Q4 2025 Neuroone Medical Technologies Corp Earnings Call

Speaker #1: Senora wants financial results, releases, and press SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ.

Speaker #1: Except as required by law , one undertakes no obligation to update such forward looking statements Nora , With that , I will turn the call over to Mr. David Rosa , CEO of Nora one .

Speaker #1: Please go ahead, sir.

Speaker #2: Operator: Thank you, and thank you everyone for joining us today. I'd like to welcome you to our fourth quarter fiscal 2025 financial results conference call.

Speaker #2: Fiscal year 2025 was the most successful year in the history of NeuroOne Medical Technologies Corporation, and an inflection point for our company.

Speaker #2: For today, I'd like to briefly start with the most significant overview milestones we achieved in the fiscal year, financially, 2025.

Speaker #2: we saw a record product sales growth of 163% to $9.1 million , reduced operating expenses significantly improved our product margins gross to 56.5% , strengthened the balance and sheet with an $8.2 million capital raise .

Speaker #2: Operationally , we received FDA 510 clearance for the one RF trigeminal nerve ablation system , advanced the development of our spinal cord stimulation electrode for lower pain back a new .

Operator: 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. Please go ahead, sir. Thank you, operator, and thank you to everyone for joining us today. I'd like to welcome you to our fourth quarter fiscal 2025 financial results conference call. Fiscal year 2025 was the most successful year in the history of NeuroOne Medical Technologies Corporation and an inflection point for our company. I'd like to start today with a brief overview of the most significant milestones we achieved in fiscal year 2025. Financially, we saw record product sales growth of 163% to $9.1 million. Reduced operating expenses significantly improved our product gross margins to 56.5% and strengthened the balance sheet with an $8.2 million capital raise.

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. Please go ahead, sir.

Dave Rosa: Thank you, operator, and thank you to everyone for joining us today. I'd like to welcome you to our fourth quarter fiscal 2025 financial results conference call. Fiscal year 2025 was the most successful year in the history of NeuroOne Medical Technologies Corporation and an inflection point for our company. I'd like to start today with a brief overview of the most significant milestones we achieved in fiscal year 2025. Financially, we saw record product sales growth of 163% to $9.1 million. Reduced operating expenses significantly improved our product gross margins to 56.5% and strengthened the balance sheet with an $8.2 million capital raise.

Speaker #2: Product development program initiated for basivertebral nerve lower back pain ablation. Reported sales of first pre-clinical drug delivery devices to a large pharmaceutical company.

Speaker #2: Strengthened our infrastructure with senior key our executive hires . Initiated the process to . Gain ISO 1345 certification for international commercial expansion lastly , bolstered our .

Speaker #2: intellectual property portfolio. Additionally, we are providing a financial plan with guidance for fiscal year 2026. Once we receive the final forecast from our distribution partner, Zimmer Biomet, we will distribute it.

Speaker #2: Also , as previously disclosed , Nasdaq granted us a 180 day extension until May 4th , 2026 to regain compliance with Nasdaq's bid price rule for listing on the minimum continued Nasdaq Market Capital .

Operator: Operationally, we received FDA 510(k) clearance for the 1RF trigeminal nerve ablation system, advanced the development of our spinal cord stimulation electrode for lower back pain, initiated a new product development program for basivertebral nerve ablation for lower back pain, reported sales of our first preclinical drug delivery devices to a large pharmaceutical company, strengthened our infrastructure with key senior executive hires, initiated the process to gain ISO 13485 certification for international commercial expansion, and lastly, bolstered our intellectual property portfolio. Additionally, we plan on providing financial guidance for fiscal year 2026 once we receive a final forecast from our distribution partner, Zimmer Biomet. Also, as previously disclosed, Nasdaq granted us a 180-day extension until 4 May 2026, to regain compliance with Nasdaq's minimum bid price rule for continued listing on the Nasdaq capital market.

Operationally, we received FDA 510(k) clearance for the 1RF trigeminal nerve ablation system, advanced the development of our spinal cord stimulation electrode for lower back pain, initiated a new product development program for basivertebral nerve ablation for lower back pain, reported sales of our first preclinical drug delivery devices to a large pharmaceutical company, strengthened our infrastructure with key senior executive hires, initiated the process to gain ISO 13485 certification for international commercial expansion, and lastly, bolstered our intellectual property portfolio. Additionally, we plan on providing financial guidance for fiscal year 2026 once we receive a final forecast from our distribution partner, Zimmer Biomet. Also, as previously disclosed, Nasdaq granted us a 180-day extension until 4 May 2026, to regain compliance with Nasdaq's minimum bid price rule for continued listing on the Nasdaq capital market.

Speaker #2: We will continue to monitor the closing bid price of our common stock and seek to regain minimum bid price requirement compliance within the extension period.

Speaker #2: Moving forward into the fourth quarter of fiscal 2025, we continued to make strong financial progress as product revenue increased 907% to $2.7 million, and product gross margins increased to 55.8% compared to 51.8% in the fourth quarter of fiscal 2020.

Speaker #2: For this direct is a result of the of commercialization efforts expansion for our one RF brain ablation system distributed by Biomet . What made this most Zimmer impressive is that we also reduced our operating expenses by 2% versus fiscal Q4 2024 , with respect to expanding our product portfolio , we are now pursuing several market opportunities as potential revenue drivers First , our .

Speaker #2: drug delivery using program our SIG platform electrode technology has received a deal of great physician interest . addition , we have been approached by In two organizations looking to potentially partner with us to use our technology for gene therapy , cell and glioblastoma drug delivery therapy development .

Operator: We will continue to monitor the closing bid price of our common stock and seek to regain compliance with the minimum bid price requirement within the extension period. Moving on to the fourth quarter of fiscal 2025, we continued to make strong financial progress as product revenue increased 907% to $2.7 million and product gross margins increased to 55.8% compared to 51.8% in the fourth quarter of fiscal 2024. This is a direct result of the expansion of commercialization efforts for our 1RF Brain Ablation System distributed by Zimmer Biomet. What made this most impressive is that we also reduced our operating expenses by 2% versus fiscal Q4 2024. With respect to expanding our product portfolio, we are now pursuing several market opportunities as potential revenue drivers. First, our drug delivery program using our SEEG Platform Electrode technology has received a great deal of physician interest.

We will continue to monitor the closing bid price of our common stock and seek to regain compliance with the minimum bid price requirement within the extension period. Moving on to the fourth quarter of fiscal 2025, we continued to make strong financial progress as product revenue increased 907% to $2.7 million and product gross margins increased to 55.8% compared to 51.8% in the fourth quarter of fiscal 2024. This is a direct result of the expansion of commercialization efforts for our 1RF Brain Ablation System distributed by Zimmer Biomet. What made this most impressive is that we also reduced our operating expenses by 2% versus fiscal Q4 2024. With respect to expanding our product portfolio, we are now pursuing several market opportunities as potential revenue drivers. First, our drug delivery program using our SEEG Platform Electrode technology has received a great deal of physician interest.

Speaker #2: And we reported the first sales of other preclinical devices, largely to a pharmaceutical company for testing purposes of interest. This gives us confidence that our technology can offer advantages over competitive devices that both caregivers and pharmaceutical organizations value.

Speaker #2: You will be hearing about our more progress in fiscal as well as our 2026, comprehensive strategy to offer various both sizes of pre-clinical and clinical devices that are use appropriate for the development cycle through for use, commercialization.

Speaker #2: Human dependent on FDA drug approval to market based on physician feedback. We also believe we have an opportunity to offer a new platform to treat glioblastomas that provides a better solution for both patients and caregivers.

Operator: In addition, we have been approached by two organizations looking to potentially partner with us to use our technology for gene therapy, cell therapy, and glioblastoma drug delivery development, and we reported the first sales of other preclinical devices to a large pharmaceutical company for testing purposes. This interest gives us confidence that our technology can offer advantages over competitive devices that both caregivers and pharmaceutical organizations value. You will be hearing more about our progress in fiscal 2026, as well as our comprehensive strategy to offer various sizes of both preclinical and clinical use devices that are appropriate for the drug development cycle through commercialization for human use, which is dependent on FDA approval to market. Based on physician feedback, we also believe we have an opportunity to offer a new platform to treat glioblastomas that provides a better solution for both patients and caregivers.

