Q4 2025 Perimeter Medical Imaging AI Inc Earnings Call

Speaker #1: Good afternoon, ladies and gentlemen. Welcome to the Perimeter Medical Fourth Quarter 2025 conference call. At this time, all are in listen-only mode. Following the presentation, we will conduct a question-and-answer session.

Speaker #1: If at any time during this call you require me to get assistance, please press star zero for the operator. This call is being recorded on Tuesday, March 31st, 2026.

Speaker #1: I would now like to turn the conference over to Stephen Kilmer, Investor Relations. Please go ahead.

Speaker #2: Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws.

Speaker #2: These may include statements regarding the future financial position, business strategy, and strategic goals, commercial activities and time, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, potential benefits of our products, including perimeter S series OCT and glare OCT, formerly perimeter B series OCT, perimeter's ability to broaden its user-based system utilization, expectations regarding new products and the timing of, and expectations regarding opportunities for market expansion.

Speaker #2: Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including risks and uncertainties described in our public filings and press releases, which are posted on theaterplus.ca from time to time.

Speaker #2: Our results may differ materially from those projected on today's call. No forward-looking statement can be guaranteed. Perimeter operator takes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

Speaker #2: On the call representing the company are Adrian Mendes, Perimeter's Chief Executive Officer; Andrew Berkeley, Perimeter's Chief Innovation Officer and Co-Founder; and Sara Brien, the company's Chief Financial Officer.

Speaker #2: With that said, I'll now turn the call over to Sara.

Speaker #3: Thanks, Steve. Good afternoon, everyone, and welcome to our fourth quarter and full year 2025 conference call. On behalf of the management team and everyone at Perimeter, I'd like to thank you for your ongoing interest in our company.

Speaker #3: For those of you who are shareholders, we appreciate your continued interest and support. I'd like to provide a brief update on our preliminary unaudited financial results.

Speaker #3: Before I do, I want to highlight a defining milestone for Perimeter and the recent FDA PMA approval of our next-generation AI-enabled glare OCT device.

Speaker #3: We believe that this achievement marks a true inflection point for the company, validates our AI-enabled technology, and positions us at the beginning of a new phase of growth.

Speaker #3: Over the past several years, we have been deliberately building towards this moment by seeking the market with our S-Series platform, expanding our proprietary image library, and developing critical clinical and commercial experience.

Speaker #3: But in many ways, we are only now just approaching that starting line. With glare, we will be introducing a solution designed for a broader adoption with the potential of significantly increased adoption, both in terms of install-based and existing system utilization.

Speaker #3: We believe this positions us to scale in a way that was not previously possible and to drive meaningful value created in the periods ahead.

Speaker #3: Atrium will provide additional detail on the broader solution needs. I felt it was important to begin this call by highlighting this exciting milestone for Perimeter and our shareholders.

Speaker #3: With that, let me turn to the brief review of our preliminary unaudited financial results for the quarter. Extreme thanks to all of the members I will refer to have been rounded.

Speaker #3: So we are fortunate and, as a reminder, we also report in US dollars. For the three-month period ended December 31, 2025, the company recorded record-quarterly revenue of $711,000, which consisted of recurring sales of S series consumables, system leases, and the sales of ESP warranty programs.

Speaker #3: This represents a 143% increase over Q4 2024. Operating expenses for the fourth quarter of 2025 were $2.5 million. Additional savings from the company cost-control efforts implemented in June 2025 resulted in this 46% year-over-year improvement from $4.7 million in the same period in 2024.

Speaker #3: Fourth quarter 2025 net loss is $2 million, or $0.02 per company share and 40% improvement from 3.4 million, or $0.06 per common share in three months ended December 31, 2024.

Speaker #3: As of December 31, 2025, cash and cash equivalents were approximately $2.5 million. With that, I will now turn the call over to Atrium.

Speaker #4: Thank you, Sara. And thanks again, everyone, for your time and attention today. As you just heard from Sara, we delivered another strong quarter, including record revenue reflecting continued execution across our standing commercial strategy.

Speaker #4: I want to take just a quick moment here to focus on the rebranding of our new product from the B Series to Glare OCT. We named the platform Glare not just because it sounds elegant, but because it captures exactly what we aim to deliver: clarity.

Speaker #4: The name comes from the French word for clear and illuminating. It reflects our mission to help surgeons better visualize margins during breast-conserving surgery. It's also intentionally feminine, keeping our focus on the millions of women impacted by breast cancer.

Speaker #4: And in 'Glare,' within the name—G-L-A-I-R-E—there is a nod to the artificial intelligence that powers the additional insight we bring into the operating room.

Speaker #4: As Sara mentioned, our primary goal last year was to seed the market with S Series OCT in order to create a strong foundation of early adopters and technology champions in preparation for a potential FDA approval and subsequent commercial rollout of Glare.

Speaker #4: We consistently executed toward achieving that objective since the start of 2025, and the fourth quarter is illustrative of that. Adoption of the S Series device accelerated even as we and our current customers waited for the requisite go-ahead from the FDA to introduce Glare to the market.

Speaker #4: To put that into perspective, we were excited to see total revenues from the S series more than double year over year in Q4, contrary to what one might expect with the pending FDA PMA approval of the AI-enabled, more user-friendly, next-generation device.

Speaker #4: With respect to Glare, as Sara also mentioned, our PMA application was approved by the FDA in line with our timing expectations at the beginning of March 2026.

