Shanghai HeartCare Medical Technology Corporation Limited 上 海 心 瑋 醫 療 科 技 股 份 有 限 公 司 （ 於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司 ） （股份代號：6609） 有關董事於禁售期進行證券交易的公告 本公告由上海心瑋醫療科技股份有限公司（「本公司」）根據香港聯合交易所有 限公司證券上市規則（「上市規則」）附錄C3第D.15段刊發。 本公司董事（「董事」）會（「董事會」）已獲執行董事張坤女士（「張女士」）告知， 寧波同創速維投資合夥企業（有限合夥）（「同創速維」，由柴燕鵬先生（張女士 的配偶）作為普通合夥人控制的有限合夥企業，且張女士被視為於同創速維擁 有權益的相同數量股份中擁有權益）於2025年7月30日至2025年8月22日期間進 行場內交易，出售本公司合共99,650股H股（「H股」），代價為每股H股52.0港元至 65.2港元（「該轉讓」），惟於該轉讓前並無根據上市規則附錄C3第B.8段的規定事 先告知本公司。由於該轉讓，張女士被視為擁有的持股權益由約4.42%減少至 於2025年8月22 ...

消息面上，心玮医疗近日公布中期业绩。上半年公司营业收入达1.86亿元，同比增长44.4%；股东应占 净利润5090万元，同比实现扭亏为盈，已顺利跨越盈亏平衡点。智通财经APP在《新品放量叠加研产销 一体化闭环构筑，心玮医疗-B(06609)迎来"戴维斯双击"》中指出，随着上半年出血性产品开启量化贡 献与缺血性产品矩阵持续迭代，持续完善的通路/止血的"术式闭环"成为心玮医疗上半年收入增量主引 擎。 此外，在加速"开源节流"的同时，近年来心玮医疗也在进一步完善自身研产销一体化创新闭环，夯实公 司从"结构铺垫"到"商业兑现"跨越的基础。截至目前，公司共有32款器械产品获NMPA批准，三款器械 产品获FDA批准及一款产品获得CE标志，产品管线广泛涵盖急性缺血性脑卒中及神经血管狭窄治疗、 缺血性脑卒中预防、出血性脑卒中治疗以及介入通路。 心玮医疗-B(06609)尾盘涨近7%，截至发稿，涨6.8%，报64.4港元，成交额2505.96万港元。 ...

此外，在加速"开源节流"的同时，近年来心玮医疗也在进一步完善自身研产销一体化创新闭环，夯实公 司从"结构铺垫"到"商业兑现"跨越的基础。截至目前，公司共有32款器械产品获NMPA批准，三款器械 产品获 FDA批准及一款产品获得CE标志，产品管线广泛涵盖急性缺血性脑卒中及神经血管狭窄治疗、 缺血性脑卒中预防、出血性脑卒中治疗以及介入通路。 智通财经APP获悉，心玮医疗-B(06609)尾盘涨近7%，截至发稿，涨6.8%，报64.4港元，成交额2505.96 万港元。 消息面上，心玮医疗近日公布中期业绩。上半年公司营业收入达1.86亿元，同比增长44.4%；股东应占 净利润5090万元，同比实现扭亏为盈，已顺利跨越盈亏平衡点。智通财经APP在《新品放量叠加研产销 一体化闭环构筑，心玮医疗-B(06609)迎来"戴维斯双击"》中指出，随着上半年出血性产品开启量化贡 献与缺血性产品矩阵持续迭代，持续完善的通路/止血的"术式闭环"成为心玮医疗上半年收入增量主引 擎。 ...

