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Clinical Evidence
Axon Therapies has a well-established clinical strategy that includes multiple published peer-reviewed articles and on-going clinical research studies.
SAVM FIH Results
12-month results published in JACC: Heart Failure in October 2022.
Improved
Quality of Life
+37
in KCCQ
Reduced
NT-proBNP
-55
%
Increase in
6-min. walk
+67
meters
No Device-Related
Adverse Events
0

Clinical Roadmap

 
All of our studies to date have demonstrated meaningful improvements in clinical and physiological parameters.

REBALANCE-HF IDE Study

Endovascular Ablation Of The Right Greater Splanchnic Nerve In Heart Failure With Preserved Ejection Fraction: Early Results Of The REBALANCE-HF Trial Roll-In Cohort

These results from the initial roll-in patients of the REBALANCE-HF IDE study support safety and efficacy of the SAVM procedure and signal clinical improvements in key data, including reductions in pulmonary capillary wedge pressure (PCWP) with exercise and improvements in exercise capacity and quality of life.

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Pilot Endovascular Study in HFpEF

Durability Of Right Greater Splanchnic Nerve Ablation For The Treatment Of HFpEF

These results demonstrate, for the first time, the feasibility of treating HFpEF with endovascular right-sided GSN ablation. The encouraging safety and efficacy results provide rationale for a phase 2 randomized controlled trial.

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Procedure Overview

Splanchnic Nerve Modulation in Heart Failure: Mechanistic Overview, Initial Clinical Experience, and Safety Considerations

There’s strong basis for continued efforts to study splanchnic nerve therapy in HF provided by the pathophysiological role of the greater splanchnic nerve (GSN) in volume redistribution, the encouraging findings of acute and chronic pilot splanchnic nerve modulation (SNM) studies and the safety profile from permanent SNM for pain.

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Pilot Surgical Study in HFpEF

Surgical Ablation Of The Right Greater Splanchnic Nerve For The Treatment Of HFpEF

In this first-in-human study, GSN ablation in HFpEF proved to be feasible, with a suggestion of reduced cardiac filling pressure during exercise, improved quality of life and exercise capacity.

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FURTHER ANALYSIS

Early Hemodynamic Changes following Surgical Ablation of the Right Greater Splanchnic Nerve for the Treatment of Heart Failure with Preserved Ejection Fraction

Demonstrates that GSN ablation results in a significant reduction in pulmonary capillary wedge pressure as soon as 24 hours after the procedure compared to baseline.

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Editorial

The Splanchnic Reservoir: An Oasis for Blood Volume in Heart Failure with Preserved Ejection Fraction?

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Pilot Endovascular Study in HFrEF

Endovascular Ablation Of The Right Greater Splanchnic Nerve For The Treatment Of HFrEF

These results demonstrate early success using SAVM to treat HFrEF using the Axon Ablation System. Follow-up is ongoing.

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Presented at HFSA 2021



Mechanism Overview

Role of Volume Redistribution in the Congestion of Heart Failure

This review highlights the importance of volume shifts in addition to the established concept of sodium and fluid retention as the main drivers of cardiovascular decompensation.

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The Axon Ablation System is an investigational device and is not currently approved for clinical use in any geography.

CAUTION – Investigational Device. Limited by Federal (or United States) law to Investigational Use.

 ClinicalTrials.gov identifier:  NCT04592445

©2022 Axon Therapies Inc. All rights reserved. Axon is a trademark of Axon Therapies, Inc.
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