Speaker #4: There are several advantages to PMA approval for Glare over the previous 510(k) clearance for first-generation S series device. The first is that PMA creates a higher barrier to entry for competitors.

Speaker #4: Secondly, the PMA pathway requires extensive clinical evidence to demonstrate safety and effectiveness of the device. In that regard, our PMA application was supported by the strong pivotal troubled result of Glare, where the primary endpoint of a statistically significant reduction in patients with residual cancer during breast-conserving surgery was met with a p-value of 0.005 in superiority compared to standard care alone was achieved.

Speaker #4: And third, a PMA approval signals that hospitals and surgeons have a high level of FDA scrutiny and review, helping to build credibility and confidence in the product's safety and effectiveness.

Speaker #4: With all that being said, we've now added a third moat to our business. We believe our PMA approval establishes a high regulatory barrier to entry, while our patented OCT technology and proprietary imaging capabilities differentiate our platform at the point of care.

Speaker #4: In addition to both of those, the image library we've built over time serves as a critical foundation for our AI engine, creating a data advantage that we expect will continue to improve performance in clinical utility over time.

Speaker #4: We believe these three moats—regulatory, imaging system, and multi-million image data library—position Perimeter to sustain leadership as adoption of intraoperative imaging and AI continues to grow.

Speaker #4: It's also important to note that Glare has also received FDA breakthrough device designation before our PMA application was submitted. That helped us while the FDA conducted its substantive review of the PMA application, and while I don't want to go into too much of its future potential implications at this stage, I will say that we believe it should help us with securing reimbursement for the technology as we move forward with our US commercialization strategy.

Speaker #4: Perimeter is clearly at an important inflection point. As we look to leverage the clinical and the commercial adoption of the FDA 510(k) cleared first-generation series S OCT and prepare to soon begin bringing game-changing FDA PMA-approved AI innovation to operating rooms nationwide via the pending rollout of Glare.

Speaker #4: And so, to summarize the incredible progress we're making, first, we delivered yet another quarter of positive commercial traction with our current S series product as demonstrated by our 143% revenue growth in the first quarter in the fourth quarter.

Speaker #4: Secondly, we were carefully managing our resources as we grow, as a result of our cost control efforts. We were able to reduce operating expenses by 46% in the quarter.

Speaker #4: Third, we received FDA PMA approval for our next-generation AI-enabled cleared device in early March 2026. And finally, now that FDA approval for Glare has been achieved, we are making final preparations for a full and aggressive commercial launch, representing a major step in our go-to-market strategy for interoperative cancer margin assessment with OCT and an opportunity to significantly broaden our US-based our customer-based across the US.

Speaker #4: As we move forward through 2026, commercialization strategy will be focused on leveraging our existing installed base and expanding within leading healthcare institutions, while also targeting new accounts through a combination of clinical evaluation, surgeon education, and direct sales efforts.

Speaker #4: We believe our initial early investments in building clinical champions and generating real-world data will enable a more efficient and scalable go-to-market approach for Glare.

Speaker #4: Based on the level of engagement we are seeing, we expect to close our first commercial sale or sales of Glare in the second quarter, making it an important initial step in what we believe will be a broader adoption cycle over time.

Operator: Good afternoon, ladies and gentlemen. Welcome to the Perimeter Medical Q4 2025 Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Tuesday, 31 March 2026. I would now like to turn the conference over to Stephen Kilmer, Investor Relations. Please go ahead.

Operator: Good afternoon, ladies and gentlemen. Welcome to the Perimeter Medical Q4 2025 Conference Call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Tuesday, 31 March 2026. I would now like to turn the conference over to Stephen Kilmer, Investor Relations. Please go ahead.

Speaker #4: Importantly, our model is designed to scale as adoption increases. With revenue-driven not only system placements, but also by growing consumable scan volumes, as we expand our installed base and drive deeper usage within our existing accounts, we expect to see increased system utilization, which in turn supports a higher margin recurring revenue stream from the sale of per-procedure consumables.

Speaker #4: Over time, we believe increased adoption of Glare will position Perimeter to deliver attractive revenue visibility and operating leverage. As excited as we are about the tremendous growth we see ahead in breast-conserving surgery, we also believe the introduction of Glare represents the beginning of an even broader platform opportunity.

Stephen Kilmer: Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws. These may include statements regarding the future financial position, business strategy, and strategic goals, commercial activities and timing, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, the potential benefits of our products, including Perimeter S-Series OCT and Claire OCT, formerly Perimeter B-Series OCT, Perimeter's ability to broaden its user base and system utilization, expectations regarding new products and the timing thereof, and expectations regarding opportunities for market expansion.

Stephen Kilmer: Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws. These may include statements regarding the future financial position, business strategy, and strategic goals, commercial activities and timing, competitive conditions, research and development activities, projected costs and capital expenditures, research and clinical testing outcomes, the potential benefits of our products, including Perimeter S-Series OCT and Claire OCT, formerly Perimeter B-Series OCT, Perimeter's ability to broaden its user base and system utilization, expectations regarding new products and the timing thereof, and expectations regarding opportunities for market expansion.

Speaker #4: As we continue to advance our clinical data, AI capabilities, and product roadmap, we do see the potential to expand Perimeter's AI-enabled OCT technology beyond breast-conserving surgery and into additional applications, further increasing our addressable market and reinforcing our long-term growth trajectory.

Speaker #4: As you see, this is an exciting time for us, and we look forward to keeping you updated on our progress. And with that, I will now open up the call for your questions.

Speaker #4: Operator?

