Axon Therapies is a private medtech company developing a minimally invasive therapy called Splanchnic Ablation for Volume Management (SAVM) to address a root cause of heart failure. The SAVM procedure utilizes the company's Satera Ablation System to perform targeted ablation of the overactive sympathetic nervous system, which is a key driver of worsening heart failure. This implant-free, catheter-based procedure aims to restore volume balance, stop disease progression, and improve heart failure symptoms in patients with preserved ejection fraction (HFpEF).
The SAVM therapy works by using unilateral radiofrequency to selectively ablate the greater splanchnic nerve (GSN), reducing sympathetic tone and enabling targeted venodilation of the splanchnic bed. This normalizes blood volume in the heart and lungs, preventing congestion. Data from the REBALANCE-HF feasibility trial showed significant reductions in pulmonary capillary wedge pressure (PCWP) with exercise and improvements in functional capacity, symptoms, and quality of life metrics at one month. Updated results announced in March 2023 demonstrated these benefits were sustained for six months in a roll-in cohort.
The REBALANCE-HF trial, which enrolled 116 patients across 18 sites, met its objectives of demonstrating the safety and ease of the SAVM procedure while identifying a responder group. This group, comprising over half the cohort, experienced clinically meaningful improvements at six months, including a 13-point increase in quality of life score, 36-meter improvement in walking ability, 39% relative improvement in cardiac function, and reduced filling pressures. These results were further confirmed after the trial completed. The SAVM procedure was found to be quick (averaging 53 minutes) with a 98% success rate and no significant increase in adverse events compared to a sham procedure.
In October 2023, Axon Therapies announced that a subgroup of HFpEF patients able to augment cardiac output during exertion and without advanced structural heart disease were most likely to benefit from SAVM therapy based on the REBALANCE-HF data. The company was acquired by an undisclosed entity in September 2024.
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