First Irish patient implanted with innovative heart failure management system from Irish Company FIRE1

DUBLIN–(BUSINESS WIRE)–Dublin-based FIRE1 today announced that the first Irish patient has been successfully implanted with its FIRE1™ System for remote heart failure monitoring. The innovative system has the potential to positively impact thousands of people living with heart failure in Ireland every year and alleviate the burden on hospital emergency rooms. The successful implantation took place at University Hospital Galway in the First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF). The study will assess FIRE1’s novel solution to improve outcomes for those living with heart failure.

“We are delighted to bring this new, transformative technology to Ireland for the first time”

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Irish medtech company FIRE1, whose CEO Conor Hanley was recently announced as a 2024 EY Entrepreneur of the Year finalist, seeks to transform heart failure management by enabling patients to monitor and control their fluid volume themselves with a device at home, similar to how continuous glucose monitoring transformed diabetes care. Fluid overload is a classic clinical feature of heart failure, which affects approximately 90,000 Irish people and is a leading cause of hospitalisations, including high admission and re-admissions rates in Ireland.

FIRE1 CEO and President Conor Hanley said, “I am especially pleased to announce our first patient in Ireland. This represents a true clinical research success for Ireland, being one of the first systems of its nature to be developed, manufactured and now to be in a clinical trial in Ireland. It showcases Ireland’s capability for groundbreaking medical innovation with the potential to change healthcare delivery globally. The FIRE1 team is steadfast in our mission to help millions of people around the world living with heart failure to get their normal lives back, but it is very special to be able to give access to people here at home. It is gratifying to see the physician interest in our novel technology. I would like to extend my thanks on behalf of the whole FIRE1 team to the fantastic staff at UHG, and most importantly to the patients who continue to put their trust in us and participate in this important research.”

The FIRE1 sensor is implanted into the body’s largest vein, located in the abdomen, known as the inferior vena cava (IVC) and works by continuously measuring the size of the IVC, giving a marker of the amount of fluid in the body. High levels can increase the risk of breathing difficulties and a build-up of fluid in the lungs which lead to an emergency hospital admission. The patient wears a belt reader around the abdomen for around a minute a day to take a reading from the sensor and the data is sent to the patient’s clinical team at the hospital. The system is designed to alert whenever the patient’s condition deteriorates.

Professor of Interventional Cardiology and Translational Medicine at University Hospital Galway (UHG), Prof Faisal Sharif performed the implant. “We are delighted to bring this new, transformative technology to Ireland for the first time,” said Prof Sharif. “The procedure was very straightforward, minimally invasive and the patient was confident using the FIRE1 system and taking the readings. The data we will get from this patient will give a new window into heart failure management and has the potential to dramatically improve our understanding of this patient’s condition, and to enable proactive changes in medications that will keep them healthy and at home. We hope to implant further patients at UHG while recruitment is still active.”

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Notes to Editors

About FIRE1

Headquartered in Dublin, Ireland, FIRE1 is a connected medical device solutions company dedicated to improving outcomes for people suffering with chronic diseases. Its investors include Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, New Enterprise Associates, Novo Holdings and Seventure. Its mission is to empower millions of people suffering from heart failure to get their normal lives back. The FIRE1 team is led by an experienced medical devices team that is working closely with world-leading researchers, clinicians, patients and payors to help reduce the burden of heart failure. Further information: www.fire1foundry.com.

The FIRE1 system is currently undergoing global clinical trials to test the safety and effectiveness of the technology. More information about the Future-HF Study (NCT04203576) may be found on clinicaltrials.gov.

About University Hospital Galway

Prof Faisal Sharif is a Professor of Interventional Cardiology and Translational Medicine at University Hospital Galway/ University of Galway. He is Principal investigator for Cardiovascular trials and Academic research at the Health Research Board Clinical Research Facility (HRBCRFG) at the University of Galway, supported by a highly skilled and experienced research team lead by Clinical Nurse Specialists Eileen Coen and Nicola Glynn. The Research CT scanner infrastructure which this trial in Galway was enabled through a Science Foundation Ireland (SFI) grant (SFI17/RI/5353) and an investment partnership between SFI, University of Galway and Saolta University Health Care Group.

University College Hospital Galway is a Model 4 hospital providing 24/7 acute surgery, acute medicine and critical care and is recognised for Higher Medical training in all specialties. Galway University Hospitals, comprising of University Hospital Galway (UHG) and Merlin Park University Hospital, play a leadership role in acute service delivery providing regional services for a wide range of specialties and is a designated supra regional centre for cardiac and cancer services serving a catchment area in the region of 1 million people along the West of Ireland.