In addition, we have been approached by two organizations looking to potentially partner with us to use our technology for gene therapy, cell therapy, and glioblastoma drug delivery development, and we reported the first sales of other preclinical devices to a large pharmaceutical company for testing purposes. This interest gives us confidence that our technology can offer advantages over competitive devices that both caregivers and pharmaceutical organizations value. You will be hearing more about our progress in fiscal 2026, as well as our comprehensive strategy to offer various sizes of both preclinical and clinical use devices that are appropriate for the drug development cycle through commercialization for human use, which is dependent on FDA approval to market. Based on physician feedback, we also believe we have an opportunity to offer a new platform to treat glioblastomas that provides a better solution for both patients and caregivers.

Speaker #2: Unfortunately , I am sure most of us know someone who has been affected by a brain tumor at neuro one , our chief technology officer , Steve Mertens , was diagnosed with two years one Thankfully , he's doing well , also committed to trying to help others by advancing neuro ones but is ago .

Speaker #2: , drug delivery represents a potentially massive opportunity number of when you patients consider the suffering with brain related neurological disorders , such as glioblastomas , epilepsy and Parkinson's disease , to name a few .

Speaker #2: In 2026, our goal is to be commercially ready with preclinical drug delivery, as well as to develop offerings to gain FDA clearance.

Speaker #2: Regarding pain our management platform , we have programs two active development for treating lower back pain in . first is our The percutaneously placed paddle electrode , which can be delivered through a 14 gauge needle in the spine , which then expands to offer broader customizable stimulation requiring less energy consumption than traditional standard percutaneous electrodes .

Operator: Unfortunately, I am sure most of us know someone who has been affected by a brain tumor. At NeuroOne, our Chief Technology Officer, Steve Mertens, was diagnosed with one two years ago. Thankfully, he is doing well but is also committed to trying to help others by advancing NeuroOne's technology. Drug delivery represents a potentially massive opportunity when you consider the number of patients suffering with brain-related neurological disorders such as glioblastomas, epilepsy, and Parkinson's disease, to name a few. In 2026, our goal is to be commercially ready with our preclinical drug delivery offerings, as well as to develop a pathway to gain FDA clearance. Regarding our pain management platform, we have two active programs in development for treating lower back pain.

Unfortunately, I am sure most of us know someone who has been affected by a brain tumor. At NeuroOne, our Chief Technology Officer, Steve Mertens, was diagnosed with one two years ago. Thankfully, he is doing well but is also committed to trying to help others by advancing NeuroOne's technology. Drug delivery represents a potentially massive opportunity when you consider the number of patients suffering with brain-related neurological disorders such as glioblastomas, epilepsy, and Parkinson's disease, to name a few. In 2026, our goal is to be commercially ready with our preclinical drug delivery offerings, as well as to develop a pathway to gain FDA clearance. Regarding our pain management platform, we have two active programs in development for treating lower back pain.

Speaker #2: We are in the process of finishing chronic studies to evaluate histology and other product metrics, and expect to initiate additional long-term animal studies in fiscal Q2 2026.

Speaker #2: We continue to also explore partnership opportunities with strategic organizations. The second technology in our pain management platform is our ablation nerve vertebral system, which was kicked off in fiscal 2025.

Speaker #2: This past quarter, in Q4, we held our first advisory meeting with leading pain experts that have great experience with board performing this. Our strategy is to leverage our existing generator procedure and SEG probe to perform this one RF procedure.

Operator: The first is our Percutaneously Placed Paddle Electrode, which can be delivered through a 14-gauge needle in the spine, which then expands to offer broader, customizable stimulation requiring less energy consumption than traditional standard percutaneous electrodes. We are in the process of finishing chronic animal studies to evaluate histology and other product metrics and expect to initiate additional long-term studies in fiscal Q2 2026. We also continue to explore partnership opportunities with strategic organizations. The second technology in our pain management platform is our Basivertebral Nerve Ablation System, which was kicked off in fiscal Q4 2025. This past quarter, we held our first advisory board meeting with leading pain experts that have great experience with performing this procedure. Our strategy is to leverage our existing 1RF Generator and sEEG probe to perform this procedure.

The first is our Percutaneously Placed Paddle Electrode, which can be delivered through a 14-gauge needle in the spine, which then expands to offer broader, customizable stimulation requiring less energy consumption than traditional standard percutaneous electrodes. We are in the process of finishing chronic animal studies to evaluate histology and other product metrics and expect to initiate additional long-term studies in fiscal Q2 2026. We also continue to explore partnership opportunities with strategic organizations. The second technology in our pain management platform is our Basivertebral Nerve Ablation System, which was kicked off in fiscal Q4 2025. This past quarter, we held our first advisory board meeting with leading pain experts that have great experience with performing this procedure. Our strategy is to leverage our existing 1RF Generator and sEEG probe to perform this procedure.

Speaker #2: that To we end , are in early discussions regarding this with , technology and will seek a partnership Strategics with an established organization with a presence in the pain management space Up .

Speaker #2: Animal studies continued with testing next. Our R&D to confirm that the system will perform as required in August. We received FDA clearance 510(k) for our OneRF Trigeminal Nerve Ablation System to treat facial pain by ablating the trigeminal nerve.

Speaker #2: Furthering our validating technology platform and providing an alternative to other surgical pharmaceutical treatments. As discussed previously, we indicated that we would have a limited commercial launch in the fourth quarter of 2025.

Speaker #2: To that end, I am pleased to report first that the two patients were successfully treated at University Hospitals Cleveland, with both patients reporting pain relief from the procedure without any complications.

Speaker #2: case is The confirmed that unlike traditional ablation systems , our probe required only one placement due to the contacts the device . This allowed the present on neurosurgeon to multiple area of the locate the nerve , triggering the facial patient's pain .

Operator: To that end, we are in early discussions with strategics regarding this product technology and will seek a partnership with an established organization with a presence in the pain management space. Up next are animal studies with continued R&D testing to confirm that the system will perform as required. In August, we received FDA 510(k) clearance for our 1RF Trigeminal Nerve Ablation System to treat facial pain by ablating the trigeminal nerve, further validating our technology platform and providing an alternative to pharmaceutical and other surgical treatments. As discussed previously, we indicated that we would have a limited commercial launch in the fourth quarter of calendar 2025. To that end, I am pleased to report that the first two patients were successfully treated at University Hospitals Cleveland, with both patients reporting pain relief from the procedure without any complications.

To that end, we are in early discussions with strategics regarding this product technology and will seek a partnership with an established organization with a presence in the pain management space. Up next are animal studies with continued R&D testing to confirm that the system will perform as required. In August, we received FDA 510(k) clearance for our 1RF Trigeminal Nerve Ablation System to treat facial pain by ablating the trigeminal nerve, further validating our technology platform and providing an alternative to pharmaceutical and other surgical treatments. As discussed previously, we indicated that we would have a limited commercial launch in the fourth quarter of calendar 2025. To that end, I am pleased to report that the first two patients were successfully treated at University Hospitals Cleveland, with both patients reporting pain relief from the procedure without any complications.

Speaker #2: The traditional may require multiple probe placements, which can cause additional patient discomfort. As a reminder, this system utilizes the same one RF brain ablation system.

Speaker #2: It also includes additional accessories specific to the procedure pursued for this indication, based on neurosurgeon interest and the fact that this is the same customer performing brain procedures using our system.

Speaker #2: This ablation, with additional capability, also potentially helps to justify the financial case, given its multi-use capabilities. We will continue to perform additional cases to obtain post-market clinical performance information regarding distribution.

