REBALANCE-HF early feasibility trial met objective of identifying responder group with demonstrated benefits in heart function, hemodynamics, and physical activity at 6 months

REBALANCE-HF早期可行性试验的目的是确定6个月时在心脏功能，血流动力学和身体活动方面表现出益处的应答者组

SAVM procedure quick and easy to perform with high success rate and no significant increase in procedure-related adverse events

SAVM手术快速简便，成功率高，手术相关不良事件无明显增加

SANTA CLARA, Calif., Oct. 8, 2023 /PRNewswire/ -- Axon Therapies, a private company focused on addressing a root cause of heart failure, today announced 6-month results of the REBALANCE-HF randomized, blinded feasibility trial of the Splanchnic Ablation for Volume Management (SAVM) procedure for heart failure with preserved ejection fraction (HFpEF).

加利福尼亚州圣克拉拉，2023年10月8日/PRNewswire/-Axon Therapies，一家专注于解决心力衰竭根本原因的私营公司，今天宣布了REBALANCE-HF随机，盲法可行性试验的6个月结果。保留射血分数（HFpEF）的心力衰竭的内脏消融容量管理（SAVM）程序。

The main objectives of the feasibility study were to demonstrate safety, evaluate the ease and repeatable nature of the procedure, and identify the subtype of patients most likely to respond to the therapy to inform future clinical trials. While there was no improvement with the SAVM procedure compared to a control sham procedure in the full study cohort, preliminary results identified HFpEF patients who are sensitive to acute shifts in blood volume during exercise or stress were more likely to be responsive to SAVM.

可行性研究的主要目标是证明安全性，评估手术的简便性和可重复性，并确定最有可能对治疗有反应的患者亚型，以便为未来的临床试验提供信息。虽然SAVM程序与完整研究队列中的对照假手术相比没有改善，但初步结果确定，在运动或压力期间对血容量急性变化敏感的HFpEF患者更可能对SAVM有反应。

The responder group, which made up more than half of the full cohort, saw clinically meaningful improvements in functional capacity, symptoms and quality of life metrics at 6 months after treatment with SAVM. The results were presented by Marat Fudim, MD, MHS, Advanced Heart Failure Specialist at Duke University Medical Center, during the Late Breaking Clinical Trials session at the Heart Failure Society of America's (HFSA) Annual Scientific Meeting in Cleveland, OH..

应答者组占整个队列的一半以上，在SAVM治疗后6个月，在功能能力，症状和生活质量指标方面有临床意义的改善。结果由杜克大学医学中心高级心力衰竭专家Marat Fudim医学博士在美国心力衰竭学会（HFSA）年度科学会议上的最新临床试验会议上提出。。

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SAVM is a novel, front-line interventional (transcatheter) therapy for heart failure that aims to reduce sympathetic tone, enabling targeted venodilation of the splanchnic bed to normalize blood volume in the heart and lungs and prevent congestion.

SAVM是一种新型的心力衰竭一线介入（经导管）治疗方法，旨在减少交感神经张力，使内脏床有针对性地静脉注射，使心肺血容量正常化，防止充血。

'SAVM utilizes a novel mechanism of action for treating heart failure, so we designed the REBALANCE-HF early feasibility trial to enable us to identify potential responder groups from a broad range of HFpEF patients. These results show that HFpEF patients who are able to augment cardiac output during exertion and those without advanced structural heart disease may benefit most from SAVM,' explained Sanjiv Shah, MD, Principal Investigator for the REBALANCE-HF early feasibility trial, and Advanced Heart Failure Specialist and Director of Research, Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine.

'SAVM利用一种新的治疗心力衰竭的作用机制，因此我们设计了REBALANCE-HF早期可行性试验，使我们能够从广泛的HFpEF患者中识别潜在的应答者群体。这些结果表明，能够在运动过程中增加心输出量的HFpEF患者和没有晚期结构性心脏病的患者可能从SAVM中获益最多，“REBALANCE-HF早期可行性试验首席研究员Sanjiv Shah博士解释说，心力衰竭专家和研究主任，西北大学芬伯格医学院Bluhm心血管研究所。

An overactive sympathetic nervous system is a known root cause of heart failure and can drive shifts in blood volume from the splanchnic bed, the body's main blood reservoir, to the heart and lungs during periods of exercise or stress. SAVM is a novel, front-line interventional (transcatheter) therapy that calms the overactive sympathetic nervous system by using unilateral radiofrequency to selectively ablate the greater splanchnic nerve (GSN).

过度活跃的交感神经系统是心力衰竭的已知根本原因，并且可以在运动或压力期间驱动血容量从内脏床（身体的主要血液储存器）到心脏和肺的变化。SAVM是一种新型的一线介入（经导管）疗法，通过使用单侧射频选择性消融较大的内脏神经（GSN）来镇静过度活跃的交感神经系统。

The minimally invasive, implant-free procedure aims to reduce sympathetic tone, enabling targeted venodilation of the splanchnic bed to normalize blood volume in the heart and lungs and prevent congestion..

