QT Imaging Holdings Q3 2026 Earnings Call Transcript
QT Imaging Holdings (NASDAQ:QTI) reported third-quarter financial results on Tuesday. The transcript from the company’s third-quarter earnings call has been provided below.
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Summary
QT Imaging Holdings reported third-quarter revenue of $7.3 million, a 75% increase year-over-year, with 15 scanners sold compared to 9 a year ago.
The company’s U.S. commercialization efforts are gaining momentum, supported by an expanded sales organization and a new agreement with Premier Inc., granting access to a large network of hospitals.
A significant milestone was achieved with CMS establishing a Medicare payment pathway for QTscan examinations, effective January 2027, enhancing the business case for adoption.
Operational highlights include the relocation to a larger facility in Petaluma, California, doubling manufacturing capacity and reducing lease costs.
International expansion saw regulatory approvals in Israel, Bahrain, and Qatar, and a first commercial order from American Hospital Dubai, though shipments to the Middle East are delayed due to regional conflict.
The company revised its 2026 revenue guidance down to approximately $34 million from $39 million due to shipment delays in the Middle East.
Management highlighted ongoing efforts to enhance technology, expand clinical adoption, and pursue additional reimbursement opportunities.
Full Transcript
OPERATOR
Welcome to the QT Imaging Holdings Third Quarter 2026 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today’s presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad, and to withdraw your question, please press star then two.
Please note today’s event is being recorded. I’d now like to turn the conference over to your host, Tirth Patel with Investor Relations. Please go ahead.
Tirth Patel (Investor Relations)
This is Tirth Patel with CORE IR. Thank you for participating in today’s call. Joining me from QT Imaging Holdings are Dr. Raluca Dinu, Chief Executive Officer, and Jay Walter Jennings, Chief Financial Officer. I want to remind listeners that comments made during this call by management will include forward-looking statements within the meaning of federal securities laws. Any statements that are not statements of historical facts should be deemed to be forward-looking statements.
Such statements involve known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from those implied by such statements. All forward-looking statements are based on QT Imaging Holdings’ current beliefs as well as assumptions made by and information currently available to QT Imaging Holdings. These relate to, among other things, commercialization and manufacturing of the breast Acoustic CT scanner, the QTI Precision Pathway, cloud platform, software development, reimbursement and clinical evidence initiatives, commercial distribution, international shipments, product sales, growth, and projected revenue, including the 2026 revenue outlook. For a list and description of the risks and uncertainties associated with the company’s business, please see its filings with the Securities and Exchange Commission.
Furthermore, the content of this call contains information that is accurate only as of the date of the live broadcast, November 10, 2026. QT Imaging Holdings disclaims any obligation, except as required by law, to update or revise any financial or operational projections or other forward-looking statements, whether because of new information, future events, or otherwise. We will also refer to certain non-GAAP measures during the call. The definitions of these measures and reconciliations to the most directly comparable GAAP measures are available in today’s earnings release.
And now I’d like to turn the call over to Dr. Raluca Dinu.
Raluca Dinu (Chief Executive Officer)
Thank you, Tirth. Good afternoon, everyone. Our third quarter results demonstrate the progress we are making in commercializing our breast acoustic CT imaging modality. Revenue was 7.3 million, an increase of 75% year over year, and we sold 15 scanners compared to nine a year ago. For the first nine months, revenue reached 21.3 million compared to 10.7 million last year, and scanner sales increased to 43 from 23. These results reflect meaningful growth.
Our next responsibility is to translate that growth into broader clinical adoption. I want to discuss today our execution in four areas: 1) U.S. commercialization, 2) clinical adoption and reimbursement, 3) technology and operational scale, and 4) international expansion and financial discipline. First, Commercial Execution. Our U.S. commercial business continued to gain momentum during the third quarter, supported by a stronger direct sales organization, a significantly expanded pipeline of qualified opportunities nationwide, and the receipt of purchase orders directly from customers across the country. We strengthened our commercial leadership structure, with three sales leaders now reporting directly to our Chief Commercial Officer, Satajit Mish.
