QT Imaging Holdings Canaccord Genuity's MedTech, Diagnostics and Digital Health & Services Forum

Great. Thank you. At QT Imaging, our mission is very simple: transforming breast health for every woman. Our goal is to replace outdated breast imaging workflows with the first scalable 3D safe imaging platform for dense breast diagnostics and precision breast oncology. The company was founded in 2012 by Dr. John Klock. Since 2012, it has received funding from NIH of approximately $18 million to develop supplemental imaging modality to resolve dense breasts. It received FDA clearance in 2017. It went public on Nasdaq in March 2024. The company has raised funding in 2024 through 2026 through a series of PIPE transactions, the largest being $18 million in October 2025. In addition, we raised $10 million via an underwritten public offering in May 2026. We received regulatory approval in Saudi Arabia, UAE, Israel, Bahrain, and Qatar throughout 2026.

We received a CPT Category III code, which went effective in October 2026. We just announced on Monday that CMS added a Medicare hospital outpatient reimbursement that will begin on January 1, 2027, which is a pretty significant accomplishment. Currently, mammography is approved for primary screening and is reimbursed by payers. However, with mammography, there is ionizing radiation, there is compression, and it is missing cancers. There is supplemental imaging, which is handheld ultrasound, which is very targeted and is very operator-dependent. There is also MRI, which is expensive, $1.5 million. There is $1 million plus for the infrastructure and ongoing annual maintenance. It is uncomfortable, and it uses a contrast injection. QTscan provides accurate diagnosis for dense breasts. It catches tumors that are missed by mammography. There is no compression, there is no radiation, there is no contrast injection, and it also provides biomarkers.

Our sweet spot is women at intermediate risk, so those with dense breasts. Half the women in the U.S. have dense breasts, and that is higher internationally. For women under 40 years of age, we are targeting those who are not receiving primary screening, and more than 30% of women in the U.S. are not receiving primary screening. We are also targeting women over 40 who begin mammography and are obtaining a mammogram annually or biannually. We also are targeting women of high risk, so those with dense breasts, those that are carrying the BRCA gene. Those women tend to start an MRI at 25 or 30 years of age and add mammography at 30. With the radiation that accumulates over time, with QT Imaging, it is ultrasound, so there is no buildup of radiation. Our value proposition for the patient is a one-stop shop supplemental and diagnostic imaging platform.

No radiation, no compression, no contrast. There's less patient anxiety and a a lower recall rate, and it's operator-independent. For clinicians, it's one test with multiple results and MRI-like imaging. It provides calcium visualization and biomarkers, the low recall rate, the operator independence, and the potential to reduce unnecessary biopsies. For administrators, there's 2.5 times more revenue per scan compared to mammography and handheld ultrasound. There's also reduced labor costs because it does not require specialized personnel. With five patients per day, we estimate an investment recovery period of three years. This is one of the rare cases where patients, doctors, and providers all win. Effective October 1st, our CPT Category III code went effective. CMS just added the reimbursement for eligible physician-ordered medically necessary diagnostic examinations.

Reimbursement will drive growth through accelerated scanner adoption, especially the business case for hospitals and outpatient imaging providers, an increase in patient utilization, expanded recurring revenue, and this is something where we will be rolling out a SaaS platform in beginning of 2027, and strengthen commercial expansion. Yep. Here we go. For a reimbursement strategy, there's three clinical growth opportunities that we're focused on. One is supplemental imaging for dense breasts. The second is neoadjuvant therapy monitoring. The third is re-engaging under-screened women. Primary screening, currently, that's being done with mammography. With supplemental screening and diagnostic imaging, that's handheld ultrasound and MRI, with biopsies being handled by a handheld ultrasound and MRI as well. Alternatively, the QTscan is approved for supplemental screening and diagnostic imaging. However, it's patient-friendly and has the potential to reduce unnecessary biopsies. Also, it does a better job with dense breasts.

QTscan discovers tumors that are not seen in dense breasts. The first two images here are of mammography and handheld ultrasound, where the tumor is not being identified. The third is MRI, the fourth is QTscan, and both of those are identifying the tumor just below the blue arrow. QT Imaging is undergoing trials to monitor tumor response to neoadjuvant chemotherapy to detect early tumor response and guide treatment management. Currently, when a woman is going through chemotherapy, the standard is to do an MRI every three months because of the radiation exposure. Since we use ultrasound, that can be done every week or two. In this example, we can show a baseline, an image at week one, week four, week 16, demonstrating the reduction in the size of the tumor and showing that the efficacy of the therapy.

QTscan offers women who have avoided mammography due to pain, radiation concerns, or discomfort, a patient-friendly entry point into the standard breast care screening and diagnostic care pathway, helping to improve early detection. Again, 30% of women in the U.S. are not getting primary screening, and that's higher internationally. Our technology is FDA cleared. It's pain-free, safe, with no radiation or contrast. It's inherently a 3D quantitative imaging modality, thus it's high resolution, similar to MRI. We obtain images from two different sources. One is transmission images, which allows us to identify the biomarkers, and reflection images that depict tissue interfaces. Again, there's operator independence with the QTscan. Quantitative imaging allows QTscan to provide biomarkers. That allows for early detection of malignancy using defined quantitative thresholds, therapy monitoring, personalized medicine, and automated lesion characterization.

