Company: QTIWW
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001844505-25-000038
Chunk: 34

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 34
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uided Breast Cancer Cryoablation, 213 Am. J. Roentgenol. 3, 716-722 (2019), available at https://www.ajronline.org/doi/10.2214/AJR.19.21329. 

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The Open Partial Angle Scanner or Open Breast Scanner will be able to operate with the same accuracy as the full 360º rotation all views breast scan, as shown below (Image 27): 

All views breast reconstruction (left) vs open angle breast reconstruction (right) of the same human breast 

Image 27 

Furthermore, the images reconstructed of scans performed on the open-angle scanner do not show any significant artifacts in the presence of an intervening device (e.g., a needle) (Image 28). 

Top view (left panel) and frontal view (right panel) 

An ablation needle shown in a human cadaver breast using the Company’s platform 

Image 28 

Manufacturing 

The Company’s products are manufactured in small scale in Novato, California. With the entry into the Canon Manufacturing Agreement as discussed below, the Company will be manufacturing the QT Brast Scanners in parallel between Novato, California and using Canon Medical Systems Corporation (“CMSC”) as a contract manufacturer pursuant to the Canon Medical Agreement Starting with the second half of 2025. The products are designed under the FDA’s design control guidelines and manufactured in accordance with the Company’s quality management system. 

The Company’s devices are made up of custom designed components and off-the-shelf components, both of each are supplied by the Company’s approved vendors in the U.S. 

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Currently all subassemblies are manufactured at the Company and verified prior to the final assembly of the device. The controls software and image reconstruction software are loaded on the imaging devices at the Company’s facility in Novato. Prior to shipping, 100% of the products are verified for functionality, performance, and safety. 

The Company intends to scale up its production by initially using CMSC, and may also look at strategic original equipment manufacturing (“OEM”) agreements for large production throughput. 

The suppliers that the Company purchases from and engages with are limited to those that are approved by our Quality Assurance department, which maintains an Approved Supplier List. The Company categorizes suppliers into three groups: (i) non-critical, (ii) important, and (iii) critical. For example, our “non-critical” suppliers include general distributors and/or suppliers of commercially available “off