This expanded organization is improving our ability to engage customers, advance opportunities through the sales cycle, and convert growing market interest into purchase orders. These developments represent important progress in building a scalable U.S. commercial operation and expanding our market presence. In parallel, we continue working with our distribution partner, NXC Imaging, a subsidiary of Canon Medical Systems USA, to improve customer placement, strengthen service execution, and drive greater commercial effectiveness. As we finalize our 2027 commercial structure, we are focused on accelerating sales growth, strengthening customer relationships, and establishing clear accountability across both our direct sales organization and the distribution channel.
Looking ahead to 2027, our current domestic distribution agreement with NXC Imaging runs through the end of this year. We are engaged in constructive discussions with NXC and Canon Medical Systems USA regarding our future commercial relationship and scanner purchase commitments for the Precision Pathway SaaS platform. While the new agreement has not yet been finalized, we are encouraged by the progress and see opportunities to strengthen collaboration as we extend into hospitals and imaging centers.
An important part of our U.S. commercial strategy is expanding access to large hospital networks and integrated healthcare systems. We also made significant progress in expanding our access to United States hospitals and health systems through Premier Inc., one of the nation’s largest healthcare group purchasing organizations, or GPO. Our breast acoustic CT technology was recognized at Premier Supplier Innovation Celebrations, following evaluation by a national committee of clinicians and healthcare supply chain experts.
Building on this recognition, in October our distribution partner NXC Imaging secured a national group purchasing agreement with Premier, providing access to nearly 4,400 hospitals and health systems nationwide. The agreement establishes pre-negotiated pricing and purchasing terms, simplifying procurement for participating providers. This significantly expands our commercial reach. Our focus now is to convert this access into purchase orders and scanner installations.
Second, Clinical Adoption and Reimbursement. On November 4, just a few days back, we achieved a major reimbursement milestone when the Centers for Medicare and Medicaid Services, or CMS, reversed its earlier proposed non-payment decision and established separate Medicare hospital outpatient payment for diagnostic QTscan examinations, effective January 1, 2027. Under the final 2027 Medicare rule, CMS assigned our dedicated CPT billing code 179T to Ambulatory Payment Classification 5522, with payment status indicator S. Importantly, CMS recognized that physician-ordered QTscan examinations addressing specific diagnostic findings qualify under Medicare’s existing diagnostic ultrasound coverage framework. Together with the October 1st implementation of our dedicated CPT billing code, this decision removes significant reimbursement uncertainty and establishes a clear Medicare hospital outpatient payment pathway for medically necessary diagnostic QTscan examinations.
This is a very meaningful commercial milestone for QT Imaging Holdings. Hospitals now have both a dedicated billing code and an established Medicare payment classification, strengthening the business case for adopting our breast imaging technology. Our focus is now on translating this progress into scanner installations and clinical adoption. We have developed a comprehensive coding and billing guide to support hospitals and imaging providers while continuing our engagement with Medicare and commercial payers and expanding the clinical and economic evidence needed for broader coverage.
Medicare payment applies to medically necessary, physician-ordered diagnostic examinations rather than routine screening. We will continue pursuing additional reimbursement opportunities related to our SaaS platform and AI software improvements. An essential part of our commercial execution is ensuring that imaging centers and hospitals have access to breast radiologists properly trained to interpret the QTscans. We have initiated a structured training program with two established radiology groups under the leadership of Dr. Emeria Mashita. This relationship will expand our clinical reading capacity and support the adoption of the breast acoustic CT imaging modality across our growing install base.
Approximately 13,000 women have now been imaged using QT Imaging breast acoustic CT technology, marking a significant milestone in clinical adoption and reinforcing the growing real-world foundation for advancing quantitative breast imaging. Equally important, our multi-site repeatability and reproducibility research demonstrated less than 1% variability in speed-of-sound measurements under the conditions studied. These findings support the operator-independent nature of our automated imaging modality, a significant advantage over conventional handheld ultrasound, where image acquisition and measurements are highly dependent on operator technique and experience.
