{"url_path":"/sec/avr/10-q/2026/item-1a","section_key":"item-1a","section_title":"Item 1A Risk Factors","topic":"sec","document":{"doc_type":"10-Q","doc_date":"2026-05-12","source_url":"https://www.sec.gov/Archives/edgar/data/2011514/0001140361-26-020806-index.html","accession_number":"0001140361-26-020806","cik":"0002011514","ticker":"AVR","issuer_name":"Anteris Technologies Global Corp.","edgar_url":"https://www.sec.gov/Archives/edgar/data/2011514/0001140361-26-020806-index.html","primary_entity_key":"0002011514","primary_entity_name":"Anteris Technologies Global Corp."},"word_count":261,"has_tables":true,"body_markdown":"Item 1A.\n\nRisk Factors\n\n \n\nWe face a number of risks that could materially and adversely affect our business, results of operations, cash flow, liquidity, or financial condition. Please refer to the factors discussed in Part I, Item 1A. “Risk Factors” in the Annual Report. Other than the supplemental risk factor provided below, there have been no material changes or additions to our risk factors discussed in such report that could materially impact our business, results of operations, cash flow, liquidity, or financial condition.\n\n \n\nAlthough we have received regulatory approvals to begin the PARADIGM Trial, there can be no guarantee that the study will be successful or that we will receive PMA from the FDA as a result.\n\n \n\nAlthough we have received approval from the FDA to proceed with the PARADIGM Trial under the IDE, the current approval from the FDA to proceed could be revoked, the study could be unsuccessful, and PMA from the FDA may not be obtained or could be revoked. Even if we obtain PMA for our DurAVR® THV System, the FDA or other regulatory authorities may require expensive or burdensome post-market testing or controls. Any delay in, or failure to receive or maintain, clearance or approval for our DurAVR® THV System could prevent us from generating revenue or achieving profitability. Additionally, the FDA and other regulatory authorities have broad enforcement powers. Regulatory enforcement or inquiries, or other increased scrutiny on us, could dissuade some physicians from using our products and adversely affect our reputation and the perceived safety and efficacy of our products.\n\n \n\n17\n\n[Table of Contents](#TO)"}