管理層發言
Good day, and thank you for standing by. Welcome to ProFound Medical's Second Quarter 2026 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Stephen Kilmer, Investor Relations.
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 in the United States and Canada. All forward-looking statements are based on ProFound's current beliefs, assumptions and expectations, and relate to, among other things, any expressed or implied statements or guidance regarding current or future financial performance, position and expectations regarding the efficacy of ProFound's technology. Such statements involve known and unknown risks and uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from those implied by such statements. No forward-looking statement can be guaranteed. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. ProFound 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. Representing the company today are Arun Swarup Menawat, Co-Founder, Chief Executive Officer and Chairman; Mathieu Burtnyk, ProFound's President; and Tom Tamberrino, our Chief Commercial Officer. Also filling in for our CFO, Rashed, due to a scheduling issue, is our Corporate Controller, Matthew Sobczyk. With that said, I will now turn the call over to Arun.
Good afternoon, everyone. And welcome to the second quarter 2026 Conference Call. On behalf of the management team, and everyone at ProFound, 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 will turn the call over to Mathieu in a moment to provide clinical updates. However, before I do, I would like to provide a brief summary of our second quarter 2026 financial results. All of the numbers I will refer to have been rounded, so they are approximate. For the three-month period ended June 30, 2026, the company recorded revenue of $2.5 million with $1.6 million from recurring revenue and $871 thousand from capital equipment sales. Second quarter 2026 revenue was up 12% from $2.2 million for the same three-month period a year ago. As noted in today's press release, this does not fully reflect our sales performance in Q2 2026. $3.1 million of TULSA product shipments originally anticipated in the final weeks of June were completed in July, affecting the period of revenue recognition. Excluding the shipment timing, second quarter revenue would have been approximately $5.6 million, representing a 153% year-over-year growth. Gross margin in Q2 2026 was 78% compared to 73% in Q2 2025. We continue to have confidence that the gross margin for our business will remain above our stated goal of over 70% over the long haul. Total operating expenses in the second quarter of 2026 were $13 million, down 16% from $15.4 million in the second quarter of 2025. Overall, the company recorded a second quarter 2026 net loss of $9.5 million, or $0.26 per common share, compared to a net loss of approximately $15.7 million, or $0.52 per common share, in the three months ended June 30, 2025. As of June 30, 2026, ProFound had cash of $38.3 million. As Tom and Arun will discuss later in the call, despite the revenue recognition timing issue in the second quarter, based on record order activity, ProFound continues to project total revenue for full-year 2026 to be approximately $25 million, which represents 56% growth compared to prior year revenue.
With that, I will now provide an update on clinical and development activities. Thank you, and good afternoon. On past calls, I have highlighted the growing body of clinical evidence supporting the TULSA procedure as a new platform for prostate disease management, capable of delivering whole-gland treatment efficacy while preserving quality of life. The CAPTAIN trial has already proven that TULSA delivered statistically superior quality of life outcomes compared to robotic radical prostatectomy, achieving its primary safety endpoint with statistically higher preservation of the composite endpoint of urinary incontinence and erectile function at six months. In addition, patients treated with TULSA experienced superior perioperative outcomes including no blood loss, no overnight hospital stay, less pain, and faster recovery, along with statistically significantly fewer serious complications and a faster return to normal activities and paid employment. Most recently, at SRS, we presented positive incremental data from CAPTAIN demonstrating that whole-gland TULSA provided statistically superior penile length preservation compared to robotic prostatectomy. At one month following the TULSA procedure, there was no median change in penile length after TULSA compared with a median 0.65-centimeter reduction in penile length after robotic prostatectomy. To some people, and please pardon the pun, that might not sound like a super big deal. But even modest amounts of penile shortening can contribute meaningfully to patient distress and reduce satisfaction following treatment. This new data points to the greater peace of mind that the TULSA procedure can deliver to patients by gently, safely, and precisely ablating prostate tissue while actively protecting surrounding structures such as the prostatic urethra. As we noted before, one of CAPTAIN's primary objectives is to support broader payer coverage. Randomized controlled trials remain the gold standard for coverage