Core Insights - The TRINITY clinical trial results for LuX-ValvePlus were presented at the 2025 New York Valve Conference, demonstrating its safety and efficacy in patients with severe tricuspid regurgitation and high surgical risk [1][2] Group 1: Clinical Trial Overview - TRINITY is a global, prospective, multi-center, single-arm clinical trial involving 149 patients from 20 centers, primarily located in Europe [1] - The average age of patients was 77.4 years, with a high Tri-Score of 13.6%, indicating significant comorbidities [1] - Over 75% of patients used valve sizes of 55mm, 60mm, 65mm, and 70mm, with a notable percentage showing severe to torrential tricuspid regurgitation [1] Group 2: Efficacy Results - 95.7% of patients showed no moderate or greater regurgitation at 30 days post-procedure, with 95.4% of large annulus patients and 100% of small annulus patients achieving this outcome [3] - 84.1% of patients improved to New York Heart Association functional class I/II, with similar rates for both large and small annulus groups [3] - Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved by an average of 14 points, with large annulus patients showing a 15-point increase [3] Group 3: Safety Results - The overall device success rate was 97% for large annulus patients and approximately 94% for small annulus patients [2] - The 30-day composite event rate was 14.8%, with low rates of cardiovascular mortality (1.3%) and myocardial infarction (0.0%) [2][3] - The study indicated a low incidence of serious adverse events, suggesting a favorable safety profile for LuX-ValvePlus in treating severe tricuspid regurgitation [3]

Core Insights - The article highlights the significant advancements made by the company in the field of cardiovascular intervention, particularly through its products LuX-Valve Plus and JensClip, showcased at the EuroPCR 2025 conference [1][20]. Product Development - LuX-Valve Plus has achieved a 97% success rate in the TRINITY clinical study, which involved high-risk patients with severe tricuspid regurgitation [3][4]. - The device's unique design allows for a wide range of valve sizes (40mm to 70mm), with over 75% of patients using valves ≥55mm, leading to a 95.7% rate of no moderate or severe regurgitation at 30 days post-operation [4][6]. - JensClip has demonstrated a 95% success rate in its one-year follow-up study, with significant improvements in patients' heart function and quality of life [11][13]. Safety and Efficacy - LuX-Valve Plus reported a low 30-day composite event rate of 14.8%, with a cardiovascular mortality rate of just 1.3% [8][9]. - JensClip's one-year all-cause mortality rate was 1.8%, with no incidents of single leaflet grasping or device-related air embolism [14]. Market Positioning - The company is strategically positioned in the global structural heart disease market, which is valued in the hundreds of billions, leveraging its innovative technology and clinical data to build expert consensus [15][20]. - The Chinese medical device industry is experiencing a global expansion, with a reported 5.03% year-on-year increase in medical device exports in Q1 2025 [17]. Global Strategy - The company is executing a multi-regional clinical validation strategy, with ongoing trials in Europe and the U.S., and has established a clinical support network across China and other regions [18][19]. - By cultivating a network of over 90 core operators globally and expanding its presence in approximately 320 key hospitals, the company is enhancing its international medical ecosystem [19]. Financial Performance - The company's stock has surged over 150% year-to-date, indicating market recognition of its differentiated innovative products and strong clinical validation [21].