Speaker #2: We currently have interest from strategics to potentially license this technology, and will provide an update on those discussions when appropriate. Regarding the one RF brain ablation system, currently Zimmer Biomet—

Operator: The cases confirm that, unlike traditional ablation systems, our probe required only one placement due to the multiple contacts present on the device. This allowed the neurosurgeon to easily locate the area of the nerve triggering the patient's facial pain. The traditional systems may require multiple probe placements, which can cause additional patient discomfort. As a reminder, this system utilizes the same 1RF Brain Ablation System, yet also includes additional accessories specific to the procedure. We pursued this indication based on neurosurgeon interest and the fact that this is the same customer performing brain ablations with our system. This additional capability also potentially helps justify the financial case given its multi-use capabilities. We will continue to perform additional cases to obtain post-market clinical performance information. Regarding distribution, we currently have interest from a strategic to potentially license this technology and will provide an update on those discussions when appropriate.

The cases confirm that, unlike traditional ablation systems, our probe required only one placement due to the multiple contacts present on the device. This allowed the neurosurgeon to easily locate the area of the nerve triggering the patient's facial pain. The traditional systems may require multiple probe placements, which can cause additional patient discomfort. As a reminder, this system utilizes the same 1RF Brain Ablation System, yet also includes additional accessories specific to the procedure. We pursued this indication based on neurosurgeon interest and the fact that this is the same customer performing brain ablations with our system. This additional capability also potentially helps justify the financial case given its multi-use capabilities. We will continue to perform additional cases to obtain post-market clinical performance information. Regarding distribution, we currently have interest from a strategic to potentially license this technology and will provide an update on those discussions when appropriate.

Speaker #2: We continue to gain market traction as accounts are released to the product sites. Clinical outcomes have also continued to be positive, without any reportedly adverse events to date regarding temperature.

Speaker #2: Our control probe is performing exactly as intended and offers an additional safety mechanism during procedures that ensures excessive temperatures do not occur during the ablation.

Speaker #2: We also recently met with key personnel from sites participating in the One RF registry, which is intended to gather a variety of data for performance on ablations using our system.

Speaker #2: Hospital Institutional Review Board and site contracts expected are to occur during the year, vary this and can center. We attended the following trade shows in Q4 2025 through today.

Speaker #2: The society for by , Congress fiscal Neurological and the Surgeons , American neuroscience Epilepsy Society of all included meeting meetings posters and or presentations on our technology , as well as Mayo Clinic physician testimonials on their experience with our technology at AES , at the Zimmer Biomet .

Operator: Regarding the 1RF Brain Ablation System currently marketed by Zimmer Biomet, we continue to gain traction with accounts as the product is released to additional sites. Clinical outcomes have also continued to be reportedly positive without any adverse events to date. Our Temperature Control Probe is performing exactly as intended and offering an additional safety mechanism during procedures that ensures excessive temperatures do not occur during the ablation. We also recently met with key personnel from sites participating in the 1RF registry, which is intended to gather a variety of performance data for patients that have had ablations with our system. Hospital institutional review board approvals and site contracts are expected to occur during the course of this year and can vary by center. We attended the following trade shows in fiscal Q4 2025 through today: the Society for Neuroscience, Congress of Neurological Surgeons, and the American Epilepsy Society meeting.

Regarding the 1RF Brain Ablation System currently marketed by Zimmer Biomet, we continue to gain traction with accounts as the product is released to additional sites. Clinical outcomes have also continued to be reportedly positive without any adverse events to date. Our Temperature Control Probe is performing exactly as intended and offering an additional safety mechanism during procedures that ensures excessive temperatures do not occur during the ablation. We also recently met with key personnel from sites participating in the 1RF registry, which is intended to gather a variety of performance data for patients that have had ablations with our system. Hospital institutional review board approvals and site contracts are expected to occur during the course of this year and can vary by center. We attended the following trade shows in fiscal Q4 2025 through today: the Society for Neuroscience, Congress of Neurological Surgeons, and the American Epilepsy Society meeting.

Speaker #2: As we the booth enter new progress our markets and , we concurrently continue to strengthen our patent portfolio . Recently , we were granted a notice of by the US Patent and Trade Allowance Office for both the manufacturing methods used deposit our contact material onto our electrode , and a second notice of that our temperature control allowance covers When used with our probe .

Speaker #2: On the proprietary international front, we have also received our first granted European patent for the temperature probe. The company has, in total, seventeen issued and pending patents, which were all developed and owned in-house with the exception of the initial three patents.

Speaker #2: We licensed pertaining to our cortical electrode family. Before I turn the call over to Ron, I wanted to reiterate our driving revenue from our confidence in one RF increased system, along with ablation initiating preparation for future sales.

Operator: All meetings included posters and/or presentations on our technology, as well as Mayo Clinic physician testimonials on their experience with our technology at the AES at the Zimmer Biomet booth. As we progress our technology platform and enter new markets, we concurrently continue to strengthen our patent portfolio. Recently, we were granted a notice of allowance by the US Patent and Trademark Office for both the manufacturing methods used to deposit our contact material onto our electrode and a second notice of allowance that covers our proprietary temperature control probe when used with our SEEG electrode. On the international front, we have also received our first granted European patent for the temperature probe. In total, the company has 17 issued and pending patents, which were all developed and owned in-house, with the exception of the initial three patents we licensed pertaining to our cortical electrode family.

All meetings included posters and/or presentations on our technology, as well as Mayo Clinic physician testimonials on their experience with our technology at the AES at the Zimmer Biomet booth. As we progress our technology platform and enter new markets, we concurrently continue to strengthen our patent portfolio. Recently, we were granted a notice of allowance by the US Patent and Trademark Office for both the manufacturing methods used to deposit our contact material onto our electrode and a second notice of allowance that covers our proprietary temperature control probe when used with our SEEG electrode. On the international front, we have also received our first granted European patent for the temperature probe. In total, the company has 17 issued and pending patents, which were all developed and owned in-house, with the exception of the initial three patents we licensed pertaining to our cortical electrode family.

Speaker #2: I'd like to add to our note that anticipated growth internationally will include neuralgia, also like ablation. Strategic revenue agreements for pain, not management technology, or drug delivery partnerships or sales.

Speaker #2: The prospects for current and future growth are bright. Our goal is to continue to execute on our plan. I would now like to turn the call over to Ronald McClurg, Chief Financial Officer, to provide a review of our fiscal fourth quarter and full year financial results.

Speaker #2: Ron .

Speaker #3: Dave, thanks. Product revenue increased 907% to $2.7 million in the fourth quarter of fiscal 2025, compared to product revenue of $0.3 million in the fourth quarter of fiscal 2024.

Speaker #3: For the full fiscal year 2025, product revenue increased to $9.1 million, compared to $3.5 million for the full fiscal year 2024, representing an increase of 163%.

Operator: Before I turn the call over to Ron, I wanted to reiterate our confidence in driving increased revenue from our 1RF ablation system, along with initiating preparation for future international sales. I'd also like to note that our anticipated growth will not include trigeminal neuralgia ablation revenue, strategic agreements for pain management technology, or drug delivery partnerships or sales. The prospects for current and future growth are bright, and our goal is to continue to execute on this plan. I would now like to turn the call over to Ron McClurg, Chief Financial Officer, to provide a review of our fiscal fourth quarter and full-year financial results. Ron? Thanks, Dave. Product revenue increased 907% to $2.7 million in the fourth quarter of fiscal 2025, compared to product revenue of $0.3 million in the fourth quarter of fiscal 2024.

Before I turn the call over to Ron, I wanted to reiterate our confidence in driving increased revenue from our 1RF ablation system, along with initiating preparation for future international sales. I'd also like to note that our anticipated growth will not include trigeminal neuralgia ablation revenue, strategic agreements for pain management technology, or drug delivery partnerships or sales. The prospects for current and future growth are bright, and our goal is to continue to execute on this plan. I would now like to turn the call over to Ron McClurg, Chief Financial Officer, to provide a review of our fiscal fourth quarter and full-year financial results. Ron?

Speaker #3: The company also had license revenue of $3 million in fiscal 2025, which is not included in our product revenue, compared to no license revenue in fiscal 2024.

Speaker #3: License revenue in fiscal 2025 was derived from the expanded exclusive distribution agreement with Zimmer Biomet. Product gross profit increased significantly to $1.5 million, or 55.8% of our revenue, in the fourth quarter of fiscal 2020.