decisions, and CAPTAIN continues to generate evidence demonstrating meaningful quality of life advantages that resonate with both patients and payers. In addition to ongoing CAPTAIN readouts and analyses, the clinical value of TULSA is continuing to become sharper as presentations focus more on what specifically make TULSA most versatile. Beyond demonstrating overall efficacy and quality of life benefits, ongoing clinical analyses are increasingly helping physicians understand where TULSA's capabilities may be particularly valuable. Examples include patients with apical cancer, where the enhanced visualization of the MRI allows urologists to precisely carve out tumor from the boundary of the sphincter muscle that controls continence. These patients almost always end up with urinary incontinence following robotic radical prostatectomy, but their continence can almost always be saved if treated with TULSA. Secondly, patients with unilateral disease, or cancer on one side of the prostate, where the nerves that maintain erectile function can be spared by not ablating the benign side of the prostate. Thirdly, patients where multiparametric MRI provides a clear hot zone that is suspicious for cancer within the prostate, thereby giving surgeons better guidance of what part of the prostate to target. And patients with very large prostates, where TULSA has demonstrated treatment flexibility without the increased side effect burden often associated with other modalities. I would like to conclude my remarks by reiterating that as gold-standard treatment findings detect durable five-year outcomes, generating compelling Level 1 data, the clinical foundation supporting TULSA continues to strengthen. We believe this growing body of evidence increasingly positions TULSA as a differentiated platform capable of delivering whole-gland efficacy, superior quality of life outcomes, and expanded reimbursement support.
Thank you. There is no question that momentum in our business is continuing to build. As Matthew Sobczyk mentioned, we recorded a year-over-year increase of 12% which would have been 153% absent the $3.1 million shift in Q2 orders that were shipped in July and will be recognized in the current quarter. Speaking of temporary interruptions, you may have also noticed that while same-store sequential quarter-over-quarter growth as measured by our new Index 20 declined by 12%, it grew 39% in the first half of 2026 over the same period in 2025 and 22% year-over-year. The sequential change was mainly attributable to five sites not realizing the expected growth due to short-term issues. For example, one of the sites converted from a placement to a capital model in Q2 and paused treatments during the transition. That site is now back online. Despite these one-time and temporary issues, Q2 2026 marked another true commercial inflection point, and so far we have seen that momentum continue into Q3. We estimate that our qualified sales pipeline, defined as being within verify, negotiate and contracting stages for TULSA PRO and Sonalleve, is now $70 million. While we cannot predict the extent and timing with which that qualified sales pipeline will translate into recognized revenue, it has been growing steadily, which certainly bodes well for the future. We had another monthly record for new orders in July, none of which included any of the shift or rollover from Q2. And SRS-26 was the most productive medical meeting I have ever been a part of. To put that into perspective, our team's work generated more than 160 qualified leads over the four days of the event—around four or five new commercial opportunities per hour. Again, it is not possible to predict what number will translate into actual sales, but it is also boding well for the future. Three additional tailwinds helping drive our commercial momentum acceleration are higher and expanding reimbursement. With respect to Medicare, a few weeks ago CMS released the current-year 2027 Hospital Outpatient Prospective Payment System, or OPPS, and Ambulatory Surgical Center, or ASC, proposed rules. Under the OPPS proposal, TULSA furthers its favorable reimbursement level relative to other treatment modalities. To summarize those proposed changes, TULSA remains at urology APC Level 7, with OPPS payment increasing 14.9% to $15.5 thousand per procedure. That compares to an 11.6% increase for HIFU and Aquablation to $10.8 thousand and $12.3 thousand for robotic radical prostatectomy. So, assuming the final rule does not change these numbers, starting in January 2027 hospitals would be paid 44% or $4.7 thousand more per procedure for TULSA than HIFU and Aquablation, and 26% or $3.19 thousand more for TULSA than robotic radical prostatectomy. Keeping in mind that hospitals can generally perform as many or more TULSA procedures versus those other modalities in a day, our premium there is clearly growing, making our relative profitability for hospitals higher as well. With respect to ASCs, the proposed rule would reduce TULSA to $6.87 thousand; however, we do not currently have any active ASC sites, and we believe there may be an opportunity for us to correct the hospital cost reporting that appears to have driven the reduction. On the physician payment schedule side, TULSA is more than