Company: APXIF
Filing Date: 2025-07-03
Form Type: F-4/A
Source: 0001213900-25-061545
Chunk: 175

Company: APx Acquisition Corp. I
Filing Date: 2025-07-03
Form: F-4/A
Chunk 175
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 our partners, to thoroughly evaluate local opportunities, adapt our products to meet cultural and regulatory requirements, and effectively navigate varying market conditions. Our consortium strategy emphasizes partnerships with local laboratories and healthcare providers to ensure compliance with each country’s regulations while minimizing operational risks. To date, we have commenced market research and exploratory discussions with potential partners in key Latin American countries, including Mexico, Peru, Colombia, Chile, Ecuador, Uruguay, Dominican Republic, Costa Rica, and Panama, to align on regulatory requirements and market dynamics. 65 Each country presents unique risks, primarily related to the adoption and growth of our products and services, as healthcare systems can vary significantly across the region. If there are issues with the expansion of our products in any of these countries, our operations abroad may be limited and our business may be adversely affected. Our regional processing hub in Mexico will expose us to Mexican regulations related to the handling, transport, and processing of biological samples. Non -compliancewith these regulations, or any changes to the regulatory environment, could result in increased operational costs or delay the establishment and operation of the hub. Such developments may adversely affect our business operations and financial performance. In countries outside the U.S., existing regulations or those that are under consideration may limit or prevent the sale of direct -to -consumergenetic tests. Regulatory conditions in Latin America could potentially influence our product and service offerings. In some countries, like Australia, regulatory bodies require premarket reviews similar to those mandated by the FDA in the United States. Additionally, countries such as Australia, Germany, France, and Switzerland, for example, require a physician’s prescription for genetic tests that provide health information, limiting our offerings in these markets to ancestry -onlytests. Other regions may mandate genetic counseling prior to testing. If similar regulations are enacted in Latin America, they could constrain the market for our products and services or escalate the costs related to their marketing and distribution, affecting availability in certain areas. If we fail to comply with any of these regulations, we could become subject to enforcement actions or the imposition of significant monetary fines, other penalties, or claims, which could harm our operating results, our ability to conduct our business and our growth prospects. If we fail to comply with certain laboratory licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business. We are required to maintain certain laboratory licenses and approvals to conduct testing. We may also be subject to regulation in foreign jurisdictions as we seek to expand international utilization of our tests or such jurisdictions adopt new licensure requirements, which