Company: QTIWW
Filing Date: 2025-02-05
Form Type: 424B3
Source: 0001628280-25-004061
Chunk: 8

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-02-05
Form: 424B3
Chunk 8
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 clarity, OTViewer can measure both 2D and 3D, while 2D is standard of care, 3D is the better way to quantify a lesion when not standard of care.

The current version of the QT Breast Scanner 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.” The QT Breast Scanner has current applicability as a supplementary imaging device, not as a replacement for screening mammography. Current applicability is for measuring fibroglandular tissue volume, measuring mass size and growth will be addressed in short term by submitting letter to

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

#### Table of Contents
file to the Food and Drug Administration (“

#### FDA
”). Determining breast density and diagnosing lesions using artificial intelligence will be addressed in the near term, the Company plans to address with the FDA the applicability for breast screening in medium-to long-term.

#### Sales and Marketing
Since our inception, we have devoted substantially all our financial resources to acquiring and developing the base technology for our body imaging systems, conducted research and development activities, secured related intellectual property rights, and for general corporate operations and growth. Our first product, the QT Ultrasound Breast Scanner (which was later renamed “QT Breast Scanner”), received FDA’s 510(k) market clearance in June 2017.

Prior to the Closing of the Business Combination, QT Imaging initiated some marketing initiatives outside the U.S. In November 2022, QT Imaging entered into a three-year distribution relationship with Innovador Healthcare (Asia) Pte. Ltd. (“

#### Innovador
”), based in Singapore. The Company will assess future sales and distribution opportunities outside of the U.S., but there can be no guarantees that the Company will find additional partners on terms acceptable to it, if at all. Additionally, in the near term, the Company will focus its resources on the U.S. market, as we are supported by strong distribution and business partnership with NXC Imaging (“

#### NXC
”), a wholly owned subsidiary of Canon Medical USA, Inc. (“

#### CMSU
”).

On May 31, 2023, QT Imaging initially entered into a confidential Sales Agent Agreement with NXC (the “

#### NXC Sales Agent Agreement
”), pursuant to which QT Imaging appointed NXC as the non-exclusive agent for the sale of QT Imaging products and services in the following non-exclusive