Company: QTIWW
Filing Date: 2025-01-31
Form Type: S-1/A
Source: 0001628280-25-003316
Chunk: 202

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-01-31
Form: S-1/A
Chunk 202
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/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    |
| A.I.-Based Mass Diagnostics                                                                     |     | Reduce unnecessary procedures (biopsies, additional imaging) by identifying lesion type                                                                                                                                                        |     | Short term    |
| Screening for High-Risk Young Women                                                             |     | Provide young women a safe, comfortable, accurate method to screen for breast cancer                                                                                                                                                           |     | Medium term   |
| Alternative to Screening Mammography                                                            |     | Provide all women a safe, comfortable, accurate method to screen for breast cancer                                                                                                                                                             |     | Long term     |
|                                                                                                 |     | Table 1                                                                                                                                                                                                                                        |     |               |

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* Note: the foregoing is based on the Company’s current estimates and the timeframe is subject to change due to various factors, including those described in the “Risk Factors” section and elsewhere in this registration statement/prospectus.

Breast Scanner Clinical Images

The images below (Image 5 and Image 6) compare an artist’s depiction of the normal breast anatomic features (top) and QTscan® images rendered by the QT Breast Scanner of a normal human breast (below) showing the skin, fat, breast duct and glandular (terminal) units of the living breast. The Cooper’s ligaments, ducts, and glandular structures are not visible in conventional breast screening imaging.

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Schematic anatomy of the breast