continued to expand, launching new capabilities through both equipment and the hiring of talent, including PET and SPECT tracers as well as radiopharmaceuticals. We will continue adding equipment and capabilities this year and next as we build a boutique yet comprehensive neuro-focused drug delivery program, which also includes potential BCI partners that we have worked with in prior years. Our goal is to offer a set of neuro focused services that is differentiated in North America once the build-out is complete.

For pillar #2, neurosurgery navigation, we saw our largest capital sales quarter in our history. We believe this highlights both the demand by large academic centers to get access to ClearPoint in preparation of drug delivery trials and commercialization as well as interest in our ICT operating room solution that is more practical for routine DBS and biopsy cases. Early experience with our ICT solution was recently published in the Journal of Stereotactic and Functional Neurosurgery and demonstrated both procedural efficiency and targeting accuracy.

These findings suggest that with ClearPoint in the operating room, physicians do not need to trade one objective for the other. You can have both speed and accuracy, particularly in bilateral procedures, including DBS and drug delivery. We also continued development of our robotic platform and are increasingly confident in the need for a company like ClearPoint to deliver a dedicated cranial robot where both hardware and software decisions are driven by the requirements of cranial neurosurgical procedures rather than broader surgical applications.

We will continue to work closely with both neurosurgeon teams and our biopharma partners to build a system with all the functionality required for fast, accurate, multi-trajectory cases. This also includes unique disposable accessories like bolts and z-axis adjusters that are specifically designed for the required flexibility during the infusion itself.

For pillar #3, laser therapy and access, I will focus on one exciting milestone, which we just announced in our press release earlier today. ClearPoint is an industry partner in a 5-year competitively awarded NCI R01 grant led by Dartmouth Health to advance MR-guided laser therapy for spinal metastasis. This program runs from benchtop through large preclinical subject validation and into a clinical trial using the ClearPoint Prism system. ClearPoint contributes technical, software development and procedural expertise to the program. This is early-stage research that supports our spine laser therapy road map.

We believe spine LITT could represent a meaningful new opportunity for ClearPoint, potentially addressing more than 10,000 patients globally who today may require highly invasive open surgery before radiation. The standard of care open procedure can involve substantial blood loss, reconstruction and a prolonged recovery that may delay systemic cancer therapy. A minimally invasive MR-guided approach could significantly reduce that procedural burden. Prism, while not currently available for spinal use, may be particularly well suited for this application with longer 15- and 25-millimeter ablation windows, a non-cooled platform that simplifies workflow and rapid imaging updates for real-time monitoring and control near this very critical anatomy.

While our Prism laser therapy system is third to market for cranial applications, spine could be a very different story where we may have first-mover advantage. If successful, we believe our unique product features will provide a compelling competitive advantage, enabling us to capture a leadership position in this emerging spinal tumor market. We believe the spinal LITT market represents a substantial long-term opportunity and over time, could rival the size of cranial tumor and epilepsy markets for our Prism platform.

Finally, pillar #4, our intracranial fluid management. We are now more confident than ever that the IRRAflow product is well positioned to become an important advancement in neurocritical care. We are targeting 5 key product and clinical milestones in 2027. These include launching our Shoreline software, our Dart catheter and our next-generation forward tunneling catheter as well as presenting results from the randomized ARCH trial and pursuing a specific on-label FDA indication for subdural hematoma, one of the largest potential indications for the IRRAflow product. We believe this broader portfolio and supporting evidence will justify the continued measured expansion of our clinical account manager and specialist teams so that these company representatives will be ready and productive by the time these new products and data are released.

In addition to the positive direction of our 4-pillar growth strategy overall, the company made financial progress compared to the second quarter growth as well. Revenue grew 36% year-over-year compared to the operating expense growth of 23%, which reflects progress towards our additional scale. The primary drivers of this improvement versus last quarter are: number one, the results of the commercial reorganization, which now prioritizes clinical case support and is reflected in a more than 15% reduction in sales and marketing expenses compared to the second quarter; and number two, the continued integration of the IRRAflow product and team as the synergies start to materialize into our P&L.