Our PEAR strategy builds on the newly established Medicare reimbursement pathway for medically necessary diagnostic QTscan examinations and focuses on the following clinical applications: 1) diagnostic evaluation of women with dense breasts who require additional imaging following mammography; 2) diagnostic evaluation of high-risk women, particularly those who face barriers to breast MRI; 3) quantitative monitoring of response to neoadjuvant cancer therapy; and 4) beyond these applications, we see a significant opportunity to improve participation in breast cancer screening. More than 30% of eligible women are not up to date with recommended screening. Our radiation-free, compression-free technology has the potential to help bring women back into the standard of care. Although routine screening is not currently covered under Medicare, we will work diligently to generate the clinical evidence to pursue the necessary regulatory approvals and expand reimbursement pathways to make QTscan accessible to more women, particularly those who face barriers to conventional breast imaging.
We’re aligning our clinical research programs with these priorities, working with our clinical partners to demonstrate QTscan’s incremental diagnostic value, potential to reduce unnecessary biopsies, and ability to provide quantitative biomarkers for treatment monitoring. Our objective is to generate the clinical and economic evidence needed to extend payer coverage, strengthen physician adoption, and accelerate broader patient access. Third, Technology and Operational Scale. We’re building an integrated breast imaging platform, not simply manufacturing a scanner. Our breast acoustic CT technology provides radiation-free, compression-free 3D imaging and quantitative information derived from the acoustic properties of breast tissue. The QTI Olea Viewer supports clinical interpretation, while QTI Precision Pathway is our cloud platform for image processing and quantitative analysis.
We continue to advance our reconstruction software, improve reflection imaging quality, and streamline radiologist workflows. These investments are designed to strengthen clinical performance and support the scalability of our technology. We strengthened our scientific leadership in July with the appointment of Dr. Julia Albright as Chief Science Officer. Her role is to connect our research, product development, and clinical evidence priorities. We also completed the relocation of our headquarters and manufacturing operations to a new approximately 22,000-square-foot facility in Petaluma, California, under the leadership of our Chief Operating Officer, Steve Choate. This expansion more than doubles our available space and has approximately doubled our scanner manufacturing capacity while significantly reducing our lease cost per square foot. The new facility allows us to streamline production workflows, improve operational efficiency, and strengthen quality control as manufacturing volumes increase.
Importantly, this investment positions QT Imaging Holdings to support growing demand in the U.S. and international markets as we scale our commercial operations in 2027 and beyond. Execution at scale depends on quality. In July, we completed our first routine FDA inspection with zero Form FDA 483 observations. This is an important result for our team and the systems we have put in place. Fourth, International Expansion and Financial Discipline. In July, we received regulatory registration from Israel’s Ministry of Health, enabling commercialization in that market. We are working toward a scanner placement and clinical collaboration with Rambam Healthcare Campus, focused on women with hereditary breast cancer risk. Our international expansion reached a major milestone with our first commercial order in the Gulf Cooperation Council region, secured with American Hospital Dubai through our distribution partner, Al Naghi Medical.
American Hospital Dubai was the first healthcare institution in the Middle East to join the Mayo Clinic Care Network and operates a multidisciplinary breast institute integrating advanced imaging, breast surgery, oncology, pathology, and high-risk patient care. Beyond this first commercial order, we intend to work closely with American Hospital Dubai and Al Naghi Medical on joint marketing initiatives, physician education, and clinical research evaluating performance, patient acceptance, and quantitative tissue measurement.
The clinical need in the UAE is significant. A 2023 study found that only 23% of surveyed women had undergone mammography, while separate research reported a median breast cancer diagnosis age of 48, with 50% presenting with locally advanced or metastatic disease. Women die of breast cancer in the UAE 12 years earlier than in the United States. We also received regulatory approval for our breast acoustic CT scanner in Bahrain and Qatar, further expanding our authorized market presence in the Gulf region.
