近日，国家药品监督管理局公布创新医疗（002173）器械特别审查名单——苏州云合景从新材料科技有限公司研发的"表面多孔聚醚醚酮椎间融合器"成功 入选。继3月卓阮医疗科技(苏州)有限公司生物疝修补补片通过审查后，太仓又一企业产品跻身国家创新赛道。至此，太仓已有6个产品进入国家及省级创 新通道2个通道内产品斩获医疗器械注册证创新矩阵初具规模。 搭建平台，赋能发展通过承接各类培训、会议，构建多元化的政企交流新平台。今年已承办新形式下的医疗器械可用性工程与审评核查监管论坛及多个上 级部门组织的面对面服务活动，为辖区企业搭建信息互通、资源共享的有效桥梁。 据了解，太仓市市场监管局将继续以更高标准建设江苏省药品监督管理局审评核查太仓工作站，通过高效运作"一站式"服务窗口，灵活运用市场监管"工 具箱"，主动强化部门协同联动，共同推动生物医药领域创新成果的快速转化与应用，助推全市生物医药企业高质量发展。 精准对接，护航全程创新推出"专班对接+定制服务"机制，聚焦企业需求，为企业量身定制服务方案，今年以来已累计开展各类生物医药产业服务70余 次，让企业在发展道路上少走弯路，轻装上阵。 专家指导，破解难题积极联动省级审评核查专家 ...

Financial Data and Key Metrics Changes - Worldwide revenue for Q1 2025 reached $47.3 million, representing approximately 25% growth compared to the prior year [6][26] - U.S. revenue was $44.8 million, reflecting approximately 27% growth, driven by a 27.3% increase in procedure volume [7][26] - Gross profit was $37.7 million, an increase of $7.8 million or 26.2%, with a gross margin rate of 79.7% [27] - Net loss narrowed to $6.5 million or $0.15 per diluted share, compared to a net loss of $10.9 million or $0.27 per diluted share in the prior year [28] - Positive adjusted EBITDA of approximately $5 million compared to an adjusted EBITDA loss of $4 million in Q1 2024 [29] Business Line Data and Key Metrics Changes - The company experienced broad-based demand for existing technologies and rapid adoption of new solutions launched in 2024 [7][39] - The number of physicians performing procedures using the company's products grew by 27%, with over 1,400 U.S. physicians engaged [19] - The number of four implant Granite cases grew approximately 69% compared to the prior year period [13] Market Data and Key Metrics Changes - The total addressable market has increased to over $3.5 billion, with a cumulative procedure volume growth of 25% over the last three years [9][10] - The company is targeting nearly 100,000 degenerative procedures annually with its Granite product, which became eligible for transitional pass-through payment starting January 1, 2025 [13][14] Company Strategy and Development Direction - The company focuses on innovation, engagement, commercial execution, and operational excellence as key priorities [9] - The strategy includes diversifying the product platform with unique yet complementary technologies to expand the target modalities and physician footprint [9][10] - The company aims to reach 100 territories over the next 12 to 15 months, leveraging a hybrid commercial model combining territory managers and third-party agents [24][58] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong results over the long term, supported by resilient business trends and favorable reimbursement conditions [8][9] - The updated full-year revenue guidance is between $193.5 million to $197.5 million, implying year-over-year growth of approximately 16% to 18% [32] - Management noted that the company is well-positioned to achieve free cash flow in 2026, with a focus on maintaining operational discipline [30][32] Other Important Information - The company has a strong pipeline of novel technologies under development, with plans to launch new products over the next 12 to 18 months [16][18] - The company does not anticipate any material impact on gross margins or supply chain from proposed tariffs, as most manufacturing is domestic [30][31] Q&A Session Summary Question: Contribution from new products and channels to growth - Management noted broad-based growth and strong demand for current solutions, with impressive adoption of new products launched in 2024 [39] Question: Drivers of gross margin and future expectations - Management highlighted better-than-expected average selling price (ASP) and efficiency initiatives as key drivers of gross margin improvement [42][44] Question: Long-term growth expectations - Management expressed confidence in sustained growth potential, driven by technology leadership and expanding physician engagement [53][56] Question: Expected cadence of new guidance and sequential growth - Management indicated that while they do not think about the business in quarters, they expect to manage seasonality effectively with new product rollouts [66] Question: Operating expenses guidance - Management explained that elevated R&D investments and higher commissions linked to revenue growth are driving the expected increase in operating expenses [70][72] Question: Update on surgeon base and engagement - Management reported a record increase in the physician base, with broad engagement across various specialties [76][78] Question: Updates on reimbursement proposals - Management provided insights on CMS proposals and the potential for increased reimbursement rates, which could accelerate adoption of products [80][81] Question: Traction and adoption of TNT product - Management noted that TNT is seeing rapid adoption and is expected to benefit from upcoming reimbursement changes [97]

