Company: QTIWW
Filing Date: 2025-12-31
Form Type: 424B3
Source: 0001628280-25-059235
Chunk: 181

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-12-31
Form: 424B3
Chunk 181
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 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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| Use of the QT Breast Scanner         |     | Value it Adds                                                                           |     | QT Timeframe* |
| 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 images rendered by the QT Breast Scanner known as a QTscan® image 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.

Schematic anatomy of the breast

<div align='center'>Image 5

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Transmission (left) and reflection tomograms of the breast. The white and black squares in the speed of sound image (left) mark fat and glandular tissue, respectively. Single and double black arrows mark ductal tissue and skin, respectively. Reflection image (right): Single white arrows mark the connective tissue identified as Cooper’s ligaments.

Image 6</div>

Two key metrics in breast imaging are sensitivity and specificity. Mammography has well-recognized challenges with sensitivity in dense breasts. Image 7 below compares the same breast across different