Together with our first commercial order from American Hospital Dubai, this milestone strengthens our foundation for commercial expansion across the GCC. The Middle East conflict and disruption affecting regional logistics has delayed anticipated shipments to our customers and distribution partners in Saudi Arabia and the UAE. We are maintaining and further developing those relationships, but we cannot responsibly commit to a shipment date while conditions remain uncertain.
Beyond these commercial and operational milestones, October was also an important opportunity to reinforce why we’re building this company. On October 2nd, we had the honor of ringing the NASDAQ closing bell to mark Breast Cancer Awareness Month, just days after World Dense Breast Day. I emphasized the principle at the heart of QT Imaging Holdings: for decades, women have been asked to adapt to breast imaging technology. We believe technology should adapt to women.
Patient comfort matters because adherence to screening matters, and women deserve better imaging options. Our vision is a future of breast imaging that is multimodal, quantitative, and personalized. The NASDAQ ceremony celebrated how far we’ve come, but our responsibility now is to bring this technology to more physicians, more communities, and more women around the world. We have substantially grown our revenue, strengthened our commercial organization, substantially advanced our reimbursement strategy, and expanded our manufacturing capabilities. We are building the infrastructure to bring QT breast acoustic CT imaging technology to more physicians and more women while maintaining our focus on commercial execution, clinical adoption, and financial discipline.
With that, I will turn the call over to Jay to review our financial results. Jay.
Jay Walter Jennings (Chief Financial Officer)
Thank you, Raluca, and good afternoon, everyone. Revenue for the third quarter of 2026 was $7.3 million, up 75% from $4.2 million in the third quarter of 2025. The increase was primarily attributable to sales of 15 breast acoustic CT scanners in the 2026 quarter compared with 9 scanners in the prior-year period. For the first nine months, revenue was $21.3 million compared with $10.7 million a year ago. Gross profit for the quarter was $3 million compared with $1.8 million a year ago. Gross margin was 41.3% compared with 41.2% in the second quarter of 2026. Total operating expenses for the quarter were $5.5 million compared with $3.5 million in the third quarter of last year and $4.9 million in the second quarter of 2026. As we discussed on our last call, we expected operating expenses to increase as we added commercial personnel and advanced clinical work.
Third-quarter research and development expense was $1.7 million compared with $0.9 million a year ago. Selling, general and administrative expense was $3.8 million compared with $2.5 million in the prior year. Operating loss for the third quarter was $2.4 million compared with $1.7 million in the year-ago period. Net loss was approximately $297,000, or $0.02 per share, compared with a net loss of $4.6 million, or $0.47 per share, in the third quarter of 2025.
The smaller reported net loss reflects, in substantial part, changes in the fair values of financial liabilities. In particular, the quarter included a $2.4 million non-cash gain related to the earnout liability compared with a $2.2 million expense in the prior year. Net cash used in operating activities during the third quarter of 2026 was $2.2 million compared with $0.9 million during the third quarter of 2025 and $4.8 million during the second quarter of 2026. For the first nine months of 2026, net cash used in operating activities totaled $10.7 million compared with $5.9 million in the prior-year period. As of September 30, we had cash, cash equivalents and restricted cash of approximately $8.4 million compared with approximately $11 million on June 30.
Now turning to our full-year 2026 outlook, we are revising our revenue expectation to approximately $34 million compared with our previous guidance of approximately $39 million. The revision reflects shipment delays to our distribution partners in Saudi Arabia and the United Arab Emirates arising from the conflict in the Middle East and severe disruption to the region’s normal shipping routes. Our U.S. scanner shipment plan is unchanged. We remain engaged with our partners, but the timing of Middle East shipments and any associated revenue recognition remain uncertain.
We believe it is appropriate to reflect those conditions in our current outlook. Please refer to our third quarter earnings release and Form 10-Q for more information about the quarter’s results, liquidity and risk factors. And now I’ll turn the call back to Raluca.