Speaker #1: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press R1 on your touch-tone phone. You will hear a prompt that your hand has been raised.

Stephen Kilmer: Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our public filings and press releases, which are posted on sedarplus.ca. Our results may differ materially from those projected on today's call. No forward-looking statement can be guaranteed. Perimeter undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. On the call representing the company are Adrian Mendes, Perimeter's Chief Executive Officer, Andrew Berkeley, Perimeter's Chief Innovation Officer and Co-Founder, and Sara Brien, the company's Chief Financial Officer. With that said, I'll now turn the call over to Sara.

Stephen Kilmer: Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our public filings and press releases, which are posted on sedarplus.ca. Our results may differ materially from those projected on today's call. No forward-looking statement can be guaranteed. Perimeter undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. On the call representing the company are Adrian Mendes, Perimeter's Chief Executive Officer, Andrew Berkeley, Perimeter's Chief Innovation Officer and Co-Founder, and Sara Brien, the company's Chief Financial Officer. With that said, I'll now turn the call over to Sara.

Speaker #1: Should you wish to decline from the holding process, please press R2. If you're using a speakerphone, please lift the handset before pressing any keys.

Speaker #1: One moment, please, for your first question. Your first question comes from Michael Freeman of Freeman James. Your line is already open.

Speaker #3: Hi there. I'm Adrian Mendes. Congratulations on winning this proposal. A big deal for the company, for patients, and I'm very happy for you. My first question, for you, is I wonder if you describe how you're communicating with your current customer base.

Speaker #3: About the Glare OCT: about its capabilities, about what's written and labeled, about how they might be able to adopt it, and then some of the feedback you might have already been receiving from them.

Sara Brien: Thanks, Steven. Good afternoon, everyone, and welcome to our Q4 and full year 2025 conference call. On behalf of the management team and everyone at Perimeter, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I'd like to provide a brief update on our preliminary unaudited financial results, but before I do, I want to highlight a defining milestone for Perimeter and the recent FDA PMA approval of our next generation AI-enabled Claire OCT device. We believe that this achievement marks a true inflection point for the company, validates our AI-enabled technology, and positions us at the beginning of a new phase of growth.

Sara Brien: Thanks, Steven. Good afternoon, everyone, and welcome to our Q4 and full year 2025 conference call. On behalf of the management team and everyone at Perimeter, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I'd like to provide a brief update on our preliminary unaudited financial results, but before I do, I want to highlight a defining milestone for Perimeter and the recent FDA PMA approval of our next generation AI-enabled Claire OCT device. We believe that this achievement marks a true inflection point for the company, validates our AI-enabled technology, and positions us at the beginning of a new phase of growth.

Speaker #2: Yeah, thanks, Michael. Thanks for the question—it's a great one. The nice thing about having been in market already with the S Series and having run this trial, and having the product going through GLARE, going through FDA, is that the surgeon community is well aware of what's coming down the line.

Speaker #2: They've been educated to some extent through different conferences and papers. So they have an idea—our existing customer base knows the benefits that the OCT portion of the technology can provide to them.

Speaker #2: And they understand what happens when you then add that AI assistant on top of that because they've seen it in conferences. They've seen the data from trials, etc., etc.

Sara Brien: Over the past several years, we have been deliberately building towards this moment by seeding the market with our S-Series platform, expanding our proprietary image library, and developing critical clinical and commercial experience. In many ways, we are only now just approaching that starting line. With Claire, we will be introducing a solution designed for a broader adoption with the potential to significantly increase adoption, both in terms of installed base and existing system utilization. We believe this will position Perimeter to scale in a way that was not previously possible and to drive meaningful value creation in the periods ahead. Adrian will provide additional detail on the progress we've made. I felt it was important to begin today's call by highlighting this exciting milestone for Perimeter and our shareholders.

Sara Brien: Over the past several years, we have been deliberately building towards this moment by seeding the market with our S-Series platform, expanding our proprietary image library, and developing critical clinical and commercial experience. In many ways, we are only now just approaching that starting line. With Claire, we will be introducing a solution designed for a broader adoption with the potential to significantly increase adoption, both in terms of installed base and existing system utilization. We believe this will position Perimeter to scale in a way that was not previously possible and to drive meaningful value creation in the periods ahead. Adrian will provide additional detail on the progress we've made. I felt it was important to begin today's call by highlighting this exciting milestone for Perimeter and our shareholders.

Speaker #2: And so that makes the conversation very easy. It's not like we're coming at them with a whole brand-new concept. And it's very intuitive for them to sort of understand what it means to go from the product they're using today into the next-generation product.

Speaker #2: So from the education standpoint, from a how it improves usability, how it improves outcomes, I think that those conversations are very easy. We're not starting from scratch on that.

Speaker #2: So, that's great. At this point in time, having gotten the approval just a few weeks ago—I think we're only up to week three at this point—the conversations we've been having with all our customers is, 'Okay, let's start to go through the contracting process,' and we've already started to get the Glare product into those customers.

Speaker #2: One thing we're very careful to do is to ensure that we are communicating the value of the AI, of the Glare, to customers and not 'giving it away for free.' So we're being quite disciplined in the way we're pricing the product.

