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]

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Financial Data and Key Metrics Changes - Sales in Q3 2025 grew 12.6% to $1.55 billion, leading to an increase in full-year sales growth guidance to the high end of the previous 9% to 10% range [5][27] - Adjusted earnings per share (EPS) for Q3 was $0.67, exceeding expectations, while GAAP EPS was $0.50 [22][27] - Adjusted gross profit margin was 77.9%, down from 80.7% year-over-year, primarily due to foreign exchange and operational expenses [23] Business Line Data and Key Metrics Changes - TAVR global sales reached $1.15 billion, a 10.6% increase year-over-year, driven by renewed clinician focus on aortic stenosis treatment [13][14] - TMTT product group sales were $144 million, up 53% year-over-year, fueled by strong performance of Pascal and EVOKE [17] - Surgical product group sales were $258 million, increasing 5.6% year-over-year, supported by the adoption of Resilia therapies [20] Market Data and Key Metrics Changes - TAVR growth was supported by new evidence, guideline updates, and expanded education, with strong procedure growth in the U.S. and Europe [14][16] - In Japan, TAVR sales growth improved, reflecting a gradual recovery in market growth [16] - The global market for TMTT is expected to grow to an estimated $2 billion by 2030 [12] Company Strategy and Development Direction - The company is focused on structural heart therapies, positioning itself for sustainable multi-year growth [6][12] - There is a commitment to expanding into heart failure and aortic regurgitation as next-generation contributors to patient impact and growth [12][30] - The company plans to discuss long-term financial goals and market potential at the upcoming investor conference in December [27][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing strong Q3 performance and multiple growth drivers [5][6] - The management highlighted the importance of recent clinical data and guideline changes in driving TAVR adoption [14][37] - There is optimism regarding the upcoming approval of SAPIEN M3 in the U.S. by early 2026, which is expected to enhance treatment options for mitral patients [20][46] Other Important Information - The company has approximately $3 billion in cash and cash equivalents, with a share repurchase authorization of about $2 billion remaining [25] - The CFO announced plans to transition out of the role by mid-2026, with a succession plan in place [27][29] Q&A Session Summary Question: What drove the strength in TAVR growth this quarter? - Management attributed the strong performance to renewed focus on TAVR, new evidence, and a lack of typical summer seasonality [32][33] Question: How does the recent TCT data impact physician practices? - The data presented at TCT reassured physicians about TAVR's long-term performance, encouraging earlier treatment in the disease progression pathway [36][37] Question: What is the outlook for TAVR growth excluding Boston Scientific's exit? - Management indicated that while the growth was strong, it should not be considered the new normal, and they expect continued good performance in Q4 [32][33] Question: How does the company view the potential for broader diagnostic rates for AS? - Management sees the recent studies validating the market potential for AS as positive, suggesting that greater awareness and referral could lead to increased adoption [43][44] Question: What is the expected impact of FX on margins next year? - Management stated that they would provide detailed guidance on FX impacts at the upcoming investor conference [40] Question: What are the expectations for the SAPIEN M3 launch compared to EVOQUE? - The SAPIEN M3 launch is being approached with a controlled strategy, focusing on training and ensuring optimal outcomes before broader adoption [46][47]

Core Viewpoint - The rumors about Hao Su, an associate professor at UCSD, joining Fudan University could significantly impact the landscape of embodied intelligence in China, although there is currently no authoritative confirmation of this news [1][12]. Group 1: Current Situation - There are widespread rumors in the research community regarding Hao Su's potential move to Fudan University, but no concrete evidence has emerged to confirm this [1][12]. - Both Hao Su and Fudan University have not publicly disclosed any information regarding this potential appointment [5][12]. Group 2: Hao Su's Background - Hao Su is a key figure in the ImageNet project and has made significant contributions to 3D vision and robotics, including the development of foundational works like ShapeNet and PointNet [6][10]. - He has a strong academic background, having studied at prestigious institutions and published extensively, with over 133,000 citations to his work [10][11]. Group 3: Potential Impact on Fudan University - If Hao Su joins Fudan, he could attract students and establish a strong research focus on embodied intelligence, an area currently underrepresented in Chinese universities [15][17]. - His expertise could help Fudan build a competitive edge in embodied intelligence by integrating it with existing strengths in computer vision, automation, and engineering [17][18]. Group 4: International Collaboration and Innovation - Hao Su's return could facilitate international projects and collaborations, enhancing Fudan's global presence in the field of embodied intelligence [18]. - His entrepreneurial experience with Hillbot could lead to synergies between academia and industry, accelerating the commercialization of technologies in robotics and automation [19][21]. Group 5: Challenges and Considerations - The potential hiring of Hao Su involves various challenges, including institutional support, resource allocation, and team integration [22][24]. - Fudan's commitment to making embodied intelligence a core strategic focus will be crucial for successfully leveraging Hao Su's expertise [24].

Listing Announcements - Poloniex listed new tokens: $COPE, $FPX, $SAPIEN, $CMEW, $WLFI [1] - Trading for the listed tokens is available on Poloniex [1]

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