MINNEAPOLIS and BRISBANE, Australia, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced today it has completed a $90 million strategic investment from Medtronic, plc (Galway, Ireland) (NASDAQ: MDT) (Medtronic), the world’s largest medical technology company. The investment closed i ...

Core Insights - Edwards Lifesciences Corporation is positioned for growth due to its innovative Surgical Structural Heart segment and the successful TAVR platform, despite facing macroeconomic challenges and litigation expenses [1][8]. Business Performance - The Surgical Structural Heart segment grew by 5.3% year-over-year in Q3 2025, driven by the adoption of RESILIA tissue and technologies like INSPIRIS, MITRIS, and KONECT [3][4]. - The TAVR business experienced a 10.6% year-over-year growth in Q3 2025, supported by stable pricing and competitive positioning [5][6]. - The TMTT segment saw a remarkable 53% increase in sales in Q3 2025, fueled by the performance of PASCAL and EVOQUE systems [9][10]. Market Position - Edwards Lifesciences has a market capitalization of $48.33 billion and has outperformed the industry with a 13.4% stock increase over the past year, compared to a 2.1% decline in the industry [2]. - The company has consistently surpassed earnings estimates, achieving an average surprise of 8.89% over the last four quarters [2]. Challenges - The company faces macroeconomic pressures, including a 31.3% increase in cost of goods sold (COGS) due to inflation and supply chain issues [11]. - Ongoing litigation related to patent rights poses risks to the company's growth and reputation [12]. Future Outlook - The Zacks Consensus Estimate for Edwards Lifesciences' 2025 earnings per share (EPS) is $2.59, with projected revenues of $6.03 billion, indicating a 1% increase from the previous year [13].

Edwards Lifesciences 2025 Investor Conference 2025 Investor Conference Mark Wilterding Cautionary Statement Presentations and comments made today by management of Edwards Lifesciences Corporation (the "Company") will include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can sometimes be identified by the use of words, such as "may," "will," "should," ...

Financial Data and Key Metrics Changes - The company reported a delay in FDA approval by approximately one month due to a government shutdown, but European approval was achieved on time, and the paradigm study commenced largely as scheduled [46][47] - The cost structures are expected to reflect the scale-up into the study and the pathway to commercialization, with increased investments in R&D and manufacturing [47][48] - Access to capital has improved significantly with the company's data, transitioning from a penny dreadful to a legitimate multi-billion dollar product [48][52] Business Line Data and Key Metrics Changes - The company is focused on scaling up manufacturing and ensuring high-quality product delivery, with recent facility expansions tripling capacity [15][16] - The ADAPT process is highlighted for its unique anti-calcific response and improved patient outcomes, which is critical for clinical trials and production [12][13] Market Data and Key Metrics Changes - The company has seen a significant increase in liquidity, up 1,000%, following its listing on Nasdaq, which has improved access to capital [58] - The share price has been volatile, influenced by broader market trends, particularly in the MedTech sector, which has faced challenges [59][60] Company Strategy and Development Direction - The company aims to lead in the TAVR space by focusing on innovation and quality, with a commitment to patient outcomes and a strong corporate culture [4][5][6] - The management emphasizes the importance of quality and manufacturing processes to support the investment thesis and ensure successful commercialization [43][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, highlighting the importance of resilience and vision in navigating the complex healthcare landscape [7] - The company is positioned to lead the market, with competitors following its advancements in addressing aortic stenosis [44][45] Other Important Information - The company has expanded its distribution center significantly, preparing for increased volume in the upcoming months [33] - The leadership team includes experienced professionals from major global companies, enhancing the company's operational capabilities [43] Q&A Session Summary Question: What are the key milestones that support the investment thesis? - The integration of a team of leaders and experienced physicians has been crucial in achieving milestones, ensuring that the product meets market needs [76] Question: How does the company differentiate itself from competitors? - The company focuses on fundamentally different approaches to product development, aiming for significant improvements rather than incremental changes [70][71]