Core Insights - The recent clinical trial results for LuX-ValvePlus and JensClip were presented at EuroPCR 2025, highlighting their safety and efficacy in treating severe tricuspid and mitral valve regurgitation [1][2] Group 1: LuX-ValvePlus - The TRINITY trial is a global, prospective, multi-center, single-arm clinical study assessing the safety and efficacy of LuX-ValvePlus in high-risk patients with severe tricuspid regurgitation [1] - The study included 161 patients from 20 centers worldwide, primarily from France, Germany, Spain, Denmark, and the UK [1] - The 30-day follow-up results demonstrated good safety and efficacy, with a low incidence of adverse events and improved quality of life for patients [1] - LuX-ValvePlus offers an excellent treatment option for patients with severe tricuspid regurgitation, particularly for those with large annuli, where treatment options are currently limited [1] - Long-term follow-up data and FDA clinical research data for LuX-ValvePlus are still being collected [1] Group 2: JensClip - JensClip is an innovative medical device designed for the treatment of severe mitral valve regurgitation, noted for its ease of use and reliability [2] - The one-year follow-up results showed a low all-cause mortality rate of only 1.8%, with minimal device-related complications [2] - 96.3% of patients exhibited no moderate or severe regurgitation, along with sustained improvements in various clinical metrics such as NYHA functional class, Kansas City Cardiomyopathy Questionnaire scores, and six-minute walk distance [2]

Group 1 - The trend of Chinese medical device companies "going global" is long-term positive, especially in the upstream supply chain which has formed a certain scale [1] - In Q1 2025, China's medical device export trade total is projected to reach 69.26 billion yuan, a year-on-year increase of 5.03%, with high-end medical devices seeing significant growth [1] - The export value of China's medical device industry is expected to reach 48.75 billion USD in 2024, reflecting a year-on-year growth of 7.3% [1] Group 2 - Over 100 listed medical device companies have already initiated "going global" operations in 2024, covering various product areas such as medical consumables and diagnostic equipment [2] - Companies are advised to consider business, supply chain, and localization strategies for global expansion [2][3] - Localized production and supply chain management are essential for adapting to market demands in different regions [3] Group 3 - Companies like Haier Bio emphasize the importance of localizing product design and marketing to enhance user experience in overseas markets [4] - The trend of "going global" is common among mature, growth, and startup medical device companies, focusing on high-value and high-end products [6] - High-value medical devices, such as deep brain stimulators, require careful economic calculations and long-term service planning before entering foreign markets [6] Group 4 - Companies are encouraged to leverage digitalization and smart technologies to enhance their global strategies, as seen with Mindray Medical's remote monitoring capabilities [7] - Brand building is crucial for domestic medical device companies, with strategies including sponsorship of international sports events to enhance global influence [7] - The medical device market in Europe and the US accounts for over 65% of the global market share, making it a primary target for Chinese companies [8] Group 5 - Key conditions for Chinese medical device companies to "go global" include having sufficient capital, production capacity, and independent R&D capabilities [8] - Collaboration with local hospitals and doctors for joint R&D and clinical trials can facilitate product entry into new markets [8]

Financial Performance - The company reported a significant increase in revenue, achieving a total of RMB 500 million for the fiscal year, representing a growth of 25% compared to the previous year[10]. - The company provided a positive outlook for the next fiscal year, projecting a revenue growth of 20% to RMB 600 million[10]. - The company reported a pre-tax loss of RMB 185,829 thousand for the fiscal year ending December 31, 2024, an improvement from a loss of RMB 379,096 thousand in 2023, indicating a reduction of approximately 51% year-over-year[21]. - The company reported a basic and diluted loss per share of RMB 0.43 for the fiscal year 2024, an improvement from RMB 0.89 in 2023[21]. - The company reported a net asset value of RMB 916,953 thousand as of December 31, 2024, down from RMB 1,226,254 thousand in 2023[21]. - The company reported a cash and cash equivalents decrease of 34.7% from RMB 927.8 million in 2023 to RMB 606.0 million in 2024[64]. - The company reported a total of 211 employees, down from 376 employees as of December 31, 2023[75]. Market Expansion and Product Development - User data showed an increase in active users, reaching 1.2 million, which is a 30% increase year-over-year[10]. - New product launches included the LuX Valve Plus, which is expected to contribute an additional RMB 100 million in revenue in the upcoming year[10]. - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by the end of the next fiscal year[10]. - The company aims to deepen its global strategy and continue providing high-quality treatment solutions for structural heart disease patients[19]. - The company is exploring potential acquisitions to enhance its product portfolio, with a budget of RMB 200 million allocated for