As Danilo mentioned, we accessed our existing ATM facility for the first time in Q3, and we ended the quarter with $46.2 million in cash and cash equivalents. We believe the time was appropriate to use our ATM for a few reasons. First, the start-up cost to get the CAL facility operational require some front-loaded investment in construction, equipment and hiring. These investments will start to recover once we launch our full scope of services in the months ahead.

Second, the continued integration and expansion investment of the IRRAflow product portfolio, including the 5 new product and clinical milestones that we now expect to deliver in 2027, which will unlock significant value. The time to bring these programs to completion was in parallel, not in series, so we wanted to make the investment now to fuel this portfolio growth in 2027 and beyond.

And third, the potential of both our robotic and focused ultrasound systems, which this new capital will allow us to invest simultaneously and not have to choose one over the other. As we have said previously, our priority is to maintain our leadership position in neuro drug delivery, which is unwavering and multiple market factors and opportunities require this investment now.

The cell and gene therapy market has become exceptionally dynamic with new BLA submissions, confirmatory and Phase III clinical trials, significant program consolidation and continued acquisitions by large, well-capitalized partners and has created a timely opportunity to strengthen our advantage.

I will now open the call to any questions from our analyst team.

Operator

[Operator Instructions] Our first question comes from Frank Takkinen with Lake Street Capital Markets.

Phần hỏi đáp

Frank Takkinen

I've got two. I'm going to ask them both upfront and then hop in queue as I'm on a few calls. Joe, maybe the first one, obviously, you've got a lot of partners with different assets and development on different time lines. I was hoping maybe you could help us kind of stack and rank some of those upcoming catalysts. I'm sure it's a conversation for a longer call, but maybe thinking through kind of like first half '27, second half '27, what are the important milestones that were -- that we should be watching for from your partners to better track the biologic and drug delivery opportunity?

And then as my second question, you've talked about in the past kind of some front-loaded investment expected from the field in anticipation of some of these drugs getting to market. Can you maybe talk through if any of that has started to materialize or if you're starting to hear anything in the market about some of those investments?

Joseph Burnett

Yes, absolutely, Frank. Thanks for the question as well. So I'll start with the first one. I do want to provide an important caveat here is that ClearPoint, the way that we work with our partners, we take our confidential information very, very seriously as well. So we really don't want to be the primary resource for folks to get an understanding of where our partners happen to be in their regulatory process or their development process. It puts us in a position where we are then tracking 60 different companies and have to figure out private, public, disclosed, undisclosed, what information that we want to share.

So our primary reference is always going to be pointing just right to our partner to simply say, hey, whether it's on their website or if the information is in some sort of public document or a press release, that's always going to be the go-to for us. What I would tell you to your question about what's happening in the near term and what we sort of are expecting here, there's 2 that really -- 2 buckets, I'd say, that really materialize the most. The first one is, again, the uniQure BLA submission, which took place almost 2 months ago at this point. And there have been a number of clinical updates that have taken place since then.

We do still expect a decision to be made by the FDA at some point here in the next month or so, where they would either formally accept or reject or in some fashion, delay that BLA submission. If in a best case scenario, the BLA would be accepted. As we mentioned, at that point, we would submit our companion 510(k). And if you look to the limited experience we have with the FDA in these neuro gene therapies, the expectation would be a final formal decision sometime 6 to 8 months after the acceptance of that BLA, again, if everything went perfectly. So that would put a potential approval for the very first neuro gene therapy to treat Huntington's disease sometime middle to second half of next year, again, if everything went according to plan. So that would obviously be an incredible milestone, I think, for the entire gene therapy space, the Huntington's community, certainly for uniQure, certainly for ClearPoint as well.

And as we mentioned, we have resources that we are hiring and training now to prepare for such an event, whether the product is commercially approved next year, and we're supporting those cases or if there's some delay to that time line, as I mentioned there, putting us in a position where that same clinical team is supporting potentially a uniQure parallel confirmatory study, which they've announced could be up to 200 patients, all the way to supporting all of the other Phase III trials that are either enrolling today or we're expecting to enroll in the future.

