Periodic Reporting for period 1 - HAPGuide (Smart and sensing robotic system for endovascular interventions with haptic feedback) Periodo di rendicontazione: 2019-07-01 al 2019-12-31 Sintesi del contesto e degli obiettivi generali del progetto Endovascular management of cardiovascular disease is the gold standard with more than 5.6 million procedures performed annually and 5% annual growth. Despite all the progress over the last decades in endovascular field, the physician is still standing in front of X-ray beam source, protecting himself with heavy lead apron. This leads to a lot of occupational hazards (including brain tumors and orthopedic injuries), suboptimal interpretation of live images, imprecise stent deployment, additional amount of radiation and contrast media used. In addition to that, there is no possibility to perform remote urgent procedures for patients in remote locations. Existing three endovascular robotic solutions have lots of technical issues, only part of the procedure could be performed robotically with a limited number of endovascular tools. This leads to very limited spread of endovascular robotic systems. UAB Inovatyvi Medicina has created a new endovascular robotic system HAPguide, which solves the main issues of existing robotic systems and opens up possibilities for safer, faster, more effective, fully robotic endovascular interventions. This disruptive technology still needs to overcome legal requirements of certification, prove its safety, efficacy and benefit over manual endovascular procedures in clinical setting to become widespread over the world. Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti A feasibility study has been carried out during the last 6 months as an output of the Phase 1 of the SME Instrument:1. Assessment of the technological feasibility by i) distinguish key technological features of HAPGuide that form competitive advantage over competing solutions, ii) assessing the regulatory requirements towards market introduction, iii) determining the technical compliance requirements of HAPGuide to enable seamless interfacing with Hospital /Cathlab equipment and iv) undertaking small pilot demos of HAPGuide to end users and get their feedback;2. Assessment of the pre-clinical and clinical feasibility by ii) performing a small-scale animal study (40 data sets) to document the added value of HAPguide, ii) define the installation sites for clinical study and create KOL network supporting the technology, iii) defining clinical development strategy;3. Development of a viable business plan for market entry – including market entry strategy and research, funding strategy, etc.All tasks where successfully completed with the details listed in full report.Preclinical trial showed 100% technical success rate and there were no safety issues. Positive feedback from participating physicians were expressed. Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora) UAB Inovatyvi Medicina will finish development of HAPguide and will prepare it for certification and clinical trials with humans. Successful clinical trials will allow to sell the system and single use cassettes in EU market. Further staged development, outside of this project is planned:1. Technological development - telemedicine procedures (this will allow urgent treatment in remote locations, where time=loss of one’s health, for instance, stroke); Artificial Intelligence enhanced procedures. 2. Clinical indications expansion (cardiology, neurointerventions, oncology). 3. Geographical expansion to other markets.According to the feasibility study carried out during this action, we can conclude without any hesitation that the project shall continue – i.e. we should proceed with the already ongoing work for bringing the HAPGuide into a broad market. HAPguide in Cath-lab
