Table of Contents 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, 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: 001-38468 ______________________________ Inspire ...

公司业绩 - 公司在2022年12月31日实现了4.079亿美元的收入，毛利率为83.8%，净亏损为4490万美元[24] Inspire疗法表现 - 公司开发的Inspire疗法在多项临床研究中表现出显著的疗效，包括对数千名患者进行的七项赞助和90多项独立临床研究，显示出对患者OSA严重程度的显著和持续减轻，改善睡眠相关生活质量和减少打鼾，以及高患者依从率和强大的安全性[19] - 公司的Inspire疗法是首个获得FDA批准的神经刺激技术，为中度至重度OSA患者提供安全有效的治疗，且已获得2014年FDA的PMA[25] - Inspire疗法的长期疗效得到了验证，研究显示，中度至重度OSA患者的AHI中位数在治疗后12个月从29.3次/小时降至9.0次/小时，五年后仍保持在6.2次/小时[20] - Inspire疗法是首个且唯一获得FDA批准的闭环神经刺激技术，用于治疗中度至重度睡眠呼吸暂停症[40] - Inspire疗法通过提供安全、有效和持久的治疗，克服了CPAP等目前治疗方式的许多局限性[49] - Inspire系统使用专有算法持续监测患者的呼吸，并在吸气期间提供电刺激，保持呼吸周期中的气道开放[50] - Inspire疗法具有与CPAP相似的疗效和使用情况[53] - Inspire系统的植入组件在约90分钟的门诊手术中放置，手术创伤小，患者通常能够在几天内恢复正常活动[54] - Inspire疗法在临床试验中显示出与CPAP相当的改善效果[69] - Inspire疗法患者在睡眠质量和白天活力方面有显著改善[70] - Inspire疗法在实际使用中表现出高效的结果[73] 市场拓展与发展 - 公司通过直销组织向美国和欧洲部分国家的医院和日间手术中心销售Inspire系统，通过分销商向日本和新加坡销售，截至2022年12月31日，公司在美国拥有225个销售领域，在欧洲有12个[21] - 公司的市场开发和患者参与方法有针对性，通过与三个关键利益相关者（医生、睡眠中心和患者）积极互动，建立长期关系，提高对Inspire系统的认知和采用率[28] - 公司有一支专注于为患者和提供者提供市场准入的团队，帮助患者和提供者与支付者合作，提前获得Inspire系统的先前授权批准[30] - 公司计划扩大销售和营销组织，以促进Inspire疗法的采用[36] - 公司计划在现有和新的国际市场进一步渗透和扩展[39] 创新与发展 - 公司的目标是成为提供改善睡眠、生活质量和健康的临床验证创新解决方案的全球领导者[34] - 公司计划扩大销售和营销组织，以促进Inspire疗法的采用[36] - 公司计划在现有和新的国际市场进一步渗透和扩展[39] 法规与合规 - FDA将设备分为不同类别，其中Class III设备需要PMA批准[122] - PMA申请需要包括大量数据，包括临床研究数据[124] - FDA会根据PMA中的数据和信息来决定设备是否安全有效[125] - 对已批准设备的某些改变可能需要提交PMA补充申请[126] - 临床研究通常需要支持PMA申请[127] - FDA实施了Breakthrough Devices Program，以加速某些医疗设备的发展和审查[131] - 设备获得市场批准后，仍需遵守多项监管要求，包括QSR要求、标签和营销法规等[132] - 设备制造过程必须符合QSR的适用部分[134] - FDA对违规行为有广泛的监管和执法权力，可能会采取多种制裁措施[135] - 在欧盟市场销售产品需要获得相关的监管批准和符合各国的产品和质量体系法规[137] - 欧盟医疗器械法规要求制造商在将设备（非定制设备）投放市场之前，必须向电子系统（Eudamed）提交身份信息进行注册[145] - 制造商必须为设备分配唯一标识符，并将其与其他核心数据一起提供给唯一设备标识符（UDI）数据库，以确保设备更好地识别和追踪[145] - 制造商必须在Eudamed中输入必要数据，并保持数据的最新状态，以满足有关信息交换的义务[146] - 所有在欧盟市场投放医疗器械的制造商必须遵守欧盟医疗器械警戒系统，必须向欧盟成员国的相关机构报告严重事件和现场安全纠正措施[147] - 制造商有责任采取技术或医疗原因的现场安全纠正措施，以防止或减少与市场上可用医疗器械使用相关的严重事件风险[148]

Inspire Medical Systems, Inc. (NYSE:INSP) Q4 2022 Results Conference Call February 7, 2023 5:00 PM ET Company Participants Ezgi Yagci - Vice President of Investor Relations Tim Herbert - President & Chief Executive Officer Rick Buchholz - Chief Financial Officer Conference Call Participants Travis Steed - Bank of America Robbie Marcus - JPMorgan Adam Maeder - Piper Sandler Rich Newitter - Truist Larry Biegelsen - Wells Fargo John Block - Stifel Michael Polark - Wolfe Research Chris Pasquale - Nephron Resear ...

Sleep Apnea Innovation 1 Inspire Medical Systems, Inc. February 2022 NYSE: INSP Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forwardlooking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' '' ...

Sleep Apnea Innovation 1 Inspire Medical Systems, Inc. February 2022 NYSE: INSP Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forwardlooking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' '' ...

Sleep Apnea Innovation 1 Inspire Medical Systems, Inc. August 2021 NYSE: INSP Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forwardlooking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' ''pr ...

Sleep Apnea Innovation 1 Inspire Medical Systems, Inc. June 2021 NYSE: INSP Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forwardlooking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' ''proj ...

Sleep Apnea Innovation 1 Inspire Medical Systems, Inc. May 2021 NYSE: INSP Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forwardlooking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' ''proje ...

1 Inspire Medical Systems, Inc. November 2020 NYSE: INSP Disclaimer 2 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' ''project,'' ''contemp ...

1 Inspire Medical Systems, Inc. August 2020 NYSE: INSP Disclaimer 2 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' ''project,'' ''contempla ...