Financial Data and Key Metrics Changes - The company reported a slight delay in FDA approval, which was impacted by a government shutdown, but European approval was achieved on time and the paradigm study commenced largely as planned [74][75] - The cost structures are increasing as the company scales up for the study and commercialization, particularly in R&D and manufacturing, which is essential for future growth [75][76] - Access to capital has improved significantly with the company's data, transitioning from a penny dreadful to a legitimate multi-billion dollar product [76][79] Business Line Data and Key Metrics Changes - The company is focused on scaling up manufacturing and ensuring high-quality product delivery, with recent facility expansions tripling capacity [18][19] - The quality control lab is integral to ensuring that every component meets high standards before manufacturing, emphasizing patient safety and regulatory compliance [25][29] Market Data and Key Metrics Changes - The company has seen a significant increase in institutional support, with healthcare funds now investing heavily, indicating a shift in market perception [77][79] - The share price has been volatile, influenced by broader market trends rather than the company's clinical progress, with analysts generally maintaining a buy rating [86][90] Company Strategy and Development Direction - The company is committed to innovation in cardiac care, focusing on developing a valve that mimics a healthy aortic valve to reduce patient prosthesis mismatch [62][66] - The management emphasizes the importance of quality and manufacturing processes as critical to maintaining competitive advantage in the market [70][71] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's direction and the potential for significant impact in cardiac care, driven by a strong commitment to innovation and quality [6][72] - The competitive landscape is characterized by the company leading in scientific advancements, with competitors following its lead rather than the other way around [71][72] Other Important Information - The company has a diverse workforce, with a balanced gender ratio and a strong emphasis on cultural diversity, which is seen as beneficial for innovation and decision-making [83][84] - The transition to a U.S.-listed company has improved liquidity and access to capital, which is crucial for future growth and partnerships [85][86] Q&A Session Summary Question: What is the significance of the PPM rate in the clinical trial? - The company reported a 3% rate of patient prosthesis mismatch in their trial, significantly lower than traditional market-leading valves, which is expected to lead to better long-term patient outcomes [62][64] Question: How does the company plan to compete with other TAVR products? - Management stated that the company is leading the field in innovation and that competitors are following its advancements, indicating a strong competitive position [71][72] Question: What are the expectations for the upcoming paradigm trial? - The company is ahead of its goals for pivotal trial capacity and is well-prepared for the next phase of commercialization [19][20]

ANTERIS TECHNOLOGIES GLOBAL CORP. (Exact name of registrant as specified in its charter) TABLE OF CONTENTS As filed with the Securities and Exchange Commission on November 26, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 3842 99-1407174 (I.R.S. Employer Identific ...

Core Insights - Anteris Technologies Global Corp. announced the presentation of one-year clinical outcomes for the DurAVR Transcatheter Heart Valve (THV) at the TCT 2025 conference, highlighting its commitment to innovative heart solutions [1][2]. Company Overview - Anteris Technologies is a global structural heart company focused on designing, developing, and commercializing advanced medical devices aimed at restoring healthy heart function. The company has a significant presence in both Australia and Minneapolis, USA [4]. - The DurAVR THV is the company's lead product, designed in collaboration with leading interventional cardiologists and cardiac surgeons to treat aortic stenosis, a serious condition caused by the narrowing of the aortic valve [5]. Product Details - The DurAVR THV is the first biomimetic valve, engineered to replicate the performance of a healthy human aortic valve and normal aortic blood flow. It is constructed from a single piece of molded ADAPT tissue, which is FDA-cleared and has been used in over 55,000 patients globally [5]. - The DurAVR THV System includes the DurAVR valve, ADAPT tissue, and the balloon-expandable ComASUR Delivery System [5]. Clinical Trials - The clinical outcomes for the DurAVR THV have been encouraging, with over 100 patients implanted. These outcomes will be further assessed in the global pivotal PARADIGM Trial, which is a prospective randomized controlled trial evaluating the safety and effectiveness of the DurAVR THV against existing transcatheter aortic valve replacements [3].

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 ...