Cuộc họp công bố kết quả kinh doanh Quý 3 năm tài chính 2026 của NeuroOne (NMTC): Đơn hàng tăng 43%, biên lợi nhuận đạt 59,9%

Thông tin chính

• Công ty NeuroOne Medical Technologies (NASDAQ: NMTC) đã báo cáo doanh thu sản phẩm quý 3 năm tài chính 2026 đạt 2,0 triệu USD, tăng 16% so với cùng kỳ năm ngoái, nhờ doanh số bán các sản phẩm OneRF tăng cao.
• Các đơn đặt hàng sản phẩm mới tăng 43% lên 2,7 triệu USD. Giá trị đơn hàng tồn đọng (backlog) đứng ở mức 1,7 triệu USD tính đến ngày 30 tháng 6 năm 2026, do lượng đơn đặt hàng vượt quá doanh thu được ghi nhận.
• Biên lợi nhuận gộp của sản phẩm mở rộng lên 59,9% từ mức 53,9%, phản ánh cơ cấu sản phẩm thuận lợi hơn với các sản phẩm có biên lợi nhuận cao hơn.
• Ban lãnh đạo dự kiến các đơn đặt hàng sản phẩm trong năm tài chính 2026 sẽ đạt khoảng 11,2 triệu USD và doanh thu được ghi nhận từ 9,2 triệu USD đến 10,5 triệu USD, trong đó kết quả cuối cùng phụ thuộc vào thời điểm sản xuất và giao hàng.
• NeuroOne đã nhận được chứng nhận ISO 13485, cho phép công ty theo đuổi việc thương mại hóa quốc tế các dòng sản phẩm OneRF và Evo, tùy thuộc vào các yêu cầu quy định tại địa phương.
• Tiền và các khoản tương đương tiền giảm xuống còn 2,0 triệu USD vào cuối quý. Công ty đã huy động được 0,4 triệu USD thông qua chương trình phát hành cổ phiếu theo giá thị trường (ATM) trong quý và thêm 1,0 triệu USD sau khi quý kết thúc.

Dữ liệu tài chính cốt lõi

Tất cả các số liệu về cổ phiếu và trên mỗi cổ phiếu đã được điều chỉnh hồi truy cho đợt gộp cổ phiếu ngược tỷ lệ 1:6 của NeuroOne, có hiệu lực giao dịch trên Nasdaq vào ngày 16 tháng 4 năm 2026.

Hoạt động kinh doanh và vận hành

Hệ thống đốt sóng não OneRF

Doanh thu từ Hệ thống đốt sóng dịch não OneRF tăng 16% so với cùng kỳ năm ngoái, trong khi tổng đơn đặt hàng sản phẩm tăng 43%. NeuroOne cho biết một nghiên cứu quan sát hồi cứu của Mayo Clinic được xuất bản trên Tạp chí Thần kinh học (Journal of Neurosurgery) cho thấy các thủ thuật sử dụng OneRF có thể được thực hiện ở những bệnh nhân đã cấy ghép thiết bị điều hòa thần kinh mà không gây ảnh hưởng đến phần cứng hiện có, đồng thời mang lại hiệu quả giảm co giật đáng kể.

Công suất sản xuất vẫn là hạn chế chính. NeuroOne hiện chủ yếu sản xuất theo đơn đặt hàng, với thời gian cung ứng của nhà cung cấp có thể lên đến 6 tháng. Do đó, những thay đổi trong cơ cấu sản phẩm được yêu cầu có thể làm chậm trễ việc giao hàng. Công ty đang thẩm định cơ sở sản xuất thứ hai lớn hơn mà ban lãnh đạo dự kiến sẽ đưa vào hoạt động trong đầu năm dương lịch 2027.

Hệ thống đốt dây thần kinh tam thoa OneRF

NeuroOne đang chuẩn bị mở rộng thương mại hóa thông qua đội ngũ nhân sự hiện có và các nhà phân phối độc lập. Ban lãnh đạo ước tính thị trường dụng cụ dùng một lần tại Mỹ, không bao gồm phần cứng, đạt 40 triệu USD và cho biết hầu hết các thủ thuật tập trung ở khoảng 30 trung tâm.