Raluca Dinu (Chief Executive Officer)
Thank you, Jay. In summary, our progress reflects meaningful advances across the business: 1) Commercial growth: strong year-over-year revenue growth with 15 breast acoustic CT scanners sold in the third quarter and 43 during the first nine months of 2026. 2) U.S. commercialization: a strengthened direct sales organization, an expanding pipeline of qualified opportunities and continued collaboration with NFC Imaging and Canon Medical USA to accelerate customer placement. 3) Reimbursement: CMS established a separate Medicare Hospital Outpatient payment for diagnostic QT Scan examinations effective January 1, 2027, building on the implementation of our dedicated CPT billing code in October. 4) Clinical adoption: we expanded radiologist training and ongoing clinical research programs aligned with our payer strategy, focusing on supplemental breast imaging, high-risk diagnostic applications, cancer treatment response monitoring and reabsorption of women needing breast screening in the standard of care. 5) International expansion: our first commercial order from American Hospital Dubai, regulatory approvals in Israel, Bahrain and Qatar, and progress towards clinical collaboration in this market. 6) Operational execution: the successful relocation to our expanded Petaluma headquarters and manufacturing facility doubled our capacity to support future growth. 7) Technology innovation: continued advancement of our integrated breast acoustic CT platform combining quantitative imaging, improved reconstruction software, the QTI OLEA viewer and the QTI Precision Pathway cloud capabilities.
As we approach year-end, our priorities are clear: accelerate U.S. commercial sales, convert our growing pipeline into purchase orders and scanner installations, extend clinical adoption and continue building the evidence to support broader reimbursement. While regional instability has delayed certain shipments to our Middle East customers and distribution partners, our United States commercial strategy remains on track. We are focused on delivering strong execution through the remainder of 2026 and positioning QT Imaging Holdings for continued growth in 2027.
Thank you for your interest in QT Imaging Holdings and for your continued support. With that, we are ready to take questions.
OPERATOR
Thank you. We will now begin the question-and-answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we’ll pause for just a moment to assemble our roster. And today’s first question comes from Jeffrey Cohen at Ladenburg Thalmann. Please go ahead.
Jeffrey Cohen (Analyst)
Hello, Raluca and Jay, thanks for taking our questions. A couple from our end. So, firstly, could you talk about Q4 as far as placements and expectations? I know that based upon your commentary you’re anticipating 27 placements. Wondering beyond MXC where you see the balance of those placements emanating from.
Raluca Dinu (Chief Executive Officer)
Hi Jeff, thank you so much for being with us on the call. We do expect 25 scanners sold in 2024 with 17 in the United States and the rest of them in the GCC area.
Jeffrey Cohen (Analyst)
Okay, got it. And could you talk about anticipated cost of goods for Q4? I think that you probably have already assembled some scanners, and would we see, on a percentage basis, COGS for Q4 decreasing on a percentage basis?
Jay Walter Jennings (Chief Financial Officer)
COGS will add. So first of all, as you know, the gross margin for United States for our scanners is 41%. And the gross margin for the scanners sold outside the United States in the GCC area, as the price is higher, the COGS is lower. So we do expect that the overall gross margin for Q4 to increase rather than be exactly as we have it today for United States.
Jeffrey Cohen (Analyst)
Okay, got it. And then lastly, could you talk about the U.S. commercial organization as it stands now with the recent adds? How many folks and how are you characterizing by geography?
Raluca Dinu (Chief Executive Officer)
Yes, very senior sales VPs reporting into the Chief Commercial Officer, Satajit Misra. Two of them covering the East Coast, one covering the West Coast. And that was actually absolutely an incredible progress for us to start addressing directly the customers, Jeff, on both the coasts. Obviously, the middle of the country is split equally between the sales managers of the two regions. But we’re bringing in POs ourselves, and we are obviously working collaboratively with NFC Imaging, making sure that the sales channel is kept without noise.
But very happy to have them part of the team.
Jeffrey Cohen (Analyst)
Perfect. Thanks for taking our questions.
Raluca Dinu (Chief Executive Officer)
Thank you so much, Jeff. Appreciate it. Thank you.
OPERATOR
Thank you. And our next question today comes from Matt Hewitt at Craig-Hallum Capital Group. Please go ahead.
