Orchestra BioMed Holdings Inc. has received U.S. Food and Drug Administration (FDA) investigational device exemption approval to begin its global BACKBEAT study, evaluating the efficacy and safety of atrioventricular interval modulation (AVIM) therapy (a.k.a., BackBeat CNT) in treating hypertensive patients requiring a dual-chamber cardiac pacemaker. .

Orchestra BioMed Holdings Inc.已获得美国食品和药物管理局（FDA）研究设备豁免批准，开始其全球BACKBEAT研究，评估房室间隔调节（AVIM）治疗（a.k.a.，BACKBEAT CNT）治疗需要双腔心脏起搏器的高血压患者的疗效和安全性。。.

Orchestra BioMed and Medtronic plc formed a strategic collaboration last summer to develop and commercialize AVIM therapy for hypertensive pacemaker patients. Under the collaboration, Medtronic is providing Orchestra BioMed with development, clinical, and regulatory support for the BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study, which Orchestra BioMed is sponsoring.

Orchestra BioMed和Medtronic plc去年夏天成立了战略合作，为高血压起搏器患者开发和商业化AVIM疗法。在合作下，美敦力正在为Orchestra BioMed提供开发，临床和监管支持，支持Orchestra BioMed赞助的BACKBEAT（心动过缓起搏器，用于血压治疗的房室间隔调节）全球关键研究。

If approved, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems for this target population. Orchestra BioMed will share in the revenues generated from Medtronic sales of the AVIM-enabled pacing systems. .

如果获得批准，美敦力将拥有为该目标人群商业化AVIM起搏系统的独家全球权利。Orchestra BioMed将分享美敦力销售AVIM起搏系统的收入。。.

“We are thrilled to receive IDE approval from the FDA and move forward with plans to initiate the BACKBEAT global pivotal study, which is designed to support potential future regulatory review and potential approval of AVIM therapy for hypertensive patients indicated for a pacemaker. Achieving this milestone a little over a year after starting our strategic collaboration with Medtronic is a significant accomplishment for our company,” Orchestra Biomed Founder/Chairman/CEO David Hochman said.

“我们很高兴获得FDA的IDE批准，并计划启动BACKBEAT全球关键性研究，该研究旨在支持潜在的未来监管审查和AVIM治疗对起搏器指示的高血压患者的潜在批准。在开始与美敦力的战略合作一年多后，实现这一里程碑我们公司的重大成就，“管弦乐队生物医学创始人/主席/首席执行官大卫霍奇曼说。

“We believe this therapy has the potential to substantially improve the standard of care for hypertensive pacemaker patients and we look forward to initiating the study before the end of 2023.”.

“我们相信这种疗法有可能大大提高高血压起搏器患者的护理标准，我们期待在2023年底之前开始这项研究。”。

The BACKBEAT study IDE was supported by encouraging results from MODERATO II, a prospective, multi-center, randomized, double-blind, pilot study of pacemaker patients with persistent HTN. MODERATO II showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour aSBP and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. .

BARBEAT研究IDE得到了MODERATO II的令人鼓舞的结果的支持，这是一项针对持续性HTN起搏器患者的前瞻性，多中心，随机，双盲，试验性研究。Modero II显示，与对照组患者相比，接受AVIM治疗的患者在24小时aSBP中净减少8.1 mmHg，在6个月时收缩压（oSBP）减少12.3 mmHg。。.

“Hypertension is the world’s leading modifiable risk for death and affects over 1 billion people worldwide. While existing pharmaceutical treatments can be effective, more than half of individuals with hypertension do not meet blood pressure treatment goals. A device-based treatment like AVIM therapy has the potential to complement existing standards of care and reduce blood pressure to improve clinical outcome,” stated David Kandzari, M.D., chief of the Piedmont Heart Institute and chief scientific officer for Piedmont Healthcare (Atlanta) and co-principal investigator for the BACKBEAT trial..

