Company: APXIF
Filing Date: 2025-07-03
Form Type: F-4/A
Source: 0001213900-25-061545
Chunk: 385

Company: APx Acquisition Corp. I
Filing Date: 2025-07-03
Form: F-4/A
Chunk 385
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, data -drivenapproach, and local partnerships enable us to address the specific needs of the Latin American market effectively. Seasonality Our business remains largely unaffected by seasonal patterns and external factors that influence other industries. However, as we enter new markets and launch new products, seasonality may become more pronounced, potentially causing fluctuations in our operating results. Regulation We are, and will continue be, subject to laws and regulations of the countries where we operate, which include laws and regulations governing biotechnology and precision medicine companies related to the development, approval, processing, import, export, marketing and sale of our products. Regulations Applicable to our Laboratory Operations We uphold the highest standards in our laboratory operations, as evidenced by the quality certifications we have obtained by CAP, EMQN, and UKNEQAS for our Argentina facility. For our Heritas services, we have obtained certification from the CAP that ensures that our Non -InvasivePrenatal, Clinical Exome, and CMA tests meet the global standard of laboratory quality assurance, reflecting our commitment to excellence and patient care. In addition, we have accreditation from EMQN and the United Kingdom National External Quality Assessment Service (“UKNEQAS”) to oversee our Hereditary Cancer testing protocols, offering an external quality assessment that guarantees our tests’ standards, as well as precision and diagnostic reliability. These certifications from CAP, EMQN, and UKNEQAS exemplify Heritas Diagnostics’ dedication to quality, which is foundational to our operations and instrumental to provide global quality services to patients and healthcare providers alike. It is important to note that if our laboratory is found to be out of compliance with the requirements to uphold these certifications, we may be subject to sanctions and suspension, limitation, or revocation of the CAP, UKNEQAS and EMQN certificates. As such, we maintain the highest standards to comply with all requirements. We are subject to survey and inspection every year to assess compliance with CAP’s and EMQN’s program standards, and we may be subject to additional unannounced inspections. Additionally, our laboratory operations, for both Rewell and Heritas Diagnostics’ products, are certified under the ISO 9001:2015 standard, a testament to commitment to quality management. This certification underscores our commitment to consistent, high -qualityprocesses and procedures that enhance customer satisfaction and operational efficiency. It is an integral part of our quality assurance program, ensuring that every aspect of our service adheres to international best practices and continual improvement strategies. This ISO certification, which is also subject to