Welcome to AtriAN

AtriAN Medical

Restoring Rhythm through Science

Mission & Vision

Resolving Atrial Fibrillation at its origin

Current therapies are failing patients and their physicians. Medication fails 70% of the time, and ablations fail 30% within the first year and 50% within three. We are targeting the cardiac autonomic nervous system which should lead to a more durable solution significantly reducing the need for repeat procedures.

About Us

TECHNOLOGY

A Disruptive Approach to Rhythm restoration

First, we navigate to the heart’s epicardial (outside) surface, where the errant signals originate in specialized neurons. Secondly, we use new and non-thermal energy (PFA) to disable the neurons permanently.

THE DISRUPTION

AtriAN’s Business Pathway

Growing Market

Atrial Fibrillation is a large and quickly growing condition. Unfortunately, there is yet to be a perfect solution for its resolution. AtriAN’s mission is to change this for patients and their physicians.

Robust and Innovative Intellectual Property (IP)

The idea and technology were conceived and first developed at the Mayo Clinic (Rochester, MN, USA) by Dr. Sam Asirvatham with issued patents across the globe. We continue to innovate the technology.

Unique Solution

AtriAN takes a novel and unique approach to the resolution of the disease by targeting and disabling the hyperactive signals responsible for the arrhythmia.

Funding in Place

AtriAN has raised over €5M in funding, bringing us to that exciting stage of first clinical treatments. We are seeking expressions of interest from investors for the next phase of our journey.

Unmet Need

Existing medications have a very high failure rate and affect every organ in the body. Current ablation technologies only seek to block the signals responsible for this condition; this results in recurrence rates that are far too high.

First In Human (FIH) Trials

AtriAN is excited to announce that we have enrolled and treated 36 patients in two First-In-Human (FIH) trials.

Clinical Trials

In addition to our work with Pulsed Field Ablation (PFA), we are progressing our R&D with innovative, unique and minimally-invasive catheters to reach and deliver the energy to the epicardial surface of the heart.

Pulsed Field Ablation (PFA)

This energy is revolutionising the field of electrophysiology due to its safety profile. While most companies replace thermal energy with PFA, on the inside of the heart (endocardial) AtriAN takes it directly to the condition’s origin on the outside (epicardially).

Autonomics Remodeling

Neuromodulation has been one of the most exciting and disruptive approaches to medicine in recent years. Our approach is to restore the autonomic tone of the heart by targeting and disabling the ganglionated plexi (GP) structures.

Sub-Xiphoid Approach

We are using a unique, small incision in the sub-xiphoid region using our small IP-protected catheters.

GENTLE, NON-THERMAL ENERGY

Pulsed Field Cardioneuroablation

AtriAN selectively targets the hyperactive ganglionated plexi (GPs) located on the outside (epicardial) surface of the heart, rebalancing the autonomic tone bringing the heart back to its natural rhythm.

Selectively targets and disables the GPs

Gently spares the myocardium (heart muscle).

Gentle

AtriAN uses Pulsed Field Ablation (PFA) to ablate neuronal cells selectively.
As a result, the other tissues, such as healthy heart muscle, are spared.

Non-Thermal

Most ablation techniques use either heat (burning) or cold (freezing) to ablate tissue with an intent to create scar tissue which damage surrounding healthy tissues. Our PFA is non-thermal.

Long-Term

Our unique approach of targeting neuronal cells in clusters known as ganglionated plexi (GPs) should prove, from a “first principles” approach to provide a more durable solution.

Catheters

Unique, IP-Protected Catheters

Our unique and patent-protected catheter designs ensure excellent field coverage using saline-infusion while also ensuring navigation to the local sites.

Publications

Epicardial Pulsed Field Ablation for the Treatment of Paroxysmal Atrial Fibrillation During Cardiac Surgery

Clinical
DR Musikantow, VY Reddy, T Shaburishvili et al
J Am Coll Cardiol EP 2024.

This Research Letter presents AtriAN’s second clinical study in which 12 cardiac surgery patients, with concomitant paroxysmal AF, underwent the epicardial GP ablation treatment. No post- operative AF occurred. Patients were monitored by 24-hour Holter at 1, 3, 6 and 12 months post- procedurally. One patient recorded a short asymptomatic event at 3 months but otherwise no AF was detected in any of the patients. Two heart rate variability parameters (rMSSD and HF power) showed durable decreases, thereby providing a further indication of denervation.