this purpose[10]. - The company aims to accelerate the registration process for the LuX-Valve series products in Europe and the US, targeting CE certification and FDA approval as key milestones for international expansion[20]. - The company is actively promoting the commercialization of Ken-Valve, with expectations to achieve commercial implantation in the first half of 2025[29]. Research and Development - Research and development expenses increased by 10%, totaling RMB 50 million, to support innovation and new technology[10]. - R&D expenses decreased from RMB 288.2 million in 2023 to RMB 142.6 million in 2024, primarily due to reductions in share-based compensation, employee costs, and raw material costs[54]. - The company has established a comprehensive commercialization system covering the entire product lifecycle for Ken-Valve, ensuring robust market promotion[15]. - The company has developed proprietary technologies for TAVR, TMVR, and TTVR products, with no guarantee of successful commercialization[44]. Clinical Trials and Regulatory Approvals - LuX-Valve Plus completed a one-year follow-up in clinical trials, showcasing unique advantages for large annulus patients[12]. - Ken-Valve product received market registration certification from the National Medical Products Administration, establishing a solid foundation for rapid market penetration[14]. - JensClip completed all enrollment for confirmatory clinical trials, demonstrating excellent clinical value and potential application prospects[16]. - The company plans to submit registration applications for JensClip to the National Medical Products Administration in 2025, expanding its product pipeline[16]. - The TRAVEL II multi-center clinical trial for LuX-Valve Plus received widespread recognition at major academic conferences in the US and UK[12]. - The company is participating in the FDA's Total Product Life Cycle Advisory Program (TAP) pilot for LuX-Valve Plus, which is expected to enhance clinical development guidance[35]. Corporate Governance and Management - The company has adopted the corporate governance code as per the listing rules, with compliance noted except for the combined roles of chairman and CEO[99]. - The board consists of one executive director, five non-executive directors, and three independent non-executive directors, ensuring strong independence[101]. - The company has implemented a management structure where the executive directors and senior management are responsible for daily operations and strategy execution[104]. - The board is responsible for overseeing major affairs, including policy formulation, overall strategy, and risk management systems[102]. - The company has established a risk management and internal control system, which is reviewed annually and deemed effective and sufficient[135]. Employee Engagement and Development - The company plans to implement a new employee stock ownership plan to enhance employee engagement and retention[10]. - The company emphasizes competitive salaries and benefits to attract and retain employees, along with continuous education and training programs[75]. - The company has a structured performance evaluation system to determine employee compensation, promotions, and career development[75]. - The group has implemented a mentorship program for new employees to help them integrate into the work environment and enhance their business capabilities[188]. - The employee turnover rate for 2024 is 48.2%, with the highest turnover among employees aged 30 and below at 53.9%[184]. Environmental Sustainability - The company is committed to sustainable development by integrating ESG management into its core operations and regularly evaluating the effectiveness of its sustainability strategies[153]. - The total greenhouse gas emissions for 2024 were approximately 841.8 tons of CO2 equivalent, with a density of 3,989.8 kg CO2 equivalent per person, reflecting a 37.5% reduction from 2023[161]. - The company aims to continuously improve energy efficiency and reduce emissions through systematic management and optimization of operational processes[166]. - The company strictly adheres to environmental protection policies and has implemented waste classification and recycling plans to improve resource utilization rates[174]. - The company has set a goal to enhance water usage efficiency by maintaining water equipment and promoting water-saving practices among employees[173]. Shareholder Relations - The company has adopted a shareholder communication policy to enhance dialogue with investors and ensure effective communication regarding business performance and strategies[145]. - Shareholders holding more than 10% of the company's shares can request a special general meeting within 10 days, and those holding over 1% can propose temporary resolutions[142]. - The company encourages shareholders to provide feedback and inquiries, ensuring that the board of directors addresses shareholder concerns during meetings[146].

报名：首届全球眼科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 报名：首届全球骨科大会 | 奖项评选 合作伙伴征集：2025全球手术机器人大会 心未来 2025年3月24日， 健世科技 发布了2024年度业绩公告。 2024年，公司主营业务尚未产生收入，利润端 亏损 1.8亿元 ，亏损同比收窄 52.2% 。经计算，公司24H2亏损0.75亿元，亏损同比收窄61.6%。 公司经营亮点： 三尖瓣介入置换产品 LuX-Valve Plus 在中国大陆已完成注册临床试验一年期随访，并积极根据国家药监局注册审批要求递交数据； 于欧洲进行以获取CE认证为目标的临床试验完成全部入组；在美国已经进入临床试验阶段，美国本土 临床积极推进中。 # 财报数据 主动脉瓣反流（或兼并狭窄）置换产品 Ken-Valve 已于近期获得国家药监局批准上市注册，预计于2025年上半年实现商业化植入。 二尖瓣反流修复产品 JensClip 完成确证性临床试验全部入组以及一年期随访，临床结果优异，预计在2025年尽快递交国家药监 局注册申请。 # 关于 健世科技 宁波健世科技股份有限公司 （09877.HK，简称" 健世科技 "， ...

