How is the US commercial activity progressing, especially with the new hires and the interplay with NXE?

The company is executing its US shipment plan, with 15 scanners shipped in Q2 and plans for 15 and 17 in Q3 and Q4, respectively, through the partnership with NXE Imaging. The direct sales team is making progress in imaging centers and hospitals, and no further hires are planned for 2026 to manage operational costs and gather market data for 2027 strategy. “We do plan to ship another 15 scanners and 7 teams respectively, from Q3 and Q4 in the United States, obviously, through a very strong partnership with NCC Imaging. We did move on, as we discussed last quarter, Jeff, with us starting to strengthen our direct sales team.”

Will the $5 million OpEx from Q2 be flat for the second half of the year?

OpEx is anticipated to increase slightly in the second half due to the hiring of the sales team and shifting of some clinical study expenses. “We anticipate it going up a little bit with the hiring of the sales team as well as shifting of some of the clinical studies, expenses from the first half of the year into the second half of the year.”

Is the Mayo Clinic 100-patient study new, and what are the expectations for coding/reimbursement from it?

It is a new study at Mayo Clinic, aiming to confirm that QT Imaging's technology identifies all MRI findings and reduces unnecessary biopsies. All data will be recorded under the Category I CPT code starting January 1, 2027, but no additional add-on codes are expected immediately. “Yes, Jeff, it's a new study at Mayo and we -- what we're looking towards -- we were looking out of the results is the following: number one, to make sure that all the findings from MRI are discovered by QT and second, to reduce the number of biopsies.”

QTI

QT Imaging (QTI) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 12, 2026

Source: earnings call transcript

Executive summary

QT Imaging Q2 FY26 — Strong Revenue Growth and Strategic Expansion

QT Imaging delivered robust Q2 FY26 results, driven by significant growth in scanner shipments and revenue, affirming its full-year guidance. The company continues to build out its commercial, clinical, and regulatory foundations, expanding its US sales team and international presence while securing key regulatory clearances and a CPT reimbursement code. Despite a decline in gross margin and increased operating expenses, strategic investments in infrastructure and clinical evidence are positioning the company for broader adoption and sustainable growth.

Highlights

Revenue increased by 103% year-over-year to $7.4 million in Q2 FY26.
Shipped 15 breast acoustic CT scanners in Q2 FY26, compared to 8 in the prior year quarter.
Affirmed full-year 2026 revenue guidance of approximately $39 million, more than double 2025 revenue.
Achieved successful FDA inspection with zero Form FDA 483 observations, reflecting strong quality management.
Secured AMA approval for a dedicated Category 3 CPT reimbursement code, effective January 1, 2027.

Concerns

Gross margin decreased to 41% in Q2 FY26 from 50% in Q2 FY25 due to a higher weighted average cost of inventory sold.
Operating expenses increased to $4.9 million in Q2 FY26 from $2.9 million in Q2 FY25, driven by higher employee compensation, professional services, and marketing.
Reported a net loss of $11.1 million in Q2 FY26, including an $8.3 million noncash loss on debt extinguishment and modification.

Guidance & targets

Category	Target	Timeline	Confidence
Revenue	approximately $39 million high materiality	FY26	High

Product announcements

Product	Type	Timeline
Enhanced scanner configuration	update	first half of this year
Software functionality for volumetric measurement	update	first half of this year
Software version 4.50	update	—
QTR viewer	roadmap	—

Deals & partnerships

Ali Imaging (a subsidiary of Canon Medical Systems United States) Exclusive distribution partnership

Continuing to leverage our exclusive distribution partnership with Ali Imaging a subsidiary of Canon Medical Systems United States.

Golf Medical Distribution partnership

Our distribution partnerships with Golf Medical in Saudi Arabia

Alnagi Medical Distribution partnership

and Alnagi Medical United Arab Emirates.

Reinvent Pharma Sales agent partnership

Together with our sales agent partnership, reinvent pharma in Pakistan provide a capital-efficient model for expanding our commercial reach and supporting local market development.

Ole Medical Collaboration for productization

Our collaboration with Ole Medical was focused during the quarter on productization of the QTR viewer as an advanced modality imaging solution for breast acoustic City platform.

Intelerad Collaboration for cloud/PACS infrastructure

In parallel, our collaboration with Intelerad provides the secure cloud and tax infrastructure supporting image management, clinical and research connectivity and enterprise deployment of QT imaging precision pathways.