Matt Hewitt (Analyst)
Good afternoon. Thanks for taking the questions. Maybe first up, congratulations on the CMS decision. I’m just curious, what are the next steps from a reimbursement perspective? Private payers, other portions of the government. Could you walk us through that, please?
Raluca Dinu (Chief Executive Officer)
Matt, thank you so much for joining. Very much appreciate it. Yes, big news from CMS. It was great to see the reimbursement news for QT Scan. It’s the first time in the history of this company and it’s extraordinary news for us. The next will be the following. We will make sure that everybody is up to speed with the content of our billing and coding guide to make sure that each one of our clinics is aware of the fact that the clinics can get the reimbursement from CMS.
We have already started discussions with the payers to make sure that as we get in 2027, expand that reimbursement to other payers. Matt, a lot ahead of us, but Medicare payment for this technology is an incredible step. Hospitals can be addressed now with QT Imaging technology, imaging modality, directly as much as all the other imaging modalities.
Matt Hewitt (Analyst)
Got it. That’s helpful. And then regarding the Middle East, obviously unfortunate situation, but I’m curious, once the shipping lanes do reopen, will there be a catch-up period? Meaning if you were supposed to ship, you know, five this quarter and five next quarter, would you ship 10 as soon as things open, or will you just get back to that kind of expected number?
Raluca Dinu (Chief Executive Officer)
Matt, our plan is to ship the scanners that are lagging behind as soon as we can actually do that. We have very good relationships in both Saudi Arabia and UAE, obviously through the distributor, but directly with the customers. The moment that we see the shipments happening, we will start addressing all those customers that are waiting for our scanners.
Matt Hewitt (Analyst)
Got it. And then maybe one final one regarding the U.S. internal or direct sales team. As you look at fiscal ’27, I’m sure you’re just starting that planning now, but as you look at fiscal ’27, is it your expectation that you will be adding resources to that team, or do you want to kind of get these three up and running first? Thank you.
Raluca Dinu (Chief Executive Officer)
So Matt, good question. So first of all, the three senior sales managers are doing a great job, and they’ll be covering both Q1 and Q2 of next year, and they already have a very strong backlog for us to start sailing into 2027. Obviously, the discussions with NXC Imaging and Canon Medical USA progress very well, and we’re going to the news, to the market the moment that we have final terms for our agreement. Are we going to increase our sales team?
I strongly believe that we have to see the first two quarters in 2027, how we bring in the orders and how the backlog looks like to decide if we are going to increase the number of sales managers in the United States.
Matt Hewitt (Analyst)
Got it. Thank you.
Raluca Dinu (Chief Executive Officer)
Appreciate it. Thank you, Matt.
OPERATOR
Thank you. And our next question today comes from Pat McCann at Deborah Capital. Please go ahead.
Pat McCann (Analyst)
Hi. Thanks for taking my questions. Just a couple here. First, I wanted to touch on the cash balance of, I believe, around 8 or so million at the end of the quarter, and then the receivables that you collected in October. What would be your updated kind of expectations around your cash runway? How has that changed at all in terms of your potential need for capital and how you view your ability to continuing to progress with the cash you have on hand right now?
Raluca Dinu (Chief Executive Officer)
Thank you so much for being with us. Very much appreciate it. Wonderful to have you all with us. We pushed out some of the scanners’ revenue, not necessarily depleting our cash. We’re very careful about our cash, and we do make sure that we stay within the limits of our balance sheet. Without doubt. Do we plan to go out to the market for money? Not for now. We do feel that we have to close Q4 and see how the year ends up, and then we’ll decide if there is a need for accelerated growth.
For now, we are on solid ground, and thank you so much for asking.
Pat McCann (Analyst)
Thanks for that. And then my other question, just, you know, having to do with the issue in the Middle East, I just wanted to drill in a little bit on that. You know, it’s about, I think, what $5 million in revenue that you kind of is being accounted for in from the Middle East in the kind of the revision that you did for full year. I’m wondering, given that it’s hard for anyone to know when that situation will be resolved internally. When you look at 2027, could you give any sense of how significant maybe the Middle East and those channels would be in your internal projections?