Sara Brien: With that, let me turn to a brief review of our preliminary unaudited financial results for the quarter. To streamline things, all the numbers I will refer to have been rounded, so they are approximate. As a reminder, we also report in US dollars. For the three-month period ended 31 December 2025, the company recorded record quarterly revenue of $711 thousand, which consisted of recurring sales of S-Series consumables, system leases, and the sale of ESP warranty programs. This represents a 143% increase over Q4 2024. Operating expenses for Q4 2025 were $2.5 million. Additional savings from the company's cost control efforts implemented in June 2025 resulted in this 46% year-over-year improvement from $4.7 million in the same period in 2024.

Sara Brien: With that, let me turn to a brief review of our preliminary unaudited financial results for the quarter. To streamline things, all the numbers I will refer to have been rounded, so they are approximate. As a reminder, we also report in US dollars. For the three-month period ended 31 December 2025, the company recorded record quarterly revenue of $711 thousand, which consisted of recurring sales of S-Series consumables, system leases, and the sale of ESP warranty programs. This represents a 143% increase over Q4 2024. Operating expenses for Q4 2025 were $2.5 million. Additional savings from the company's cost control efforts implemented in June 2025 resulted in this 46% year-over-year improvement from $4.7 million in the same period in 2024.

Speaker #2: We're being quite disciplined in the way we're communicating those advantages to the purchasers, and we're working through that process now. So we expect over this quarter, this upcoming quarter, Q2, to be able to close on a handful of accounts, and we're looking forward to that.

Speaker #3: Excellent, thank you very much. And that leads into my next question nicely. I wonder if you could describe the ways that your revenue model might be evolving as you introduce Glare. If you could speak to pricing, and perhaps new revenue lines related to the AI and updates—perhaps subscriptions—that'd be helpful.

Speaker #2: Yeah, sure. So just as a baseline, the revenue model that we'll have for Glare will look similar, plus additional, as for the S Series. So the S Series, we've got three revenue streams.

Sara Brien: Q4 2025 net loss is $2 million or $0.02 per common share, a 42% improvement from $3.4 million or $0.06 per common share in the three months ended 31 December 2024. As of 31 December 2025, cash and cash equivalents were approximately $2.5 million. With that, I will now turn the call over to Adrian.

Sara Brien: Q4 2025 net loss is $2 million or $0.02 per common share, a 42% improvement from $3.4 million or $0.06 per common share in the three months ended 31 December 2024. As of 31 December 2025, cash and cash equivalents were approximately $2.5 million. With that, I will now turn the call over to Adrian.

Speaker #2: The primary one is from consumable sales, but the consumable is used one per patient via immobilizer. We also sell the imaging system itself, the parts, in some cases.

Speaker #2: And in the case where we don't sell them, we have a volume minimum volume guarantee that we ask our new customers to sign up for.

Speaker #2: And then we have service contracts. So which brings us in revenue on a regular basis. So those are our three current revenue streams: two of them are recurring, the consumable revenue and the service contract recurring, and one of them is not recurring, which is the device sales, when we sell the device.

Adrian Mendes: Thank you, Sara. Thanks again to everyone for your time and attention today. As you just heard from Sara, we delivered another strong quarter, including record revenue reflecting continued execution across our expanded commercial strategy. I want to take just a quick moment here to focus on the rebranding of our new product from B-Series to Claire OCT. We named the platform Claire, not just because it sounds elegant, but because it captures exactly what we aim to deliver, clarity. The name comes from the French word for clear and illuminating. It reflects our mission to help surgeons better visualize margins during breast conserving surgery. It's also intentionally feminine, keeping our focus on the millions of women impacted by breast cancer. Embedded within the name Claire, C-L-A-I-R-E, is a nod to the artificial intelligence that powers the additional insight we bring into the operating room.

Adrian Mendes: Thank you, Sara. Thanks again to everyone for your time and attention today. As you just heard from Sara, we delivered another strong quarter, including record revenue reflecting continued execution across our expanded commercial strategy. I want to take just a quick moment here to focus on the rebranding of our new product from B-Series to Claire OCT. We named the platform Claire, not just because it sounds elegant, but because it captures exactly what we aim to deliver, clarity. The name comes from the French word for clear and illuminating. It reflects our mission to help surgeons better visualize margins during breast conserving surgery. It's also intentionally feminine, keeping our focus on the millions of women impacted by breast cancer. Embedded within the name Claire, C-L-A-I-R-E, is a nod to the artificial intelligence that powers the additional insight we bring into the operating room.

Speaker #2: The way we're coming to market with the AI is to make sure that there are really two different models we're looking at right now. One is to have a model where we sell a version of the AI upfront, which allows the customer access to that initial version.

Speaker #2: But as we do major upgrades to that version, there will be an upgrade fee attached to that. So that's one model. The other model we're looking at and working with customers on is a per-procedure model.

Speaker #2: We're really there to—so what's important for us is to make sure that we're able to monetize all of the advantages and value that the AI brings to the customer.

Speaker #2: And in terms of how we monetize it, we're fairly agnostic. And there's, I mean, it's kind of just math. So we can make the math work in either of those two different models.

Adrian Mendes: As Sara mentioned, our primary goal last year was to seed the market with S-Series OCT in order to create a strong foundation of early adopters and technology champions in preparation for a potential FDA approval and subsequent commercial rollout of Claire. We consistently executed toward achieving that objective since the start of 2025, and Q4 is illustrative of that. Adoption of the S-Series device accelerated even as we and our current customers waited for the requisite go-ahead from the FDA to introduce Claire to the market. To put that into perspective, we were excited to see total revenues from the S-Series more than double year over year in Q4. Contrary to what one might expect with the pending FDA PMA approval of an AI-enabled, more user-friendly next generation device.

