Company: QTIWW
Filing Date: 2025-11-03
Form Type: S-1
Source: 0001628280-25-048373
Chunk: 47

Company: QT IMAGING HOLDINGS, INC.
Filing Date: 2025-11-03
Form: S-1
Chunk 47
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 if we obtain FDA approval of our products and product candidates, market acceptance of our products in the healthcare community, including physicians, patients and third-party payors, will depend on many factors, including:

• our ability to provide incremental clinical and economic data that shows the safety and clinical efficacy and cost-effectiveness of, and patient benefits from, our products;

• the availability of alternative products;

• whether our products or the use thereof are included on insurance company formularies or coverage plans;

• the willingness and ability of patients and the healthcare community to adopt our technologies;

• customer demand;

• liability risks generally associated with the use of new product candidates;

• the training required to use new product candidates;

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• perceived inadequacy of evidence supporting clinical benefits or cost-effectiveness over existing alternatives;

• the convenience and ease of use of our products relative to other treatment methods;

• the pricing and reimbursement of our products relative to other treatment methods; and

• the marketing and distribution support for our products.

Even if we obtain all necessary FDA approvals, our products may fail to achieve market acceptance. If our products achieve market acceptance, they may not maintain that market acceptance over time if competing products or technologies are introduced that are received more favorably or are more cost-effective. Failure to achieve or maintain market acceptance would limit our ability to generate revenue and would have a material adverse effect on our business, financial condition, results of operations and prospects.

The outcome of any future claims and litigation could have a material adverse impact on our business, financial condition and results of operations.

We may, from time to time, be subject to claims and may become party to litigation in the normal course of business, including class action lawsuits. Such claims and litigation proceedings may be brought by third parties, including our customers, competitors, advisors, service providers, partners or collaborators, employees, and governmental or regulatory bodies. The final outcome of these claims and litigation, including any settlements, may be significant and may differ substantially from our expectations. We may not be able to determine the amount of any potential losses and other costs we may incur due to the inherent uncertainties of litigation and settlement negotiations. In the event we are required or decide to pay amounts in connection with any claims or lawsuits, such amounts could be significant and could have a material adverse impact on our liquidity, business, financial condition and results of operations.

We could become subject to product liability claims, product recalls, and warranty claims that could be expensive, divert management’s attention and harm our