I’m just trying to get a sense of what the impact could be if this situation persists for a longer term.
Raluca Dinu (Chief Executive Officer)
Yeah, very good question. First of all, remember this: the CMS reimbursement opens up the business for QT Imaging Holdings to the hospitals. There’s a segment that we didn’t even project in 2027. So it’s a segment that we really believe will open up doors for United States business. We do have scanners planned for the GCC. Obviously it’s a very important segment for us. But we do believe that the business in the United States will take us to 25% growth year over year in revenue.
Pat McCann (Analyst)
Excellent. Thank you so much. That’s all I had. Appreciate it.
Raluca Dinu (Chief Executive Officer)
I appreciate it. Thank you so much for great questions.
OPERATOR
Thank you and our next question today comes from Ben Haynor at Lake Street Capital Markets. Please go ahead.
Ben Haynor (Analyst)
Good afternoon. Thanks for taking the questions and congrats on the CMS outcome here recently.
Raluca Dinu (Chief Executive Officer)
Hi, Ben. Thank you so much.
Ben Haynor (Analyst)
Yeah, no problem. First off for me, just on, you know, kind of the medically necessary diagnostic language. I mean, is that something that applies to, you know, kind of all women with dense breasts, those under 40 with a family history? What kind of group is that? Does that kind of total up to?
Raluca Dinu (Chief Executive Officer)
Yeah, so all women that come to—sorry, Ben, can you hear me? Yeah. So it’s diagnostic imaging; it’s supplemental imaging, Ben, for everybody that needs it. It’s not screening, and it’s like we always discussed: we do not have clearance for screening like mammography, for example, has. But we do have clearance for all women that need this imaging modality for diagnostics, which is obviously a large category of women. As we know, Ben, 50% of women in the United States have dense breasts. The cancers are hiding in dense breasts. The cancers are hiding in dense breasts that are being imaged by mammography. So this is where we shine.
Ben Haynor (Analyst)
Yeah, that’s helpful. And then, you know, it looks like the potential of the hospital market with the Premier agreement not too long ago, you know, that seems to obviously fit well with the CMS development. Have the sales folks that you have on board now, have they already started to have conversations with this channel? And if so, how are they going so far?
Raluca Dinu (Chief Executive Officer)
Absolutely. Our direct sales force, NXC Imaging, our distributor partner in the United States—everybody is extremely excited about the reimbursement news from CMS, definitely the relationship with Premier. We have a big year ahead of us. So we’ll put our head down and execute as we’ve done until now.
Ben Haynor (Analyst)
Okay, got it. And then any plans for other international markets entering next year?
Raluca Dinu (Chief Executive Officer)
So, Ben, first of all, we have properly developed Saudi Arabia, UAE, Israel, Bahrain, Qatar, and towards the middle of next year we are going to get hopefully the reimbursement—I’m sorry, the regulatory approval—in Europe. It is a lot to do within a year because obviously our main focus is the United States and, as a second priority, growing the business in GCC countries. And after that, Europe is next. But yes, Ben, that’s our focus.
Ben Haynor (Analyst)
Okay, great. Well, thank you so much for the color and congrats on the progress.
Raluca Dinu (Chief Executive Officer)
Bye. Thank you so much, Ben. Thank you so much for being with us.
OPERATOR
Thank you. And that concludes our question and answer session. I’d like to turn the conference back over to Raluca Dinu for closing remarks.
Raluca Dinu (Chief Executive Officer)
Thank you so much. I want to thank everyone for joining us today and for your continued interest in QT Imaging Holdings. We remain focused on disciplined execution as we finish the year and prepare for 2027. We look forward to discussing our progress during our next conference call. Until then, have a nice evening. Thank you so much.
OPERATOR
Thank you. The conference is now concluded and we thank you all for attending today’s presentation. You may now disconnect your lines and have a wonderful day.
Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company’s SEC filings and official press releases. Corporate participants’ and analysts’ statements reflect their views as of the date of this call and are subject to change without notice.