holding its ground as well when viewed on an apples-to-apples basis. Adjusting for the fact that TULSA is a zero-day procedure while competitors often have a 90-day period, physicians will be paid $880 for each TULSA procedure compared to $865 for HIFU, $1,060 for robotic radical prostatectomy and $539 for Aquablation. Turning to other payers, coverage for the TULSA procedure expanded by approximately 18.3 million covered lives during the second quarter. Most of the newly covered lives came through state Medicaid and managed Medicaid and similar programs. This follows the addition of 8.5 million covered lives in the first quarter, which included 6.9 million covered lives with Humana. And just today, we announced that the Johns Hopkins and the Prime Healthcare employee health plans, together covering more than 105 thousand employees, medical staff and family members, became the first employer-owned health plans to list the TULSA procedure as a covered service. And we are just getting started. ProFound will continue to work collaboratively with payers, providers and health systems to expand coverage and streamline patient access pathways for the TULSA procedure. Looking ahead, I am confident in our ability to further accelerate. We are well positioned to capitalize on the expanding interest in image-guided, incisionless and autonomous robotic surgery. We are anticipating an extended reimbursement premium for TULSA in hospitals and for physicians. We are growing an already formidable body of evidence demonstrating the superiority of our technology, and we are continuing to scale our commercial footprint both at home and abroad. Thank you for your time. I will turn the call over to Arun now.
Thanks, Tom, and good afternoon, everyone. As I discussed in our Q1 call, the dynamics in the prostate disease treatment space continue to change at a rapid pace. Open or robotic prostatectomy and radiation therapy are the standard of care for treating prostate cancer today. And for BPH, mainstream treatment with transurethral resection of the prostate, or TURP, has largely been unchanged over the past 100 years. It remains our belief that today's standards have plateaued and that we can do better than the clinical outcomes from these standards. Just a few days ago, at SRS 2026, we saw firsthand that robotic surgeons are beginning to not only understand the potential of TULSA clinically, but also recognize that TULSA is the only prostate treatment system that is MRI guided. TULSA is the only modality that offers the flexibility to treat the prostate gland regionally, meaning whole-gland or near-gland, subtotal, or focal ablation. The time for incisionless surgery has come. The most tangible evidence of this is that the new Society of Incisionless Surgery, or SIS, began its activities at SRS 2026, and ProFound, HistoSonics and InsightSAC are among the most prominent founding members of the new society. TULSA is the only modality that deploys supervised robotic autonomy, meaning it executes predetermined and/or AI-driven tasks independently. This compares to all competitive so-called master-slave robotic systems that rely entirely on direct real-time human hand movement and control. Today, TULSA's autonomous robotics enables operators to deliver consistent, highly personalized treatment based on each patient's unique anatomy and disease. In the future, it may also give us an even stronger competitive advantage as incisionless surgery advances to its next frontier, including potentially tele-ablation. With respect to MRI guidance, I would like to directly address what many of our competitors have tried to use as a mark against TULSA. While it is true that when we first started commercialization, finding compatible MR available time and convincing urology and radiology to work together to adopt a program was a hurdle to climb, today TULSA is compatible with an installed base of about 5,000 MRs in the United States and more worldwide, and that number continues to grow. It is therefore a lot easier to find an MR and justify TULSA, particularly with the economic proposition as its facility fee is already higher than that of any other treatment modality and based on the proposal for 2027, the TULSA premium is only going to get higher. Our relationship with MR companies also continues to expand as they see interventional MRs as a growth opportunity for them too. And as we have talked about on past calls, MRs specifically designed for interventional procedures are now becoming commercially available. These MRs are significantly smaller, lighter, and easier to use to the point that even an MR tech is not necessary to operate them. They are also less costly to acquire and maintain and can be placed just about anywhere since they do not need the same shielding as larger magnets. The Siemens Free.Max series is a prime example of such an MR. Hook Medical has created an iMRI division with the purpose of selling a turnkey interventional MR solution to hospitals that includes the smaller Siemens MR. The idea is that just as cath labs and robotic operating rooms were created in the past, the future is about creating interventional MR suites. We currently anticipate that if all goes well, TULSA will get FDA clearance for integration with