一次创新思维的碰撞，一场探索医疗科技创新的合作之旅！ 医生 ×CEO ×工程师 ×投资人 强强联合，破解医疗器械创新难题！ 如果你对 医疗器械创新、医工结合、技术转化 充满兴趣，那么这次 上海交通大学医学院 × 附属医院 × 生物医学工程学院 联合打造的 「医疗器械医工创新转化工作 坊」 ，就是你的绝佳机会！ 课程亮点 你将获得 培训信息 时间： 2025年6月（周末2天，具体时间提前一个月通知） 地点： 上海交通大学医学院 费用： 8999元/人（含课程、教材、茶点等，食宿自理） 主办单位： 上海交通大学医学院继续教育学院 支持 单位： 中关村联新生物医药产业联盟 第一天：医疗创新与技术布局 晚上：技术解决方案对接会 第二天：创新产业化与资金路径 医工创新产业的关键点及资金来源 课程安排 课程安排 | 2天高强度实战训练，全面掌握医工创新转化 让医学痛点与工程技术深度融合，打造医疗创新产品，助力成果转化！ 是否曾有一个医疗创新的想法，却不知如何落地？ 是否苦于医生与工程技术团队难以有效协作？ 是否希望掌握医疗器械从概念到市场的完整路径？ Biodesign 医工创新方法论： 全球前沿医工创新模式，助力高效转 ...

报名：首届全球眼科大会 | 议程更新 报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 合作伙伴征集：2025全球手术机器人大会 近日，中国植入式给药装置领域的创新先锋—— 炜璨医疗 宣布 完成数千万元天使轮融资 。本轮融资由元禾 原点和诺庾资本联合领投，南京江北科投跟投。 此前，公司还获得了华创资本 数千万元种子轮 融资。 本轮 资金将主要用于加快第一代产品上市步伐、加速新一代产品研发以及推动颠覆性创新产品的项目落地。 # 关于炜璨医疗 炜璨医疗成立于2023年4月11日，总部位于江苏省南京市。公司是一家 专注于传统肿瘤介入通路与植入式智 能化介入产品 的创新型医疗器械公司， 聚焦介入式医疗器械与智能化技术赛道 。公司早期采用国际国内成熟 技术储备，依靠企业自研团队开发静脉、动脉、镇痛、腹腔、透析通路等各种应用场景下的植入式给药装置系 列产品，其中大量产品为国内外首创。 产品与技术 炜璨医疗的产品线主要围绕植入式给药装置展开，其核心产品包括 静脉、动脉、镇痛、腹腔、透析通路等各 种应用场景下的植入式给药装置 。公司采用校企联合研发模式，与创新型新材料团队合作，打磨了可以国产 替代 ...

预计2024年净亏损不超过2.75亿美元（约合19.9亿元人民币）， 较上年同期亏损收窄超过 58% 。亏损的显 著收窄主要归因于资源聚焦和成本优化措施，使得经营费用占收入比率同比下降约28个百分点。 报名：首届全球眼科大会 | 暂定议程 报名：首届全球心血管大会 | 奖项报名倒计时 报名：首届全球骨科大会 | 奖项报名倒计时 2025年3月9日，微创医疗（00853.HK）发布了2024年度业绩预告。 # 财务数据 收入增长 尽管面临快速变化的外部环境和行业政策影响，微创医疗预计2024年收入同比增长近10%，剔除汇率影响 后， 收入预计达到 74.07亿 元人民币 。 净亏损收窄 合作伙伴征集：2025全球手术机器人大会 海外业务增长 通过全球化平台的协同效应， 微创医疗出海业务收入同比增长约 80% ，进一步推动了整体收入增长。 产品注册与创新 报告期内，集团及联营公司共有6款产品进入国家创新医疗器械审批程序（绿色通道）， 累计达到36款，连 续十年在同行业中排名第一 。此外，集团及联营公司共获得46项国家药品监督管理局颁发的三类医疗器械首 次注册证，并在43个海外市场获得184项首次注册证，其中包括1 ...