Periodic Reporting for period 1 - DMUT (Easy to use, contactless Dual-Mode Ultrasound Technology for high accuracy treatment of Atrial Fibrillation, improving outcomes)
Período documentado: 2022-09-01 hasta 2023-08-31
Atrial fibrillation (AFib) is a common cardiac arrhythmia characterized by irregular and often rapid heartbeats originating in the atria, the upper chambers of the heart. This irregular electrical activity disrupts the normal rhythm, leading to inefficient blood pumping and potential blood clot formation. One of the key risks associated with AFib is an increased likelihood of blood clots, which can lead to stroke if they travel to the brain. The erratic heartbeat can also result in decreased blood flow, potentially causing fatigue, dizziness, and shortness of breath. Long-standing AFib can lead to heart failure, as the heart's pumping efficiency becomes compromised over time. Additionally, the condition may exacerbate other cardiovascular problems, such as hypertension and coronary artery disease. Golden standard procedure for Afib is called catheter ablation in which targeted areas of abnormal electrical activity are identified and eliminated with technologies that depend on consistent contact with the heart tissue, provide no real-time imaging and depends on physicians’ skills. Funded by the European Innovation Council, the DMUT (Dual-Mode Ultrasound Technology) project aims to develop a contactless approach for tissue ablation. The proposed technology delivers ultrasonic energy through a miniature-transcatheter ultrasound-based approach. Importantly, it combines signal and image processing for real-time tissue monitoring. The activities of the DMUT project cover the transition from preclinical to clinical studies as well as efficacy and safety validation.
Our mission is to radically change the landscape of cardiac ablation. Our products, based on proprietary ultrasound technology, allow contactless tissue ablation with real-time lesion monitoring, bringing Healium to the forefront of the cardiac ablation market. The project is now focused on completion of the development journey: the transition from preclinical to clinical studies. Leveraging an EC investment of €12.75M we can demonstrate the efficacy and safety of our product, establish a manufacturing line and regulatory framework, and access the market as a self-sustained company.
Our mission is to radically change the landscape of cardiac ablation. Our products, based on proprietary ultrasound technology, allow contactless tissue ablation with real-time lesion monitoring, bringing Healium to the forefront of the cardiac ablation market. The project is now focused on completion of the development journey: the transition from preclinical to clinical studies. Leveraging an EC investment of €12.75M we can demonstrate the efficacy and safety of our product, establish a manufacturing line and regulatory framework, and access the market as a self-sustained company.
The activities in the DMUT project this year were focused on further developing the hardware infrastructure to include embedded software and software integration. In addition, the entire software architecture was developed to support end-devices communications, ablation power management and control and software application design and implementation. Furthermore, the robotic-like function of the system was conceptualized, designed, prototyped, and tested in conjunction with the Dual-Mode ultrasound ablation catheter. The company have reached hardware design freeze stage, working software supporting pre-clinical studies and functional ultrasound catheter allowing femoral-access approach to the left atrium in animal studies.
The company has collected acoustic information of over 100 lesion points in animal studies using its latest hardware & software version and presented the results in the annual European Heart Rhythm Association meeting. Lesions have been created without making contact with the tissue from various distances and showed directional controlled results. Furthermore, it has been demonstrated in in vivo studies that imaging can be created to locate the exact connection point between the vein and the atrium while evaluating tissue thickness using image processing techniques. In addition, the company has reached the stage of functional catheter system with motorized ultrasound transducer operation control by an external motor unit. We have demonstrated that a circumferential ablation using the motorized ultrasound transducer can form a continuous lesion around the pulmonary vein in an animal model. Key existing needs to successfully complete the development and start clinical studies is continuous improvement in procedure development, pre-clinical data collection and chronic evidence and financing.