Company: APXIF
Filing Date: 2025-07-03
Form Type: F-4/A
Source: 0001213900-25-061545
Chunk: 177

Company: APx Acquisition Corp. I
Filing Date: 2025-07-03
Form: F-4/A
Chunk 177
---
 and helps laboratories achieve the highest standards of excellence to positively impact patient care. While not required to operate a CLIA -certified 66 laboratory, many private insurers require CAP accreditation as a condition to contracting with clinical laboratories to cover their tests. In addition, some countries require CAP accreditation as a condition to permitting clinical laboratories to test samples taken from their citizens. We have CAP accreditations for our laboratories. Failure to maintain CAP accreditation could have a material adverse effect on the sales of our tests, which in turn would negatively affect our business, financial condition, results of operations or growth prospects. We expect to rely on third parties to conduct any future studies of our technologies that may be required by U.S. or foreign regulatory bodies, and those third parties may not perform satisfactorily. We expect to rely on third parties such as contract research organizations, medical institutions and clinical investigators to conduct studies. Our reliance on these third parties for clinical development activities will reduce our control over these activities. We may not be able to secure partnerships or agreements with these third parties, or these third parties may not complete activities on schedule or conduct studies in accordance with regulatory requirements or our study design. Our reliance on third parties that we do not control will not relieve us of our requirement to prepare, and ensure our compliance with, various procedures required under good clinical practices, even though third -partycontract research organizations may prepare and comply with their own, comparable procedures. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if the third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our studies may be extended, delayed, suspended or terminated, and we may not be able to obtain a required regulatory approval. Our products, if used for the diagnosis of disease, could be subject to government regulation, and the regulatory approval and maintenance process for such products may be expensive, time -consuming , and uncertain both in timing and in outcome. Some of our products, including tests developed for use in clinical settings, such as the ones in our Heritas Diagnostics operating segment, are classified as diagnostic products, which may be subject to various regulatory frameworks depending on the country where they are offered. In Latin America, our diagnostic tests are primarily developed and validated through our partner laboratories, such as CIBIC in Argentina, where the laboratory assumes responsibility for ensuring compliance with local regulatory and licensing requirements. For example,