QT Imaging Holdings (QTI) Investor presentation summary

Product and clinical proposition

• Breast Acoustic CT is a 3D, FDA-cleared imaging modality using acoustic transmission and reflection to produce quantitative images without radiation, compression, or contrast.

• The proposed workflow combines supplemental and diagnostic imaging in one exam, aiming to reduce follow-up procedures, patient anxiety, and attrition for dense-breast imaging.

• Exams take 10–12 minutes per breast; imaging is described as quiet and suitable for dense breasts and implants.

• The QTI Precision Pathway SaaS platform is intended to add quantitative biomarkers, automated analysis, collaboration, and precision reporting to scanner sales.

Reimbursement and market opportunity

• Category III CPT code 1079T took effect Oct. 1, 2026; separate Medicare hospital outpatient payment under APC 5522 is scheduled to begin Jan. 1, 2027 for eligible, physician-ordered, medically necessary diagnostic exams.

• The reimbursement pathway is positioned to support scanner adoption, exam volumes, SaaS, service, and consumables; potential screening PMA is a separate future expansion lever.

• Presentation estimates a $2.5B global TAM in 2026, growing to $3.8B by 2030, and a $1.7B accessible reimbursed SAM growing to $2.6B; both use an 8.5% CAGR.

• A ~10% SAM share by 2030 is associated with $200–250M in revenue; the presentation also cites a $1B SaaS biomarkers market.

Clinical validation and development

• A Mayo Clinic feasibility study of 26 high-risk women found strong breast-level agreement with MRI across 52 breasts; QTscan identified all MRI-suspicious lesions.

• An ongoing Sunnybrook 100-patient study compares quantitative ultrasound findings with neoadjuvant treatment response; prior lesion-volume comparisons showed strong correlation with MRI.

• A two-site repeatability study reported <1% variability for speed of sound, ~5% for total breast volume, and ~12% for the fibroglandular-volume-to-total-breast-volume ratio.

• Clinical trials are evaluating quantitative biomarkers for early neoadjuvant response assessment and treatment management.

• Regulatory approvals were reported in Saudi Arabia, UAE, Israel, Bahrain, and Qatar; clinical studies include Mayo Clinic and Sunnybrook, with Stanford and Harvard planned.