文章核心观点 - 公司成功获得欧盟医疗器械法规(MDR)认证,这是公司在外科机器人市场取得的重要里程碑 [1][2][3][4] - 该认证不仅巩固了公司现有产品线,也为未来创新奠定了基础,有利于提高市场竞争力 [5][6] - 公司通过严格的监管要求,提升了市场信誉,为最小创伤治疗的普及铺平道路 [6] 行业概况 - 根据Future Market Insights报告,机器人辅助血管内系统市场预计将从2023年的9400万美元增长到2033年的2.147亿美元,复合年增长率为8.6% [7] - 该市场涉及在最小创伤手术中使用机器人技术治疗心血管和血管疾病,受益于相关疾病患病率上升、机器人技术进步以及医生对其认知度提高等因素 [7] 公司表现 - 公司股价今年迄今上涨13.2%,优于同行业8.2%的涨幅 [8] - 公司目前被评为中性评级(Zacks Rank 3) [10] - 同行业中Hims & Hers Health和Medpace被评为强烈买入(Zacks Rank 1),ResMed被评为买入(Zacks Rank 2) [10] - Hims & Hers Health和Medpace过去一年股价分别上涨75.3%和93.2%,超越行业 [11][12] - 这三家公司近期业绩和盈利预测均有所改善 [11][12][13]

Stereotaxis (STXS) recently announced that the first robotic cardiac heart program in Southern Italy had been developed at Hospital Santa Maria della Pietà, Nola. With the help of this cutting-edge technology, patients with heart rhythm abnormalities can now be effectively treated with robotic ablation treatments. Hospital Santa Maria della Pietà is the first hospital in Italy to use the latest generation of Genesis Robotic Magnetic Navigation (RMN) system. Price Performance For the past six months, STXS’s ...

ST. LOUIS, May 24, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework. The recertification under MDR covers all Stereotaxis devices currently available in Europe. MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed ...

ST. LOUIS, May 24, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE:STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received CE Mark recertification under the European Union's new Medical Device Regulation (MDR) regulatory framework. The recertification under MDR covers all Stereotaxis devices currently available in Europe. MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed t ...

gehringj/E+ via Getty Images Stereotaxis Reports Solid Results We must contextualize Stereotaxis’ (NYSE:STXS) reported results until their new products get approved. The company will have limited sales growth and a modest cash burn in the meantime. This doesn’t mean we shouldn’t analyze the current business. It just shouldn’t be where the majority of our focus lies. I have fairly low expectations for the existing business, but very high expectations for the medium term (next ~2 years). With that in mind, le ...

ST. LOUIS, May 22, 2024 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE:STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced that Hospital Santa Maria della Pietà, in Nola in the Metropolitan City of Naples, has established the first robotic cardiac heart program in Southern Italy. Patients suffering from heart rhythm disorders are now being successfully treated with robotic ablation procedures using this advanced technology, and Hospital Santa Maria della Pietà is t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (MARK ONE) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NUMBER 001-36159 STEREOTAXIS, INC. (Exact name of the Registrant as Specified in its Charter) DELAWARE 94-3120386 (State or Other Jurisdict ...

财务数据和关键指标变化 - 第一季度收入为6.9亿美元,同比增长5% [41] - 系统收入为2.6亿美元,经常性收入为4.3亿美元 [41] - 毛利率为58%,其中经常性收入毛利率为76%,系统收入毛利率为27% [42] - 营业费用为8.7亿美元,其中2.6亿美元为非现金股票补偿费用 [43][44] - 剔除股票补偿费用后的调整营业亏损为2.2亿美元,调整净亏损为1.9亿美元 [45] - 自由现金流为负2.3亿美元,3月31日现金余额为18.2亿美元,无债务 [46] 各条业务线数据和关键指标变化 - 系统收入增长,体现在交付一台Genesis系统并部分确认其他配套系统收入 [41] - 经常性收入受到强生导管短缺的持续影响,导致手术量下降 [41][42] 各个市场数据和关键指标变化 - 欧洲市场订单增加,有两家现有客户订购Genesis机器人升级 [9] - 中国市场,合作伙伴微创已提交Genesis等产品的监管申请,预计今年夏季获批 [22][23] 公司战略和发展方向及行业竞争 - 公司正在推进多项创新,包括自主研发的消融导管、更小型的机器人、扩展到血管介入等领域 [12][16][20] - 收购APT公司,获得介入器械研发和制造能力,有助于公司未来创新 [29][30][36] - 公司正在为新产品的商业化做准备,包括培训销售团队、完善供应链等 [23][18] 管理层对经营环境和未来前景的评论 - 尽管面临产品生态系统的挑战,但公司仍保持商业进展 [8] - 公司创新战略是推动大规模商业成功的关键 [27] - 新产品的监管进展顺利,为未来增长奠定基础 [12][16][22] - 预计2024年全年收入将实现温和的两位数增长 [49] 问答环节重要的提问和回答 问题1 **Frank Takkinen 提问** APT公司的收购如何影响公司当前的产品开发,如MAGiC导管和机器人导丝等 [51][52] **David Fischel 回答** 公司将继续与现有的合作伙伴保持长期关系,APT公司主要用于未来的诊断导管和血管导管的开发 [52][53] 问题2 **Jason Wittes 提问** MAGiC导管从PMA补充申请改为传统PMA申请,对时间线有何影响 [62][63] **David Fischel 回答** 这是一个持续的监管对话过程,FDA的转换决定是为了更全面的审查,但不会对整体时间线产生重大影响 [63] 问题3 **Adam Maeder 提问** APT公司在脉冲场消融技术方面有何进展和计划 [75][76] **David Fischel 回答** APT公司已经在这方面有一些临床试验和知识产权,公司也在与其他公司合作开发相关的机器人导管 [76]

Exhibit 99.1 Stereotaxis Reports 2024 First Quarter Financial Results ST. LOUIS, May 13, 2024 (GLOBE NEWSWIRE) – Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the first quarter ended March 31, 2024. “Stereotaxis is driving continued commercial, technological, and strategic progress,” said David Fischel, Chairman and CEO. “We are pleased to report revenue growth in the first quarter and an incr ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (MARK ONE) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NUMBER 001-36159 STEREOTAXIS, INC. (Exact name of the Registrant as Specified in its Charter) DELAWARE 94-3120386 (State or Other Jurisdiction o ...