Clinical Accelerator, a full-service contract research organization is pleased to report on its continuous collaboration with Axon Therapies, an early-stage, US-based medical technology company. Axon Therapies has developed a novel device – the Axon System – with a neuromodulation approach to treating heart failure. The First-In-Human study is specifically focused on endovascular ablation of the greater splanchnic nerve in patients who have chronic heart failure with preserved ejection fraction (HFpEF).
Heart Failure is a major public health issue with more than 5 million cases and 600,00 new cases per year in the United States. Almost half of these patients have HFpEF. At this moment in time, there are no therapies for this other than diuretic control for fluid overload and standard treatments for comorbidities. In addition, the 5-year mortality rate has been reported to be as high as 50-65%. This unmet medical need is what Axon is trying to treat with their novel medical device.
In patients with HFpEF, sympathetically driven mobilization of blood from the splanchnic reservoir to the central circulation leads to an increase in venous return with subsequent hemodynamic deterioration. This causes congestions, diuretic resistance, acute decompensations leading to rehospitalization, dyspnea and intolerance to even mild exercise, and progressive diastolic dysfunction. The Axon Endovascular GSN Ablation System is to be used to perform unilateral GSN ablation which should selectively block sympathetic signalling to the splanchic circulation. The system is made up of the Axon Catheter, Axon Generator, Axon Pump, Axon Cable and Axon Tubeset. Beneficial outcomes to this approach include but are not limited to:
- Lower pulmonary pressures at rest upon exercising
- Improved capacity to exercise
- Reduced mortality
- Improved responsiveness to diuretics
- Reduced re-hospitalizations for heart failure
The study is a prospective, multi-center, single-arm, non-blinded feasibility clinical study. The purpose of this study is to assess the safety and efficacy of the Axon System when performing catheter-based unilateral ablation of the greater splanchnic nerve (GSN) in patients with Heart Failure. Clinical Accelerator is pleased to be able to make a contribution to this exciting study in the Czech Republic and in the Republic of Georgia.
About Axon Therapies
Axon Therapies is an early stage medical device company with a dedicated focus on Heart Failure. Founded in 2014 in New York, the company is led by CEO Dr Howard Levin – a veteran in the field of biomedical engineering and cardiology, with a specialty in heart failure and transplantation. Axon Therapies is a portfolio company of Coridea, a New-York based incubator, founded by Howard Levin and Mark Gelfand – two prominent experts in device development and serial entrepreneurs.
About Clinical Accelerator
Clinical Accelerator is a boutique academically oriented clinical CRO focused on the needs of emerging MedTech companies. The organization was founded by a heart failure cardiologist and performs many clinical investigations of cardiovascular medical devices, with a special focus on heart failure. Studies are mostly implemented in Central and Eastern Europe, a region with well-known advantages for clinical trials such as – fast start-up timelines and good access to patients. Clinical Accelerator aims to accelerate clinical development programs of international medical technology companies through early entry into the clinic and fast and efficient implementation of both feasibility and pivotal clinical investigations.