Công ty đã ưu tiên công suất sản xuất cho các đơn hàng đốt sóng dịch não của Zimmer Biomet trong khi giải quyết lượng đơn hàng tồn đọng. Ban lãnh đạo cho biết các trung tâm điều trị dây thần kinh tam thoa bổ sung dự kiến sẽ mở cửa sau quý tài chính hiện tại và xác nhận rằng Zimmer Biomet vẫn quan tâm đến sản phẩm này.

Mở rộng quốc tế

Chứng nhận ISO 13485 mở ra con đường tiến vào thị trường quốc tế cho Hệ thống đốt sóng não OneRF, Hệ thống đốt đau dây thần kinh tam thoa OneRF, cùng các sản phẩm chẩn đoán Evo Cortical và sEEG.

NeuroOne có kế hoạch hợp tác với Zimmer Biomet tại các khu vực lãnh thổ nằm trong thỏa thuận của họ và đánh giá các nhà phân phối độc lập ở các khu vực địa lý khác. Thời điểm gia nhập thị trường sẽ khác nhau vì một số cơ quan thẩm quyền có thể chấp nhận phê duyệt của FDA và đăng ký sản phẩm, trong khi những nơi khác yêu cầu tài liệu chất lượng, hồ sơ thiết kế hoặc dữ liệu lâm sàng. Ban lãnh đạo kỳ vọng sẽ có định hướng rõ ràng hơn về các ưu tiên quốc tế ban đầu trong quý tới.

Nền tảng phân phối thuốc StereoCED

StereoCED đang được phát triển như một nền tảng phân phối thuốc nội sọ có sự hỗ trợ của robot, sử dụng thiết bị và quy trình phẫu thuật thần kinh đã thiết lập. NeuroOne tin rằng việc phân phối đồng thời theo nhiều quỹ đạo có thể rút ngắn các thủ thuật hiện có thể mất từ 8 đến 12 giờ và phụ thuộc vào hướng dẫn MRI trong phẫu thuật.

Ban lãnh đạo dự kiến nền tảng này sẽ sẵn sàng cho các nghiên cứu thử nghiệm trên người vào cuối tháng 9 năm 2026 và có thể sớm hơn đối với nghiên cứu trên động vật. Các nghiên cứu ban đầu trên động vật với Đại học Minnesota về động kinh khu trú và Mayo Clinic về u đệm đường giữa lan tỏa đã được lên kế hoạch bắt đầu trong tháng diễn ra cuộc họp báo cáo kết quả kinh doanh, với dữ liệu dự kiến có vào mùa thu năm 2026.

Công ty cũng kỳ vọng sẽ có đợt bán thiết bị đầu tiên cho một công ty dược phẩm để nghiên cứu trên động vật linh trưởng không phải người vào cuối năm 2026.

Chương trình điều trị đau lưng BVNA

NeuroOne đã hoàn thành các yêu cầu thiết kế của người dùng và bắt đầu thử nghiệm tiền lâm sàng cho Hệ thống đốt dây thần kinh Basivertebral. Công ty có kế hoạch tận dụng máy phát OneRF hiện có, phụ kiện nhiệt độ và điện cực đốt, đồng thời tìm kiếm các công cụ tiếp cận từ nguồn bên ngoài.

Ban lãnh đạo tái xác nhận rằng lộ trình pháp lý có khả năng nhất là nộp hồ sơ 510(k) và dự kiến sẽ xin phê duyệt của FDA trong nửa sau năm dương lịch 2027. Công ty nhấn mạnh rằng mốc thời gian này là mục tiêu và không có gì đảm bảo.

Dự báo của ban lãnh đạo

Ban lãnh đạo cho biết phạm vi doanh thu năm tài chính 2026 được xác định chủ yếu bởi sản lượng sản xuất và thời điểm giao hàng. Công ty chỉ ra rằng khoảng 11,2 triệu USD doanh thu có thể đã được hỗ trợ bởi các đơn đặt hàng nếu công suất sản xuất cho phép hoàn thành tất cả các đơn hàng.