就LuX-Valve系列产品，我们将通过在全球多个国家及地区开展注册临床试验及获取批准、持续扩大业 务发展区域、建立国际战略合作等多元化方式，奠定此系列产品的全球技术优势，并为后续其他重点产 品提供帮助。就已获得国家药监局批准注册的Ken-Valve产品，我们已就该产品生产和销售获得相关许 可，启动了多个省、直辖市、自治区的挂网申报工作，并且已于多家医院向其术者及团队进行了术式教 育和产品推广。公司正在积极推动其商业化相关工作，预计于2025年上半年实现商业化植入。 智通财经APP讯，健世科技-B(09877)发布截至2024年12月31日止年度业绩，该集团取得其他收入及收益 4155.9万元，同比减少5.2%;研发开支1.43亿元，同比减少50.5%;母公司拥有人应占亏损1.78亿元，同比 减少52.2%;每股亏损0.43元。 截至本公告日期，我们有多款处于不同商业化、研发阶段的产品，覆盖包含经导管三尖瓣介入治疗、经 导管主动脉瓣介入治疗、经导管二尖瓣介入治疗在内的多种常见结构性心脏病治疗领域。我们近期的经 营重点将集中于经导管三尖瓣介入置换产品LuX-Valve系列的全球推广，以及经导管主动脉瓣介入置换 ...

Financial Performance - The company reported a pre-tax loss of RMB 185,829,000 for the year ending December 31, 2024, a 51.0% improvement compared to RMB 379,096,000 in 2023[3]. - The net loss attributable to the parent company was RMB 177,510,000, representing a 52.2% decrease from RMB 371,736,000 in the previous year[3]. - Total revenue for the year ended December 31, 2024, was RMB 41,559,000, a decrease from RMB 43,828,000 in 2023[12]. - The company reported a pre-tax loss of RMB 185,829,000 for 2024, an improvement from a loss of RMB 379,096,000 in 2023[12]. - The net loss for the year was RMB 185,829,000, compared to RMB 379,096,000 in the previous year, reflecting a significant reduction in losses[14]. - The group incurred a pre-tax loss of RMB 70,318 thousand in 2024, significantly reduced from RMB 238,906 thousand in 2023, indicating an improvement of about 70.7%[25]. - The company did not declare or pay any dividends during the year, consistent with the previous year[26]. - The company reported total other income of RMB 41,559 thousand for the year 2024, a decrease from RMB 43,828 thousand in 2023, representing a decline of approximately 5.2%[24]. Research and Development - Research and development expenses for 2024 were RMB 142,637,000, down from RMB 288,151,000 in 2023, indicating a reduction of approximately 50.5%[12]. - The company aims to enhance R&D efficiency through process reengineering and internal collaboration, optimizing the R&D cost structure[57]. - The company focuses on developing innovative products to address core clinical pain points in structural heart disease, ensuring a sustainable leading position in the market[58]. - The company is committed to deepening collaboration between industry, academia, and healthcare to provide more effective treatment strategies for structural heart disease patients[58]. - The company emphasizes continuous improvement in R&D capabilities and product technology innovation to maintain its competitive edge in the global market[55]. Product Development and Commercialization - The company has received regulatory approval for its Ken-Valve product, which is expected to enhance its market presence in treating aortic regurgitation[4]. - The LuX-Valve Plus clinical trial results demonstrated a low incidence of safety events and improved patient outcomes, with significant attention from global professionals[5]. - The company is actively preparing for the commercialization of Ken-Valve, expanding its sales and marketing teams to cover more hospitals[8]. - JensClip registration is being expedited to enhance the company's product pipeline and commercialization efforts[9]. - The company is focused on the global promotion of the LuX-Valve series and the commercialization of the Ken-Valve product, with expectations to achieve commercialization by the first half of 2025[35]. - The company has multiple products in various stages of commercialization and development, including TTVR, TAVR, and TMVR systems[34]. - The company aims to establish international strategic partnerships to enhance the global technical advantage of its product series[35]. - The company has initiated the commercialization process for Ken-Valve® and is actively promoting its products in hospitals across several provinces and municipalities[35]. Financial Position and Assets - Non-current assets increased to RMB 341,710,000 in 2024 from RMB 172,179,000 in 2023, indicating a growth of approximately 98.7%[16]. - Current assets decreased to RMB 685,855,000 in 2024 from RMB 1,154,913,000 in 2023, a decline of about 40.6%[16]. - Cash and cash equivalents decreased by 34.7% from RMB 927.8 million as of December 31, 2023, to RMB 606.0 million as of December 31, 2024[78]. - Current assets net value decreased from RMB 1,096.2 million to RMB 621.7 million, attributed to bank deposits, R&D expenses, and administrative costs incurred during the reporting period[79]. - Total bank and other borrowings increased from RMB 40.7 million in 2023 to RMB 60.3 million in 2024, with approximately RMB 44.3 million due after one year[85]. Governance and Compliance - The company has adopted the corporate governance code as per the listing rules, ensuring compliance with all applicable rules except for a specific deviation regarding the roles of the Chairman and CEO[102]. - The board consists of one executive director, five non-executive directors, and three independent non-executive directors, ensuring strong independence and diverse skills[104]. - The audit committee, composed of three independent non-executive directors, has reviewed the annual performance and internal controls, confirming compliance with applicable accounting standards[110]. - The company is committed to compliance with international financial reporting standards as set by the International Accounting Standards Board[116]. Market Presence and Partnerships - The company is exploring partnerships with overseas collaborators to accelerate