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Digital Variance Angiography, a ground-breaking X-ray angiography innovation: dose management and quality enhancement by Kinepict Medical Imaging Tool

Periodic Reporting for period 2 - KMIT-ACC (Digital Variance Angiography, a ground-breaking X-ray angiography innovation: dose management and quality enhancement by Kinepict Medical Imaging Tool)

Reporting period: 2022-03-01 to 2023-08-31

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. 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. In the EU alone, there are about 1.2 M 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 CVDs. 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).

The overall objective of the KMIT-ACC project (grant agreement No 968430) was 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 8 level by the end of the grant period and d) baseline commercial activities. Software and hardware optimisation was performed in the first phase of the project and the new imaging tool was tested during clinical validation. Clinical aims were fully achieved as the clinical data provide evidence for the 1) improved image quality in novel indication areas including prostatic artery embolization and transarterial chemoembolization of liver tumours, 2) radiation dose reduction capability in lower limb angiography and prostatic artery embolization, 3) contrast agent dose reduction capability in carotid angiography. The clinical result related to this project have been published in peer-reviewed, open-access scientific journals. Based on the feedback of the clinical studies the KMIT software was upgraded and reached TRL 8.

The project also supported the organization of the reference laboratory. The commercial backbone of KMIT marketability has been also established. Kinepict knows the market where it wants to reach success. The KMIT has the regulatory approval to enter the market.
The results of the project were communicated and disseminated throughout the execution phase. At the end of the project, we have a unique imaging tool in our hands that is ready to be marketed and can revolutionize x-ray angiography. Kinepict Medical Imaging Tool will provide great benefits for patients and for medical professionals across the European Union and around the world.
In WP1 the focus was on innovation management. During the IP monitoring and protection activities we ensured that the KMIT has unrestricted marketability and freedom to operate. Throughout the execution of the project proper coordination, reporting and financial management was done and the risks were monitored continuously and handled in time. Communication activities were also in place. 5 peer-reviewed scientific publications were published and many more on our channels. Our regulatory activities ensured that the KMIT can be placed on the market legally in the EU.

In WP2 the tangible outcome was a matured prototype ready for clinical demonstration with documentation. After the first year we reached the point where we had a matured prototype with the required documentation ready for clinical demonstration.

The goal in WP3 was the clinical validation and qualification of the KMIT. The overall aim was to elevate our prototype to TRL8. The clinical studies were closed successfully and KMIT tune-up was performed: 1) The potential benefit was verified in prostatic artery embolization and liver transarterial chemoembolizaion, 2) The radiation reduction capability was verified in a prospective randomized controlled trial. 3) The iodinated contrast media reduction capability was investigated in a prospective randomized controlled trial, 4) Adjustment of the KMIT platform based on clinical feedback were made.

In WP4 we developed the baseline commercial backbone that can enable KMIT to has an impactful market entry. During the project’s execution phase the reference site network was established. The project team analysed the relevant angiography market and final business model was created. The results of these activities provide evidence that KMIT is ready for market entry with a reliable business plan.

We can conclude that we have a unique solution, called Kinepict Medical Imaging Tool, in our hand that has the potential to revolutionize x-ray angiography. With the support of the grant the software tool reached TRL 8. Kinepict Health Ltd. has all the rights to sell and market this solution for the benefit of patients and medical professionals alike.
In the end of the project, Kinepict has a market-ready, safer, and cost-effective platform to be sold for the cath labs. The product is compatible with the most common angio devices providing better diagnosis and lower risk intervention with less radiation and contrast media use backed up with clinical data to support these claims. This has a strong and measurable impact on patients’ lives and radiologists’ exposure to radiation.

Through KMIT, we 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 is contributing to achieve 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 of 7.4% market penetration, 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 allowed us to create a measurable impact on our company. The project helped Kinepict to start growing and to potentially reach an accumulated revenue and net profit of €36m and €30m by 2028 after sufficient investment of venture capital in 2024 and creating at least 40 full-time FTEs. Moreover, our project will contribute to advancing the EU healthcare industry and improving the diagnosis and treatment of CVDs and cancer with 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.