Adrian Mendes: As Sara mentioned, our primary goal last year was to seed the market with S-Series OCT in order to create a strong foundation of early adopters and technology champions in preparation for a potential FDA approval and subsequent commercial rollout of Claire. We consistently executed toward achieving that objective since the start of 2025, and Q4 is illustrative of that. Adoption of the S-Series device accelerated even as we and our current customers waited for the requisite go-ahead from the FDA to introduce Claire to the market. To put that into perspective, we were excited to see total revenues from the S-Series more than double year over year in Q4. Contrary to what one might expect with the pending FDA PMA approval of an AI-enabled, more user-friendly next generation device.

Speaker #2: But what's important to us is to be able to monetize that in some sort of continuous revenue model, sorry, recurring revenue model, and as we continue to go through the negotiation process, we'll see which one ends up being more attractive to different customers.

Speaker #3: That's great, that's great. Again, just squeezing in a few more questions. Could you share if you're able to see the total number of OCT devices that have been installed by your end, if you're able to share, up to today?

Speaker #3: And then if you could share your expectations for OPEX during 2026 relative to fourth-quarter levels.

Speaker #2: Yeah, maybe I'll hand that to Sarah to take.

Adrian Mendes: With respect to Claire, as Sara also mentioned, our PMA application was approved by the FDA in line with our timing expectations at the beginning of March 2026. There are several advantages of PMA approval for Claire over the previous 510(k) clearance for our first generation S-Series device. The first is that PMA creates a higher barrier to entry for competitors. Secondly, the PMA pathway requires extensive clinical evidence to demonstrate safety and effectiveness of the device. In that regard, our PMA application was supported by the strong pivotal trial results for Claire, where the primary endpoint of a statistically significant reduction in patients with residual cancer during breast conserving surgery was met with a P value of 0.005 in superiority compared to standard of care alone was achieved.

Adrian Mendes: With respect to Claire, as Sara also mentioned, our PMA application was approved by the FDA in line with our timing expectations at the beginning of March 2026. There are several advantages of PMA approval for Claire over the previous 510(k) clearance for our first generation S-Series device. The first is that PMA creates a higher barrier to entry for competitors. Secondly, the PMA pathway requires extensive clinical evidence to demonstrate safety and effectiveness of the device. In that regard, our PMA application was supported by the strong pivotal trial results for Claire, where the primary endpoint of a statistically significant reduction in patients with residual cancer during breast conserving surgery was met with a P value of 0.005 in superiority compared to standard of care alone was achieved.

Speaker #4: In some case, at the end of 2025, it's 23 devices there. With regards to OPEX, we're anticipating a similar level of OPEX in the next few quarters.

Speaker #3: Okay. And then do you have expectations as to scale further up in this kind of 2026?

Speaker #4: Yes, as we look to expand our commercial team and operations.

Speaker #3: Yeah. Yep. That's rational. Okay, thank you very much. Congrats again, and I'll pass the line.

Speaker #5: There are no further questions at this time. I would now hand over the call to Adrian Mendes for closing comments. Go ahead.

Speaker #2: Okay, thank you. And thanks, everyone, for joining our call today. As you can see, we are stronger and more focused than we've ever been. We have optimized our commercial engine, and we've aligned our infrastructure with long-term scale.

Adrian Mendes: Third, a PMA approval signals to hospitals and surgeons a high level of FDA scrutiny and review, helping to build credibility and confidence in the product's safety and effectiveness. With all that being said, we've now added a third moat to our business. We believe our PMA approval establishes a high regulatory barrier to entry, while our patented OCT technology and proprietary imaging capabilities differentiate our platform at the point of care. In addition to both of those, the image library we've built over time serves as a critical foundation for our AI engine, creating a data advantage that we expect will continue to improve performance and clinical utility over time. We believe these three moats, regulatory, imaging system, and multi-million image data library, positions Perimeter to sustain leadership as adoption of intraoperative imaging and AI continues to grow.

Adrian Mendes: Third, a PMA approval signals to hospitals and surgeons a high level of FDA scrutiny and review, helping to build credibility and confidence in the product's safety and effectiveness. With all that being said, we've now added a third moat to our business. We believe our PMA approval establishes a high regulatory barrier to entry, while our patented OCT technology and proprietary imaging capabilities differentiate our platform at the point of care. In addition to both of those, the image library we've built over time serves as a critical foundation for our AI engine, creating a data advantage that we expect will continue to improve performance and clinical utility over time. We believe these three moats, regulatory, imaging system, and multi-million image data library, positions Perimeter to sustain leadership as adoption of intraoperative imaging and AI continues to grow.

Speaker #2: We ended the fourth quarter with a leaner, more efficient platform that positioned to drive durable growth. And we expect that growth to start accelerating as a result of the launch of the next-gen AI-powered Glare OCT product.

Speaker #2: We believe there's a clear inflection in momentum in 2025. Supported by higher utilization, stronger surge in engagement, and expanding clinical adoption. This bodes incredibly well for what we see as a potential breakout in 2026 and beyond as we deepen hospital penetration and scale procedure volumes via the commercial rollout of Glare.

Speaker #2: We're in very exciting times here at Perimeter, and we thank you for your interest and support.