global commercialization of its products[11]. - The company improved its global intellectual property layout, enhancing protection of its intellectual property rights[11]. - The company has participated in various high-quality academic conferences to enhance market awareness of its products and share clinical results[64]. - The company is exploring global business development partnerships with overseas medical device manufacturers to accelerate product commercialization[65]. Employee and Operational Changes - As of December 31, 2024, the company had 211 employees, a decrease from 376 employees as of December 31, 2023[91]. - Administrative expenses decreased from RMB 150.3 million in 2023 to RMB 68.2 million in 2024, primarily due to reductions in share-based compensation and professional service fees[69]. - Share-based compensation expenses dropped significantly from RMB 80.3 million in 2023 to RMB 1.3 million in 2024[71].

Financial Performance - The company reported a revenue of RMB 500 million for the first half of 2024, representing a 20% increase compared to the same period last year[13]. - The company reported a pre-tax loss of RMB 105,765,000 for the first half of 2024, a 40.64% improvement compared to a loss of RMB 178,161,000 in the same period of 2023[19]. - The total comprehensive loss for the period was RMB (107,867,000), a decrease of 35.8% from RMB (167,966,000) in the same period last year[80]. - Basic and diluted loss per share for the period was RMB (0.25), compared to RMB (0.42) in the previous year[80]. - The company reported a loss attributable to equity holders of the parent of RMB 102,261,000 for the six months ended June 30, 2024, compared to a loss of RMB 175,754,000 for the same period in 2023, representing a 41.7% improvement in losses year-over-year[96]. Revenue and Growth Expectations - The company expects revenue growth to continue at a rate of 25% for the second half of 2024, driven by new product launches and market expansion[18]. - User data showed a growth in active users by 15%, reaching a total of 1.2 million users by June 30, 2024[14]. - Other income and gains decreased from RMB 341 million to RMB 170 million, primarily due to reduced government subsidies and foreign exchange gains[39]. Research and Development - Research and development expenses increased by 30% to RMB 50 million, focusing on the development of the new LuX-Valve Plus product line[14]. - Research and development expenses for the period were RMB (82,233,000), down 40.3% from RMB (137,603,000) in the previous year[80]. - The company aims to optimize its product pipeline by focusing resources on core products and accelerating global commercialization to achieve breakeven and high growth profitability[27]. Product Development and Clinical Trials - The LuX-Valve Plus device achieved a clinical success rate of approximately 97% in the TRAVEL II study, with an average procedure time of 35.56 minutes and 91.86% of patients improving their NYHA heart function classification[20]. - The LuX-Valve Plus device has completed a one-year clinical follow-up and is expected to submit a registration application to the National Medical Products Administration soon[20]. - The Ken-Valve is currently in the registration application review stage and has entered the priority review process by the National Medical Products Administration, making it the first valve product in this program[21]. - The LuX-Valve Plus clinical trial has received positive feedback from multiple clinical centers across seven countries, with a six-month follow-up result presented at major conferences in July 2024[29]. Market Expansion and Strategic Initiatives - The company plans to expand its market presence in Southeast Asia, targeting a 10% market share by the end of 2025[13]. - A strategic acquisition of a local competitor is anticipated to be completed by Q4 2024, expected to enhance the company's product offerings and market reach[18]. - The company is exploring global partnerships with overseas medical device manufacturers to accelerate the application of its products worldwide[22]. Financial Position and Cash Flow - Cash and cash equivalents increased by 1.9% to RMB 714.3 million as of June 30, 2024, from RMB 701.1 million as of June 30, 2023[48]. - The company reported a net cash outflow from investing activities of RMB 58,383,000, compared to a cash inflow of RMB 12,410,000 in the prior year[85]. - The company incurred a loss of RMB 1,463,000 due to impairment of property, plant, and equipment, which was not recorded in the previous year[91]. Shareholder Actions and Corporate Governance - The board has approved a share buyback program of up to RMB 100 million to enhance shareholder value[17]. - The company does not recommend the payment of an interim dividend for the reporting period ending June 30, 2023[59]. - The board has adopted corporate governance measures to enhance accountability and protect shareholder interests, complying with applicable governance codes[60]. Management and Key Personnel - Total remuneration paid to key management personnel was a loss of RMB 9,732,000 for the six months ended June 30, 2024, compared to RMB 68,019,000 for the same period in 2023, indicating a significant reduction in management costs[107]. - The company has trained over 50 independent doctors in mainland China and nearly 30 independent doctors in regions outside of China, covering North America, Europe, Asia-Pacific, and Latin America[23].

