Clinical Development and Trials - The DurAVR® THV system has been clinically developed with significant physician input, treating a total of 83 patients across the United States, Canada, and Europe as of January 2025[32]. - The FDA approved the early feasibility study for the DurAVR® THV system in November 2022, with 30-day post-procedure results showing a mean effective orifice area of 2.2 cm² and a mean pressure gradient of 7.5 mmHg[38]. - The anticipated design of the Pivotal Trial will be a prospective, randomized, controlled multicenter study to demonstrate non-inferiority of the DurAVR® THV compared to commercially available TAVR systems[36]. - The company has treated seven patients in ViV procedures using the DurAVR® THV system as of January 2025, indicating progress in clinical applications[39]. - Clinical trials have shown that the DurAVR® THV system resulted in an average effective orifice area (EOA) increase of 311% at 30 days and 294% at 12 months post-procedure in the first cohort[82]. - The mean pressure gradient (MPG) across the valve decreased by 87% at 30 days and 85% at 12 months from baseline in the first cohort[82]. - The six-minute walk test distance (6MWTD) improved by 21% at 30 days and 44% at 12 months post-procedure in the first cohort[82]. - The second cohort observed an average EOA increase of 164% at 30 days and 165% at 12 months post-procedure[83]. - The MPG across the valve in the second cohort decreased by 79% at 30 days and 80% at 12 months from baseline[83]. - The third cohort showed an average EOA increase of 170% at both 30 days and 12 months post-procedure[84]. - The MPG across the valve in the third cohort decreased by 87% at 30 days and 85% at 12 months from baseline[84]. - The fourth cohort demonstrated an average EOA increase of 165% at 30 days post-procedure[85]. - The fifth cohort reported an average EOA increase of 208% at 30 days post-procedure[86]. - The Early Feasibility Study (EFS) for the DurAVR® THV system commenced in August 2023, enrolling 15 patients across four heart valve centers in the U.S.[90]. - The EFS demonstrated a 100% precise placement and implant success for all 15 patients, with a 172% increase in average EOA from baseline at 30 days post-procedure[92]. - At 30 days post-procedure, there was an 82% reduction in mean pressure gradient (MPG) from baseline, and a 121% increase in DVI[92]. - No mortality, disabling stroke, life-threatening bleeding, or reinterventions were reported at 30 days post-procedure[92]. - The EU EFS is set to evaluate the safety and feasibility of the DurAVR® THV system, with plans to enroll up to 40 patients starting in January 2025[98]. - The DurAVR® THV was used for the first time in a Valve-in-Valve (ViV) procedure in Canada in July 2023, addressing patients with failing bioprosthetic aortic valves[96]. Market Opportunity and Financials - The total global market opportunity for TAVR related to severe aortic stenosis is expected to reach $9.9 billion by 2028, with North America and Europe accounting for 53% and 38% of the market share, respectively[46]. - The market opportunity for ViV procedures is projected to reach $2.5 billion by 2028, highlighting the growth potential in this segment[41]. - The annual volume of TAVR procedures in the United States has significantly increased, with an estimated 73,000 patients undergoing the procedure in 2019[41]. - The company reported total losses after income tax of $76.0 million for the year ended December 31, 2024, compared to $46.8 million for 2023, indicating a significant increase in losses year-over-year[209]. - Negative cash flows from operating activities were $61.2 million for 2024 and $34.6 million for 2023, reflecting ongoing financial challenges[209]. - As of December 31, 2024, the company had an accumulated deficit of $276.4 million, up from $200.1 million in 2023, highlighting the growing financial strain[209]. - The company completed its initial public offering on December 12, 2024, raising net proceeds of $80.1 million from the sale of 14,878,481 shares at a price of $6.00 per share[194]. Intellectual Property and Partnerships - The company has a strong intellectual property position with 51 issued patents and 53 pending patent applications, which supports its innovative technology[47]. - Anteris has a total of 51 active patents expiring between 2025 and 2042, and 53 pending patent applications as of December 31, 2024[102]. - The company entered into a development agreement with v2vmedtech in April 2023 to enhance its business operations and profitability through innovative heart valve repair technology[45]. - The company has a 30% interest in v2vmedtech, which focuses on implantable medical devices for mitigating heart valve regurgitation, with six pending patent applications[108]. - The company purchased 30% equity in v2vmedtech for $0.2 million and is providing development services