Speaker #3: Five, compared to product gross profit of $0.1 million, or 51.8% of revenue, in the same quarter of the prior fiscal year.

Ron McClurg: Thanks, Dave. Product revenue increased 907% to $2.7 million in the fourth quarter of fiscal 2025, compared to product revenue of $0.3 million in the fourth quarter of fiscal 2024.

Speaker #3: For the full fiscal year 2025 . Product gross profit increased significantly to 5.1 million , or 56.5% of revenue , compared to product gross profit of 1.1 million , 31.3% of revenue full fiscal or , in the year 2024 .

Operator: For the full fiscal year 2025, product revenue increased 163% to $9.1 million, compared to $3.5 million for the full fiscal year 2024. The company also had licensed revenue of $3 million in fiscal 2025, which is not included in our product revenue, compared to no licensed revenue in fiscal 2024. Licensed revenue in fiscal 2025 was derived from the expanded exclusive distribution agreement with Zimmer Biomet. Product gross profit increased significantly to $1.5 million, or 55.8% of revenue, in the fourth quarter of fiscal 2025, compared to product gross profit of $0.1 million, or 51.8% of revenue, in the same quarter of the prior fiscal year. For the full fiscal year 2025, product gross profit increased significantly to $5.1 million, or 56.5% of revenue, compared to product gross profit of $1.1 million, or 31.3% of revenue, in the full fiscal year 2024.

For the full fiscal year 2025, product revenue increased 163% to $9.1 million, compared to $3.5 million for the full fiscal year 2024. The company also had licensed revenue of $3 million in fiscal 2025, which is not included in our product revenue, compared to no licensed revenue in fiscal 2024. Licensed revenue in fiscal 2025 was derived from the expanded exclusive distribution agreement with Zimmer Biomet. Product gross profit increased significantly to $1.5 million, or 55.8% of revenue, in the fourth quarter of fiscal 2025, compared to product gross profit of $0.1 million, or 51.8% of revenue, in the same quarter of the prior fiscal year. For the full fiscal year 2025, product gross profit increased significantly to $5.1 million, or 56.5% of revenue, compared to product gross profit of $1.1 million, or 31.3% of revenue, in the full fiscal year 2024.

Speaker #3: Total operating expenses decreased 2% to $2.9 million in the fourth quarter of fiscal 2025, compared to $3.0 million in the same quarter of the prior year.

Speaker #3: Expenses for R&D in the fourth quarter of fiscal 2025 were $1.1 million, the same as in fiscal 2024. G&A expense in the fourth quarter of fiscal 2025 was $1.8 million, compared to $1.8 million in the same quarter of the prior year.

Speaker #3: For the full fiscal year 2025 . Total operating expenses decreased 5% to 12.4 million , compared to fiscal year 2024 . R&D expense in the full fiscal year 2025 13.0 million for the full decreased 2% to compared 5.0 million , to 5.1 million in fiscal year 2024 .

Speaker #3: SGA expense in the full fiscal year 2025 decreased 7% to 7.4 million , compared 7.9 million in the fiscal year 2024 . loss in the fourth quarter of to fiscal 2025 improved 52% to by Net 1.6 million , $0.03 per share , compared to a net loss of or or 3.4 million , $0.11 per share , in the same the prior year .

Operator: Total operating expenses decreased 2% to $2.9 million in the fourth quarter of fiscal 2025, compared to $3.0 million in the same quarter of the prior year. R&D expenses in the fourth quarter of fiscal 2025 was $1.1 million, the same as the fourth quarter of fiscal 2024. SG&A expense in the fourth quarter of fiscal 2025 was $1.8 million, compared to $1.8 million in the same quarter of the prior year. For the full fiscal year 2025, total operating expenses decreased 5% to $12.4 million, compared to $13.0 million for the full fiscal year 2024. R&D expense in the full fiscal year 2025 decreased 2% to $5.0 million, compared to $5.1 million in fiscal year 2024. SG&A expense in the full fiscal year 2025 decreased 7% to $7.4 million, compared to $7.9 million in the fiscal year 2024.

Total operating expenses decreased 2% to $2.9 million in the fourth quarter of fiscal 2025, compared to $3.0 million in the same quarter of the prior year. R&D expenses in the fourth quarter of fiscal 2025 was $1.1 million, the same as the fourth quarter of fiscal 2024. SG&A expense in the fourth quarter of fiscal 2025 was $1.8 million, compared to $1.8 million in the same quarter of the prior year. For the full fiscal year 2025, total operating expenses decreased 5% to $12.4 million, compared to $13.0 million for the full fiscal year 2024. R&D expense in the full fiscal year 2025 decreased 2% to $5.0 million, compared to $5.1 million in fiscal year 2024. SG&A expense in the full fiscal year 2025 decreased 7% to $7.4 million, compared to $7.9 million in the fiscal year 2024.

Speaker #3: Net the full quarter of fiscal year 2025 improved loss for by 71% 3.6 million , to or $0.09 per share , compared with a net loss of 12.3 million , or $0.46 per share , for full fiscal year 2024 .

Speaker #3: As of September 30th , 2025 , the company had cash and cash equivalents of compared 6.6 million , to 1.5 million as of September 30th , 2024 .

Speaker #3: Of note , funded through at least fiscal 2026 , neuro one is longer if key potentially milestones are hit . The company had working 7.9 million as of September 30th , capital of to working capital of 2.4 million as of September 30th , 2024 .

Speaker #3: We had no debt outstanding as of September 30th, 2025. I will now turn the call back over to Dave for his closing remarks.

Operator: Net loss in the fourth quarter of fiscal 2025 improved by 52% to $1.6 million, or $0.03 per share, compared to a net loss of $3.4 million, or $0.11 per share, in the same quarter of the prior year. Net loss for the full fiscal year 2025 improved by 71% to $3.6 million, or $0.09 per share, compared with a net loss of $12.3 million, or $0.46 per share for full fiscal year 2024. As of 30 September 2025, the company had cash and cash equivalents of $6.6 million, compared to $1.5 million as of 30 September 2024. Of note, NeuroOne is funded through at least fiscal 2026, potentially longer if key milestones are hit. The company had working capital of $7.9 million as of 30 September 2025, compared to working capital of $2.4 million as of 30 September 2024. We had no debt outstanding as of 30 September 2025.

Net loss in the fourth quarter of fiscal 2025 improved by 52% to $1.6 million, or $0.03 per share, compared to a net loss of $3.4 million, or $0.11 per share, in the same quarter of the prior year. Net loss for the full fiscal year 2025 improved by 71% to $3.6 million, or $0.09 per share, compared with a net loss of $12.3 million, or $0.46 per share for full fiscal year 2024. As of 30 September 2025, the company had cash and cash equivalents of $6.6 million, compared to $1.5 million as of 30 September 2024. Of note, NeuroOne is funded through at least fiscal 2026, potentially longer if key milestones are hit. The company had working capital of $7.9 million as of 30 September 2025, compared to working capital of $2.4 million as of 30 September 2024. We had no debt outstanding as of 30 September 2025.

Speaker #2: Thank you, Ron. As I stated at the top of

Speaker #2: the call , fiscal 2025 was the most year in the successful history of the company . . our FDA five 10-K clearance for the one RF trigeminal ablation system to nerve our expanded partnership with Zimmer Biomet , our first pre-clinical sales for our drug delivery platform , initiation of a new product development program for Basivertebral nerve ablation and strong financial performance and balance sheet neuro one medical technologies successfully our technical , commercial and executed financial plan .

Speaker #2: We also have great momentum leading into fiscal year 2026 with a recent announcement that our first two OneRF Trigeminal Neuralgia cases were successfully performed.

Speaker #2: Expect to hear more about advancements with brain pain management and drug delivery on our platforms in the near future. Finally, in January, we will be attending the J.P.