“高血压是世界上领先的可改变的死亡风险，影响全球超过10亿人。虽然现有的药物治疗方法可能有效，但超过一半的高血压患者无法达到血压治疗目标。像AVIM疗法这样的基于设备的治疗有可能补充现有的护理标准并降低血压临床结果，”皮埃蒙特心脏研究所主任，皮埃蒙特医疗保健公司（亚特兰大）首席科学官兼BACKBEAT试验联合首席研究员David Kandzari博士说。。

BACKBEAT is a global, multi-center, prospective, randomized, double-blind study investigating the efficacy and safety of AVIM therapy in patients who recently underwent a Medtronic dual-chamber cardiac pacemaker implant and have uncontrolled hypertension (HTN) despite the use of antihypertensive medications.

BACKBEAT是一项全球性，多中心，前瞻性，随机，双盲研究，研究AVIM治疗对最近接受美敦力双腔心脏起搏器植入并具有不受控制的高血压（HTN）的患者的疗效和安全性，尽管使用了抗高血压药物。

The study will randomize approximately 500 patients 1:1 to AVIM along with continued medical therapy and pacing (treatment) or continued medical therapy and pacing alone (control). The study’s primary efficacy endpoint is the between group difference in the change of mean 24-hour ambulatory systolic blood pressure (aSBP) at three months post randomization.

该研究将随机分配约500名患者1:1至AVIM，同时继续药物治疗和起搏（治疗）或继续药物治疗和单独起搏（对照）。该研究的主要疗效终点是随机分组后3个月平均24小时动态收缩压（aSBP）变化的组间差异。

The primary safety endpoint is freedom from unanticipated serious adverse device effects in the treatment arm at three months post-randomization. Double-blind follow up will continue through 12 months to enable collection of additional clinical endpoints. The company plans to begin enrollment in the BACKBEAT study before the year's end, upon completion of standard clinical trial initiation activities, including clinical center Institutional Review Board approvals. .

主要安全性终点是在随机化后三个月在治疗组中没有意外的严重不良器械效应。双盲随访将持续12个月，以便收集额外的临床终点。该公司计划在完成标准临床试验启动活动（包括临床中心机构审查委员会批准）后，在年底之前开始参加BACKBEAT研究。。.

“Hypertension is the most common comorbidity in the pacemaker population, affecting more than 70% of patients,' noted Andrea Russo, M.D., academic chief, Division of Cardiology, director of Cardiac Electrophysiology and Arrhythmia Services, Cooper University Hospital, and co-principal BACKBEAT study investigator.

“高血压是起搏器人群中最常见的合并症，影响超过70%的患者，”Cooper大学医院心脏电生理学和心律失常服务主任心脏病科学术主任Andrea Russo博士和联合首席BACKBEAT研究调查员指出。

'Patients who have pacemakers are generally older and at higher risk for major cardiovascular events. AVIM therapy represents a potentially transformative hypertension treatment for these patients since it can be administered using the same pacemaker they already need and managed by the same physicians already caring for them.

'有起搏器的患者一般年龄较大，发生重大心血管事件的风险较高。AVIM疗法代表了对这些患者的潜在变革性高血压治疗，因为它可以使用他们已经需要的相同起搏器进行管理，并由已经照顾他们的相同医生进行管理。

We are excited to participate in the BACKBEAT study, which has been thoughtfully designed to evaluate the safety and efficacy of this therapy.” .

我们很高兴参加BACKBEAT研究，该研究经过深思熟虑的设计，旨在评估该疗法的安全性和有效性。”。.

HTN is characterized by elevated blood pressure, which increases the force of blood pushing against blood vessels, requiring the heart to work harder and consume more oxygen. HTN accelerates the progression of atherosclerosis and leads to increased risk of major cardiac events like heart attack, heart failure, kidney disease and other end organ damage.