Core Viewpoint - The domestic medical device industry has experienced a bifurcated landscape in the first half of the year, with overall revenue declining while innovative companies like Xinwei Medical have shown significant growth and profitability improvements [1][14]. Group 1: Industry Overview - The medical device sector's overall revenue in Q2 2025 declined by 4.77% year-on-year, with net profit dropping by 23.71% [1]. - Despite the industry's challenges, the medical device sector has seen a market increase of over 20% year-to-date, indicating investor confidence in innovative medical devices [1]. Group 2: Company Performance - Xinwei Medical reported a revenue of 186 million yuan in the first half of 2025, marking a 44.4% year-on-year increase, and achieved a net profit of 50.9 million yuan, successfully turning a profit [4][14]. - The company has demonstrated strong internal growth capabilities, with a 60% increase in the overall implantation volume of its ischemic products and a 563% increase in revenue from hemorrhagic products [5][6]. Group 3: Product Development and Innovation - Xinwei Medical has launched several key products, including the "Great Wall" stent for aneurysm embolization, which has rapidly expanded its market presence [6]. - The company has a robust pipeline with 32 products approved by NMPA and several others in various stages of clinical trials and registration [9][11]. Group 4: Operational Efficiency - Xinwei Medical has improved its operational efficiency, reducing sales and management expenses as a percentage of total revenue from 44.8% to 37.0% [8]. - The company achieved a significant increase in operating cash flow, reaching 5.4 million yuan, a year-on-year growth of over 80% [7]. Group 5: Market Expansion - Xinwei Medical has established a wide distribution network covering over 2,500 hospitals across China and is actively pursuing international market opportunities [12][13]. - The global peripheral intervention market is estimated at $10 billion, with the Chinese market accounting for approximately 12%-15% of this total [12].

Core Viewpoint - The domestic medical device industry is experiencing a bifurcated landscape, with revenue and profit declines in the sector due to factors like volume-based procurement and DRG cost control, while innovative companies like Xinwei Medical are showing strong growth and profitability, indicating market confidence in long-term value [1][14]. Industry Overview - The medical device sector saw a 4.77% year-on-year decline in overall revenue and a 23.71% drop in net profit attributable to shareholders in Q2 2025 [1]. - Despite the challenges, the medical device sector has shown a more than 20% increase in the secondary market, reflecting optimism for innovative medical devices [1]. Company Performance - Xinwei Medical reported a 44.4% year-on-year increase in revenue for the first half of 2025, reaching 186 million yuan, and achieved a net profit of 50.9 million yuan, marking a turnaround from losses [4][13]. - The company’s strong performance is attributed to its innovative product offerings and effective operational strategies, which have led to a significant improvement in its financial health [4][7]. Product Development - Xinwei Medical has successfully launched several key products, including the Captor® thrombectomy stent and a comprehensive treatment solution for intracranial aneurysms, contributing to a 563% increase in revenue from hemorrhagic products [5][6]. - The company has a robust pipeline with 32 products approved by NMPA and several others in various stages of clinical trials and registration [9][11]. Operational Efficiency - Xinwei Medical has improved its operational efficiency, with a significant reduction in sales and management expenses from 44.8% to 37.0% of total revenue, and a 35.1% decrease in R&D spending [8]. - The company achieved a gross profit of 127 million yuan, a 53.9% increase year-on-year, with a gross margin of 68.2% [8]. Market Expansion - Xinwei Medical is expanding its market presence, with over 1,400 hospitals actively implanting its ischemic products, a 24% increase year-on-year [12]. - The company is also pursuing international markets, with products registered in 15 countries and ongoing registration efforts in 21 additional regions [13]. Strategic Outlook - The company is positioned for growth through a combination of innovative R&D, integrated operations, and international expansion, aiming to become a leading player in the global medical device market [14].

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 上海心瑋醫療科技股份有限公司 (於中華人民共和國註冊成立的有限責任公司) 呈交日期: 2025年9月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | | 於香港聯交所上市 (註1) 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 06609 | 說明 | H股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 31,565,804 | RMB | | 1 RMB | | 31,565,804 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 31,565,804 | RMB | | 1 RMB | | 31,565,804 | | 2. 股份分類 ...