Operator: I will now turn the call back over to Dave for his closing remarks. Thank you, Ron. As I stated at the top of the call, fiscal 2025 was the most successful year in the history of the company. From our FDA 510(k) clearance for the 1RF trigeminal nerve ablation system to our expanded partnership with Zimmer Biomet, our first preclinical sales for our drug delivery platform, initiation of a new product development program for basivertebral vertebral nerve ablation, and strong financial performance and balance sheet, NeuroOne Medical Technologies successfully executed our technical, commercial, and financial plan. We also have great momentum leading into fiscal year 2026 with the recent announcement that our first two 1RF trigeminal neuralgia cases were successfully performed. Expect to hear more about advancements with our brain pain management and drug delivery platforms in the near future. Finally, in January, we will be attending the J.P.

I will now turn the call back over to Dave for his closing remarks.

Dave Rosa: Thank you, Ron. As I stated at the top of the call, fiscal 2025 was the most successful year in the history of the company. From our FDA 510(k) clearance for the 1RF trigeminal nerve ablation system to our expanded partnership with Zimmer Biomet, our first preclinical sales for our drug delivery platform, initiation of a new product development program for basivertebral vertebral nerve ablation, and strong financial performance and balance sheet, NeuroOne Medical Technologies successfully executed our technical, commercial, and financial plan. We also have great momentum leading into fiscal year 2026 with the recent announcement that our first two 1RF trigeminal neuralgia cases were successfully performed.

Speaker #2: Morgan Healthcare Conference and invite investors and analysts to meet with Neuro. January 12th, and 13th or 14th, to learn more about our amazing company and its story.

Speaker #2: Operator: At this time, I think we can open up for questions.

Speaker #1: Certainly, at this time we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone.

Speaker #1: A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it is necessary to pick up and may require handset pressing. One moment, please.

Speaker #1: While we pull for the star keys, questions. Your first question for today is from Cohen.

Expect to hear more about advancements with our brain pain management and drug delivery platforms in the near future. Finally, in January, we will be attending the J.P. Morgan Healthcare Conference and invite investors and analysts to meet with NeuroOne January 12, 13, or 14 to learn more about our amazing company and its story. Operator, at this time, I think we can open up for questions.

Speaker #1: Ladenburg Good

Speaker #4: morning . questions I'd . like to start with face pain . If we could . I know that you had those two Jeff patients treated earlier this month .

Speaker #4: This is Destiny. On for Jeff. Thank you for taking our—

Operator: Morgan Healthcare Conference and invite investors and analysts to meet with NeuroOne January 12, 13, or 14 to learn more about our amazing company and its story. Operator, at this time, I think we can open up for questions. Certainly. At this time, we will 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 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Your first question for today is from Jeff Cohen with Ladenburg. Good morning. This is Destiny on for Jeff. Thank you for taking our questions.

Speaker #4: So congratulations on that . I'm wondering if we should expect any more procedures prior to year end . I know we're getting into the thick of the holidays , so I'm just curious .

Speaker #2: If . Thanks for joining the . Destiny call . We do have three other centers that have indicated they have that cases that they have planned .

Operator: Certainly. At this time, we will 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 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Your first question for today is from Jeff Cohen with Ladenburg.

Speaker #2: The question more getting around some of the ancillary equipment that they is need to do the procedure , not not our equipment . And at one of the centers , local centers here , they're also to get waiting the generator installed in the facility .

Speaker #2: So the cases are there. There are just a few more steps that we have to go through, and we do think that there's a good chance we'll have more cases done this month.

Destiny Hance: Good morning. This is Destiny on for Jeff. Thank you for taking our questions.

Speaker #4: Okay , great . Thank you . I And historically you had said that with this type of know procedure , they could be stacked .

Operator: I'd like to start with face pain, if we could. I know that you had those two patients treated earlier this month, so congratulations on that. I'm wondering if we should expect any more procedures prior to year-end. I know we're getting into the thick of the holidays, so I'm just curious. Yes. Thanks for joining the call, Destiny. We do have three other centers that have indicated that they have cases that they have planned. The question is more around getting some of the ancillary equipment that they need to do the procedure, not our equipment. And at one of the centers, local centers here, they're also waiting to get the generator installed in the facility. So the cases are there.

I'd like to start with face pain, if we could. I know that you had those two patients treated earlier this month, so congratulations on that. I'm wondering if we should expect any more procedures prior to year-end. I know we're getting into the thick of the holidays, so I'm just curious.

Speaker #4: the treating physicians could do more . I'm wondering , first of all , were these procedures back maybe Maybe not on the But in terms of the hour .

Speaker #4: Days, and then based on what you heard just from to back, you feel like something that still—that is feasible, or is it attainable?

Dave Rosa: Yes. Thanks for joining the call, Destiny. We do have three other centers that have indicated that they have cases that they have planned. The question is more around getting some of the ancillary equipment that they need to do the procedure, not our equipment. And at one of the centers, local centers here, they're also waiting to get the generator installed in the facility. So the cases are there. There are just a few more steps that we have to go through, and we do think that there's a good chance we'll have more cases done this month.

Speaker #2: Yeah . So both of those cases were back sure were to back . I'm not , you know , they were done within an hour , but they they back to back .

Speaker #2: And yes were done , that that's one of the nice things I think about these trigeminal neuralgia cases is that the neurosurgeons will schedule them in advance , and it makes it a lot more convenient support for us to those cases to because we know that the ablation is going to be done , you know , in that particular as opposed case , to brain ablations , where there's usually a waiting period until the has been identified .

Operator: There are just a few more steps that we have to go through, and we do think that there's a good chance we'll have more cases done this month. Okay. Great. Thank you. And I know historically you had said that with this type of procedure, they could be stacked, so the treating physicians could do more. I'm wondering, first of all, were these procedures back to back, maybe not on the hour, but in terms of the days? And then based on what you heard just from those two, do you still feel like that's something that is feasible or is attainable? Yeah. So both of those cases were back to back. I'm not sure they were done within an hour, but they were done back to back.

Destiny Hance: Okay. Great. Thank you. And I know historically you had said that with this type of procedure, they could be stacked, so the treating physicians could do more. I'm wondering, first of all, were these procedures back to back, maybe not on the hour, but in terms of the days? And then based on what you heard just from those two, do you still feel like that's something that is feasible or is attainable?

Speaker #2: So we expect that, yes, forward foci.

Speaker #4: Okay , moving great . And I know you mentioned the strategic partner here . At what point feel do you like you would just go forward it and do yourself ?

Speaker #2: Well , if the discussions didn't appear to be going in a fruitful direction , we could do But that . but you know , I feel confident that we'll be able to reach an agreement with strategic partner for this .

Dave Rosa: Yeah. So both of those cases were back to back. I'm not sure they were done within an hour, but they were done back to back.

Speaker #4: Okay . Okay . Thank you . And then just a couple on drug delivery , may if I . I'm wondering if there will be more orders from this large pharma player .

Operator: And yes, that's one of the nice things I think about these Trigeminal Neuralgia cases, is that the neurosurgeons will schedule them in advance. It makes it a lot more convenient for us to support those cases too, because we know that the ablation is going to be done in that particular case as opposed to brain ablations where there's usually a waiting period until the foci has been identified. So yes, we expect that moving forward. Okay. Great. And I know you mentioned a strategic partner here. At what point do you feel like you would just go forward and do it yourself? Well, if discussions didn't appear to be going in a fruitful direction, we could do that. But I feel confident that we'll be able to reach an agreement with a strategic partner for this. Okay. Okay. Thank you.

Operator: And yes, that's one of the nice things I think about these Trigeminal Neuralgia cases, is that the neurosurgeons will schedule them in advance. It makes it a lot more convenient for us to support those cases too, because we know that the ablation is going to be done in that particular case as opposed to brain ablations where there's usually a waiting period until the foci has been identified. So yes, we expect that moving forward.

Speaker #4: And I'm not sure how visibility you have much there , they . Are but are they going to do additional testing ? Is there the to opportunity you what are you expand a bit ?

Speaker #4: seeing What do there ?

Speaker #2: think do that I Yeah , somewhere around midyear we'll will be in a where situation we'll be able to ship additional units . These be for preclinical testing .