the Siemens Free.Max by early next year, and we believe that will meaningfully contribute to our growth in 2027. And we are not stopping with TULSA image guidance at MRI. In May, Illuccix Pharmaceuticals announced a collaboration with us as well as with a competitor that focuses on focal therapy. Illuccix makes a PSMA PET imaging agent that binds preferentially to prostate cancer and provides a clear view of the geographic location of cancer within the prostate. Our team is exploring the potential to integrate these types of PSMA images into the TULSA PRO treatment planning software. Approximately 85% of prostate cancer is multifocal, meaning there are two or more distinct index lesions and/or satellite lesions present in different areas of the organ. The other 15% is unifocal, meaning there is only one distinct index lesion. It follows that whole-gland and subtotal ablation is likely the most appropriate approach for the vast majority of prostate cancer that is multifocal, while focal ablation may be best for patients with unifocal disease. We are already seeing urologists use PSMA to complement MRI to better define treatment extent with appropriate margins extending to the prostate capsule. So for TULSA, this is not about patient selection; it is about empowering physicians to plan and deliver the best possible regional ablation from whole-gland to focal and everything in between. To summarize, ProFound is pioneering iMRI procedures which enable precise incisionless therapies that improve clinical confidence, procedural control, and patient outcomes. By leveraging real-time MRI guidance and autonomous robotics, ProFound's technologies are designed to replace uncertainty with consistency and clarity across treatment planning, delivery and confirmation. In prostate cancer, we believe we are now crossing the chasm by transitioning TULSA from early-adopter customers to the mainstream market by establishing the technology as a third distinct regional ablation category that lets physicians or patients choose between whole-gland or focal treatments because TULSA can do both, and anything in between. The TULSA PRO install base was 84 at the end of Q2 2026. We estimate that the current aggregate total dollar value of our qualified sales pipeline for TULSA PRO and Sonalleve is approximately $70 million. We are reiterating our approximate $25 million total revenue outlook for full year 2026, which represents 56% growth compared to 2025. We also continue to expect full-year gross margin to be 70% or higher. Based on the CMS proposed rule for 2027, the premium hospitals are reimbursed for TULSA over competing technologies is expanding, and at the same time more and more lives are being covered by other payers including employer-owned health plans. We continue to believe that we are on a path to profitable growth. This ends our prepared remarks for today. With that, we are happy to take any questions you might have. Operator.
分析師問答
At this time, we will conduct a question-and-answer session. As a reminder, to ask a question, you will need to press 11 on your telephone, and wait for your name to be announced. To withdraw your question, please press 11 again. Please stand by. First question comes from the line of Ben Haynor of Lake Street Capital Markets. Your line is now open.
Good afternoon, gentlemen. Thanks for taking the questions. First off, just thinking about the $3.1 million that slipped from Q2 to Q3, is that both capital and consumables? And then just generally speaking, how soon after quarter end did those units or product ship?
Good afternoon, Benjamin. Good question. So it was actually a consolidated shipment that went from Canada, and the only reason it was not recognized is because we did not get all of the delivery receipts within the quarter time frame. Some of them shipped in July, so pretty much everything has been sent. And I think it sort of begs the second question: how do we make sure this kind of stuff does not happen again? I can provide a little bit of color on that. We have since increased our logistics and operating staff, and we are actually in the final stages of bringing a very experienced vice president-level operations person aboard. So this is part of our growing operations. It was a consolidated shipment; we did not get all the receipts, so we did not recognize it in Q2 but it will most likely be recognized in Q3.
$7 million of new orders—maybe you can share what the previous record was and then, obviously, you had a great conference recently with the 160 new qualified opportunities. Do you have a sense based upon history how quickly some of those can shake out into actual orders?
That is a great question, and I appreciate you asking it. As mentioned in the prepared remarks, it is very difficult to give a definitive answer. But what I can tell you anecdotally is some of those leads have already materialized into deals that were not in our pipeline that are already well down the funnel and into the negotiating and contract stage, which is extremely exciting. As is often said in the line of medical device sales, deals can take a year to develop and a day to dissolve, or they can take a day to develop and a year to complete. So it completely runs the gamut. Time will tell, Benjamin.