Core Viewpoint - The company has successfully transitioned to a profitable phase in 2024, showcasing strong commercialization capabilities and resilience in profitability through differentiated product layout, efficient cost control, and a global strategic vision [1][2]. Financial Performance - In the first half of the year, the company achieved revenue of 186 million RMB, a year-on-year increase of 44.4%, driven by the collaborative performance of three major business lines [3]. - The net profit reached 50.94 million RMB, reversing the loss from the same period last year, with operating cash flow rising to 53.6 million RMB, indicating a sustainable self-sustaining development phase [4]. - The gross margin improved by 4 percentage points to 68.2%, reflecting enhanced production process maturity and cost optimization from scale effects [4]. - The sales and management expense ratio decreased from 44.8% to 37%, marking a transition from high investment in market expansion to a new phase of efficiency improvement [4]. Research and Development - The company focused R&D resources on core pipelines, resulting in a 35.1% decrease in R&D expenses to 20.62 million RMB, while accelerating the approval and market entry of key products [5][10]. - The complete commercialization of core product matrices, including devices for hemorrhagic stroke treatment, has established a competitive barrier against imported brands [11]. Global Expansion - The company has accelerated its internationalization process, obtaining CE or FDA certifications for several products and registering approximately 100 products in 21 countries [16]. - The global strategy aligns with the industry's growth window, as the demand for medical infrastructure in emerging markets and the cost-performance advantage of Chinese devices create a favorable environment for expansion [18]. Market Dynamics - The continuous improvement in the company's fundamentals resonates with positive signals from the capital market, reflecting a reconstruction opportunity in the innovative medical device industry [20]. - The recent recovery in the Hong Kong pharmaceutical sector, with the Hang Seng Healthcare Index rising over 100% this year, indicates a consensus on the industry's turning point [20][23]. - The combination of accelerated approvals and optimized payment policies is expected to benefit companies like the company that possess both innovative strength and profitability resilience [23]. Valuation Potential - Despite a stock price increase of over 300% in the past year, the company's valuation remains at historical low levels, suggesting that its growth potential is not fully reflected in the current stock price [24]. - The company is entering a critical phase of value reassessment, supported by comprehensive financial improvements, a dense pipeline of innovations, and steady progress in global expansion [24].

Core Viewpoint - Company achieved profitability in the first half of the year with a net profit of 50.94 million yuan, entering a phase of scaled profitability [2] - The company plans to initiate clinical trials for its intravascular brain-machine interface by the end of next year and will conduct a share buyback of 80 million HKD to demonstrate confidence in future prospects [2] Financial Performance - The company reported sales revenue of nearly 200 million yuan, with a growth rate exceeding 40%, and an overall gross margin returning to nearly 70% [2] - Sales and management expense ratio decreased by 8 percentage points to 37% [2] - The company forecasts a profit level of approximately 70 to 80 million yuan for the full year of 2025, aiming for a compound annual growth rate of 35% in revenue and over 50% in profit growth in the coming years [2] Product Development and Market Expansion - The company has three main product lines: ischemic stroke, hemorrhagic stroke, and access devices, all showing strong performance this year [2] - In the hemorrhagic stroke sector, the company has rapidly expanded hospital partnerships, with nearly 200 new collaborations, aiming for over 400 to 500 hospital approvals by year-end [2] - The launch of the first domestic coated flow-directed stent positions the company as the only entity with a complete aneurysm treatment solution in China [2] Ischemic Stroke Sector - The company is focusing on promoting aspiration catheter products and related technologies, with a significant increase in active implanting hospitals and a 60% year-on-year growth in implant volume [3] - The projected market size for product terminal implantation is expected to approach 700 million yuan, with a conservative market share estimate of 10% to 12% [3] - New products, including carotid stents and intracranial drug-eluting stents, are in the registration process, with significant market potential anticipated [3] Interventional Access Products - Sales in this segment grew by 28% in the first half of 2025, with a market share exceeding 20% in the vascular closure field [3] - The company completed its first business development project in collaboration with Matrix to launch a new generation of occluders, which will further expand market share [3] International Expansion - The company's overseas business has reached over 30 countries and regions, with plans to expand to more than 50 by 2026 [3] - Expected overseas sales for this year are around 2 million USD, with growth rates projected between 50% and 100% in the coming years [3] Policy Environment - The company expressed optimism regarding healthcare policies, believing that innovative devices will benefit from diverse payment methods and that their products will be supported by commercial insurance [5] - The company anticipates that its innovative products, such as intracranial drug-eluting stents and brain-machine interfaces, will gain from favorable policy changes [5] Brain-Machine Interface Development - The company is set to begin formal clinical trials for its interventional brain-machine interface by the end of next year, utilizing a minimally invasive approach [6] - The brain-machine interface product, which uses stent electrodes, has shown high signal stability and clarity, with advantages over traditional methods [6] - The project has been in collaboration with Nankai University since 2021, with multiple animal experiments completed and theoretical validation concluded [6]