HTN的特征是血压升高，这增加了血液对血管的推动力，需要心脏更加努力地工作并消耗更多的氧气。HTN加速动脉粥样硬化的进展并导致心脏病发作，心力衰竭，肾脏疾病和其他终末器官损害等主要心脏事件的风险增加。

HTN is the leading global risk factor for death, affecting an estimated 1.28 billion adults worldwide. In the United States, 122 million adults, or approximately 47% of all adults, are estimated to have HTN. While many patients do not notice high blood pressure, cardiovascular risk doubles for every 10 mmHg increase in systolic blood pressure and the mortality rate doubles with an increase of 20 mmHg in systolic blood pressure. .

HTN是全球死亡的主要风险因素，影响全球约12.8亿成年人。在美国，估计有1.22亿成年人，约占所有成年人的47%，患有HTN。虽然许多患者没有注意到高血压，但收缩压每增加10 mmHg，心血管风险就会增加一倍，死亡率随着收缩压增加20 mmHg而增加一倍。。.

It is estimated that more than 70% of the approximately 1.1 million people globally who are implanted with cardiac pacemakers each year are also diagnosed with HTN. Based on updated ACC/AHA guidelines, an even higher percentage (approximately 80%) of U.S. patients that are indicated for the implant of a pacemaker have HTN. Pacemaker patients tend to be elderly and are more likely to suffer from co-morbidities such as atherosclerosis, hyperlipidemia, diabetes mellitus and chronic kidney disease, and harder to treat effectively with medical therapy for many reasons including co-morbidities and a high prevalence of isolated systolic HTN. .

据估计，全球每年植入心脏起搏器的约110万人中，超过70%也被诊断患有HTN。根据更新的ACC/AHA指南，指示植入起搏器的美国患者比例更高（约80%）患有HTN。起搏器患者往往年龄较大，更容易患有动脉粥样硬化，高脂血症，糖尿病和慢性肾脏疾病等并发症，并且由于多种原因（包括合并症和高患病率）难以用药物治疗有效治疗孤立的收缩期HTN。。.

AVIM therapy, also known as BackBeat CNT, is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour aSBP and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients.

AVIM疗法，也称为BackBeat-CNT，是一种与标准双腔起搏器兼容的研究性疗法，旨在显着和持续降低血压。已经在高血压患者的试点研究中对其进行了评估，这些患者也适用于起搏器。MODERATO II是一项双盲，随机试验研究，与对照组患者相比，接受AVIM治疗的患者在24小时aSBP中净降低8.1 mmHg，在6个月时收缩压（oSBP）降低12.3 mmHg。

The planned global pivotal BACKBEAT study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in a similar target population of patients who have been indicated for, and recently implanted with, a dual-chamber cardiac pacemaker. .

计划中的全球关键性后退研究将进一步评估AVIM治疗在降低血压方面的安全性和有效性，这些患者已被指示并最近植入双腔心脏起搏器。。.

Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through partnerships with medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with medical device companies to successfully commercialize the products it develops.

Orchestra BioMed是一家生物医学创新公司，通过与医疗器械公司的合作，为患者加速高影响力技术。Orchestra BioMed的合作伙伴业务模式专注于与医疗器械公司建立战略合作，以成功将其开发的产品商业化。

Orchestra BioMed’s flagship product candidates include AVIM therapy for treating hypertension, and Virtue Sirolimus AngioInfusion Balloon (SAB) for treating atherosclerotic coronary artery disease. In addition to its partnership with Medtronic, Orchestra BioMed also has a strategic collaboration with Terumo to develop and commercialize Virtue SAB.

Orchestra BioMed的旗舰产品候选人包括用于治疗高血压的AVIM疗法和用于治疗动脉粥样硬化性冠状动脉疾病的VITURE西罗莫司血管输注球囊（SAB）。除了与美敦力合作外，Orchestra BioMed还与Terumo进行战略合作，开发和商业化德性SAB。

Orchestra BioMed has additional product candidates and plans to potentially expand its product pipeline through acquisitions, strategic collaborations, licensing, and organic development.  .

Orchestra BioMed拥有额外的产品候选人，并计划通过收购，战略合作，许可和有机开发来扩大其产品渠道。  .