Okay. Fair enough. And then on the penile shortening that you get with the robot, is there a plan to publish that data and maybe is it possible to characterize the range of outcomes there? I would think a lot of guys would care about the worst-case scenario rather than an average or median.
Hey Benjamin. Thanks. We are preparing that data as part of the broader picture of perioperative outcomes that we have released in the past. To package it together as a total patient experience: on the surface a difference of a few millimeters may not sound like a major outcome; however, for many men undergoing treatment for prostate cancer, literally every millimeter matters. Penile shortening is not just a physical measurement; it can also serve as a constant reminder of both their cancer and the treatment they underwent, which can affect confidence, emotional well-being, intimate relationships, and overall satisfaction with treatment. We view this result in the broader context of the CAPTAIN dataset. In and of itself, penile length preservation is not the sole reason a physician or a patient may choose a treatment. However, when you combine this result with previously reported superiority in preserving erectile function and urinary continence, as well as the benefits of no blood loss, no overnight stay, faster recovery and fewer major complications, it paints a compelling picture of the overall patient experience. We do believe the future of prostate cancer treatment will be driven not only by cancer control but also by quality-of-life outcomes, and this penile length result is another example of how the TULSA procedure's ability to precisely ablate prostate tissue while protecting surrounding structures can translate into benefits that matter to patients. As more quality-of-life data emerge, we believe this will increase the influence of patient preference, physician recommendations, and overall demand for treatments that preserve quality of life. On the range, there was a range around the median change; this is a non-conventional endpoint that we included in the protocol, and the measurements include a median change and the associated distribution.
Okay. I have just a quick anecdote: there was actually a publication at SRS where effectively its conclusion was that every millimeter counts for patients.
Yeah. It makes sense. I believe there was an Italian study out there that showed some even greater impact for the robot. But I will leave it there, and congrats on the progress. Thanks for taking the questions.
Thank you, Ben. Thanks a lot.
Our next question comes from the line of Michael Freeman of Raymond James. Your line is now open.
Hi, Arun. It is Matthew. A few questions following up on Benjamin. I am curious on the shipment timing challenge. We also saw a shipment timing statement in the first quarter indicating that six TULSA systems were shipped but not installed by the first quarter, and noticed that the incremental increase in TULSA installs was four quarter-to-quarter. Could you tell us what logistically or operationally is happening on these shipments? What challenges or delays are you running into? I know you mentioned you hired extra staff to manage this, so could you shed some light on this timing challenge?
Michael, I am happy to. These are actually two different issues. The one related to revenue recognition in the second quarter is about shipping to fulfill orders we have received. Given that we did not get all the delivery receipts, we did not recognize revenue, but we will recognize it in Q3. That is more of a logistics issue for shipment, and we are already addressing it. The other issue is after the product is shipped and installed, the site needs training, they have to schedule patients and so on. When we look at the install base, we count sites actually treating patients. Normally there is a gap of a minimum of 60 days to 120 days based upon hospital scheduling, training programs, and their ability to start educating their patient population. That is a separate issue—how they convert the TULSA system into a treatment program and confirm reimbursement. I hope that answers your question regarding the install base.
Gotcha. That is helpful. Now maybe a question for Tom: on the pipeline, earlier you were quantifying the pipeline in terms of number of TULSA systems, and now you are talking about dollars in aggregate value and splitting between TULSA and Sonalleve. Are you able to give a number of new TULSA systems in your pipeline? And could you shed some light on what proportion of Sonalleve sales might make up that $70 million aggregate value?
Michael, great questions. I will tackle the latter first. Of the $70 million that fall within the verify, negotiate and contract categories of the sales funnel, it is roughly a 70%-30% split between the United States and international in terms of dollars forecasted within those respective categories. And as it relates to TULSA PRO versus Sonalleve, it is roughly a 90% TULSA PRO, 10% Sonalleve split. The reason we have moved away from providing units versus dollars is we want to stay focused on maximizing top-line revenue and gross margin and growing TULSA and Sonalleve programs versus simply installing systems. That is one of the major reasons we introduced the Index 20 as well. We want to get to the point where we have 200 TULSA PRO systems installed and treating men across the world, with an average of 50 men per year, which would allow us to treat over 10,000 men per year. I hope that answers your question and I am happy to answer any follow-ups.