Adrian Mendes: It's also important to note that Claire has also received FDA Breakthrough Device designation before our PMA application was submitted. That helped us while the FDA conducted its substantive review of the PMA application. While I don't want to go into too much of its future potential implications at this stage, I will say that we believe it should help us with securing reimbursement for the technology as we move forward with our US commercialization strategy. Perimeter is clearly at an important inflection point as we look to leverage the clinical and the commercial adoption of the FDA 510(k) cleared first generation S-Series OCT and prepare to soon begin bringing game-changing FDA PMA approved AI innovation to operating rooms nationwide via the pending rollout of Claire.

Adrian Mendes: It's also important to note that Claire has also received FDA Breakthrough Device designation before our PMA application was submitted. That helped us while the FDA conducted its substantive review of the PMA application. While I don't want to go into too much of its future potential implications at this stage, I will say that we believe it should help us with securing reimbursement for the technology as we move forward with our US commercialization strategy. Perimeter is clearly at an important inflection point as we look to leverage the clinical and the commercial adoption of the FDA 510(k) cleared first generation S-Series OCT and prepare to soon begin bringing game-changing FDA PMA approved AI innovation to operating rooms nationwide via the pending rollout of Claire.

Adrian Mendes: If so, to summarize the incredible progress we're making, first, we delivered yet another quarter of positive commercial traction with our current S-Series product, as demonstrated by our 143% revenue growth in Q4. Secondly, we were carefully managing our resources as we grow. As a result of our cost control efforts, we were able to reduce operating expenses by 46% in the quarter. Third, we received FDA PMA approval for our next generation AI-enabled Claire device in early March 2026. Finally, now that FDA approval for Claire has been achieved, we are making final preparations for a full and aggressive commercial launch, representing a major step in our go-to-market strategy for intraoperative cancer margin assessment with OCT and an opportunity to significantly broaden our US base, our customer base across the US.

Adrian Mendes: If so, to summarize the incredible progress we're making, first, we delivered yet another quarter of positive commercial traction with our current S-Series product, as demonstrated by our 143% revenue growth in Q4. Secondly, we were carefully managing our resources as we grow. As a result of our cost control efforts, we were able to reduce operating expenses by 46% in the quarter. Third, we received FDA PMA approval for our next generation AI-enabled Claire device in early March 2026. Finally, now that FDA approval for Claire has been achieved, we are making final preparations for a full and aggressive commercial launch, representing a major step in our go-to-market strategy for intraoperative cancer margin assessment with OCT and an opportunity to significantly broaden our US base, our customer base across the US.

Adrian Mendes: As we move forward through 2026, our commercialization strategy will be focused on leveraging our existing installed base and expanding within leading healthcare institutions, while also targeting new accounts through a combination of clinical validation, surgeon education, and direct sales efforts. We believe our early investments in building clinical champions and generating real-world data will enable a more efficient and scalable go-to-market approach for Claire. Based on the level of engagement we are seeing, we expect to close our first commercial sale or sales of Claire in Q2, making an important initial step in what we believe will be a broader adoption cycle over time. Importantly, our model is designed to scale as adoption increases, with revenue driven not only by system placements, but also by growing consumable scan volumes.

Adrian Mendes: As we move forward through 2026, our commercialization strategy will be focused on leveraging our existing installed base and expanding within leading healthcare institutions, while also targeting new accounts through a combination of clinical validation, surgeon education, and direct sales efforts. We believe our early investments in building clinical champions and generating real-world data will enable a more efficient and scalable go-to-market approach for Claire. Based on the level of engagement we are seeing, we expect to close our first commercial sale or sales of Claire in Q2, making an important initial step in what we believe will be a broader adoption cycle over time. Importantly, our model is designed to scale as adoption increases, with revenue driven not only by system placements, but also by growing consumable scan volumes.

Adrian Mendes: As we expand our install base and drive deeper usage within our existing accounts, we expect to see increased system utilization, which in turn supports a higher margin recurring revenue stream from the sale of per procedure consumables. Over time, we believe increased adoption of Claire will position Perimeter to deliver attractive revenue visibility and operating leverage. As excited as we are about the tremendous growth opportunity we see ahead in breast conserving surgery, we also believe the introduction of Claire represents the beginning of an even broader platform opportunity. As we continue to advance our clinical data, AI capabilities, and product roadmap, we do see the potential to expand Perimeter's AI-enabled OCT technology beyond breast conserving surgery and into additional applications, further increasing our addressable market and reinforcing our long-term growth trajectory.

Adrian Mendes: As we expand our install base and drive deeper usage within our existing accounts, we expect to see increased system utilization, which in turn supports a higher margin recurring revenue stream from the sale of per procedure consumables. Over time, we believe increased adoption of Claire will position Perimeter to deliver attractive revenue visibility and operating leverage. As excited as we are about the tremendous growth opportunity we see ahead in breast conserving surgery, we also believe the introduction of Claire represents the beginning of an even broader platform opportunity. As we continue to advance our clinical data, AI capabilities, and product roadmap, we do see the potential to expand Perimeter's AI-enabled OCT technology beyond breast conserving surgery and into additional applications, further increasing our addressable market and reinforcing our long-term growth trajectory.

Adrian Mendes: As you can see, this is an exciting time for us, and we look forward to keeping you updated on our progress. With that, I will now open up the call for your questions. Operator?

Adrian Mendes: As you can see, this is an exciting time for us, and we look forward to keeping you updated on our progress. With that, I will now open up the call for your questions. Operator?

Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Your first question comes from Michael W. Freeman of Raymond James. Your line is already open.

Operator: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question. Your first question comes from Michael W. Freeman of Raymond James. Your line is already open.