We currently provide seven biomarkers, which will continue to improve and expand over time. We have optimized the patient experience. Again, no ionizing radiation since we are using an acoustic source. There is no breast compression and associated discomfort. Exams take approximately 10-12 minutes per breast. It is quiet and comfortable, unlike an MRI. There is no contrast injection or associated risk, and there is no limitation for dense breasts or implants. The current market for breast imaging is estimated at $6 billion. The global opportunity for dense breast supplemental screening and biomarkers is $2.5 billion, estimated to increase to $3.8 billion by 2030. The accessible reimbursed markets are estimated at $1.7 billion, increasing to $2.6 billion in 2030. There are three tailwinds currently positioning QT Imaging for growth. One is regulatory, so the FDA has recognized the importance of breast density in breast cancer screening. The second is AI. Radiology is the leading specialty for clinical AI adoption. 30%-48% of radiologists report active clinical AI use.

Additionally, most FDA-cleared clinical AI tools are in radiology. The third is oncology. Oncology is moving from a one-size-fits-all treatment towards biomarker-guided therapy. Additionally, breast cancer treatment increasingly requires earlier response assessment. Our clinical advisory board consists of Dr. Mary Yamashita from USC, Dr. Barry Roseman, Dr. John Tentinger, who is an early adopter of the QT Imaging technology, and Dr. Elaine Iuanow. We also have growing global validation. We have the FDA clearance in the U.S. We received approval in Saudi Arabia, UAE, Israel, Bahrain, and Qatar, and we are working on a CE mark, which we anticipate mid to late 2027. We have received $18 million of funding from NIH to generate the safe imaging modality for women with dense breasts.

We have ongoing clinical studies with Mayo, with Sunnybrook Cancer Center, and soon to start Stanford and Harvard, and we are in discussions with UCSF. Our Category III CPT code went live in October, and CMS just added the hospital outpatient Medicare reimbursement code, which will go live January 1, 2027. The clinical study at Mayo is comparing QTscan versus MRI. The study consists of 26 high-risk women comparing QTscan versus MRI. There is strong breast level agreement with MRI. There is a comparable detection profile, and most importantly, all MRI suspicious lesions were identified by QTscan. So this pilot provides strong clinical validation and supports larger studies aimed at expanding QT Imaging's adoption in high-risk and supplemental screening. At Sunnybrook Cancer Center, we are comparing QTscan versus MRI. It is an ongoing 100-patient study to compare advanced quantitative ultrasound findings with treatment response.

Lesion volume agreement has been demonstrated between QTscan and the MRI images. We have also conducted a multi-site repeatability and reproducibility study, which demonstrated less than a 1% variability in speed of sound measurements under the conditions studied. So this reproducibility is a key prerequisite for using QT biomarkers in longitudinal monitoring and treatment response tracking, not just for single time point screening. To date, our focus has been on the sale of our Breast Acoustic CT Scanners. In 2027, we will be moving image reconstruction off of the scanner and into the cloud. In addition, we will launch our QTI Precision Pathway SaaS platform with an AI diagnostic layer. So this will add recurring revenue and improve our gross margin. Hardware gets us in the door, software builds the company. The QTI Precision Pathway will start with system software updates to allow the scanners to remain evergreen.

On top of that, we can add collaboration and data sharing, quantitative biomarkers, automated analysis, precision reporting, and then for enterprises, multi-user access and enterprise collaboration. To date, our sales were through a distributor, NXC Imaging, which is owned by Canon. in July, August, we hired three senior sales VPs to build out our internal sales group. The team will be focused on hospitals and IDNs, focusing on supplemental imaging and therapy monitoring, and also focusing on outpatient imaging chains. We will continue to work with NXC, our distribution partner, in the functional medicine space. This commercial strategy balances capital efficiency today with increasing control and margin expansion over time. Our business partners consist of NXC Imaging in the U.S., Gulf Medical in the Kingdom of Saudi Arabia, Al Naghi Medical in the UAE, and Re-Invent Pharma in Pakistan.

We just announced, earlier this week, our first order that came through Al Naghi Medical. We recently received the 2026 Breakthroughs Innovation Award from Premier. Premier is one of the largest healthcare group purchasing organizations with nearly 4,400 U.S. hospitals and health systems. In addition, with the assistance of NXC Imaging, we were able to obtain a national group purchasing agreement where Premier members can access pre-negotiated pricing and terms, which will simplify the purchasing process. This purchasing will support conversion of hospital interest into scanner adoption. Revenue in 2024 was $4.9 million. In 2025, it was $18.9 million, and we are forecasting revenue of just over $34 million in 2026. That is revenue growth of 81%. In Q1 2026, we shipped 13 scanners, and we have shipped 15 scanners in both Q2 and Q3 2026.