Yeah, that is really helpful. And then on the decline in the utilization index, could you speak more about those sites that ran into temporary issues and the trends you are seeing? You mentioned good numbers in July—could you provide more color on that topic?
Of course, Michael. There is a lot presented within the Index 20, and we are excited to share it. While we did see a 12% decline quarter-over-quarter, we saw a 39% increase in the first six months of 2026 versus the first six months of 2025, and a 22% increase Q2 26 compared to Q2 25. The main drivers were five sites that did not grow as expected due to short-term issues. To give color to the example in the prepared remarks: in different countries and distribution networks or health systems, they have different policies. If we are required to come in on a placement model, that placement normally has a set period with metrics and milestones, and after that point they may pause the program until they determine whether to acquire the technology. In this instance, it's a high-class problem: we were successful with the placement, the timeline associated with that agreement came to a close, and there was a gap before the capital acquisition took place. With our modeling, it is beneficial to the hospital to go to the capital ownership model because that lowers the cost per procedure related to the TULSA PRO kits. All in all, that is a net positive, but it impacted quarter-over-quarter sequential growth.
Got you. All right. Thank you very much for the color. I will pass it on now.
Thank you, Michael.
Thank you.
Our next question comes from Scott McAuley with Paradigm Capital. Your line is open.
Thanks. Afternoon, everyone. Thanks for taking the questions. Maybe just to circle back on some of Michael's questions: regarding install base versus units sold, correct me if I'm wrong, but if you had 84 installed at the end of Q2 and 80 installed at the end of Q1, that's net four new in the quarter. But if at the end of Q1 there were six units that had been sold but not installed, does that mean there are still two more from that Q1 period that have not been installed and up and running yet? And then versus net new sales in Q2—trying to get a little more color on those numbers.
Yeah, Scott, the way you analyzed it is exactly right. We shipped six systems in Q1, four of them were installed in Q1. Two of them are still in process. We shipped about the same number in Q2 but you already heard about the logistics thing. We are continuing to install more sites and so in Q3 you will again see an increase in the install base. So your analysis is exactly right.
And in terms of that pipeline moving from sale to install, you referenced 60 to 120 days. I know it is a lot out of your hands, but are you trying to accelerate that?
Yes. We are continuing to grow our teams in every key department, and I do think over time those numbers will continue to drop. It used to be higher—around six months—but now it is indeed less. I also think as momentum builds, people begin to see this is the next thing, which adds a bit of urgency in multiple sites. I do think over time that number will shrink closer to 60 days than it is today. Tom described that we are moving more towards a pipeline described in dollars. One early indicator we are gaining confidence in our pipeline is that Q2 in terms of purchase orders in dollars was actually the best quarter we've ever had. That is tangible data showing this pipeline is very real.
That makes sense. Maybe on the pipeline question—understand wanting to present it in dollars versus units, but is there any way to quantify how that pipeline expanded or grown from the initial number of units versus dollar amount? Any other color there?
I do not have an exact number for you, but as you heard from Tom, at SRS we generated 160 leads. Q2 was also a very good quarter for new leads. We are dollarizing and will start qualifying earlier pipeline that we built to add to this. Most certainly this number is probably 30%–40% higher than what we were looking at before. If you get beyond 100 systems, unit counts become less meaningful and a dollar number becomes more meaningful—hence the reason for using dollars.
On the team and operations side, the press release mentioned operating costs went down. As you expand the team to accelerate installations and handle the pipeline, any comments on how you see operating costs scaling in the next few quarters? I understand they will move with revenue growth, but how do you see that expense side evolving in the next few months?
Great question, Scott. First, it speaks to the leverage of our product: good dollar revenue for capital and high per-patient revenue on utilization at good margin. We're not seeking growth at any cost; we expect to head toward profitable growth as revenues come in. Second, your point is correct: we are adding resources as we go, and we are careful with expenses, but we need to add to support growth. Those additions won't always sync perfectly with revenue in every quarter, so you will see some up-and-down. On a bigger time interval, I think you'll see a trend where costs grow close to revenue growth. There will be some quarter-to-quarter variation, but over time the trend should be favorable toward growth and potential profitability.