Speaker #2: But really, the work that we're doing now is to get the devices manufactured, to get our processes validated, so that we can be in a position mid-year to ship devices pre-clinical.

Destiny Hance: Okay. Great. And I know you mentioned a strategic partner here. At what point do you feel like you would just go forward and do it yourself?

Dave Rosa: Well, if discussions didn't appear to be going in a fruitful direction, we could do that. But I feel confident that we'll be able to reach an agreement with a strategic partner for this.

Speaker #4: Okay . Got it . And then for epilepsy , I missed what you said about the registry . What is the timing on getting that established and opened ?

Speaker #2: Yeah . So , you know , in terms of the like protocol , we we feel very confident that the protocol that we have makes sense We just .

Destiny Hance: Okay. Okay. Thank you. And then just a couple on drug delivery, if I may. I'm wondering if there will be more orders from this large pharma player. And I'm not sure how much visibility you have there, but are they going to do additional testing? Is there the opportunity to expand a bit? What are you seeing there?

Operator: And then just a couple on drug delivery, if I may. I'm wondering if there will be more orders from this large pharma player. And I'm not sure how much visibility you have there, but are they going to do additional testing? Is there the opportunity to expand a bit? What are you seeing there? Yeah. I do think that somewhere around mid-year, we'll be in a situation where we'll be able to ship additional units. These units are all going to be for preclinical testing. But really, the work that we're doing now is to get the devices manufactured, to get our processes validated so that we can be in a position mid-year to ship preclinical devices. Okay. Got it. And then for epilepsy, I missed what you said about the registry. What is the timing on getting that established and opened? Yeah.

Speaker #2: met at AES , which was the first week in December with sites that had agreed to participate . They had some comments , you know , offered some suggestions and also each its site own process internal that it has to go able through .

Dave Rosa: Yeah. I do think that somewhere around mid-year, we'll be in a situation where we'll be able to ship additional units. These units are all going to be for preclinical testing. But really, the work that we're doing now is to get the devices manufactured, to get our processes validated so that we can be in a position mid-year to ship preclinical devices.

Speaker #2: to participate in these To be And , and get sign registries . off from administration . You know , some are a matter of months , some could take longer .

Speaker #2: So, you know, I really think that in terms of when that paperwork's done and the actual sites get signed off, I don't think we'll see that happen until Q2.

Speaker #2: But it really helped at this meeting in getting a better idea of when, in December, some of these sites are going to be able to actually start enrolling.

Destiny Hance: Okay. Got it. And then for epilepsy, I missed what you said about the registry. What is the timing on getting that established and opened?

Speaker #4: Okay , great . Thank you . And then last one for me , I know you've mentioned raising patient awareness , and I'm wondering if you've kind of implemented any strategies or initiatives initiatives there that could we that could maybe help with awareness in 2026 , like another Clara story , if you will ?

Dave Rosa: Yeah. So in terms of the protocol, we feel very confident that the protocol that we have makes sense. We just met at AES, which was the first week in December, with sites that had agreed to participate. They had some comments and offered some suggestions. Also, each site has its own internal process that it has to go through to be able to participate in these registries and get sign-off from administration. Some are a matter of months. Some could take longer. So I really think that in terms of when that paperwork's done and the actual sites get signed off, I don't think we'll see that happen until Q2. But it really helped at this meeting in December, getting a better idea of when some of these sites are going to be able to actually start enrolling.

Operator: So in terms of the protocol, we feel very confident that the protocol that we have makes sense. We just met at AES, which was the first week in December, with sites that had agreed to participate. They had some comments and offered some suggestions. Also, each site has its own internal process that it has to go through to be able to participate in these registries and get sign-off from administration. Some are a matter of months. Some could take longer. So I really think that in terms of when that paperwork's done and the actual sites get signed off, I don't think we'll see that happen until Q2. But it really helped at this meeting in December, getting a better idea of when some of these sites are going to be able to actually start enrolling. Okay. Great. Thank you. And then last one for me.

Speaker #2: Yeah . So we have done some work with the care organization , which is sorry , cure , which is an epilepsy organization .

Speaker #2: And we're talking to the Epilepsy Foundation to be able to partner with them to make this therapy more visible to patients.

Speaker #2: I mean , you know , we we just recently a recent posted that was a professional pianist in about Chicago and was unable to continue his career because of seizures .

Speaker #2: And we found out this case was done this summer. And there were a couple of articles published in the Chicago newspapers that were sent to us by the neurosurgeon who performed the procedure.

Destiny Hance: Okay. Great. Thank you. And then last one for me. I know you've mentioned raising patient awareness, and I'm wondering if you've kind of implemented any strategies or initiatives there that could maybe help with awareness in 2026, like another Clara story, if you will.

Operator: I know you've mentioned raising patient awareness, and I'm wondering if you've kind of implemented any strategies or initiatives there that could maybe help with awareness in 2026, like another Clara story, if you will. Yeah. So we have done some work with the CARE organization, which is—sorry, CURE, which is an epilepsy organization. And we're also talking to the Epilepsy Foundation to be able to partner with them to make this therapy more visible to patients. I mean, we just recently posted about a recent patient that was a professional pianist in Chicago and was unable to continue his career because of seizures. And we found out this case was done this summer. And there were a couple of articles published in the Chicago newspapers that were sent to us by the neurosurgeon who performed the procedure. We were completely unaware of it.

Speaker #2: We were completely stories that and getting but it's patients . That's really unaware of it , critical . I mean , in this particular gentleman's able case , he was resume his professional career when he was told really weren't there other options .

Dave Rosa: Yeah. So we have done some work with the CARE organization, which is—sorry, CURE, which is an epilepsy organization. And we're also talking to the Epilepsy Foundation to be able to partner with them to make this therapy more visible to patients. I mean, we just recently posted about a recent patient that was a professional pianist in Chicago and was unable to continue his career because of seizures. And we found out this case was done this summer. And there were a couple of articles published in the Chicago newspapers that were sent to us by the neurosurgeon who performed the procedure. We were completely unaware of it.

Speaker #2: And , you know , lucky for , he him heard patient , that Clara , that we reported on in the past , went to the same doctor .

Speaker #2: And , you a positive very outcome . know , had So are we , you know , still continuing to figure in terms of partnering with these on the best way of organizations out message out through their help .

Speaker #4: Got getting it . Okay . Thank you . I appreciate you taking the looking forward to seeing you at JP Morgan .

Speaker #1: Next question for today is Anthony Vendetti with Maxim Group.

Operator: But it's stories like that and getting that information out to other patients that's really critical. I mean, in this particular gentleman's case, he was able to resume his professional career when he was told there really weren't any other options. And lucky for him, he heard about that, the patient Clara that we've reported on in the past went to the same doctor and had a very positive outcome. So we are still continuing to figure out, in terms of partnering with these organizations, the best way of getting the message out through their help. Got it. Okay. Thank you. I appreciate you taking the questions and looking forward to seeing you at J.P. Morgan. Thanks, Destiny. Your next question for today is from Anthony Vendetti with Maxim Group. Thank you. Dave, I was wondering if you could expand on the distribution agreement that you have with Zimmer Biomet.

But it's stories like that and getting that information out to other patients that's really critical. I mean, in this particular gentleman's case, he was able to resume his professional career when he was told there really weren't any other options. And lucky for him, he heard about that, the patient Clara that we've reported on in the past went to the same doctor and had a very positive outcome. So we are still continuing to figure out, in terms of partnering with these organizations, the best way of getting the message out through their help.

Speaker #5: talk about what Can you that the development program looks like for , for Thank pain lower back and then and then I'll hop back in with one other question .

Speaker #2: Sure . And thanks for joining the call . So let's about let's talk back pain first . And that's probably the the longer the two questions we have two programs from actually back pain .

Destiny Hance: Got it. Okay. Thank you. I appreciate you taking the questions and looking forward to seeing you at J.P. Morgan.

Speaker #2: One that is the electrode paddle that I spoke about can be percutaneously placed, that is, through a 14-gauge—so that needle. The program is ongoing.

Dave Rosa: Thanks, Destiny.

Operator: Your next question for today is from Anthony Vendetti with Maxim Group.

