Company: QTIWW
Filing Date: 2025-01-16
Form Type: S-1
Source: 0001628280-25-001723
Chunk: 197

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-01-16
Form: S-1
Chunk 197
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with various functions. The QTviewer has additional functionality which enables the user to measure mass size and volume as well as fibroglandular tissue volume. 16

Image 4 below is a still image of the viewer for a patient with a cyst. The transmission (top 3 panels) and reflection (bottom 3 panels) images as seen in coronal, axial, and sagittal representations.

<div align='center'>Image 4</div>

The QT Breast Scanner is the current version of the QT Breast Scanner and is FDA-cleared “for use as an ultrasonic imaging system to provide reflection-mode and transmission-mode images of a patient’s breast. The device is not intended to be used as a replacement for screening mammography.” 17

The QT Breast Scanner has current applicability as a supplementary imaging device (not as a replacement for screening mammography); near-term applicability for determining breast density, measuring mass size and growth,

16 See, American Association for Cancer Research, R. Natesan, J. Wiskin, S. Lee, B. H. Malik, Quantitative Assessment of Breast Density: Transmission Ultrasound is Comparable to Mammography with Tomosynthesis (Dec. 3, 2019), available at https://aacrjournals.org/cancerpreventionresearch/article/12/12/871/47203/Quantitative-Assessment-of-Breast-Density.

17 U.S Department of Health and Human Services, Food and Drug Administration, 510(k) number K162372.

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and diagnosing lesions using artificial intelligence; and medium- to long-term applicability for breast screening as shown in Table 1.

| Use of the QT Breast Scanner                                                                    |     | Value it Adds                                                                                                                                                                                                                                  |     | QT Timeframe* |
| Supplementary imaging                                                                           |     | Adjunct to screening mammography (not a replacement), particularly for women with dense breasts to identify masses missed by mammography or provide additional information on masses seen, with the potential to reduce unnecessary procedures |     | Current       |
| Fibroglandular Tissue Volume & the Ratio of Fibroglandular Tissue Volume to Total Breast Volume |     | Ability to quantify this ratio (a risk factor for breast cancer), without compression or radiation of mammography                                                                                                                              |     | Current       |
| Mass Size and Growth                                                                            |     | Ability to measure response to treatment and assess mass stability                                                                                                                                                                             |     | Short term    |
|