Rủi ro và các yếu tố cần theo dõi

• Thời gian cung ứng của nhà cung cấp có thể lên tới 6 tháng, làm hạn chế khả năng phản ứng nhanh của NeuroOne trước những thay đổi về cơ cấu sản phẩm được yêu cầu từ Zimmer Biomet.
• Doanh thu ghi nhận trong năm tài chính 2026 phụ thuộc vào việc các nhà cung cấp giao linh kiện và công ty hoàn thành việc giao hàng đúng tiến độ.
• Cơ sở sản xuất thứ hai dự kiến sẽ không thể đi vào hoạt động cho đến đầu năm dương lịch 2027.
• Thời gian ra mắt quốc tế khác nhau tùy theo cơ quan thẩm quyền và có thể yêu cầu thêm tài liệu pháp lý hoặc dữ liệu lâm sàng.
• Các công ty dược phẩm đang thực hiện các chương trình lâm sàng có thể e ngại việc chuyển đổi thiết bị phân phối sau Giai đoạn I trừ khi công nghệ hiện tại hoặc dữ liệu lâm sàng tạo ra lý do buộc phải thay đổi.
• Tiền mặt giảm xuống 2,0 triệu USD từ mức 6,6 triệu USD vào ngày 30 tháng 9 năm 2025, trong khi vốn lưu động giảm xuống 3,7 triệu USD từ 7,9 triệu USD. NeuroOne đã sử dụng chương trình ATM trong và sau quý này.

Nổi bật phần Hỏi & Đáp với chuyên gia phân tích

• Nghiên cứu của Đại học Minnesota: Ban lãnh đạo cho biết chương trình điều trị bệnh động kinh tập trung vào động kinh khu trú. Thử nghiệm tiền lâm sàng dự kiến sẽ sớm diễn ra, với nghiên cứu Giai đoạn I tiềm năng phụ thuộc vào kết quả thành công và các dấu hiệu về hiệu quả.
• Đơn hàng tồn đọng trong sản xuất: Mức hạn chế này phản ánh thời gian cung ứng dài và sự thay đổi trong cơ cấu sản phẩm thay vì thiếu đơn đặt hàng. Ban lãnh đạo coi cơ sở sản xuất thứ hai là giải pháp công suất dài hạn hiệu quả nhất.
• Cơ hội quốc tế: Zimmer Biomet đang đánh giá các khu vực lãnh thổ ưu tiên. NeuroOne đang độc lập đánh giá các nhà phân phối và hiệu quả kinh tế thị trường tại các khu vực địa lý không nằm trong phạm vi của Zimmer Biomet.
• Việc ứng dụng StereoCED: Ban lãnh đạo nhận thấy các cơ hội trong nghiên cứu tiền lâm sàng, phát triển lâm sàng và thương mại hóa. Tuy nhiên, các công ty đã thúc đẩy phương pháp điều trị qua các thử nghiệm lâm sàng khó có khả năng thay đổi hệ thống phân phối nếu không có lý do thực sự thuyết phục.
• Phạm vi doanh thu năm tài chính 2026: Ban lãnh đạo cho biết phạm vi dự báo giảm hoàn toàn là do thời điểm sản xuất và giao hàng, trong khi vẫn duy trì tổng đơn đặt hàng dự kiến là khoảng 11,2 triệu USD.
• Chỉ số tài khoản thương mại: NeuroOne không có quyền truy cập theo hợp đồng vào dữ liệu chi tiết của Zimmer Biomet về các tài khoản mới hoặc mức độ sử dụng. Ban lãnh đạo cho biết phản hồi thực tế cho thấy đà tăng trưởng tiếp tục nhưng không cung cấp số liệu ở cấp độ tài khoản.

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

Good day, ladies and gentlemen, and welcome to the NeuroOne Medical Technologies Corporation's Third Quarter Fiscal 2026 Financial Results Conference Call. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa; Chris Volker, the company's Chief Financial Officer; and Dave Wambecke, the company's Chief Business Officer.

Before I turn the call over to Mr. Rosa, I'd like to remind you that this conference call will include forward-looking statements within the meaning of the U.S. federal securities laws with respect to future operations, financial results, including events, trends and performance, including our 2026 guidance, which are based on management's beliefs and assumptions as of today's call. Forward-looking statements may involve known and unknown risks, uncertainties and other factors, which may cause actual results to differ materially from those expressed or implied by such statements. See NeuroOne's financial results press release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ. Except as required by law, NeuroOne undertakes no obligation to update such forward-looking statements.