Financial Performance - The company reported a net loss of RMB 105,765,000 for the six months ending June 30, 2024, compared to a net loss of RMB 178,161,000 for the same period in 2023, representing a 40.64% improvement [2]. - The loss attributable to equity holders of the parent company was RMB 102,261,000, down from RMB 175,754,000 in the previous year, marking a 41.82% reduction [2]. - The basic and diluted loss per share was RMB 0.25, a decrease of 40.48% from RMB 0.42 in the prior year [2]. - The group reported a pre-tax loss of RMB 102,261,000 for the six months ended June 30, 2024, compared to a loss of RMB 175,754,000 for the same period in 2023, indicating a reduction in losses [20]. - The net loss for the six months ending June 30, 2023, was RMB 1,782 million, compared to RMB 1,058 million for the reporting period [48]. - The company reported other income and gains of RMB 16,950,000 for the six months ended June 30, 2024, down from RMB 34,050,000 in the same period of 2023 [6]. - Research and development expenses decreased to RMB 82,233,000 in the first half of 2024 from RMB 137,603,000 in the same period of 2023 [6]. - The company incurred a pre-tax loss of RMB 105,765,000 for the six months ended June 30, 2024, compared to a loss of RMB 178,161,000 in the same period of 2023 [6]. - The group did not declare any dividends for the six months ended June 30, 2024, consistent with the previous year [19]. Clinical Trials and Product Development - The clinical trial results for LuX-Valve Plus showed a device success rate of approximately 97% and an average procedure time of 35.56 minutes [3]. - 97.62% of patients in the TRAVEL II study experienced improvement in tricuspid regurgitation severity, with 91.86% of patients improving from NYHA class III/IV to I/II [3]. - The company plans to submit a registration application for LuX-Valve Plus to the National Medical Products Administration following the completion of a one-year clinical follow-up [3]. - LuX-Valve Plus achieved a 100% success rate in a clinical study in Hong Kong, with no adverse events reported [4]. - Ken-Valve is currently under review for market registration and has entered the priority review process by the National Medical Products Administration [3]. - The company is focused on developing interventional products for treating structural heart diseases, having established operations in China since November 2011 [25]. - The company has six products in different stages of development, focusing on optimizing its product pipeline and accelerating global commercialization efforts [26]. - The LuX-Valve Plus, a second-generation transcatheter tricuspid valve replacement system, is designed for patients with severe tricuspid regurgitation and high surgical risk, with CE certification trials ongoing [29]. - The company expects to submit registration approval for LuX-Valve Plus to the National Medical Products Administration (NMPA) in the first half of 2025, with commercialization anticipated in the second half of 2025 [27]. - The FDA has approved the Investigational Device Exemption (IDE) for the Early Feasibility Study (EFS) of LuX-Valve Plus, with enrollment expected to be completed by Q4 2024 [30]. - The company has completed nearly 600 global implantations of the LuX-Valve series, with the longest follow-up record exceeding five years [31]. - The Ken-Valve transcatheter aortic valve replacement system is expected to receive NMPA approval in Q4 2024 [27]. - The JensClip transcatheter mitral valve repair system is set to submit for NMPA approval in the first half of 2025, with commercialization expected in the first half of 2026 [27]. - JensClip, a transcatheter mitral valve repair system, completed its feasibility clinical trial in December 2022 and is set to finish all patient enrollment and one-month follow-up by March 2024 [33]. - JensRelive, a transcatheter mitral valve replacement system, is currently undergoing animal trials [33]. - SimuLock, a left atrial appendage occluder system, initiated its feasibility clinical trial in Q3 2023 and completed the first confirmed clinical trial and patient enrollment in November 2023 [34]. Market Expansion and Commercialization - The company is exploring global partnerships with overseas medical device manufacturers to accelerate product application worldwide [4]. - The company aims to enhance its global academic position and influence through continued