So that's really the second bucket I would consider, Frank, is that independent of a commercial drug delivery of a large population gene therapy like AMT-130, there's also numerous partners that have either started or will start initiating their Phase III trials in the next 12 to 15 months. What's important about a Phase III trial is, again, you're going from maybe 3 to 5 sites up to 15 to 20 sites. And it's interesting, we have a number of different partners. I'll use Parkinson's as an indication. I think epilepsy would be another one, where it's a very, very large underserved patient community that's looking for a better treatment than is what is available today.

They -- if you're a hospital, a leading clinical trialist center, you can't accept clinical trials for 5 or 10 different Parkinson's studies. It puts you in a situation where now any Parkinson's patient that comes in, as a hospital, you have to start playing favorites as to which one of these trials you're going to enroll them in. So some of our partners are now looking for many new sites from which to install ClearPoint, get access to the technology and use that new site as an enrolling center for their Phase III trial.

So that's one of the things that we have very clear examples in our capital sales results in the third quarter as well as our capital sales funnel that we expect in Q4 and for the duration of 2027, where it is these new sites that have realized, hey, I probably need ClearPoint to participate in some of these existing studies. And it's no longer just the functional neurosurgeon reaching out to ClearPoint. It could be the chair of neurosurgery. In some cases, it could even be the C-suite that's helping to move the process along.

So big picture for us is we're -- we never want to be the bottleneck with the advancement of this technology. So we're hiring, we're investing now so that our installed base grows and we have a great clinical specialist support team out there that's trained not just in navigation, but also in drug delivery broadly so that in any circumstance that the site needs ClearPoint's help, we can support not just the partner, but the hospital itself.

So sort of long answer for the first question, but I'll move on to the second one, which is some of the investments that we're seeing. And part of it is really tied to -- I'll give one example anyway that's tied to what I was just discussing in drug delivery, and that has to do with robotics. If you go to a hospital today, it's very common, you would walk through the hallway and you might see 2 or 3 different neurosurgery robotics that are there that are used possibly for different indications or at different times or sometimes and many times, just very underutilized today.

If we were just developing another neurosurgical robot, we wouldn't be as excited as we are for the ClearPoint version that we're in development right now. And the reason for that is a couple of different points. The first one is that we are focused pretty much 100% on cranial workflows, meaning things that are done in the skull itself versus many of what I would say our future competitors' focus seems to be on is spinal applications. So there are absolutely concrete decisions you would make if you're building a cranial robot versus a do-it-all neurosurgery robot, including spine. And because spine historically has been the largest part of a neurosurgery budget, it's natural that some of these large robotics companies would maybe do a new software release that's 90% improvements for spine and 10% improvements for cranial.

We've sort of flipped the script there where we are making all of our design decisions on exactly what our pharma partners would need to do to speed up these multi-trajectory cases, preload them with trajectories that are specific to some of our workflows, complement them with multiple accessories, as I mentioned, z-axis adjusters, different bolts to provide flexibility during the infusion, so that we would actually have a unique solution that is available when these new drugs start to come to commercialization and are looking for a way to scale beyond just the MRI suite that most of our procedures are done in today, right? So that's one example where an investment -- we're making the investment because we feel we have a true right to win in this space, not just to make another me-too product.

The second one I would point to is on focused ultrasound, which is a combination with our robotic platform. Our goal here is to move drug delivery for using focused ultrasound and blood-brain barrier destruction out of the MRI suite entirely and into the operating room and to an infusion clinics. To do that, we need to manipulate our transducer in a way that's very different than other focused ultrasound systems that are available today. And our robotic platform is the mechanism for software navigation, targeted movement, anything you need to operate within the CT space.

So this one investment, we believe, is not only going to unlock faster, simpler, scalable procedures for drug delivery, but it's also going to unlock focused ultrasound for us, which these things we can, in fact, start to monetize preclinically at the CAL well before we ever get FDA clearance for these things. So that's -- if you think about preloading investment, that's an example of when I can at least share with you today, Frank.

