来源：广东省药品监督管理局 tto 63 11 简体 | 繁体 开启无障碍 | 开启长者助手 首页 新闻动态 政务公开 政务服务 公众参与 科普曾传 清绮入 您 当前位置：首页 > 政务公开 > 许可信息公开 > 医疗器械 > 医疗器械质量管理体系规范考核 2025年11月医疗器械注册质量管理体系 发布时间：2025-12-24 09:29:59 | 受理号 | 企业名称 | 产品名称 | 生产地址 | 核查 | 结论日期 | | --- | --- | --- | --- | --- | --- | | | | | | 结论 | | | 广东威诺敦生 | | | | 整改 后通 | | | CQZ2501532 | 物医药科技有 限公司 | 医用臭氧治疗仪 | 佛山市顺德区乐从镇水藤村委会创富六路1号联东科创园8座101、201、301 | 过核 | 2025/11/3 | | | | | | 査 | | | 广东百生医疗 | | | | 整改 后通 | | | CQX2501755 器械股份有限 高频手术设备 | 公司 | | 江门市新会区福盛路11号 | 过核 | 2025/11/3 | | | | | ...

Core Viewpoint - Shanghai Xinwei Medical Technology Co., Ltd. has achieved a significant milestone in 2024 by reaching a breakeven point, enhancing investor confidence and positioning itself for future profitability [1][2]. Financial Performance - For the year ending December 31, 2024, the company reported revenue of 277.9 million yuan, a year-on-year increase of 19.6%, and a gross profit of 181.7 million yuan, up 11% [2]. - The pre-tax loss narrowed significantly to 12 million yuan, a reduction of 88.3% compared to the previous year, indicating a clear path towards profitability [2]. - The company's cost management efforts led to a decrease in sales and management expense ratio to 49.6%, down 16.6 percentage points year-on-year [2]. Strategic Focus - The company is concentrating on two main strategies: deepening its core business in neurointervention and accelerating overseas market expansion [3]. - In the neurointervention sector, the company has shifted resources towards differentiated therapeutic devices, achieving a 45.5% sales growth in acute ischemic stroke treatment devices and over 100% growth in hemorrhagic stroke treatment devices [3][4]. - The implementation of national centralized procurement policies has facilitated the penetration of the company's products into over 2,500 hospitals, with an active implantation hospital rate exceeding 80% [3]. Overseas Expansion - The company achieved overseas revenue of 8.395 million yuan in 2024, a staggering growth of 684% year-on-year, with Taiwan and India being the primary contributors [4]. - The company has obtained CE or FDA certifications for several key products, enabling entry into international markets, and plans to register products in over 30 countries within the next two years [4][12]. R&D and Innovation - Xinwei Medical is recognized as a leader in the neurointervention medical device sector, with a comprehensive product pipeline covering prevention and treatment of various neurological conditions [6]. - The company has received approvals for 31 medical devices from NMPA, 3 from FDA, and 1 from CE, showcasing its strong R&D capabilities [6]. - Recent product launches include innovative devices that fill gaps in the domestic market, enhancing the company's competitive edge [7]. Market Trends and Future Outlook - The aging population and increasing demand for rehabilitation technologies are expected to drive growth in the neurointervention sector [7]. - The brain-computer interface industry is projected to grow significantly, with a forecasted market size of $1.98 billion in 2023, reaching over $6 billion by 2028 [8]. - The company aims for an annual revenue growth of approximately 35% and a stable profit margin of 15%-20% once sales exceed 500 million yuan [9].

Core Viewpoint - The company reported a significant increase in revenue and a substantial reduction in losses, indicating improved operational efficiency and market positioning in the neuro-interventional medical device sector [1][2]. Financial Performance - The company achieved revenue of RMB 278 million for the fiscal year ending December 31, 2024, representing a year-on-year increase of 19.6% [1]. - Research and development costs amounted to RMB 58.94 million, a decrease of 52.4% compared to the previous year [1]. - The loss attributable to the parent company was RMB 13.62 million, a reduction of 85.51% year-on-year, with a loss per share of RMB 0.36 [1]. - The pre-tax loss narrowed significantly to RMB 12 million, down 88.3% year-on-year, despite a decline in gross margin due to bulk procurement pricing and market competition [1]. Operational Efficiency - The company successfully reduced the expense ratio for sales, distribution, and administrative expenses to 49.6%, down from 66.2% in 2023, reflecting effective cost control and efficiency measures [1]. - The sales volume of acute ischemic stroke treatment devices increased by 45.5%, while revenues from hemorrhagic stroke treatment devices and other interventional devices grew by 104.2% and 109.4%, respectively [1]. Product Development and Market Expansion - The company is focused on upgrading its neuro-interventional business and differentiating its treatment devices to adapt to rapidly changing market conditions [1]. - Research and development efforts are directed towards diverse neuro-interventional treatment devices, with plans to launch at least two major devices in the next 24 months, including self-expanding drug-eluting stents and carotid stents [2]. - The company has received NMPA approval for its intracranial aneurysm embolization assist stent and flow diversion device, which have begun sales [2]. - The company has obtained CE or FDA certifications for several products in overseas markets and is currently conducting over 40 product registrations in 10 countries or regions to expand sales channels [2].