Launching clinical evaluation of AILIS
AILIS, Krakow-based medical startup, is progressing towards clinical evaluation and certification for a novel method of breast cancer early detection. This innovation seeks to transform the landscape of breast cancer diagnosis by utilizing AI to provide a swift, painless, and individualized approach. The initiative has garnered significant interest, with individuals enrolling for participation in the upcoming research trial, set to be conducted at Galeria Kazimierz in Krakow.
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Seven years of research and development
The journey to develop AILIS technology spanned over seven years, during which a dedicated team of more than 100 experts, including scientists, doctors, biomedical engineers, and programmers from esteemed academic institutions and research centers, collaborated. This technology integrates artificial intelligence and deep neural networks with a distinctive technique for analyzing breast tissue to assess its health.
Before the AILIS method can be introduced to the healthcare market, it must undergo a thorough clinical evaluation process in line with both Polish and European regulations. The primary objective of this evaluation is to validate the efficacy of the developed technology. Prior preclinical trials conducted on a prototype device showcased the immense potential of the method in early breast cancer detection.
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The AILIS team based in Krakow is currently focusing on conducting preliminary ‘learning’ phase of artificial intelligence before the start of the clinical trials.
AILIS’ technology is based on both machine learning algorithms and deep neural networks, which are widely used in modern artificial intelligence systems. Professor Mariusz Witek, an expert in artificial intelligence, explains that AILIS algorithms possess the capability to learn and identify anomalies, and then apply this to every new examination.
The second key aspect involves continuous enhancement. With an increasing number of examinations, the algorithms become proficient in identifying cancer-related features, thereby improving diagnostic efficiency. In essence, they accumulate experience with each novel study.
Two phases of research and evaluation
The clinical evaluation will be split into two stages: firstly, a medical experiment to gather high-quality data for training AI algorithms, and a clinical phase to assess the method’s effectiveness in health monitoring – specifically, its sensitivity and specificity.
The startup has obtained Polish Bioethics Committee approval for the initial algorithm learning phase, conducted in collaboration with the University Clinical Centre in Gdańsk. Trials are scheduled to start in the second half of August at the AILIS research centre situated in Galeria Kazimierz, Krakow.
– At this stage, we need to undertake AILIS examination on a group of 1,000 women. Those interested can express their willingness to join through ailiscare.com/badania Those interested can express their willingness to join through www.ailiscare.com/badania. Every participant in this study will contribute not only to the advancement of science but also to the refinement of this novel research approach. Following this stage, the system will undergo clinical trials conducted at our AILIS research center in Galeria Kazimierz, as well as in Warsaw and Gdańsk – announces Michał Matuszewski, co-creator of AILIS.
The scientific significance of these upcoming AILIS studies cannot be measured. In addition, participants will receive supplementary diagnostic examination.
Based on a physician’s recommendation, participants in the AILIS study will be offered cost-free ultrasound, MRI, or mammogram examinations. Additionally, those with pending biopsy referrals can also take part in the study – explains Kamil Drucis, MD.
For all participans of the AILIS study, as a part of a collaboration with the cosmetics brand Dr Irena Eris, a comprehensive guide with step-by-step process for self-examination has been prepared. This guide comes together with the Dr Irena Eris SPA Resort Vibrant Rio modeling and illuminating breast cream. This ensures that the study is not only easy but also a pleasurable experience.
Enhanced personalization
Traditional breast examinations involve ultrasound, mammography, and MRI techniques. However, AILIS introduces an entirely different examination method.
Our approach is unique because it is painless, non-invasive, radiation-free and can be repeated frequently. What is important, the procedure is rapid together with at hand result delivery. Thanks to AI and automated processes, once implemented, patients can expect to receive their results within just 15 minutes of starting the test. – explains Michal Matuszewski, CEO of AILIS.
The examination technique and procedure are highly innovative. The woman sits comfortably in a chair while a cutting-edge machine, adjusted to her height, positions her correctly for the examination. An operator carries out the procedure using the device, completing it within 4 minutes.
This cutting-edge tissue imaging method is named Parametric Dynamic Imaging (POD). – The device conducts contactless and radiation-free breast examinations, capturing 250 measurements that provide concentrated insights into the functionality of the examined tissue. This enables differentiation between areas of increased activity and the normal tissue – Dr. Mateusz Moderhak, AILIS co-creator, explains, adding: – Most breast cancers shows increased activity, visible in POD due to higher metabolism and blood flow. Mammography and MRI show the tumor’s structure, not its functionality. Our method captures the functioning of the tissue, potentially revealing abnormalities before the tumor’s structural appearance. We can therefore say that we can spot cancer earlier than other methods.
This project involves leading medical experts, including Kamil Drucis, MD, PhD, from the Department of Oncological Surgery at the Medical University of Gdansk and a co-creator of AILIS. – In cancer, the process of vascular proliferation is chaotic and fast. A key aspect is its ability to activate the body’s formation of new vessels, which supply nutrients to the tumor. This process is neoangiogenesis. If we compare cancer and healthy tissue to cities, healthy tissue is a well-planned, modern city with designated structures, organized streets of different sizes for transportation. In contrast, a tumor resemples a favela, where streets emerge randomly and chaotically, forced by the construction of new buildings – Drucis explains.
Comprehensive healthcare system with user-friendly app
The upcoming holistic system will be equipped with a digital assistant. Using the app, women can easily book their examinations, with the app automatically scheduling the right date and providing reminders for regular self-exams. This all-inclusive system manages the entire process, from patient registration and medical history collection to AILIS device examinations, personalized recommendations, and planning for future actions and follow-ups. The developers emphasize that this approach guarantees continuous support for patients – they are not left on their own
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Screening during shopping
– We are delighted that the Galeria Kazimierz is a place for groundbreaking research focused on advancing breast cancer diagnostics. This is in line with our strong commitment to supporting meaningful initiatives, which is a key element of our business social responsibility. It also confirms that we are open to the ideas and projects of our renters. – says Beata Jankowska, Director of Galeria Kazimierz in Krakow, hoping the project goes well and invites customers to join in.
AILIS creators emphasize that the search for solutions to the rising breast cancer rates is not left to scientists and doctors alone. Countries and international institutions are also actively seeking answers. – We receive inquiries and words of interest from various countries, showing a strong inclination towards implementing our system locally – says Matuszewski. He adds that discussions are ongoing with multiple nations, including Dubai, Germany, Austria, and the UK.
