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MedLumics® Announces the Publication of FIM Results for the AblaView® (PF) Ablation System in (AF) Patients, Including Clinical Safety and Our Ability to Predict Durable Lesions at 3 Months With 100% Specificity

“We would like to thank the investigation site team and particularly the investigators and proctors in this groundbreaking first-in human trial and for enabling the publication of these important validating results.” Peter Hinchliffe, CEO MedLumics “Join us as we raise our Series B funding of €15m to reach our regulatory clinical trial readiness milestone. We are ready to move forward with these results toward treating the 100 million Atrial Fibrillation patients globally.”

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250305509072/en/

(Photo: Business Wire)

(Photo: Business Wire)

MedLumics® AblaView® shows the importance and capability of being able to visualize, in real time, AF Ablation treatments.

1) Initial heart wall contact confirmation: ability to differentiate between ablated and un-ablated tissue, eliminating gaps in treatment lines and avoiding non-contact and excessive ablations.

2) Stable electrode wall contact during ablation: essential to safe consistent ablations, potentially reducing the risk of hemolysis and neurovascular complications.

3) Tissue ablation analysis, as it happens: ensuring that at a tissue structure level, irreversible lesions have been delivered, confirmed by direct visual tissue birefringence (BiR) change.

MedLumics® AblaView® AF Ablation results at 3-months:

1) Safety and reliability: The use of AblaView® fiber optic, real time, Optical Coherence Reflectometry (OCR) and assessing BiR of treated verses untreated tissue is safe and reliable.

2) No hemolysis or neurovascular complications reported: Using OCR and the AblaView® PFA system, real time visualization avoided complications associated with poor contact quality and/or excessive ablations.

3) Durable lesion prediction with 100% specificity: AblaView® the patented OCR and fiber optic catheter system measures the change in BiR to predict lesion durability in real time.

Atul Verma, MD. Electrophysiology Unit, Cardiology Department, McGill University, Montreal, Quebec, Canada. "This first in human study demonstrates the ability of optics to determine durable lesions created by PFA. These optical sensors can be adopted to any catheter platform and we will be moving forward with a full approval trial as the next step."

After being presented by Atul Verma, MD. at the AF Symposium in January, the study results have been published in Europace February 2025. (https://academic.oup.com/europace/article/27/2/euaf009/7959060)

Professor Raphael Martins, Cardiology Dept, CHU Rennes, France. “It has been a privilege to take part in this first-in-human study. The ability to assess lesion durability in real-time using optical imaging may transform our approach to AF ablation. This represents a significant advancement toward more precise, safer, and more effective treatments for our patients.”

Professor Sabine Ernst, MD, PhD, FESC, Consultant Cardiologist at the Royal Brompton and Harefield NHS Foundation Trust in London and Professor of Practice (Cardiology) at Imperial College London, London, UK, commented on LinkedIn “Assessing the ablation lesion in real time: finally the “holy grail” in EP is discovered! …. A new era has begun!”

About MedLumics

Founded in 2014, MedLumics S.L. is an ISO13485 certified medical device company specializing in optically guided medical devices. Its proprietary integrated optics platform technology combines optical and electrical components, enabling multi-view optically guided treatment with high-quality real-time images during cardiac ablation. MedLumics is backed by many prestigious public and private funds including an undisclosed corporate partner. For more information visit www.medlumics.com.

The AblaView® system is investigational and not currently available for commercial use.

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