Periodic Reporting for period 1 - KMIT-ACC (Digital Variance Angiography, a ground-breaking X-ray angiography innovation: dose management and quality enhancement by Kinepict Medical Imaging Tool) Reporting period: 2021-03-01 to 2022-02-28 Summary of the context and overall objectives of the project Cardiovascular diseases (CVDs) and cancer are the first two causes of death globally, taking 27.4 m lives a year, representing 49% of all deaths worldwide. CVDs are a group of disorders of the heart and blood vessels and include coronary heart disease, cerebrovascular disease, rheumatic heart disease, and other conditions. The primary cause of the cardiovascular disease is atherosclerosis– the narrowing and eventual blockage of arteries by the deposition of fatty plaques in the walls of arteries. Eventually, these plaques can generate thrombosis which occludes blood flow causing stroke and heart attacks as the leading causes of death in developing countries. Stroke affects 17m people worldwide each year. In the EU alone, there are about 1.2m strokes annually. Thus, the diagnosis and treatment of cardiovascular and oncological disorders are of great importance and a key objective of the health care systems worldwide.A 40-year-old imaging technique called Digital Subtraction Angiography is widely used in the diagnosis and treatment of arterial and venous occlusions, in embolization procedures, and in diseases mentioned above. This medical imaging method is used for the visualization of blood vessels in patients with the use of contrast agents and X-rays. DSA technology has limitations and drawbacks, e.g.: image quality is often insufficient, high radiation exposure affects patients and medical staff, and the applied iodinated contrast media can lead to major kidney damage.To solve these limitations in the angiography field, Kinepict Health Ltd. has developed the ground-breaking Kinepict Medical Imaging Tool (KMIT) platform with the imaging technology called Digital Variance Angiography (DVA). KMIT is a major advancement in the angiography field as it drastically enhances the quality of the images, allowingthe reduction of radiation exposure and the reduction of ICM dose. In a nutshell, DVA eliminates the disadvantages of DSA technology and provides better and safer imaging during angiography procedures.The overall objective of the KMIT-ACC project (grant agreement No 968430) is to revolutionize X-ray angiography by introducing a dose management and image processing tool with the following objectives: a) clinical validation of our technology for new indications, b) organization of a reference laboratory network, c) software and hardware optimization to reach TRL 9 level and d) baseline commercial activities Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far In WP1 (Innovation management) the most significant result of the project so far is the agreement between Semmelweis University and Kinepict Health Ltd. regarding the use of the patented DVA technology. The agreement states that Kinepict Health Ltd. has all the right to use and exploit the patent freely and exclusively. In line with the timeline established in the project, Tasks 1.1 1.2. 1.3. 1.4. are ongoing.During the first 12 months of the project, the main focus was on the 7 tasks outlined in WP2 (software and hardware optimisation) where the tangible outcome is a matured prototype ready for clinical demonstration with documentation. Kinepict’s team solved these tasks step by step from Task 2.1 to 2.7. The results in WP2 are the following: 1) optimal computer hardware configuration design was established; 2) monitor compatibility study was performed to have the ability to display DVA images in the operating room; 3) optimised algorithms were implemented in the software; 4) the image generation time was decreased to a level where it can be called quasi-real-time; 5) system integration study was performed; 6) security and data protection measures were established; 7) evaluation and monitoring protocol was set up to compare DVA to DSA imaging. The results of these tasks led us to the point in M12 where we have a matured prototype with the required documentation ready for clinical demonstration (D2.1).In WP3 the setup and design of clinical studies is an ongoing task. The medical experts involved in the project are designing the clinical trials and obtaining the ethical permissions and operational documents (e.g. informed consent forms).Besides these mentioned above, in WP4 Task 4.1 was started and a case study is completed where the Kinepict Medical Imaging Tool was integrated successfully to a GE Innova IGS 540 machine. We are continuously working to establish new reference sites and in the near future, 2 additional sites will be opened. In addition to new partnerships established as reference sites, we worked out our Partner Development Strategy (Task 4.2) established a sales team to ensure the successful execution of the KMIT commercialisation through licensing and direct sales. Our goals and approach are summarized in the Interim Business Plan (D4.1). In line with the timeline established in the project, Tasks 4.1 4.3. 4.4. 4.5. and 4.6 are ongoing.Regarding the dissemination and communication activities, we tried our best to communicate the results of the project and the potential impact of this technology. We have published two peer-reviewed papers in high impact journals: a retrospective proof-of-concept study on the radiation reduction capability of DVA in lower limb examinations (Gyano et al, 2021, Sci Rep, 11:21790), and a joint publication with a German clinical site (University Hospital Marburg) on the validation of DVA technology in lower limb interventions (Thomas et al, 2022, J Vasc Intervent Radiol, 33:104-112). Several news outlets covered the story of Kinepict in the past year including ones with a great reputation and country-wide coverage (e.g.: Forbes Hungary, National Geographic, MTVA M1, RTL Klub, Magyar Hírlap). The list of these activities is available on our website under the Publications section. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) By the end of the project, we will have a market-ready, safer, and cost-effective platform in the cath labs compatible with most manufacturers angio devices providing faster diagnosis and shorter intervention with less radiation and contrast media use backed up with clinical data to support these claims. This will have a measurable impact on patients’ lives and radiologists’ exposure to radiation.Through KMIT, we will tackle the diagnoses and treatment of CVDs and oncological disorders, and thus our solution will reduce the economic and social burden of these diseases while supporting the sustainability and resilience of healthcare systems with the increasing demand from an aging population, which are key objectives in the Digital Single Market Strategy for Europe. Overall, KMIT will contribute towards achieving the EU Health Policy, as well as WHO’s Global Strategy and Action Plan on Ageing and Health and SDG 3. In our 5-years forecast, the KMIT launch will have the potential to save €329,000/ year for the healthcare system and €220,000/ year in operational costs (per cath lab) in the EU, related to the diseases associated with X-ray radiation and ICM resulting €174m yearly savings in the EU by 2028.Overall, successful implementation of this project will allow us to create a measurable impact on our company, quantified as accumulated revenue of €77m in 5 years post-project (2024-2028), equal to an accumulated net profit of €33m, and creating at least 29 full-time employments (FTEs) in Kinepict. Moreover, our project will contribute to advancing the EU healthcare industry and improving the diagnosis and treatment of CVDs and cancer with a safer and more effective technology across Europe. Secondary window of the Kinepict Medical Imaging Tool on the operating room display. Main window of the Kinepict Medical Imaging Tool with DVA and color-coded DVA images.