微创，无植入物的手术旨在减少交感神经张力，使内脏床有针对性的静脉曲张能够使心脏和肺部的血容量正常化并防止充血。。

The REBALANCE-HF trial is the largest randomized controlled, blinded, feasibility device trial in patients with HFpEF to date, enrolling 116 patients from 18 sites. The full treatment arm results confirmed the SAVM procedure was safe with no difference in procedure-related adverse events compared to the sham arm.

REBALANCE-HF试验是迄今为止HFpEF患者中最大的随机对照，盲法，可行性装置试验，招募了来自18个地点的116名患者。完整的治疗组结果证实SAVM手术是安全的，与假手术组相比，手术相关的不良事件没有差异。

SAVM was performed quickly (53 minutes on average) and had a 98% procedural success rate. The improvements SAVM demonstrated in the responder group at 6 months were sustained in patients who have available 12-month data. Key results include:.

SAVM表现迅速（平均53分钟），手术成功率达98%。在有12个月数据的患者中，应答者组在6个月时表现出的SAVM改善得以维持。主要结果包括：。

13-point improvement in quality-of-life at 6 months in treatment vs. sham (p=0.02) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) score

通过堪萨斯城心肌病问卷（KCCQ）评分测量，治疗6个月时与假手术相比生活质量提高13分（p=0.02）

36-meter improvement in ability to walk at 6 months in treatment vs. sham (p=0.08) as measured by the 6-minute walk test

通过6分钟步行测试测量，治疗6个月时行走能力与假手术相比提高了36米（p=0.08）

39% relative improvement in cardiac function (NT-proBNP measures) at 6 months in treatment vs. sham (p=0.10)

与假手术相比，治疗6个月时心功能相对改善39%（NT-proBNP测量）（p=0.10）

Reduced filling pressures at 1 month as measured by peak pulmonary capillary wedge pressure (PCWP) of -4.5 mmHg (vs. peak PCWP of -1.6 mmHg for sham, p=0.10)

通过峰值肺毛细血管楔压（PCWP）为-4.5 mmHg（相对于假手术峰值PCWP为-1.6 mmHg，p=0.10）测量，1个月时充盈压降低

'The favorable hemodynamics and improvements in clinical symptoms in this responder population versus the sham group is promising. Although we need additional data to confirm the results, the easy-to-perform SAVM procedure has the potential to become a front-line interventional procedure and change how we treat HFpEF patients, a notoriously complex population that makes up at least 50% of heart failure patients,' added Dr.

'与假手术组相比，该应答者群体的有利血液动力学和临床症状的改善是有希望的。虽然我们需要额外的数据来确认结果，但易于执行的SAVM程序有可能成为一线介入程序，并改变我们如何治疗HFpEF患者，这是一个众所周知的复杂人群，至少占心力衰竭的50%患者，“博士补充说。

Fudim.'We are highly encouraged by these results and expect the full data from REBALANCE-HF to be published next year,' said Chad Hoskins, President and Chief Executive Officer, Axon Therapies. 'I want to thank our investigators for all their work in executing this novel approach of using a randomized feasibility study to identify which patients may benefit the most from SAVM.

复旦.'Axon Therapeutics总裁兼首席执行官Chad Hoskins说，我们对这些结果非常鼓舞，并希望明年发布REBALANCE-HF的全部数据我要感谢我们的研究人员在执行这种使用随机可行性研究的新方法方面所做的所有工作，以确定哪些患者可能从SAVM中获益最多。

These data will be foundational to our efforts to bring this therapy to the patients who need it most.'About Axon Therapies, Inc.Axon Therapies, a private medtech company, is developing a novel first-line intervention for treating the overactive sympathetic nervous system, a root cause of heart failure.

这些数据将成为我们努力将这种疗法应用于最需要它的患者的基础关于Axon Therapies，Inc。私人medtech公司的Axon Therapies正在开发一种新型的一线干预措施，用于治疗过度活跃的交感神经系统，这是心力衰竭的根本原因。

Derived from an existing clinical procedure, splanchnic ablation for volume management (SAVM) using the Satera™ Ablation System enables targeted ablation to improve vasodilation and calm the sympathetic response. The minimally invasive, implant-free procedure has been proven to normalize blood volume, increase heart function and improve patient symptoms.

从现有的临床程序，内脏消融体积管理（SAVM）使用Satera™ 消融系统使靶向消融能够改善血管舒张并使交感神经反应平静。微创，无植入手术已被证明可以使血容量正常化，增加心脏功能并改善患者症状。

Axon was founded by proven medtech incubator Coridea, and is backed by leading healthcare investors, including Deerfield Management, Action Potential Venture Capital, and an undisclosed strategic investor. Learn more at axontherapies.com.SOURCE Axon Therapies, Inc..

Axon由Provent medtech孵化器Coridea创立，并得到领先的医疗保健投资者的支持，包括Deerfield Management，Action潜在风险投资和未披露的战略投资者。在axontherapies.com.SOURCE Axon Therapies，Inc.了解更多信息。。