for a heart valve repair device[121]. Regulatory Environment - The FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act, requiring extensive compliance for product design, testing, and marketing[149]. - New medical devices require either a 510(k) clearance, de novo classification, or pre-market approval (PMA), which can be resource-intensive and costly[150]. - Class III devices, such as the DurAVR® THV system, require PMA approval, which is generally more expensive and time-consuming than 510(k) processes[156]. - The FDA review of a PMA application typically takes between one and two years, but can be significantly longer depending on various factors[166]. - If the FDA's evaluation of a PMA is favorable, an approval letter is issued, allowing for commercial marketing of the device[168]. - Modifications to an approved device that affect safety or effectiveness require new PMAs or pre-market approval supplements[169]. - The IDE process is necessary for human clinical trials supporting medical device clearance, requiring FDA approval prior to commencing trials[162]. - The FDA may require post-approval studies or post-market surveillance for devices, ensuring long-term safety and effectiveness data[170]. - Manufacturers must comply with stringent cGMP regulations during the manufacturing process, including design, testing, and quality assurance procedures[172]. - The EUMDR, effective in 2021, imposes extensive regulatory requirements for medical devices in the EU, including clinical evidence and post-market surveillance[180]. - The IMDRF aims to harmonize medical device regulatory requirements across multiple countries, reducing the need for separate inspections[181]. - Non-compliance with FDA regulations can lead to sanctions, including fines, recalls, and operational restrictions[182]. Company Operations and Challenges - The company is committed to maintaining a strong corporate culture based on its AORTIC values (Accountability, Objectivity, Respect, Teamwork, Integrity, Courage) to enhance employee engagement and retention[201]. - The company has implemented training programs aimed at boosting company culture and increasing employee job satisfaction and productivity[203]. - The company is subject to evolving healthcare policies that may impact reimbursement rates and coverage for its products, potentially affecting market demand[190]. - The company faces regulatory compliance challenges due to numerous state, federal, and foreign laws governing health privacy and consumer protection, which could lead to significant penalties if not adhered to[191]. - The company is focused on developing and commercializing the DurAVR® THV system, with significant operating expenses expected to increase as the business grows[210]. - The company anticipates continued significant operating losses for the foreseeable future, raising doubts about its ability to achieve profitability[211]. - The company has historically devoted most of its financial resources to R&D, relying on equity financings and divestments to fund operations[217]. - The company faces substantial risks in completing clinical trials and obtaining regulatory approvals, which are critical for generating significant revenue[213]. - The company may encounter unforeseen expenses and complications typical of early-stage medical technology firms, impacting its financial condition[211]. - The ongoing geopolitical events, such as the war in Ukraine, may disrupt clinical studies and increase R&D expenses[228]. - The company must successfully manage growth and operational complexity to avoid negatively impacting its business and financial position[221]. - The company requires substantial additional financing to support R&D and commercialization efforts, with future capital requirements dependent on various factors[216]. - The lead product, DurAVR® THV system, is undergoing clinical trials necessary for FDA pre-market approval, with no assurance of successful completion[230]. - The company may face challenges in maintaining profitability and investor confidence if it cannot secure necessary funding or achieve commercial success[215].

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on December 9, 2024. Registration No. 333-283414 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ANTERIS TECHNOLOGIES GLOBAL CORP. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 3842 (Primary Standard Industrial Classification Code Number) 99-1407174 (I ...

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on November 22, 2024. (State or other jurisdiction of incorporation or organization) REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ANTERIS TECHNOLOGIES GLOBAL CORP. (Exact name of registrant as specified in its charter) Delaware Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 3842 (Primary Standard Industrial Classification Code Number) N/A (I.R.S. Employer Identification N ...