With that, I will turn the call over to Mr. Dave Rosa, CEO of NeuroOne.

Sir, please go ahead.

David Rosa

Thank you, operator, and thank you to everyone for joining us today. I'd like to welcome you to our third quarter fiscal 2026 financial results conference call. Before I begin, I want to first welcome both Chris Volker, the company's Chief Financial Officer; and David Wambecke, the company's Chief Business Officer, as both will be presenting for the first time in their respective roles.

Now let's get started with a brief financial summary of the quarter. Product revenue for the OneRF Brain Ablation System in the third quarter of fiscal 2026 grew 16% year-over-year to $2 million compared to $1.7 million in the third quarter of fiscal 2025. Orders for the quarter totaled $2.7 million, and we expect aggregate fiscal year 2026 product orders of approximately $11.2 million. Recognized revenue for the fiscal year is expected to be between $9.2 million to $10.5 million, depending on the timing of shipment of those orders. We are working closely with our suppliers to expedite manufacturing in order to address any remaining backlog by the end of the fourth calendar quarter of 2026.

Moving forward, we are working towards the qualification of a second manufacturing site, which will increase capacity and potentially reduce lead times. We also saw gross margins expand to 59.9% during the quarter compared to 53.9% year-over-year due to a favorable product mix. More recently, following the end of the quarter, our lead investor also increased their holdings from 7.4% to 12.5%.

Moving on from current revenue growth, let's discuss future growth opportunities and new geographical markets. As you may recall from previous releases, the company has been pursuing ISO 13485 certification, which is the international quality standard that companies must meet to market products internationally. I am very proud to announce that we received our certification recently, which now provides the opportunity to enter international markets with our OneRF Brain Ablation System, OneRF Trigeminal Neuralgia Ablation System and Evo Cortical and sEEG diagnostic product lines.

We will be working closely with our distribution partner, Zimmer Biomet, to start the process to enter geographies that optimize their existing customer relationships and with a focus on countries that have favorable economics. For those geographies that remain exclusive to NeuroOne, we will explore independent partnerships. As a reminder, certain geographies have additional requirements which could range from providing additional documentation and submissions to providing clinical data. This is another major milestone that the company has reached earlier than projected and really speaks to the quality of our procedures, processes, quality system and employees.

Now let's discuss the exciting progress we've made with our product portfolio. Regarding our OneRF Brain Ablation System, as I mentioned earlier, we experienced 16% year-over-year revenue growth for the quarter, while purchase orders for our products showed growth of 43% year-over-year. We also had a significant clinical milestone this month as the Journal of Neurosurgery published a retrospective observational study completed by the Mayo Clinic in Jacksonville, Florida, titled Stereoelectroencephalography-guided radiofrequency Thermocoagulation in patients with implanted Neuromodulation devices, a patient series. The study evaluated the use of NeuroOne's OneRF Brain Ablation System in patients who have implanted Neuromodulation devices.

The article concluded that these procedures may be performed without interfering with existing hardware as well as providing meaningful seizure reduction. This was exciting to hear as it expands the pool of treatable patients to include those with existing neuromodulation implants. We continue to build a compelling series of clinical experience that supports our goal of providing meaningful improvements for patients suffering with seizures or Trigeminal Neuralgia.

Regarding our OneRF Trigeminal Nerve Ablation System, I want to share a recent experience that highlights the potential impact of this therapy. A patient recently treated with the OneRF Trigeminal Nerve Ablation System was featured in a television interview on Cleveland 19 News, an affiliate of the CBS Television Network. She described living with Trigeminal Neuralgia as being worse than experiencing childbirth 10 times and that the condition made her feel like a zombie. Following her treatment, we are happy to state that she reported being pain-free.

Stories like this underscore both the devastating burden of this disease and the life-changing potential of our technology. Stories like this continue to demonstrate successful clinical outcomes as measured by freedom from pain, enhanced patient comfort while also having the potential to significantly reduce procedure times. U.S. market for disposables, excluding hardware, is estimated at $40 million. Because the majority of these cases are performed in approximately 30 centers, we plan on leveraging current personnel in combination with independent distributors to expand commercialization. Based on our limited market release experience, we also expect a short learning curve, which will minimize the cost of having to support every case. We are currently interviewing distributors with the intent to hire them once the agreements are finalized.

