Axon Therapies: Revolutionizing Heart Failure Treatment Through Splanchnic Ablation

Heart failure treatments have long struggled with limited options for patients with preserved ejection fraction (HFpEF), leaving millions with few effective therapies. Axon Therapies, a privately held medical device company, is pioneering a groundbreaking approach that targets the root cause of this challenging condition through its innovative Splanchnic Ablation for Volume Management (SAVM) technology.

Why Heart Failure with Preserved Ejection Fraction Needs New Approaches

HFpEF represents a critical gap in cardiovascular care, affecting approximately 50% of all heart failure patients and carrying a sobering 50% five-year survival rate. While recent studies have shown some mortality benefits with SGLT2 inhibitors in certain HFpEF populations, treatment options remain significantly more limited compared to heart failure with reduced ejection fraction (HFrEF).

HFpEF is characterized by elevated left-sided filling pressures at rest and during exercise. This significantly impacts patients' functional capacity and quality of life. A hallmark of heart failure progression is an overactive sympathetic nervous system (SNS) that chronically constricts blood vessels, particularly in the splanchnic bed, leading to increased cardiac pressures and disease progression.

A Novel Therapeutic Approach: Targeting the Splanchnic Nervous System

Axon Therapies has developed a unique solution that addresses the fundamental mechanism driving HFpEF progression. The company's SAVM procedure specifically targets the greater splanchnic nerve (GSN), which controls blood volume distribution between the splanchnic organs (liver, spleen, stomach, and intestines) and the central circulation.

The splanchnic bed holds up to 50% of the body's blood volume and serves as a critical reservoir that responds to sympathetic nervous system signals. In heart failure patients, chronic sympathetic activation causes persistent splanchnic vessel constriction, shifting blood to central circulation and creating volume overload that stresses the heart.

The Satera™ System: Minimally Invasive Innovation

Axon's proprietary catheter-based system, called Satera™, delivers targeted ablation therapy to denervate the right greater splanchnic nerve. During the procedure, the Axon Ablation Catheter is inserted through the femoral vein and navigated through the venous system to a target vessel near the right greater splanchnic nerve. Radiofrequency energy is then used to ablate the nerve, blocking sympathetic signals and normalizing volume balance in the body.

Clinical Evidence & Results

Early clinical data from Axon's feasibility studies demonstrate promising outcomes for SAVM therapy. In a study of 11 HFpEF patients, the procedure showed sustained improvements through 12 months with no device-related adverse cardiac events.

Key clinical improvements included:

• Quality of life: Kansas City Cardiomyopathy Questionnaire (KCCQ) scores improved from a baseline median of 48 to 80 at 12 months
• Exercise capacity: Six-minute walk test distance increased from 292 ± 82 meters at baseline to 359 ± 75 meters at 12 months
• Biomarkers: NT-proBNP levels decreased significantly from baseline 1,292 ± 1,186 pg/mL to 379 ± 165 pg/mL at 12 months

Recent 6-month data from a roll-in cohort for the REBALANCE-HF feasibility IDE trial confirmed sustained benefits, with positive patient outcomes consistent with prior results. The company expects the REBALANCE-HF trial to reach full enrollment of approximately 120 patients.

Funding & Development Timeline

Axon Therapies recently secured $32 million in Series A funding to advance its randomized feasibility trials and support the development of its groundbreaking technology. This substantial investment reflects growing confidence in the company's innovative approach to treating a condition with significant unmet medical need.

The funding will enable Axon to progress through critical development milestones, including completion of the REBALANCE-HF trial and preparation for pivotal studies that could support regulatory approval. The company's strong patent estate provides competitive protection for its first-in-class technology.

Competitive Positioning & Market Opportunity

Axon Therapies holds a unique position in the heart failure treatment landscape as the sole player specifically targeting splanchnic nerves for volume management. This approach differentiates the company from other neuromodulation devices like Barostim, which target different neural pathways.

With HFpEF affecting millions globally, Axon's SAVM technology addresses a substantial market opportunity. The minimally invasive, outpatient procedure can typically be completed in under an hour, with patients often going home the same day, positioning SAVM as a potentially transformative therapy.

Looking Ahead

Axon Therapies represents a compelling opportunity to revolutionize heart failure treatment through its innovative approach to splanchnic nerve modulation. The company's focus on addressing the root physiological cause of HFpEF, rather than merely managing symptoms, could transform outcomes for millions of patients worldwide.

The success of Axon's technology will ultimately depend on the results of ongoing and future pivotal trials, as well as the company's ability to navigate the regulatory pathway for this first-in-class therapy. With promising early clinical data, substantial funding, and a differentiated technological approach, Axon Therapies is well-positioned to potentially deliver an effective treatment targeting the underlying mechanisms of heart failure with preserved ejection fraction.