Anthony Vendetti: Thank you. Dave, I was wondering if you could expand on the distribution agreement that you have with Zimmer Biomet. I mean, I know you said it has expanded, but can you provide a little more color on what that includes? Then just on the lower back pain, you said you advanced the development of that product. Can you talk about what the development program looks like for lower back pain? Then I'll hop back in with one other question.

Speaker #2: We did some testing last year in a chronic animal model, and we received some biocompatibility, some histology information. Also have some WE testing that we still need to do, which is what we will be initiating in early stimulation next year.

Operator: I mean, I know you said it has expanded, but can you provide a little more color on what that includes? Then just on the lower back pain, you said you advanced the development of that product. Can you talk about what the development program looks like for lower back pain? Then I'll hop back in with one other question. Sure. Thanks for joining the call. Let's talk about back pain first. That's probably the longer of the two questions. We actually have two programs for lower back pain. One that is the paddle electrode that I spoke about that can be placed percutaneously through a 14-gauge needle. So that program is ongoing. We did some testing last year in a chronic animal model, and we received some biocompatibility, some histology information.

Speaker #2: But that program is strictly the electrode and here is really partner established to with an company in the . You know , we've we've mentioned space the goal having discussions with some of the larger companies that are , well established in spinal cord stimulation .

Dave Rosa: Sure. Thanks for joining the call. Let's talk about back pain first. That's probably the longer of the two questions. We actually have two programs for lower back pain. One that is the paddle electrode that I spoke about that can be placed percutaneously through a 14-gauge needle. So that program is ongoing. We did some testing last year in a chronic animal model, and we received some biocompatibility, some histology information.

Speaker #2: And the that is , is twofold . One , don't we have internal resources for developing pulse reason for generators . And I'm I really don't feel like that's core a competency that company has .

Speaker #2: larger The companies have this the , you the we have razor blade know , we and they have the we can provide , and that they something haven't been able to at this razor which has point , they advantages over the therapy can't or today .

Speaker #2: they're But real advantage in great my mind is the ability piggyback kind of onto to their PMA . Clearly they've already gotten FDA clearances for their systems .

Operator: We also have some stimulation testing that we still need to do, which is what we'll be initiating in early next year. But that program is strictly the electrode. And the goal here is to really partner with an established company in the space. We've mentioned that we're having discussions with some of the larger companies that are well-established in spinal cord stimulation. And the reason for that is twofold. One, we don't have internal resources for developing pulse generators. And I really don't feel like that's a core competency that the company has. The larger companies have this. We have the razor blade, and they have the razor. And we can provide something that they can't or they haven't been able to at this point, which has advantages over the therapy today.

We also have some stimulation testing that we still need to do, which is what we'll be initiating in early next year. But that program is strictly the electrode. And the goal here is to really partner with an established company in the space. We've mentioned that we're having discussions with some of the larger companies that are well-established in spinal cord stimulation. And the reason for that is twofold. One, we don't have internal resources for developing pulse generators. And I really don't feel like that's a core competency that the company has. The larger companies have this. We have the razor blade, and they have the razor. And we can provide something that they can't or they haven't been able to at this point, which has advantages over the therapy today.

Speaker #2: Able to do that, and if we are, it's going to shave years off of our timeline to get to market. So that's program.

Speaker #2: The second one is the or Devana the Daisy vertebral ablation system . And you know , completely concept , completely nerve that different condition patient's experience for this type of lower back pain and what we're doing leveraging again , generator we're the is brain using for ablation .

Speaker #2: Facial nerve ablation to really utilize that same system with our electrode, to be able to go in and ablate basivertebral. So, that put together a board of leading advisory, who are very much specialists familiar with this.

Operator: But the real great advantage in my mind is the ability to kind of piggyback onto their PMA. Clearly, they've already gotten FDA clearances for their systems. And if we're able to do that, it's going to shave years off of our timeline to get to market. So that program. The second one is the BVNA or the Basivertebral Nerve Ablation System. And completely different concept, completely different condition that patients experience for this type of lower back pain. And what we're doing is, again, leveraging the generator that we're using for brain ablation, now facial ablation, to really utilize that same system with our electrode to be able to go in and ablate the Basivertebral Nerve. So we've put together an advisory board of leading pain specialists who are very familiar with this procedure. We've had multiple meetings with them.

But the real great advantage in my mind is the ability to kind of piggyback onto their PMA. Clearly, they've already gotten FDA clearances for their systems. And if we're able to do that, it's going to shave years off of our timeline to get to market. So that program. The second one is the BVNA or the Basivertebral Nerve Ablation System. And completely different concept, completely different condition that patients experience for this type of lower back pain. And what we're doing is, again, leveraging the generator that we're using for brain ablation, now facial ablation, to really utilize that same system with our electrode to be able to go in and ablate the Basivertebral Nerve. So we've put together an advisory board of leading pain specialists who are very familiar with this procedure. We've had multiple meetings with them.

Speaker #2: We've meetings . We feel pretty confident what we that have will be able to offer advantages existing systems . Our procedure multi-contact device has over over the advantages existing Today , and of probes .

Speaker #2: course , our our temperature probe also has provides additional safety features . When you're doing any of these ablations . But like our other pain management ablation systems , we will have accessories to to to source allow other the pain specialists to able to access basivertebral nerve the .

Speaker #2: So, with respect to that program, there will be separate strategics that discussions with established in treating lower back pain. Even one of the strategics that we're talking to actually is interested in both the Basivertebral System as well as the Spinal Cord Stimulation platform.

Operator: We feel pretty confident that what we have will be able to offer advantages over the existing systems. Our multi-contact device has advantages over existing probes today. Of course, our temperature probe also provides additional safety features when you're doing any of these ablations. But like our other pain management ablation systems, we will have to source other accessories to allow the pain specialists to be able to access the Basivertebral Nerve. So with respect to that program, we also are having separate discussions with strategics that have established businesses in treating lower back pain. One of the strategics that we're talking to is actually interested in both the Basivertebral System as well as the spinal cord stimulation platform.

We feel pretty confident that what we have will be able to offer advantages over the existing systems. Our multi-contact device has advantages over existing probes today. Of course, our temperature probe also provides additional safety features when you're doing any of these ablations. But like our other pain management ablation systems, we will have to source other accessories to allow the pain specialists to be able to access the Basivertebral Nerve. So with respect to that program, we also are having separate discussions with strategics that have established businesses in treating lower back pain. One of the strategics that we're talking to is actually interested in both the Basivertebral System as well as the spinal cord stimulation platform.

Speaker #2: We still do need to do additional testing of the generator to ensure that we're able to develop the same size lesions for the vertebral that our specialists and nerve experts are looking for.

Speaker #2: then And obviously the development of the accessories through a third party . So that's the work that's needed on that program . But the goal the really leverage what we already have , is really the same strategy that we've employed over the last couple which with the years generator .

Speaker #2: And of with respect to is to the agreement . So the the expansion really pertains to a year ago when we expanded the agreement beyond just the diagnostic EEG electrodes with Zimmer to include brain ablation system that was from , I believe , October the a then ago . .

Speaker #2: And of with respect to is to the agreement . So the the expansion really pertains to a year ago when we expanded the agreement beyond just the diagnostic EEG electrodes with Zimmer to include brain ablation system that was from , I believe , October the a then ago .

Speaker #2: potential to expand beyond that . We obviously have pain technology . So there's there's potential that , you know , the relationship facial beyond could grow that the .

Operator: So we still do need to do additional testing on the generator to ensure that we're able to develop the same-sized lesions for the Basivertebral Nerve that pain specialists are looking for. And then, obviously, the development of the accessories through a third party. So that's the work that's needed on that program. But the goal is to really leverage what we already have, which is really the same strategy that we've employed over the last couple of years with the generator. And then with respect to the agreement, so the expansion really pertains to a year ago when we expanded the agreement beyond just the diagnostic SEEG electrodes with Zimmer to include the brain ablation system. So that was from, I believe, October a year ago. So there's also the potential to expand beyond that. We obviously have the facial pain technology.