Now I am turning the call over to David Wambecke to provide an update on our drug delivery system, which we have named StereoCED.

David Wambecke

Thanks, Dave. I joined NeuroOne a little over five months ago. And since then, I've had the opportunity to fully assess the intracranial drug delivery landscape. The more I've learned, the more convinced I've become that we have a definitive technological edge. Brain-delivered therapeutics are approaching a major inflection point. Dozens of promising programs are now in development, but one challenge continues to stand out. How do you deliver these therapies efficiently, reproducibly and in a way that hospitals can realistically adopt at scale.

While today's delivery technologies have enabled important clinical progress, many current procedures remain complex and resource-intensive. Depending on the indication, procedures can range from 8 to 12 hours in the operating room and rely entirely on intraoperative MRI guidance. We believe those workflow challenges matter even more at commercial scale. That's exactly the future StereoCED is designed for. Our robotic-assisted platform is intended to leverage neurosurgical equipment and workflows already established in leading hospitals. We believe it has the potential to significantly reduce procedure times through simultaneous multi-trajectory delivery while avoiding the need for hospitals to purchase an entirely new robotic platform.

Before discussing our progress, I'd like to highlight an important industry milestone. In June, the FDA reversed its earlier position, allowing uniQure to submit an accelerated approval BLA, or biologics license agreement, for AMT-130 in Huntington's disease based on its existing 3-year clinical data. If approved, AMT-130 could become the first commercially approved blockbuster therapy delivered directly into the brain. Wall Street analysts project global peak sales exceeding $2 billion, but also highlight the commercial risk associated with a complex workflow and lengthy procedures that can take 8 to 12 hours.

We were pleased to recently publish a white paper highlighting the potential scalability of our StereoCED platform. We anticipate that it will be ready for investigational human clinical studies by the end of September and possibly sooner for animal research. The feedback we've received from pharmaceutical companies and key opinion leaders has been extremely encouraging. A common theme is the familiarity of the platform. Thousands of NeuroOne sEEG electrodes have already been implanted in patients, making drug delivery feel like a natural extension of an already familiar technology.

On the preclinical front, we've also made excellent progress. We've announced collaborations with the University of Minnesota in epilepsy and with Mayo Clinic in diffuse midline glioma. The first animal studies are scheduled to begin this month, and we expect data from both programs this fall to support future clinical development.

In parallel, we're expanding our academic collaborations and expect our first device sales to a pharmaceutical company for a nonhuman primate study later this year. In closing, I believe we're still in the early innings of what could become a transformational growth opportunity for NeuroOne. There is strong pull from potential customers, and we are eager to have devices ready for human investigational studies shortly.

I'll now turn the call back over to Dave.

David Rosa

Thanks, David. Before I provide an update on our BVNA, or Basivertebral Nerve Ablation System, for back pain, I just want to reiterate what I said last quarter with the hiring of David Wambecke. He brings invaluable expertise in the gene and cell therapy space and has made a great impact in the short time he has been with us.

Okay. Moving on to our BVNA back pain management program. This quarter, we completed the user design requirements for the system and initiated preclinical testing to support continued development of the program. Our strategy remains to leverage our existing OneRF generator, temperature accessory and ablation electrode while outsourcing access tools either through outside vendors or potential distribution partners. In addition, we also completed our assessment of the regulatory path to gain clearance and reconfirm that it is likely a 510(k) submission. You may remember that the total time it took to gain clearance for our OneRF Trigeminal Nerve Ablation System was approximately 4 months, which is lightning speed in medical regulatory submissions.

While there are no guarantees, we have experienced success with both of our 510(k) submissions to FDA and expect to submit this for FDA clearance in the second half of calendar 2027. Finally, I want to reiterate that everything we develop at NeuroOne must offer unique device advantages over our competitors and the potential for better clinical outcomes for patients in a cost-effective manner. We believe these goals will also enhance shareholder value and appreciate the support we have received during volatility in the world today.