Core Insights - The company has entered its 2.0 development phase, showcasing significant growth in its mid-2025 performance report, with a revenue of 186 million yuan, a year-on-year increase of 44.4%, and a net profit of 50.94 million yuan, marking a return to profitability [1][8] Financial Performance - Revenue for the first half of the year reached 186 million yuan, reflecting a 44.4% year-on-year growth [1] - Gross margin improved to 68.2%, up four percentage points from the previous year [1] - Operating cash flow reached 53.6 million yuan, supported by a reduction in sales and management expense ratio from 44.8% to 37% [1] Product Line Growth - The company experienced explosive growth in three core product lines, particularly in the hemorrhagic stroke segment, which saw a 563% increase due to a combination of innovative products [4] - The ischemic stroke treatment devices also performed well, with a 60% increase in implant volume and a market share exceeding 10% [4] - The "Pulse" hemostatic device in the interventional access field achieved nearly 100,000 implants, a 28% increase year-on-year, capturing over 20% of the vascular closure market [5] Global Expansion and R&D - The company is accelerating its global strategy, having obtained CE or FDA certifications for several products and pursuing approximately 100 product registrations across 21 countries [6] - The R&D pipeline includes a self-expanding drug-eluting stent for intracranial stenosis, with plans to submit a registration application by the end of the year [7] Future Outlook - The management team anticipates maintaining a revenue growth rate of over 35% annually, with profit levels expected to reach between 70 million to 80 million yuan this year [9] - The company aims to expand its overseas market presence from over 30 to more than 50 regions next year, with projected sales growth of 50% to 100% in the coming years [10] - Long-term gross margin targets are set between 65% to 70%, with net profit margins expected to reach 20% to 25% as the company scales [14]

Core Insights - The company has entered its 2.0 development phase, showcasing significant growth in its mid-2025 performance report, with a revenue of 186 million yuan, a year-on-year increase of 44.4%, and a net profit of 50.94 million yuan, marking a turnaround to profitability [1][8] Group 1: Financial Performance - The gross margin improved to 68.2%, up four percentage points from the previous year [1] - Operating cash flow reached 53.6 million yuan, supported by a reduction in sales and management expense ratio from 44.8% to 37% [1] Group 2: Product Line Growth - The company experienced explosive growth in its three core product lines, particularly in the hemorrhagic stroke segment, which saw a 563% increase, aided by the introduction of innovative products [4] - The ischemic stroke treatment devices also performed well, with a 60% increase in implant volume and a market share exceeding 10% [4] - The "Pulse" hemostatic device in the interventional access field achieved nearly 100,000 implants, a 28% year-on-year growth, capturing over 20% of the vascular closure market [5] Group 3: Global Expansion and R&D - The company is accelerating its global strategy, having obtained CE or FDA certifications for several products and pursuing approximately 100 product registrations across 21 countries [6] - The R&D pipeline includes a self-expanding drug-eluting stent for intracranial stenosis, with plans for clinical trials to start in late 2026 [7] Group 4: Future Outlook - Management anticipates a revenue growth rate of over 35% annually in the coming years, with profit levels expected to reach between 70 million to 80 million yuan this year [9] - The company aims to expand its overseas market presence from over 30 to more than 50 regions next year, with projected sales growth of 50% to 100% in the coming years [10]