So we still do need to do additional testing on the generator to ensure that we're able to develop the same-sized lesions for the Basivertebral Nerve that pain specialists are looking for. And then, obviously, the development of the accessories through a third party. So that's the work that's needed on that program. But the goal is to really leverage what we already have, which is really the same strategy that we've employed over the last couple of years with the generator. And then with respect to the agreement, so the expansion really pertains to a year ago when we expanded the agreement beyond just the diagnostic SEEG electrodes with Zimmer to include the brain ablation system.

Speaker #5: Okay . So

Speaker #5: But you're having discussions with other strategics for those two programs,

Speaker #2: Zimmer actually, a few years ago—it may have been longer than that—so, back to spine, their—so this is not an active area that they are in today.

So that was from, I believe, October a year ago. So there's also the potential to expand beyond that. We obviously have the facial pain technology. So there's potential that the relationship could grow beyond that as well.

Speaker #2: .

Speaker #5: reimbursement . business . reimbursement landscape and the challenges present always when when a emerging growth company , comes comes to market new technologies , maybe just talk about a little bit of your that navigating with with .

Operator: So there's potential that the relationship could grow beyond that as well. Okay. So just to be clear, right now, the 1RF for trigeminal nerve ablation is not part of the Zimmer Biomet agreement. And as well as the lower back pain, it sounds like you're speaking to strategics about that. It doesn't mean Zimmer Biomet wouldn't be one of the strategics, but you're having discussions with other strategics for those two programs, correct? Yeah. That's absolutely correct. Today, Zimmer Biomet does not have any distribution rights for facial pain. And the strategics that we're talking to for back pain do not include Zimmer Biomet. Zimmer Biomet, actually, a few years ago, it may have been longer than that, divested their spine business. So this is not an active area that they participate in today. Okay. Great.

Anthony Vendetti: Okay. So just to be clear, right now, the 1RF for trigeminal nerve ablation is not part of the Zimmer Biomet agreement. And as well as the lower back pain, it sounds like you're speaking to strategics about that. It doesn't mean Zimmer Biomet wouldn't be one of the strategics, but you're having discussions with other strategics for those two programs, correct?

Speaker #2: So and question because the devices that we that's a big have in development all different reimbursement . have Codes , some are well established , some are some codes are more or less catch all codes in the event that there isn't one in for a particular certain procedure Yeah .

Dave Rosa: Yeah. That's absolutely correct. Today, Zimmer Biomet does not have any distribution rights for facial pain. And the strategics that we're talking to for back pain do not include Zimmer Biomet. Zimmer Biomet, actually, a few years ago, it may have been longer than that, divested their spine business. So this is not an active area that they participate in today.

Speaker #2: Think. You know, the reimbursement codes for the devices and development are very well established when talking about ablation of your brain.

Speaker #2: There is some generic codes that neurosurgeons or hospitals have been using to gain reimbursement, but not a code per se.

Anthony Vendetti: Okay. Great. And then my last question is on reimbursement, the reimbursement landscape, and the challenges that are always present when an emerging growth company comes to market with new technologies. Maybe just talk about a little bit of how you're navigating that.

Operator: And then my last question is on reimbursement, the reimbursement landscape, and the challenges that are always present when an emerging growth company comes to market with new technologies. Maybe just talk about a little bit of how you're navigating that. Yeah. And that's a big question because the devices that we have in development have all different reimbursement codes. Some are well-established. Some codes are more or less catch-all codes in the event that there isn't one in particular for a certain procedure. I think the reimbursement codes for the devices in development are very well-established. When you're talking about brain ablation, there are some generic codes that neurosurgeons, or hospitals have been using to gain reimbursement, but not a specific code per se. It really hasn't seemed to, I'll say, be a hindrance with any of these neurosurgeons in terms of adoption.

Speaker #2: really It seen seemed to say , , I'll be a hindrance with any of these neurosurgeons in terms of hasn't adoption . You know , there's there's clearly cost advantages in using our brain ablation .

Speaker #2: And the one that is pretty obvious is, ablations today done with other competing systems are done in the operating room. And to our knowledge, there hasn't been one brain ablation done in the operating room.

Dave Rosa: Yeah. And that's a big question because the devices that we have in development have all different reimbursement codes. Some are well-established. Some codes are more or less catch-all codes in the event that there isn't one in particular for a certain procedure. I think the reimbursement codes for the devices in development are very well-established. When you're talking about brain ablation, there are some generic codes that neurosurgeons, or hospitals have been using to gain reimbursement, but not a specific code per se. It really hasn't seemed to, I'll say, be a hindrance with any of these neurosurgeons in terms of adoption.

Speaker #2: They've been done at the patient's bedside cost of tying operating room . You know , for most of a given day . the ability to do this at And the the patient's bedside up and without are occupying operating room is a is a huge extreme . advantage the in the hospital .

Speaker #2: They've been done at the patient's bedside cost of tying operating room . You know , for most of a given day . the ability to do this at And the the patient's bedside up and without are occupying operating room is a is a huge extreme .

Speaker #2: But so far, we've been very fortunate. Neurosurgeons see the value of the technology, and it hasn't gotten in our way, too. So—

Speaker #5: Okay ,

Speaker #5: great . Thanks for all that color and information . And I'll hop back in the queue . Appreciate it .

Speaker #1: you would like to ask a again , if question , please press star One on your telephone date Thank keypad . you . Thank That the last appears to be question at this now like to turn the call Rosa Dave back to time .

Operator: There's clearly cost advantages in using our brain ablation system. And the one that is pretty obvious is ablations today, done with other competing systems, are done in the operating room. And to our knowledge, there hasn't been one brain ablation done in the operating room. They've been done at the patient's bedside. And the cost of tying up an operating room for most of a given day are extreme. So the ability to do this at the patient's bedside without occupying the operating room is a huge cost advantage in the hospital today. But so far, we've been very fortunate. Neurosurgeons see the value of the technology, and it hasn't gotten in our way to date. Okay. Great. Thanks for all that color and information, and I'll hop back in the queue. Appreciate it. Thank you.

There's clearly cost advantages in using our brain ablation system. And the one that is pretty obvious is ablations today, done with other competing systems, are done in the operating room. And to our knowledge, there hasn't been one brain ablation done in the operating room. They've been done at the patient's bedside. And the cost of tying up an operating room for most of a given day are extreme. So the ability to do this at the patient's bedside without occupying the operating room is a huge cost advantage in the hospital today. But so far, we've been very fortunate. Neurosurgeons see the value of the technology, and it hasn't gotten in our way to date.

Speaker #1: .

Speaker #2: you . Operator Thank I to would like first thank everyone for attending the call , look connecting with the again investor community and we throughout forward to the quarter we .

Speaker #2: you . Operator Thank I to would like first thank everyone for attending the call , look connecting with the again investor community and we throughout forward to the quarter

Speaker #2: If

Speaker #2: unable to answer any of questions your today , please reach out to our Investor Relations firm , MSG Group , who would be more than happy to assist I would .

Anthony Vendetti: Okay. Great. Thanks for all that color and information, and I'll hop back in the queue. Appreciate it.

Dave Rosa: Thank you.

Operator: Once again, if you would like to ask a question, please press star one on your telephone keypad. Thank you. That appears to be the last question at this time. I would now like to turn the call back to Dave Rosa. Thank you, Operator. I would like to first thank everyone again for attending the call, and we look forward to connecting with the investor community throughout the quarter. If we were unable to answer any of your questions today, please reach out to our investor relations firm, MZ Group, who would be more than happy to assist. Thank you. This concludes today's conference. We thank you for your participation. You may disconnect your lines at this time and have a great day.

Operator: Once again, if you would like to ask a question, please press star one on your telephone keypad. Thank you. That appears to be the last question at this time. I would now like to turn the call back to Dave Rosa.

Dave Rosa: Thank you, Operator. I would like to first thank everyone again for attending the call, and we look forward to connecting with the investor community throughout the quarter. If we were unable to answer any of your questions today, please reach out to our investor relations firm, MZ Group, who would be more than happy to assist. '

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