Michael Freeman: Hi there, Adrian, Andrew, Sara. Congratulations on winning this approval. This is a big deal for the company, for patients, and I'm very happy for you. My first question for you is I wonder if you could describe how you're communicating with your current customer base about the Claire OCT, you know, about its capabilities, you know, what's written in the label, about how, you know, how they might be able to adopt it, and then some of the feedback you might have been already receiving from them.

Michael Freeman: Hi there, Adrian, Andrew, Sara. Congratulations on winning this approval. This is a big deal for the company, for patients, and I'm very happy for you. My first question for you is I wonder if you could describe how you're communicating with your current customer base about the Claire OCT, you know, about its capabilities, you know, what's written in the label, about how, you know, how they might be able to adopt it, and then some of the feedback you might have been already receiving from them.

Adrian Mendes: Yeah. Thanks, Michael. Thanks for the question. It's a great one. The nice thing about having been in market already with the S-Series, and having run this trial, and having the product going through, you know, Claire going through FDA, is that the surgeon community is well aware of what's coming down the line. They've been educated to some extent through different conferences and papers, so they have an idea. Our existing customer base knows the benefits that the OCT portion of the technology can provide to them, and they understand what happens when you then add that AI assistant on top of that, because they've seen it in conferences, they've seen the data from the trial, et cetera, et cetera. That makes the conversation very easy. It's not like we're coming at them with a whole brand new concept.

Adrian Mendes: Yeah. Thanks, Michael. Thanks for the question. It's a great one. The nice thing about having been in market already with the S-Series, and having run this trial, and having the product going through, you know, Claire going through FDA, is that the surgeon community is well aware of what's coming down the line. They've been educated to some extent through different conferences and papers, so they have an idea. Our existing customer base knows the benefits that the OCT portion of the technology can provide to them, and they understand what happens when you then add that AI assistant on top of that, because they've seen it in conferences, they've seen the data from the trial, et cetera, et cetera. That makes the conversation very easy. It's not like we're coming at them with a whole brand new concept.

Adrian Mendes: It's very intuitive for them to see, to sort of understand what it means to go from the product they're using today into the next generation product. From an education standpoint, from a user standpoint, how it improves usability, how it improves outcomes, you know, I think those conversations are very easy. We're not starting from scratch on that, so that's great. At this point in time, having gotten the approval just a few weeks ago, I think we're only up to like week three at this point. The conversations we've been having with all our customers is, okay, let's start to go through the contracting process, and we've already started to get the Claire product into, you know, into those customers.

Adrian Mendes: It's very intuitive for them to see, to sort of understand what it means to go from the product they're using today into the next generation product. From an education standpoint, from a user standpoint, how it improves usability, how it improves outcomes, you know, I think those conversations are very easy. We're not starting from scratch on that, so that's great. At this point in time, having gotten the approval just a few weeks ago, I think we're only up to like week three at this point. The conversations we've been having with all our customers is, okay, let's start to go through the contracting process, and we've already started to get the Claire product into, you know, into those customers.

Adrian Mendes: One thing we're being very careful to do is to ensure that we are communicating the value of the AI, of the Claire to customers and not, quote-unquote, "giving it away for free." We're being quite disciplined in the way we're pricing the product. We're being quite disciplined in the way we're communicating those advantages to the purchasers, and we're working through that process now. We expect over this upcoming Q2 to be able to close on a handful of accounts, and we're looking forward to that.

Adrian Mendes: One thing we're being very careful to do is to ensure that we are communicating the value of the AI, of the Claire to customers and not, quote-unquote, "giving it away for free." We're being quite disciplined in the way we're pricing the product. We're being quite disciplined in the way we're communicating those advantages to the purchasers, and we're working through that process now. We expect over this upcoming Q2 to be able to close on a handful of accounts, and we're looking forward to that.

Michael Freeman: Excellent. Thank you very much. That just leads into my next question nicely. I wonder if you could describe the ways that your revenue model might be evolving as you introduce Claire. If you could speak to pricing, speak to perhaps new revenue lines related to the AI and updates, perhaps subscriptions, that'd be helpful.

Michael Freeman: Excellent. Thank you very much. That just leads into my next question nicely. I wonder if you could describe the ways that your revenue model might be evolving as you introduce Claire. If you could speak to pricing, speak to perhaps new revenue lines related to the AI and updates, perhaps subscriptions, that'd be helpful.

Adrian Mendes: Yeah, sure. Just a baseline, the revenue model that we'll have for Claire will look similar plus additional, as for the S-Series. The S-Series, we've got three revenue streams. The primary one is from the consumable sales of the consumable used one per patient, the ImgAssist. We also sell the imaging system itself, the carts, in some cases. In the cases where we don't sell them, we have a minimum volume guarantee that we ask our new customers to sign up for. We have service contracts, which brings us in revenue, you know, on a regular basis. Those are our three current revenue streams.

Adrian Mendes: Yeah, sure. Just a baseline, the revenue model that we'll have for Claire will look similar plus additional, as for the S-Series. The S-Series, we've got three revenue streams. The primary one is from the consumable sales of the consumable used one per patient, the ImgAssist. We also sell the imaging system itself, the carts, in some cases. In the cases where we don't sell them, we have a minimum volume guarantee that we ask our new customers to sign up for. We have service contracts, which brings us in revenue, you know, on a regular basis. Those are our three current revenue streams.