Redefining cardiac care: the promising horizon of epicardial pulse field ablation for postoperative atrial fibrillation

Clinical
Juan Carlos Zerpa Acosta & Gurukripa N. Kowlgi
J Interv Card Electrophysiol 2024.

This is an independent Commentary discussing AtriAN’s previously published FIH study. It specifically focuses on the potential for the AtriAN treatment to be also used in open-chest cardiac surgery as a means to prophylactically treat post-operative AF (POAF). POAF is costing healthcare systems over $1 billion annually and current prevention approaches are largely unsuccessful.

Targeted ablation of epicardial ganglionated plexi during cardiac surgery with pulsed field electroporation (NEURAL AF)

Clinical
DR Musikantow, VY Reddy, I Skalsky et al
J Interv Card Electrophysiol 2023.

AtriAN’s first-in-human safety and feasibility study is presented in this article. Ganglionated plexi (GP) were ablated in 24 patients undergoing concomitant open-chest coronary artery bypass grafting (CABG). There was no study-related complications and all GP sites were successfully treated. A 20% acute extension in atrial effective refractory period was recorded.

Cardioneuroablation Using Epicardial Pulsed Field Ablation for the Treatment of Atrial Fibrillation

Review
B O’Brien, J Reilly, K Coffey et al
J. Cardiovasc. Dev. Dis. 2023.

The background and development of cardioneuroablation techniques are presented in the context of AtriAN’s therapy. An overview of key work is presented, covering in vitro studies, electric field models, pre-clinical research and clinical trials. Future work and applications are discussed.

Epicardial Pulsed Field Ablation of Ganglionated Plexi: Computational and Pre-Clinical Evaluation of a Bipolar Sub-Xiphoid Catheter for the Treatment of Atrial Fibrillation

Pre-Clinical
B O’Brien, J Reilly, K Coffey et al
Bioengineering 2024.

This paper presents electric field models and ablation studies for the prototype bipolar and subxiphoid device – both porcine and canine models were used. Acute extensions in atrial effective refractory period suggest that ablations efficacy is at least equivalent to the monopolar device that has already been used in open-chest clinical settings. Ablation of neuronal cells, within the epicardial ganglionated plexi, was confirmed through histology.

Open-chest Pulsed Electric Field Ablation of Cardiac Ganglionated Plexi in Acute Canine Models

Pre-Clinical
M van Zyl, M Khabsa, JA Tri et al
J Innov Cardiac Rhythm Manage 2022.

This open-chest study was performed as full system validation before progressing to first-in-human open-chest clinical trials. It’s utilized AtriAN’s cardiac-customized pulsed field generator and devices designed specifically for open-chest epicardial treatment. Acute extensions in atrial effective refractory period (AERP) were demonstrated as well as evidence of reversible electroporation in myocardial tissue.

Safety and Feasibility of Epicardial Percutaneous Access and Maneuverability With a Novel Ablation Catheter for the Treatment of Atrial Fibrillation in a Porcine Model

Pre-Clinical
P Buszman, K Lukasik, S Deane et al
J Am Coll Cardiol 2021 (Supplement).

This was a first feasibility of epicardial access using the initial prototype of a next generation catheter system designed for sub-xiphoid access and with bipolar ablation capability. Access to the pericardial space was demonstrated with conventional needle technology and the catheter demonstrated promising tracking and navigation performance.

Electroporation of epicardial autonomic ganglia: Safety and efficacy in medium‐term canine models

Pre-Clinical
D Padmanabhan, N Naksuk, AK Killu et al
J Cardiovasc Electrophysiol 2019.

This study was performed using sub-xiphoid access with acute measurements showing that ganglionated plexi ablation produced an extension in the atrial effective refractory period (AERP). Extensive histology evaluations at four month follow-up demonstrated ablation of ganglia structures with sparing of the myocardium. The animals were resistant to AF induction at four months.

Novel Percutaneous Epicardial Autonomic Modulation in the Canine for Atrial Fibrillation: Results of an Efficacy and Safety Study

Pre-Clinical
M Madhavan, KL Venkatachalam, MJ Swale et al
Pacing Clin Electrophysiol 2016.