I would now like to turn the call over to Chris Volker to provide a review of our third quarter fiscal 2026 financial results.

Christopher Volker

Thanks, Dave. Product revenue was $2.0 million in the third quarter of fiscal 2026, a 16% increase compared to product revenue of $1.7 million in the third quarter of fiscal 2025. The increase was driven by higher sales of OneRF products. The company received $2.7 million for the new product orders during the quarter, representing 43% year-over-year growth. Product orders exceeded recognized revenue during the quarter with a backlog of $1.7 million as of June 30, 2026.

Product gross profit was $1.2 million or 59.9% of product revenue in the third quarter of fiscal 2026 compared to product gross profit of $0.9 million or 53.9% of product revenue in the same quarter of the prior fiscal year. The increase in gross profit percentage was due to a more favorable sales mix toward higher-margin products. Total operating expenses were $3.6 million in the third quarter of fiscal 2026 compared to $2.8 million in the same quarter of the prior year.

Research and development expense in the third quarter of fiscal 2026 was $1.4 million compared to $1.2 million in the same quarter of the prior year. Selling, general and administrative expense in the third quarter of fiscal 2026 was $2.2 million compared to $1.6 million in the same quarter of the prior year, with the increase being driven by increased headcount and sales and marketing costs. Net loss in the third quarter of fiscal 2026 was $2.0 million or $0.23 per basic share and $0.28 per diluted share compared to a net loss of $1.5 million or $0.19 per basic share and $0.22 per diluted share in the same quarter of the prior year. The net loss in the third quarter of fiscal 2026 was favorably impacted by a $0.4 million gain from the fair value change in the warrant liability.

All share and per share amounts have been retroactively adjusted to reflect the 1-for-6 reverse stock split of the company's issued and outstanding common stock, which began trading on a split-adjusted basis on the NASDAQ Capital Market on April 16, 2026. As of June 30, 2026, the company had cash and cash equivalents of $2.0 million compared to $6.6 million as of September 30, 2025. The company also had $1.1 million in accounts receivable as of June 30, 2026, which should be converted to cash in the fourth quarter of fiscal 2026 based on normal collection patterns.

During the third quarter of fiscal 2026, the company raised $0.4 million through its at-the-market offering program. Subsequent to quarter end, on July 13, 2026, the company raised another $1.0 million through the issuance of 400,346 shares under the ATM program, representing the second time in calendar 2026, the ATM was utilized. The company had working capital of $3.7 million as of June 30, 2026, compared to working capital of $7.9 million as of September 30, 2025. NeuroOne had no debt outstanding as of June 30, 2026.

I'll now turn the call back to Dave for his closing remarks.

David Rosa

Thank you, Chris. In summary, this was a very successful quarter for the company. We delivered 16% year-over-year product revenue growth, increased gross margins of 59.9% and received product orders of $2.7 million, representing an increase of 43% received ISO 13485 clearance, paving the way for international revenue growth, was selected by prestigious teaching institutions for upcoming animal and human studies and identified potential partners to accelerate the development of our BVNA system.

Moving forward, the catalysts include continued commercial expansion of the OneRF Brain Ablation System and OneRF Trigeminal Neuralgia Ablation Systems in the U.S. and internationally, commercial availability of our drug delivery system for FDA-approved IDE studies and animal research and continued progress on the development of our BVNA system. When I look at what we have accomplished and what is ahead of us, I believe the NeuroOne story offers compelling value to doctors, patients and investors.

With that, operator, at this time, we can open up the call for questions.

Operator

[Operator Instructions] our first question today is coming from Jeffrey Cohen with Ladenburg Thalmann.

Phần hỏi đáp

Jeffrey Cohen

I guess, firstly, can we talk about the study at University of Minnesota for epilepsy? Could you give us a sense of is that focal or general epilepsy that's being studied and what the size of the study is and what you would anticipate from a timeline perspective?

David Rosa

Yes. Thanks for attending today, Jeff. Good to talk to you again. So at the University of Minnesota, it pertains to focal. And the first step in the process is for them to actually conduct preclinical testing on the therapy they've developed. And that will happen literally expectedly most likely in the next quarter. And then once they've been able to successfully complete the testing and assuming that it's showing any efficacy, then they would look to go to a Phase I where they would then start testing it in patients. But the preclinical work is going to be happening very shortly.

