E!8355 NeoWave Vascular

Purpose and goal

The project´s aim is to develop and validate a novel, non-invasive acoustic wave-based treatment for patients with peripheral arterial disease (PAD) and critical limb ischemia (CLI). The goal is to develop a complete medical device department with therapy head, electronics and portable holder, establish preclinical models, conduct a clinical feasibility study, and develop a regulatory and commercial strategy for market introduction.

Expected effects and result

The project is expected to provide a fully developed medical device with verified safety and usability, based on preclinical and clinical studies. The results provide a new treatment method for PAD/CLI, a clear regulatory path and protected IP. In the longer term, the project contributes to improved patient quality of life, reduced risk of amputations and strengthened European competitiveness in medical technology.

Planned approach and implementation

The project will run for 33 months and includes five work packages: project management and communication (CSW, SPI), technical development of department and prototypes (CSW, PA, USONO), preclinical studies (RISE), clinical feasibility study with ≥30 patients (2CA-Braga) and regulatory strategy and commercialization (CSW, SPI). The schedule follows a step-by-step process from requirements specification to clinical validation and market strategy.