This was the first screening study at Mayo Clinic to assess the best energy source for ablation of ganglionated plexi, while minimizing myocardial damage. Following selection of pulsed field ablation (PFA) from the screening work, procedural feasibility was also demonstrated in both open-chest and sub-xiphoid models, using early prototype devices.

Difference between endocardial and epicardial application of pulsed fields for targeting Epicardial Ganglia: An in-silico modelling study

Electric Field Models
Francisco Estevez-Laborí , Barry O’Brien, Ana Gonzalez-Suarez
Computers in Biology and Medicine 2024.

This paper presents electric field models that help explain observations around epicardial PFA being more successful than endocardial approaches at ablating ganglionated plexi. Additionally, the epicardially technique largely spares the myocardium by retaining the electric field within the epicardial fat. It also shows how epicardial parameters could be tuned to additionally include thermal effects in the fat and ganglia.

Full torso and limited-domain computer models for epicardial pulsed electric field ablation

Electric Field Models
A González-Suárez, RM Irastorza, S Deane et al.
Computer Methods and Programs in Biomedicine 2022.

This is a fundamental electric field model study aiming to demonstrate the applicability of a model geometry around the treatment zone in an epicardial configuration. This monopolar model showed how the peak electric field strengths are located very close to the catheter electrodes and drop off very rapidly beyond this. The field strength levels in adjacent organs were exceptionally low, verifying the absence of collateral tissue damaged observed in pre-clinical studies.

Pulsed Electric Field Ablation of Epicardial Autonomic Ganglia: Computer Analysis of Monopolar Electric Field across the Tissues Involved

Electric Field Models
A González-Suárez, B O’Brien, M O’Halloran et al
Bioengineering 2022

This electric field modelling study assessed the field strength distribution in the epicardial fat pads (where the ganglionated plexi are located) and the underlying myocardium, when monopolar pulses are applied. The field strength tends to concentrate within the fat layer, with a substantial drop off into the myocardium. This effect further explains the observed selectivity of ganglia ablation when the treatment is performed epicardially.

In Silico Modelling to Assess the Electrical and Thermal Disturbance Provoked by a Metal Intracoronary Stent during Epicardial Pulsed Electric Field Ablation

Electric Field Models
A González-Suárez, J Perez, B O’Brien et al
J. Cardiovasc. Dev. Dis. 2022

The effect of a metallic coronary stent within the applied electric field was modelled in this study. Electrical field distortions and thermal effects were assessed. The presence of a stent causes minor electric field disruption, leading to increased field concentrations at the stent and a resulting localized temperature increase. This increase was insignificant and not at a level that would cause tissue damage or necrosis.

Establishing electroporation thresholds for targeted cell specific cardiac ablation in a 2D culture model

In-Vitro Studies
S Avazzadeh, MH Dehkordi, P Owens et al
J Cardiovasc Electrophysiol 2022.

This study of in-vitro electroporation assessed cultured layers of cardiomyocytes and neurons and showed that neurons have a slightly lower threshold compared to cardiomyocytes. In addition neurons showed continued cell death up to 24 hours after treatment, while cardiomyocytes trended towards low levels of recovery. This insight provides further understanding of how ganglionated plexi may be ablated and myocytes spared in an in vivo scenario.

Establishing Irreversible Electroporation Electric Field Potential Threshold in A Suspension In Vitro Model for Cardiac and Neuronal Cells

In-Vitro Studies
S Avazzadeh, B O’Brien, K Coffey et al
Journal of Clinical Medicine 2021

This in-vitro cellular study explored the electroporation thresholds of neurons and cardiomyocytes in suspension. This is the first published data showing that the thresholds for both cell types are similar; the data for neuron cell bodies being much lower than published data on axons. This provides initial data towards understanding the mechanism of selective ablation of ganglionated plexi.

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Address

Unit 1,
BIC Centre
Upper Newcastle
Galway Ireland
H91E79C

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Unit 1 (Physical), H91E79C
Unit 204 (Billing), H91W60E

Atrian

Unit 1, BIC Centre
Upper Newcastle
Galway, Ireland
H91E79C

This project has received funding from the European Union’s Horizon 2020 Research and Innovation Programme under Grant No. 879499.