Company: QTIWW
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001844505-25-000038
Chunk: 234

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 7
Chunk 234
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-body scanner product candidate intended for orthopedic and pediatric use.

We cannot reasonably determine the nature, timing and costs of the efforts that will be necessary to complete the enhancements of the QT Breast Scanner, or estimate the nature, timing and costs that will be necessary to complete the development of, and obtain regulatory approval for, the full-body scanner product candidate. The process of conducting the necessary research and development to obtain regulatory approval of a product candidate is costly and time-consuming, and the successful development of our product candidates is highly uncertain. Our research and development expenses may vary significantly based on factors such as, without limitation:

•The timing and progress of development activities; 

•Our ability to maintain our current research and development programs and to establish new ones;

•The receipt of regulatory approvals from applicable regulatory authorities without the need for independent clinical trials or validation; 

•Duration of subject participation in any trials and follow-ups;

•The countries and jurisdictions in which the trials are conducted; 

•Length of time required to enroll eligible subjects and initiate trials; 

•Per trial subject costs; 

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•Number of trials required for regulatory approval; 

•The timing, receipt, and terms of any marketing approvals from applicable regulatory authorities; 

•The success of our distribution arrangements, and our ability to establish new licensing or collaboration arrangements;

•Establishing contract manufacturing partnerships or making arrangements with third-party manufacturers; 

•The hiring and retention of research and development personnel; 

•Obtaining, maintaining, defending, and enforcing intellectual property rights; and 

•The phases of development of our product candidates. 

Any changes in the outcome of any of these variables with respect to the development of our products or product candidates could significantly change the costs and timing associated with the development of these products and product candidates. 

Selling, General and Administrative Expenses 

Selling, general and administrative expenses consist primarily of personnel costs, costs related to maintenance and filings of intellectual property, and other expenses for outside professional services, including legal, consulting, investor relations, audit and accounting services. Our personnel costs consist of salaries, benefits and stock-based compensation expenses. Selling, general and administrative expenses include facilities, depreciation and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance. Selling, general and administrative expenses also include consulting expenses and costs for conferences, meetings, and other events. 

We anticipate that our selling, general and administrative expenses will increase to support our expanding headcount and operations, increased costs of operating as a public company, the development of