Operator

Our next question comes from Mathew Blackman with TD Cowen.

Mathew Blackman

Can you hear me okay?

Joseph Burnett

Yes, I got you, Mathew.

Mathew Blackman

Great. Maybe I'll start with a question for Danilo. I just want to put a little bit finer point to the extent you're able to share. Obviously, healthier balance sheet. You've got a lot of stuff to invest in. Can you just give us a sense of how we should, in at least general terms, think about sort of the burn trajectory over the next 12 months, even if not an absolute number, maybe just sort of relative to what your traditional burn has been? And then I've got one follow-up question for Joe.

Danilo D’Alessandro

Yes. No, I think, Mat, so we obviously have some of these investments that Joe laid out. There is going to be in the coming 12 months more related to something that we didn't have in the past, which was a little bit tied to CapEx. So there will be some capital expenditures related to the CAL that we expect in the coming 12 months, and that will land.

In terms of the operational burn, like also Joe mentioned earlier, we're targeting now to continue on the path of operating leverage where we see that the revenue outstrips the growth of the OpEx so that we can continue to gradually reduce the burn in the coming -- quarter-over-quarter in the coming 4 to 6 quarters. I'd say when you look at, in particular, the first half of this year, it was a little heavier than usual, just given the activities related to the IRRAS integration, which were, in many cases, one-offs that we had to take. Imagine contracts that were not cancelable and all of those kind of things where we were just working to get the synergies in place. And already in the third quarter, we see that our OpEx has been reducing meaningfully compared to the OpEx in Q1 and Q2 of 2026.

Mathew Blackman

Okay. So -- and these are my words, I'm hearing maybe a little bit more burn than what you've done historically over the last -- the next 12 months, but certainly nothing of significant magnitude. You're not going out like drunken sailors is kind of the message I'm hearing.

Danilo D’Alessandro

Yes. We don't drink.

Mathew Blackman

And then, Joe, I was intrigued by the spine LITT update. I was hoping maybe just 10,000 cases worldwide. Can you just remind us what the revenue per case as we think about however far down the road this may be, what the revenue opportunity for ClearPoint could be?

And then on the regulatory side, to get a label, I would assume you would need a label to commercialize. Can you use any of the data from the NCI study to support a label? Is it something you have to do independently? Just any sort of help on sort of the pathway to get a label for spine metastases -- for spine tumors.

Joseph Burnett

Yes, sure thing. Just to highlight what makes the procedure challenging today is, remember, if you're doing a cranial laser procedure inside the brain, what you're using is you're superheating the tip of the catheter, the cannula, where the laser energy is being delivered. And then you're interpreting that heat transfer using MRI thermometry, which tells you, importantly, how hot the tissue has gotten. Have you ablated and destroyed the tissue that you want to? And then similarly, are you making sure you're in a safety zone for the other ones and you're not burning in a spot that you don't want to.

In cranial procedures, that's relatively simple because there's no motion whatsoever, right? The skull is actually pins, the brain is not really vibrating outside of a little bit of a heartbeat phenomenon and that kind of thing, but it's something that's a lot more predictable. When you're doing that same type of procedure in the spine, you're dealing with the patient breathing, so up and down, up and down, up and down, which throws thermometry off significantly. What makes our system pretty unique for this procedure is that you can, in fact, do a very, very large and necessary ablation very quickly because it's not cooled. All of the energy is delivered directly to the tumor itself. And if the patient -- if you were to hold the breath of the patient for maybe 60 seconds ago, you could get a pretty clear example. And that's what we've seen in the existing preclinical data that was submitted as a part of this grant itself.

So again, if you compare this type of product to the other ones that are available today on the market, there are some very substantial and meaningful differentiators on why making this investment, both on our own and now with the government's help to go ahead and see this take place all the way to market. I don't see any reason that this data would not be used for future clinical evidence. And it kind of remains to be seen exactly what the label would say itself. And I say that because if you read our current label for our device, it's designed for all neurosurgery procedures, which spine is one of them.