Jeffrey Cohen

Okay. Got it. And then give us a sense of the your supplier and backlog into fourth quarter. Is it related to components or it's related to labor? And then give us a sense of the second site that's come online with that -- do you expect to catch up with all the backlog during the fourth quarter and balance of the year? And also, could you talk about some of the ex-U.S. discussions you're having as far as distribution, at least in the case of OneRF?

David Rosa

I couldn't hear the last part of what you said, but let me take the first big question and then whatever I don't answer, just let me know. So the supplier situation is we -- the company has lead times and the lead times are roughly -- it can take as long as 6 months. So there is an ordering process that's in place with Zimmer Biomet today, where they give us orders in advance so that we can manufacture the product and then ship it to them on time. But we basically build to order to minimize the cost of having to carry a lot of inventory.

So what happens is that if there's any changes to the product mix, if they specify on a particular order that, for example, they want 1,000 devices at a particular size and then 500 -- and if they come back a few months later, our ability to respond in the time frame is limited based on the way the ordering is done now. So we've experienced less of that in the past. I would say more of that this year. So there's a few ways of dealing with this. One is you carry inventory and work with your partner to make sure that it's not impacting the company from a cost perspective. But I think the most effective way is to get our second site up and running. And that's what we're working on now. That's what we expect to go online in the first part of 2027.

So we're going through all the work to do that. And if you've got two facilities capable of manufacturing product and the second one is actually much larger than the one we use now. That should allow you to address it. Now there is the other option that if, say, for example, the product mix involved maybe 500 units that, well, would the company consider placing a onetime order for that difference. Then what happens if you do that is your gross margins obviously are impacted and you're not able to take advantage of the economies of scale. So we try to place big orders in, which has worked very well for us from a margin perspective. So it makes it much more difficult if we're making small changes here and there, it's just not as efficient.

So what was the other question that I may not have answered?

Jeffrey Cohen

So could you talk about the ISO certification of the second site and maybe give us a sense of some OUS potential opportunities for OneRF as far as distributors and territories?

David Rosa

Yes. So the ISO certification is kind of like the key to admission to be able to ship product internationally. And there are certain geographies that will recognize FDA clearance and at times, just rely on the company registering the product in that geography. Other geographies might require that you supply documentation of your quality system, your design records. And then others, when you look at Europe, for the most part, you've got to be able to provide also data.

So depending upon which area you're going to, there's going to be different timelines to that. Zimmer, per our last amendment that we signed over a year ago, they have certain geographies internationally, and they're assessing which ones they want to go to first. And again, the idea is how can we hit the ground running. And it's really -- you really have to work on your targets, everything from where you can go today to start planning on how do you get to Europe as well. And there's ways of even addressing the clinical data. We just released, obviously, information on the study that was done in the Mayo Clinic in Jacksonville. There was an earlier press release that talked about a number of patients they treated. So if you're able to use some existing data, you may be able to even shorten that time line. So that's all in process.

Now that's the geographies that Zimmer has, but there's others that they do not have. And those are the areas where we're assessing are the economics in those geographies, do they make sense? Are there distributors that we can utilize to commercialize the products there. That's all in process. And I don't expect that we'll have a firm answer on that until probably next quarter when we've had time to sit down with Zimmer and go through this.

Operator

Our next question is coming from Justin Walsh with Jones Trading.

Justin Walsh

I was wondering if you could provide some additional color on how you view the StereoCED opportunity. Do you think it's meaningful when used with drugs in the development stage? Or do you think it has to be adopted as a standard for an approved agent?

David Rosa

That's a good question. So the answer is no. I think it could be used in both the clinical stage -- well, actually, the preclinical stage, which is what we're seeing now with like the University of Minnesota as well as the clinical stage and then obviously, the commercialization piece as well. We really feel there's some significant differences and advantages of our system, even as it pertains to just how much time it takes to infuse a patient that may have one of these neurological conditions.

