Anbio Biotechnology is dedicated to the advancement of medical technology and the provision of in vitro diagnostics (IVD) products. Our unwavering commitment lies in transforming the diagnostics landscape on a global scale, fostering a paradigm shift towards personalized and decentralized diagnostic solutions. By doing so, we aim to significantly enhance patient prognosis and contribute to the betterment of healthcare worldwide. At Anbio Biotechnology, our extensive portfolio comprises an array of IVD products designed to cater to diverse diagnostic needs. Our comprehensive range encompasses solutions for various applications, including over-the-counter (OTC) utilization, point-of-care (POCT) settings, and laboratory applications. By offering a versatile range of products, we ensure that healthcare providers and patients alike can access reliable and efficient diagnostic tools regardless of the healthcare setting. Our IVD products are designed to detect a wide range of biomarkers associated with critical medical domains. These domains encompass infectious diseases, cancer, cardiovascular diseases, inflammation, drug abuse, endocrine disorders, renal disease, pharmacogenomics, and diabetes. By providing advanced diagnostic capabilities in these areas, we empower healthcare professionals to identify and monitor various conditions, facilitating timely intervention and patient care. Moreover, our IVD products are compatible with multiple sample collection matrices, including serum, plasma, whole blood, feces, urine, and saliva, for both healthcare providers and patients. This flexibility allows for diagnostic testing across diverse patient populations and healthcare settings. Furthermore, the IVD assays we develop utilize established and widely used IVD technology platforms and their scientific principles to allow quick adoption by the healthcare providers and cost-efficient improvements to the already available products on the market. Anbio Biotechnology offers a comprehensive range of IVD products to meet the growing demand in the POCT and OTC market. Our main sales revenue was from SARS-CoV-2 and SARS-CoV-2/Flu A/Flu B Antigen Rapid Test Kit, under our Lateral Flow Immunoassay (LFIA) technology, which accounted for over 60% and 99% of total revenue for the fiscal year ended December 31, 2023 and 2022, respectively, and 44% and 99% of total revenue for the six months ended June 30, 2024 and 2023, respectively. For the six months ended June 30, 2024 and 2023, we generated revenue of $5.85 million and $3.06 million, respectively, of which 44% and 99% were from respiratory diseases and COVID-19 related products. Our non-COVID-19 related IVD products are primarily focused on laboratory and point of care type of solutions. For the six months ended June 30, 2024 and 2023, 63% and 99% of our revenue were generated in the European Union and we have significant customer concentration. For the fiscal years ended December 31, 2023 and 2022, we generated revenue of $6.71 million and $23.54 million, respectively, of which 60% and 99% were from respiratory diseases and COVID-19 related products. Our non-COVID-19 IVD products are primarily focused on laboratory and point of care type of solutions. For the fiscal years ended December 31, 2023 and 2022, 69% and 86% of our revenue were generated in the European Union and we have significant customer concentration. Currently, all of our IVD products are ready for commercialization and do not require additional development. Prior to the sale of our IVD products in the European Union, we must register with the relevant authority for the regulatory approvals in the European Union. We also work with local distributors to determine the regulatory obligations and appropriate strategies for market entry. Currently, our local distribution partners in strategically selected countries cover countries in the EU, APAC, North and South Americas (collectively “Americas”), and Africa listed below: European Union (EU): Germany, France, Italy, Austria, Portugal, Netherlands, Poland, Slovakia, Czech Republic, Croatia, Belgium, Romania, Bulgaria, Greece, Lithuania, and Cyprus. Asia Pacific (APAC): Indonesia, India, Philippines, Malaysia, Thailand, Bangladesh, Pakistan, Hong Kong SAR, United Arab Emirates, and Vietnam Americas: Brazil, Chile, Peru, Bolivia, Guatemala, Colombia, Costa Rica, Paraguay, and Dominican Republic Africa: Nigeria, Ethiopia, Kenya, Uganda, Tanzania, Ghana, Burkina Faso, Cameroon, and Egypt Currently, all of the IVD products are CE marked under the In Vitro Diagnostic Directive (IVDD) 98/79/EC and can be commercialized in the EU. Additionally, we are currently preparing the documentation for the IVDR registration of our IVD products, and we anticipate IVDR approval by the following dates for different device classes: • high individual risk and high public health risk products (Class D): 31 December 2027; • high individual risk and/or moderate public health risk products (Class C): 31 December 2028; • moderate individual risk and/or low public health risk (Class B): 31 December 2029; • low individual risk and low public health risk products placed on the market in a sterile condition (Class A sterile): 31 December 2029. While we do not foresee any setbacks or shortcomings in obtaining regulatory approvals, we cannot guarantee the success of all our registration endeavors. Failure to secure registration for our IVD products in these countries could adversely impact our revenue performance. Since 2023, we have commenced sales of our non-COVID products in countries within the European Union (EU), Americas, APAC, and Africa. Since the IVDR provides a transitional provision, the IVDR approval process would not currently impact the sales of our non-COVID products. To ensure compliance with the evolving IVDR requirements set by regulatory authorities, we must stay vigilant to prevent potential issues that could impact our business in EU. Our principal executive offices are located at Wilhelm Gutbrod Str 21B, 60437, Frankfurt am Main, Germany. Our registered office in the Cayman Islands is located at the offices of Vistra (Cayman) Limited, P. O. Box 31119, Grand Pavilion, Hibiscus Way, 802 West Bay Road, Grand Cayman, KY1 — 1205 Cayman Islands. Our agent for service of process in the United States is C T Corporation System, 128 Liberty Street, New York, NY.
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