So whereas we are going to do software development of new products, we might have a few accessories that we develop as part of this development process that could highlight new specific indications for this tumor. It kind of -- we're not quite sure at this point exactly what the regulatory pathway would be. We are still focused primarily on making sure it works for these preclinical subjects and then the first patients in the clinical trial itself.

Mathew Blackman

Great. And then any color on revenue per procedure? I just forget...

Joseph Burnett

Sorry. Yes.

Mathew Blackman

Yes. No, it was a long question.

Joseph Burnett

Yes. If you think about our current revenue, which I would expect it's somewhere between $13,000 and $20,000 per procedure is what I would expect, both from the laser and some of the accessories and software that might be used during the procedure. Yes, if I'm modeling it, I think of it probably as $15,000 would be a non-noisy assumption.

Mathew Blackman

Even I could do that math. All right. Appreciate it.

Joseph Burnett

Yes, Mat, just to build on your question for Danilo as well, just a couple of other thoughts. We have a mix of some sort of established technology, growing technology and start-up technology within the ClearPoint portfolio. So if you think about using MRI navigation for deep brain stimulation, that is a pretty mature market that we don't really expect to grow that much, right? So that's probably a profitable business if you look at it that way. We're not spending a ton on the development of those frames. That's something that's more in the harvest stage. It's definitely the -- I'm sorry, the smallest opportunity that we have, but it's also one that's not demanding a lot of investment at this point.

You look at Prism for cranial -- Prism for cranial, you look at IRRAflow and all of the different applications that it's currently indicated for today, those are growth technologies where we can absolutely grow with our existing portfolio. We can open new sites, we can take share. We can transition people away from older technology to new technology. And then you've got the start-up investments like spine, like we were just talking about for laser tumors, like the CAL facility, like subdural hematoma indication for IRRAflow, like commercial drug delivery, where we haven't even gotten started yet. Those are the ones that are demanding a little front-loaded investment before we catch up.

And when we think about cash burn, we -- it's hard to think about it just in the totality. We're thinking about it opportunity by opportunity. And in this particular quarter, we had 2 or 3 of these opportunities screaming at us and saying, "Hey, you got to go faster, you got to make this happen, which really led us to raise a little bit more capital." A concrete example of what we're talking about as it relates to the CAL is that one of the technologies that we want to have access to, to deliver as a service to our partners is histology, right? There's a ton of benefits to be able to do the preclinical studies and the histology at the same site to not have to store the tissue, to not have to transport it, you name it. To enable histology, there's equipment that you need to buy, there's technicians that you need to hire, and you need to do all of that 3 to 6 months before you could ever do your first study.

So you think of the CAL as a series of those investments that has to take place. We're not going to get any histology revenue in the next 6 months, but we're building that capability so that we offer it as a service and we win that business down the road. So it's really just -- the magic is finding this balance between which investments we're making in our growth campaigns and which ones are true new to ClearPoint technologies or new-to-world technologies that we have to invest in that we might not recoup for 6-plus months. So hopefully, that gives a little more context.

Operator

[Operator Instructions] Our next question comes from Tom Stephan with Stifel.

Thomas Stephan

A couple on revenue, and I'll start near term with the 2026 revenue guidance. For 4Q, Joe, maybe for you, pretty decent step-up, I believe, versus 3Q in the implied guide relative to typical 4Q seasonality, I think when I look at that $49 million midpoint. So Joe, can you talk a bit to the drivers of that uptick? And more importantly, just your level of confidence that, that $49 million midpoint is achievable or hopefully conservative? And then I have a follow-up.

Joseph Burnett

Yes. Yes. I mean, so to put things in context, we think that 3 buckets of revenue that Danilo reports on could all be contributing to that growth. So it's not that there's one of those buckets that by itself would be responsible for that $1 million-plus step-up that you just described. I think they can all contribute. Capital equipment, we mentioned we just had a record quarter in capital sales. But the reality is that our funnel is larger than it's ever been as well, particularly when you start to add in IRRAflow pumps, new Prism potential customers, the demand for our navigation system for drug delivery trials and the demand for our ICT navigation system for more practical, faster, simpler procedures in the operating room.

