QT Imaging: Scaling Breast Acoustic CT – Direct Sales, International Expansion, and the Path to Reimbursement

QT Imaging Holdings (QTI) reported a strong second quarter 2026, with revenue of $7.4 million, a 103% increase year-over-year, and 15 breast acoustic CT scanners shipped. The company reaffirmed its 2026 guidance of approximately $39 million, more than double 2025's $18.9 million. Behind these numbers is a clear strategic shift: QTI is accelerating its commercial infrastructure, moving from reliance on distribution partners to a hybrid direct sales model, and expanding its regulatory footprint across the Middle East and South Asia.

Commercial Strategy: Direct Sales Take Center Stage

The most notable change in Q2 was the expansion of QTI's direct sales team. Under Chief Commercial Officer Satrajit Misra, the company appointed two regional VPs, Jason Dyer (Southeast) and Dave Reinhart (Regional Sales). Management was explicit that this is a strategic move: “We do plan to have our direct sales taking on the responsibility in 2027 and ahead. Obviously, the support from NXT and other distribution partners as they move into 2027.” — Raluca Dinu, Chief Executive Officer · 2026-08-12 This pivot is company-specific and stands out against the broader market's focus on broader adoption of imaging technologies.

QTI is not abandoning its distribution partner NXT Imaging (a Canon subsidiary) but is layering direct sales to target imaging centers and hospitals. CEO Raluca Dinu noted: “We are building a scalable commercial model designed to deepen customer engagement, accelerate clinical adoption and installed base growth, and support sustainable long term revenue growth and margin expansion.” — Raluca Dinu, Chief Executive Officer · 2026-08-12 The phrase direct sales is a new high-momentum keyword for QTI, appearing for the first time in the company's keyword trajectory this quarter.

Clinical Evidence and Regulatory Progress

QTI continues to build clinical evidence. The company announced a new multi-site study showing less than 1% variability in speed-of-sound measurements, a key step for quantitative imaging biomarkers. As Dinu stated: “The results demonstrated less than 1% variability in speed of sound measurements across scanners under the study conditions. This level of consistency is important because quantitative imaging biomarkers might be reproducible across systems, locations and operators to reliably measure changes in breast tissue over time.” — Raluca Dinu, Chief Executive Officer · 2026-08-12 This reproducibility evidence is essential for future reimbursement and adoption.

On the regulatory front, QTI secured FDA clearances for enhanced scanning and volumetric software, and received international approvals in Saudi Arabia (SFDA) and Israel (AMAR). The American Medical Association's approval of a dedicated Category III CPT code (effective January 1, 2027) is a major milestone, providing a mechanism for data collection that could lead to future coverage. The company is also deepening its clinical studies, including a >100-patient Mayo Clinic study comparing QT scan to MRI.

Financial Position and Metrics

While revenue is growing rapidly, gross margin declined to 41% from 50% in the prior year, driven by product mix. Gross margin for Q2 2026 was 41%, down from 50% in Q2 2025. Operating expenses rose to $4.9 million (from $2.9 million), reflecting investments in sales and clinical research. The company recorded a net loss of $11.1 million, including an $8.3 million non-cash loss on debt extinguishment and modification. However, QTI strengthened its balance sheet with a $10 million public offering and extended its Lynrock Lake loan maturity to 2029.

QTI's installed base is a key driver: installed base growth feeds future software and cloud revenue. The company is also expanding internationally through distributors, with the first scanner in Pakistan and a planned study in Israel at Rambam Healthcare Campus.

Outlook

With 2026 guidance of ~$39 million, QTI is on track to more than double revenue. The company expects to ship 15 and 17 scanners in Q3 and Q4, respectively, with a gradual ramp. Management is disciplined on OpEx, keeping it relatively flat sequentially.

The strategic pivot to direct sales, combined with a strong regulatory and clinical pipeline, positions QTI for sustainable growth. While the company faces margin pressure and an evolving competitive landscape, its focus on quantitative, radiation-free breast imaging is differentiated. The upcoming CPT code could be a catalyst for adoption starting in 2027.

Our vision is to transform breast health by giving women and physicians a better approach to breast imaging.

QTI's journey from no revenue in 2023 to $19M in 2025 and a projected $39M in 2026 underscores the commercial traction. The company's unique imaging modality and its strategic investments in direct sales and global expansion are the key changes to watch.