Risks & headwinds

Geopolitical developments impacting commercial activity

impacted commercial activity in parts of the Gulf region

Mitigation:beginning to see encouraging signs of renewed customer engagement supported by our regulatory authorization and distributor partnerships.

Higher weighted average cost of inventory sold Q2 FY26

Gross margin was 41% for the second quarter of 2026 and compared with 50% for the second quarter of 2025.

Mitigation:The gross margin for the second quarter of 2026 was in line with our projections for sales in the United States.

Increased operating expenses Q2 FY26

Total operating expenses for the second quarter of 2026 were $4.9 million compared with $2.9 million a year ago

Mitigation:with the increase reflecting higher employee compensation and benefits, professional service costs and marketing expenses.

Noncash loss on debt extinguishment and modification Q2 FY26

$8.3 million

Mitigation:associated with the amendment of our senior secured term loan with Ben Rock Lake, extending the maturity date by 2 years.

What to watch in Q3 FY26

US scanner shipments

Q3 FY26, Q4 FY26

Current 15 scanners in Q2 FY26

Target 15 scanners in Q3 FY26, 17 scanners in Q4 FY26

Why it matters

Continued execution on US shipment plan is crucial for meeting full-year revenue guidance and demonstrating commercial scaling.

We shipped this quarter, 15 scanners, and we do plan to ship another 15 scanners and 7 teams respectively, from Q3 and Q4 in the United States

Find out whether QTI delivers this. Inve re-checks your case every morning.

Q&A highlights

What is the status of commercial activity in Pakistan?

The company has a sales agent agreement with Reinvent Pharma in Pakistan, and a few systems are expected to be deployed there in the coming months, leveraging existing FDA clearance.

“So we do have a sales hedging agreement in Pakistan with a women-led company that's called reinvent. And we do have a few systems and they will hopefully go in the next few months towards that geography. FDA clearance is appropriate for Pakistan.”

asked by Jeffrey Cohen · answered by Raluca Dinu

2 min read 6 chapters

Detailed narrative

Commercial Expansion & Strategy

QT Imaging expanded its US commercial team with two new VPs for regional sales, aiming to deepen engagement with imaging centers, clinicians, and enterprise health systems. This direct sales effort complements their exclusive distribution partnership with Ali Imaging (Canon Medical Systems US). Internationally, they are leveraging regional partners in Saudi Arabia (Golf Medical), UAE (Alnagi Medical), and Pakistan (Reinvent Pharma) for capital-efficient market expansion.

Regulatory & Reimbursement Milestones

The company secured SFDA clearance in Saudi Arabia and MAR authorization in Israel, expanding its market access in the Middle East. Domestically, they received two FDA clearances for enhanced scanner configuration and volumetric measurement software. A critical milestone was the AMA approval of a dedicated Category 3 CPT reimbursement code, effective January 1, 2027, which provides a framework for future coverage decisions.

Clinical Evidence & Studies

QT Imaging is actively building a body of clinical evidence. A multisite study demonstrated high reproducibility (<1% variability) of speed of sound measurements. A Mayo Clinic feasibility study showed agreement between their Qscan and MRI findings, leading to a planned 100+ patient follow-up study. Additional studies are evaluating the technology in diagnostic pathways and monitoring treatment response in women receiving neoadjuvant chemotherapy.

Technology & Platform Innovation

The company released software version 4.50, improving spatial resolution for breast acoustic reflection imaging. Collaborations with Ole Medical are focused on productizing the QTR viewer for integrated image visualization and quantitative assessment, while Intelerad provides secure cloud and PACS infrastructure for the QT Precision Pathway platform, supporting future AI-enabled applications.

Operational & Financial Strengthening

QT Imaging successfully completed its first routine FDA inspection with zero Form FDA 483 observations, highlighting its quality management system. The company is relocating its headquarters and manufacturing to a new 22,000 sq ft facility in Petaluma, California, which will more than double its operational space at a 55% lower lease cost per square foot, expanding manufacturing capacity and improving efficiency.

They also strengthened their balance sheet with a $10 million public offering and extended their senior secured term loan maturity by two years.

Leadership & Vision

Dr. Julia Albright was appointed Chief Science Officer, bringing extensive experience in medical imaging and AI to align scientific strategy and product innovation. The company's long-term vision extends beyond the breast acoustic CT scanner to building a quantitative breast imaging platform that integrates hardware, software, cloud infrastructure, and AI-enabled clinical applications to enhance personalized breast health management.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.