That is great, Arun. I really appreciate the color. That is all for me for now.
Beautiful. Thank you, Scott.
Our next question comes from the line of Kyle Bauser of TI Partners. Your line is open.
Great. Thank you for taking my question. Maybe on the sales guidance, are you assuming a certain amount of additional payer coverage policies this year? Also, do you have a total number of covered lives to date? I know it was up 18.3 million in this last quarter and up 8.5 million in Q1—just wondering if you have a running total.
Yes. To answer your first question: yes, we are continuing to work with insurance companies on a routine basis. Almost every day we see patients applying for reimbursement even with insurers that do not have coverage policies, and more and more are beginning to get reimbursed. Based on that, we certainly expect the number of covered lives to continue to increase.
I do not have the entire full number offhand. Do you have the full number, Arun?
Including the 18.3 million in Q2 and the 8.5 million in Q1, I believe we are close to 30 million covered lives—maybe around 29 to 30 million. That does not include Medicare, which is on top of that.
Got it. That makes sense. You have talked extensively about how compelling the CAPTAIN data is and how it resonates with physicians, particularly showing TULSA's clear benefit over robotic radical prostatectomy across erectile dysfunction and continence. On the patient side, how involved are patients in defining a treatment path? It seems like TULSA would be a clear choice given superior quality-of-life outcomes. Any color around patient involvement would be helpful.
Thank you, Kyle. That is an excellent question. We experienced at SRS arguably the most successful medical conference I have attended. We met with over 4,000 physicians from around the world and also with the founders of the Society of Incisionless Surgery, which we plan to be a big part of at their inaugural meeting. We also spoke with men who were prostate cancer patients and survivors who shared with great vulnerability the struggles related to complications from their treatments. I think we would be remiss not to mention the mental health impact that men who get diagnosed with prostate cancer undergo—not only the diagnosis but the stress, anxiety, and uncertainty about what treatment to select. Part of what we have done at ProFound is launch a global patient advocacy group called "Let's Huddle," led by Leonard Wheeler, a prostate cancer survivor and a TULSA PRO patient. That group is not meant to promote TULSA PRO; it is meant to promote awareness around men's health, particularly prostate health and mental health. On a monthly basis Leonard hosts a group of men who can join from all over the world and provides open space for peer-to-peer conversation. In July we had men who are authors, bloggers with large followings, and consultants focused on educating men about their prostate disease journey. Personally, I am most excited about raising awareness around men's health because prostate health and mental health go hand in hand. What took place at SRS, in my opinion, is that conversations that used to happen behind closed doors are now happening publicly among clinicians and patients. We need to rally—whether it is ProFound or others offering interventions—that men should be aware, have access, and be empowered to make decisions with their clinicians based on clinical presentation and what is important to them in quality of life, sexual function, urinary continence, penile length and mental health. I apologize for the emboldened response, but I truly believe we are at an inflection point in men's health care and we must get louder.
Got it. Very helpful, thank you. One more question: we saw in the radical prostatectomy arm in CAPTAIN that about 33% of patients had positive surgical margins. Any more specific timing estimate for later this year on when we will see TULSA procedure histology and imaging for the 12-month biopsy and MRI results to quantify margins and disease control?
We are still in the process of collecting all the final data. We have a vast majority of the patient data in, but we are not all the way there yet. We are comfortable that sometime in Q4 we should be able to get the full 12-month information out. I would like to point out that in the TULSA arm we are using biopsy, which is the gold standard and is very detailed, whereas in the robotic arm the measure is positive margins, which is less comprehensive. Many patients in the robotic arm underwent nerve-sparing prostatectomy. Coming back to the trifecta concept—cancer control, erectile function, and continence—we believe the populations are different and our data is positioning us well on that trifecta. But to answer your question directly: expect the 12-month data in Q4.
Great. Very helpful, and thank you for taking my questions.
This concludes the question-and-answer session. I would now like to turn it back to Dr. Menawat for closing remarks.
Thank you so much, and thank you to all the analysts for their questions. Hopefully we have answered them comprehensively for you. We look forward to similar dialogue in Q3. Thank you.
Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.