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

Product and clinical value

• QTscan is a 3D acoustic imaging platform with no radiation, compression or contrast; exams take 10–12 minutes per breast and provide seven biomarkers.

• Targets dense-breast and supplemental imaging; images can identify tumors missed by mammography and handheld ultrasound, with operator-independent imaging and potential to reduce unnecessary biopsies.

• Neoadjuvant therapy monitoring trials aim to assess early tumor response; ultrasound imaging could be repeated weekly or every two weeks versus MRI every three months.

• Mayo’s 26-patient high-risk pilot showed strong breast-level agreement with MRI, and QTscan identified all MRI-suspicious lesions; Sunnybrook’s 100-patient treatment-response study is ongoing.

• Multi-site repeatability testing showed less than 1% variability in speed-of-sound measurements under studied conditions, supporting longitudinal biomarker monitoring.

Reimbursement and market access

• CPT Category III billing code became effective in October 2026; CMS hospital outpatient Medicare reimbursement for eligible, physician-ordered medically necessary diagnostic exams starts January 1, 2027.

• The Category III code can be used while data are accumulated and payer discussions continue to establish reimbursement; progression to Category I is expected to take time.

• Premier’s 2026 Breakthroughs Innovation Award and national purchasing agreement provide pre-negotiated pricing and access to nearly 4,400 U.S. hospitals and health systems.

• Global dense-breast supplemental screening and biomarker opportunity estimated at $2.5B, rising to $3.8B by 2030; accessible reimbursed markets estimated at $1.7B, rising to $2.6B.

• Regulatory approvals were received in Saudi Arabia, UAE, Israel, Bahrain and Qatar during 2026; CE mark anticipated mid-to-late 2027.

Commercial plans and financial outlook

• Revenue was $4.9M in 2024 and $18.9M in 2025; 2026 revenue forecast at just over $34M, with stated growth of 81%.

• Scanner shipments were 13 in Q1 2026 and 15 in each of Q2 and Q3 2026.

• Three senior sales VPs were hired in July and August to build direct sales focused on hospitals, IDNs and outpatient imaging chains; NXC Imaging remains a distributor in functional medicine.

• U.S. gross margin was about 41% in Q1–Q3 2026; direct and international sales are expected to move margins into the low 50s.

• 2027 plans include moving image reconstruction to the cloud and launching QTI Precision Pathway SaaS with an AI diagnostic layer, adding recurring revenue and supporting gross-margin improvement.