So we have 4 different capital contributors there, each of which have, I would say, the healthiest funnel that we've ever had. So you can never guarantee exactly when these deals close. Again, we recognize revenue when we deliver the equipment, install and put it into use, if you will. So if that happens December 31 or January 1, it can be these choppy swings. But if you think about the next 6 to 9 months and the totality of that capital opportunity, it's pretty significant, and like I said, healthier than it's ever been for the company. So that's one thing to think about.

The second thing to think about has to do with the disposables themselves, which is the neurosurgery navigation, which, again, with IRRAflow already grew 50-plus, 59%, I think, in the quarter. The underlying organic disposables also grew in the quarter, too. There's -- it's not even chicken or egg. It's follow the leader, I guess, is the right way to say. There's no reason to believe that all of these capital units and new customers that we opened up and placed in Q3 are not going to turn into disposable users in Q4 and beyond.

So there's no way someone would spend, I think, the $1.7 million, $1.8 million that we were talking about in the quarter on new equipment just to use it as a paper weight and not put it into use right afterwards. So at the very least, even if our current business is not growing, and that's not even true because we certainly expect it to grow, these new placements should contribute to meaningful disposable growth, including new orders, new users, et cetera, right? So that's another sort of another combination I would add on there.

And that's highlighted also globally because as we mentioned earlier, especially with IRRAflow, we canceled a lot of the traditional or legacy is a better word, legacy distributor contracts. And in some places, we're going direct. So in some cases, we've started to burn through the old inventory that was on the shelf and expect new orders, new purchases to take place through our direct channel there. So that's kind of the second bucket, I would say.

And then the third one is the CAL itself. If you think behind the scenes, we've had 3 quarters in a row where revenue at the cow has grown sequentially one after the other. Based on the studies that we're already performing in the first month of October, we think that growth will continue here in Q4 as well. So capital, disposables and CAL services, all 3 of those things, I think, could be contributing here and sort of spread the responsibility of that step-up.

Thomas Stephan

Got it. That's great. Really helpful, Joe. And I think a good segue from that kind of 4Q momentum commentary into my second question on '27. And apologies in advance if any of this has been asked or addressed topping between calls. But yes, Joe, I would love, I guess, any early view on base business growth next year. Previously, I think you guys have talked about growth in the teens, maybe the high teens. I look at Street consensus is at around low to mid-teens year-over-year revenue growth, although I'm not sure how much is base business versus other.

But yes, any comment early look on 2027 revenue growth, particularly given the commercial organization changes, the changing priorities and obviously, sort of how growth is trending in the back half of this year. It would be great to kind of rightsize our models as we exit this year and enter next year.

Joseph Burnett

Yes. Sure thing, Tom. Yes. I mean, I think, we still feel good from a base standpoint about that kind of mid-teens growth for 2027. We haven't given official guidance, I would say. And the reason for that is that I think we're going to learn quite a bit here in the next couple of months, both from the initiation of some of these Phase III trials, the progress of AMT-130 and how the FDA responds to the BLA submission that's currently underway. And then similarly, in our own portfolio, the speed of installation of some of our equipment at the CAL and the regulatory progress of those 5 IRRAflow programs that I mentioned earlier on the call as well.

So where I think a safe place for us to be right now is in that mid-teens. I think we're going to learn a lot in the next 2 months and likely be in a position come second week of January as we typically do to give some further insight, an early announcement of revenue as well as some glimpse into our guidance for 2027.

Operator

We have reached the end of the question-and-answer session. I'd like to turn the call back over to your host, Mr. Joe Burnett, for closing remarks.

Joseph Burnett

Well, thanks again for joining our call today. Our team is confident that we have built an incredible foundation across our 4 pillars today to support the future of global commercial drug delivery. Our goal is to make advanced neurological therapies available to as many patients as possible who suffer from serious and debilitating neurological diseases to improve their quality of life. We are thrilled to have you alongside as we execute on this vision and continue building for the future. Thank you for your support, and good night, everyone.

Operator

This concludes today's conference. You may disconnect your lines at this time, and we thank you for your participation.