Now the limitations that you would see with the device being used in a clinical study is if a pharmaceutical company has an ongoing clinical study, say they've completed their Phase I, they're happy with the results. They're not going to make any changes. No company would be interested in introducing a new technology, even if it's a delivery device, into a Phase II, you can never really predict what might happen. So just as a way for them to mitigate any risk, if they start with a particular technology, unless there's issues with their clinical data or with that technology, they're likely to stay with that through clearance. But once clearance has been gained, then a company like us would submit an application under what we would expect to be a 510(k) to be able to be used with whatever approved therapy has just been granted FDA approval.

Operator

Our next question is coming from Jeremy Pearlman with Maxim Group.

Jeremy Pearlman

Firstly, related to Trigeminal. I mean, again, maybe I'm -- just correct me if I'm not reading between the lines correctly. You said you're going to leverage existing personnel that you have on staff and then other distributors for that product. Does that mean that Zimmer was not -- is not interested in adding that or amending that on to their agreement? Or maybe I'm just misinterpreting that?

David Rosa

Yes, that may be what it sounds like, but it's not the case at all. When you look at discussions that we've had in the past with any strategics that we've spoken to, you always think that it should take a lot less time, but there's other factors that may be going on and not even our company, the potential partner that may delay those things. So I think at some point, you -- we, as a company, have to say, look, we need to move forward. We can't sit and wait to conclude these discussions. But it does not mean that there is no interest. There is interest on their end. Some of what's delayed us with Trigeminal is this backlog that we're dealing with, with the Brain Ablation devices.

So we've really prioritized the units that go to Zimmer because that is today the larger opportunity. But as we make progress on that, we'll start to get more devices for Trigeminal sales. And like currently, this month, we have cases scheduled at the sites that did our limited market release. We have additional sites that I even talked about last quarter that want to do an evaluation. And what you don't want to do when you're trying to address demand from another area, and that's your biggest source of revenue, you don't want to shortchange that by an opportunity that while compelling is smaller.

So we haven't opened up additional centers, but we will be beyond this quarter. So it hasn't been, I would say, a major issue for us to address because we weren't able to really do much given the backlog that we experienced on the other side. So short answer, they're definitely interested. It doesn't mean that it won't happen, but we're going to move forward. And if there's an opportunity, then great.

Jeremy Pearlman

Okay. Understood. And then lastly, I mean, in the past, you've guided towards revenue of at least $10.5 million. I know there's been some manufacturing delays. And in this -- in the press release you put out this morning, you said I think it was between $9.2 million and $10.5 million. Is that just basically you'll hit any of that within that range is based on how many -- the manufacturing, how fast you can get those products made and shipped out? Or is there anything else that's baked into that range?

David Rosa

No, it's manufacturing. I mean it's also the reason why we did alert the market that our orders actually are $11.2 million. Based on the feedback that we have from vendors, the multiple vendors, that number is very unlikely to happen. We think what's more reasonable, more conservative is that range, but it's completely dependent on everything from the vendors being able to deliver what they say they deliver with some risk that we've built into that. But from an order standpoint, the number that we -- if we were able to meet the manufacturing would have been almost around $11.2 million.

Jeremy Pearlman

Okay. Understood. Great. And then just last question from us. Maybe -- I mean, you might not have this. I know Zimmer is the one who's pushing the OneRF Ablation device and -- but is there any data or maybe KPIs you have regarding new accounts versus utilization in pre-existing accounts, how that's going, growth within those accounts -- you can share...

David Rosa

Yes. So we don't get -- we -- contractually, we are not -- we don't have the right to get that information. We have asked for more detailed information. Zimmer, and it's not just Zimmer, it's other companies as well. They like to keep that close to the vest.

In other companies, you wouldn't see them reporting on an area like this either. And Zimmer does it because they don't want their competitors to really know what's going on. But in anecdotal discussions, their feedback is they're continuing to gain additional traction. But as far as giving you hard numbers, I don't have that.

Operator

That appears to be the last question at this time. So I'd like to turn the call back over to Mr. Rosa.

David Rosa

I just want to thank everyone again for attending the call today. And we really look forward to connecting with the investor community throughout this quarter and beyond. If we were unable to answer any of your questions today, please reach out to our Investor Relations firm, the MZ Group, and they'd be more than happy to follow up.

Operator

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