product application in various regions [4]. - The company has established a professional commercialization team responsible for the preliminary market introduction and education of core products, enhancing its commercialization capabilities [5]. - Over 50 independent doctors and trainers have been trained for the LuX-Valve series products in mainland China [5]. - The company has expanded its LuX-Valve series products to over 220 influential hospitals across more than 30 provinces, municipalities, and autonomous regions in mainland China [5]. - The company plans to accelerate the global application of core products to meet the urgent treatment needs for structural heart disease [40]. - The company aims to expand its product coverage to become an industry leader in innovative products for structural heart disease [40]. - The company has a strong commitment to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value [58]. Financial Position and Cash Flow - Total non-current assets increased to RMB 293,412,000 as of June 30, 2024, from RMB 172,179,000 as of December 31, 2023 [9]. - Current assets decreased to RMB 883,100,000 as of June 30, 2024, from RMB 1,154,913,000 as of December 31, 2023 [9]. - The company's net assets decreased to RMB 1,070,477,000 as of June 30, 2024, from RMB 1,226,254,000 as of December 31, 2023 [10]. - The net cash used in operating activities for the six months ended June 30, 2024, was RMB 107.4 million, primarily due to R&D and administrative expenses [49]. - Cash and cash equivalents as of June 30, 2024, amounted to RMB 714.3 million, an increase of 1.9% from RMB 701.1 million as of June 30, 2023 [49]. - Capital expenditures decreased from RMB 43.6 million for the six months ended June 30, 2023, to RMB 21.5 million during the reporting period, mainly due to reduced spending on properties, plants, and equipment [50]. - The current ratio improved to 17.1 from 15.2, and the quick ratio increased to 16.6 from 14.9, indicating better liquidity [51]. - Total bank and other borrowings amounted to RMB 51.2 million as of June 30, 2024, with RMB 15.8 million secured by collateral [52]. - The company has no significant contingent liabilities as of June 30, 2024, and did not engage in any major investments or acquisitions during the reporting period [54]. Corporate Governance - The company has adopted the corporate governance code as per Appendix C1 of the listing rules, ensuring compliance with all applicable provisions except for the separation of the roles of Chairman and CEO [58]. - The board consists of two executive directors, four non-executive directors, and three independent non-executive directors, ensuring strong independence in its composition [58]. - The audit committee, chaired by an independent non-executive director, oversees the financial reporting process and internal controls, ensuring compliance with applicable accounting standards [61]. - The company has confirmed adherence to the standard code for securities trading by all directors and supervisors during the reporting period [59]. - The audit committee and management have reviewed the mid-term performance and confirmed that it is prepared in accordance with applicable accounting principles and regulations [61]. - The board will continue to review the effectiveness of the corporate governance structure to assess the necessity of separating the roles of Chairman and CEO [58]. Future Outlook - The company provided a positive outlook for the next quarter, projecting a revenue growth of 20% to RMB 1.8 billion [66]. - New product launches are expected to contribute an additional RMB 300 million in revenue over the next six months [66]. - The company is investing heavily in R&D, with an allocation of RMB 200 million for new technology development [66]. - Market expansion plans include entering two new international markets by the end of the fiscal year [66]. - The company is considering strategic acquisitions to enhance its market position, with a budget of up to RMB 500 million for potential targets [66]. - The board emphasized the importance of maintaining operational efficiency, aiming for a 10% reduction in costs over the next year [66]. - Customer satisfaction ratings improved to 90%, reflecting the effectiveness of recent service enhancements [66]. - The company plans to implement a new marketing strategy that is expected to increase brand awareness by 30% in the upcoming quarter [66].