Adrian Mendes: Two of them are recurring, the consumable revenue and the service contract recurring, and one of them is not recurring, which is the device sales, when we sell the device. The way we're coming to market with the AI is to make that. There's really two different models we're looking at right now. One is to have a model where we sell a version of the AI, upfront, which allows the customer access to that initial version. As we do major upgrades to that version, there will be an upgrade fee attached to that. That's one model. The other model we're looking at and working with customers on is on a per procedure model.

Adrian Mendes: Two of them are recurring, the consumable revenue and the service contract recurring, and one of them is not recurring, which is the device sales, when we sell the device. The way we're coming to market with the AI is to make that. There's really two different models we're looking at right now. One is to have a model where we sell a version of the AI, upfront, which allows the customer access to that initial version. As we do major upgrades to that version, there will be an upgrade fee attached to that. That's one model. The other model we're looking at and working with customers on is on a per procedure model.

Adrian Mendes: What's important for us is to make sure that we're able to monetize all of the advantages, and value that the AI brings to the customer. In terms of how we monetize this, we're fairly agnostic. I mean, it's kind of just math. We can make the math work in either of those two different models. What's important to us is to be able to monetize that in some sort of continuous revenue model, or sorry, recurring revenue model. As we continue to go through these negotiation process, we'll see which one ends up being more attractive to different customers.

Adrian Mendes: What's important for us is to make sure that we're able to monetize all of the advantages, and value that the AI brings to the customer. In terms of how we monetize this, we're fairly agnostic. I mean, it's kind of just math. We can make the math work in either of those two different models. What's important to us is to be able to monetize that in some sort of continuous revenue model, or sorry, recurring revenue model. As we continue to go through these negotiation process, we'll see which one ends up being more attractive to different customers.

Michael Freeman: That's great. If I could just squeeze in a few modeling questions. Could you share, if you're able, the total number of OCT devices that you've installed, I guess by year-end, and if you're able to share up to today. If you could share your expectations for OpEx during 2026, relative to Q4 levels.

Michael Freeman: That's great. If I could just squeeze in a few modeling questions. Could you share, if you're able, the total number of OCT devices that you've installed, I guess by year-end, and if you're able to share up to today. If you could share your expectations for OpEx during 2026, relative to Q4 levels.

Adrian Mendes: Yeah. Maybe I'll hand that to Sara to take.

Adrian Mendes: Yeah. Maybe I'll hand that to Sara to take.

Sara Brien: The install base at the end of 2025 is 23 devices out there. With regards to OpEx, you know, we're anticipating a similar level of OpEx in the next few quarters.

Sara Brien: The install base at the end of 2025 is 23 devices out there. With regards to OpEx, you know, we're anticipating a similar level of OpEx in the next few quarters.

Michael Freeman: Okay. Do you have expectations to scale for it to ramp up in H2 2026?

Michael Freeman: Okay. Do you have expectations to scale for it to ramp up in H2 2026?

Sara Brien: Yes, as we look to expand our commercial team and operations.

Sara Brien: Yes, as we look to expand our commercial team and operations.

Michael Freeman: Yeah. Yes. That's rational. Okay. Thank you very much. Congrats again, and I'll pass the line.

Michael Freeman: Yeah. Yes. That's rational. Okay. Thank you very much. Congrats again, and I'll pass the line.

Operator: There are no further questions at this time. I would hand over the call to Adrian Mendes for closing comments. Please go ahead.

Operator: There are no further questions at this time. I would hand over the call to Adrian Mendes for closing comments. Please go ahead.

Adrian Mendes: Okay. Thank you. Thanks to everyone for joining our call today. As you can see, Perimeter is stronger and more focused than we've ever been. We have optimized our commercial engine, and we've aligned our infrastructure with long-term scale. We ended Q4 with a leaner and more efficient platform that's positioned to drive durable growth, and we expect that growth to start accelerating as a result of the launch of the next gen AI-powered Claire OCT product. We believe there was a clear inflection in momentum in 2025, supported by higher utilization, stronger surgeon engagement, and expanding clinical adoption. This bodes incredibly well for what we see as a potential breakout in 2026 and beyond as we deepen hospital penetration and scale procedure volumes via the commercial rollout of Claire.

Adrian Mendes: Okay. Thank you. Thanks to everyone for joining our call today. As you can see, Perimeter is stronger and more focused than we've ever been. We have optimized our commercial engine, and we've aligned our infrastructure with long-term scale. We ended Q4 with a leaner and more efficient platform that's positioned to drive durable growth, and we expect that growth to start accelerating as a result of the launch of the next gen AI-powered Claire OCT product. We believe there was a clear inflection in momentum in 2025, supported by higher utilization, stronger surgeon engagement, and expanding clinical adoption. This bodes incredibly well for what we see as a potential breakout in 2026 and beyond as we deepen hospital penetration and scale procedure volumes via the commercial rollout of Claire.

Adrian Mendes: We're in very exciting times here at Perimeter, and we thank you for your interest and support.

Adrian Mendes: We're in very exciting times here at Perimeter, and we thank you for your interest and support.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and you may now disconnect.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and you may now disconnect.

Q4 2025 Perimeter Medical Imaging AI Inc Earnings Call

Demo
PINK.V

Perimeter Medical Imaging AI

Earnings

Q4 2025 Perimeter Medical Imaging AI Inc Earnings Call

PINK.V

Tuesday, March 31st, 2026 at 9:00 PM

Transcript

No Transcript Available

No transcript data is available for this event yet. Transcripts typically become available shortly after an earnings call ends.

Want AI-powered analysis? Try AllMind AI →