KRAKOW — I’m a huge fan of sci-fi films. I envy their protagonists for two things: their journeys outside of our galaxy, and the ease with which they could monitor their health. I always wanted to see the day where every medical cure, every tedious exam, would fit into a single capsule. One pill and pow! — the technology scans my body and quickly heals me. I don’t think I am the only one who has dreamed of a day where this is true.
When I first saw the AILIS machine, I felt as though this dream had finally come true. It was as if I had stepped onto a movie set. But the AILIS is very much real, and it has the ability to save women’s lives. From the outside, the machine looks like a capsule, a safe – yet futuristic – cocoon. Its speakers play electronic music, a blue-green light flashes from underneath its dome, imitating the northern lights.
I sit on a comfortable chair and feel as though I have traveled a few decades into the future. The chair shifts my body into a horizontal position, feeling so relaxed that I almost forget what the AILIS is testing me for.
Lowering a hoop from above, the machine begins its work, without having to make any contact with my body. There is no painful compression or not-so-safe ionizing radiation. And the lights, melody, and gusts of air allow for patients to relax their muscles and their bodies.
The machine also offers nearly total privacy while the exam takes place, as it only requires one trained operator. If there were no legal restrictions, the machine could be operated remotely by any specialist from around the world, with the help of an app.
Materials from aviation
“My goal was to create a machine where women would feel comfortable being examined,” said Michał Matuszewski, inventor and CEO of AILIS.
He described that the idea for the device came to him in a dream, after several members of his family died from cancer, and he witnessed the devastating fallout of their cancer diagnoses. “I saw how negatively the illness and its functioning affected families,” he said. “I had already achieved a lot for myself career-wise, and felt that it was time to start giving back to others.”
The standards in the industry are not keeping up with what we build.
The first prototype was a simple chair, with robotic arms attached to it. It stands in the company’s headquarters to this day, reminding its staff of the strides they have taken since its inception, seven years ago. The newest model of the AILIS is technologically advanced – to the point that it is hard to find manufacturers for spare parts. “A producer with 20 years of experience in dental chair production resigned from collaborating with us when they saw our mechanism. They told us that they had never seen something like this before,” Matuszewski said.
“AILIS’s covers are made from materials used in the aviation industry,” Matuszewski said, of the mechanisms’ production. “The rest is all produced by us, from the mechanisms and electronics, to the programming and software.” For the CEO, “It is thanks to this that we can regulate the entire process ourselves,” he says. “This also means that our greatest challenge is the fact that we are creating something entirely new in the medical field. The standards in the industry are not keeping up with what we build.”
Blood vessels in chaos
But what is AILIS really testing?
Parametric Dynamic Imaging (POD) — as this method is called — relies on a temporary stimulation of the flow of thermal energy inside the breast tissue. Thanks to this, the machine can detect even the smaller anomalies within the blood vessels. This is especially important because developing tumors can stimulate the formation of new blood vessels — a process known as tumor angiogenesis. Breast tissue in which cancer is developing or has already developed is also clearly characterized by increased levels of metabolism and blood supply. Pathological blood vessels have a disorganized course and the temperature in these places is elevated as a result as well.
Where do these changes in blood vessels come from? “The process of cell division in tumors is rapid and chaotic,” explains Dr. Kamil Drucis from the Department of Surgical Oncology at Gdańsk Medical University. “Such high levels of activity necessitate oxygen and nutrients supplies, just as healthy tissues do,” he says. “One of the traits of a tumor is its ability to force the body to form new blood vessels, which supply nutrients to the newly-forming cancers,” he explains.
“This is where the term neo (new) angiogenesis (vessel formation) comes from,” he says. But, as Drucis explains, these new blood vessels are distinct from those found in healthy tissues. “These quickly-formed vessels have a more primitive wall structure than normal veins and arteries, and a more chaotic blood flow,” he added.
“If we compare tumors and healthy tissue to cities, then the healthy tissue would be a modern, well-planned city, with buildings serving specific purposes, and a combination of bigger and smaller streets to facilitate transportation,” the surgeon explains. “The tumorous tissue would be more similar to a favela, where streets arise chaotically and by chance, and where the flow of traffic is interrupted by the construction of new houses.”
In order to interpret images of blood vessels in the breast, AILIS makes use of advanced algorithms, which use artificial intelligence to detect the smallest signs of irregularities. This decreased reliance on human factors has the potential to minimize the chance of misdiagnoses. It can also detect the presence of tumors earlier than traditional methods.
AILIS’s creators showed me photos taken by the machine. Based on these images, even I am able to guess which tissue is unhealthy, without making any mistakes.
The data is alarming.
The results of the analysis are provided in real time. AI processes the collected data and sends its results to an app on the patient’s phone. Those who test positive for tumors are referred for additional diagnostic work. AILIS exams are personalized because every patient’s breasts are different. The app, for instance, remembers the individual positioning of the examination chair to ensure the patients’ comfort. The system also remembers specific details of each breast’s structure and develops a specific program for further monitoring and evaluation. AI also conducts pre-screening interviews with patients prior to testing and calculates the breast density algorithm, allowing for more accurate imagery.
A density problem
The data is alarming. New instances of breast cancer are diagnosed every 20 seconds around the world, and every 60 seconds, a woman dies from the disease. This is the most commonly diagnosed malignant tumor in women by far. In Poland, only lung cancer kills women with greater frequency. For years, breast cancer diagnoses have relied on ultrasounds, mammograms, and biopsies. The problem is that not every doctor takes the individual structure of a woman’s breast into account, and not every doctor informs their patients about how this individual structure may impact the diagnostic process. Conventional medical wisdom states that, until menopause, women have a glandular (so-called dense) structure, which later shifts to a fatty structure. In the case of glandular breasts, diagnosis is often more difficult.
“Adipose (fat) and glandular tissues, in addition to their histological structure, also differ in ‘radiological density’ — that is, the ability to absorb radiation used, among other things, in mammography,” says Dr. Drucis. “The glandular tissue is the least ‘translucent’ to radiation (gives a clear image in the picture). Adipose tissue absorbs much less radiation (providing a dark image in the photo used for diagnoses).”
“Due to their structure, breast tumors are generally radiologically dense (with some exceptions),” Drucis elaborates. “The simplest explanation of why detection can be difficult is to imagine a mammography image — glandular tissue is light, fatty tissue is dark, but cancerous growths are also light, making it easier to detect tumors in fatty tissue.”
“Of course, there are many other radiological traits of breast cancer (for example, the presence of microcalcifications),” he says. But all of these features are still more difficult to observe against the background of glandular tissue. This is why AILIS, which tests for changes in blood vessels, will allow diagnoses to take place at early stages where mammograms or ultrasounds are completely helpless.
The structure of the breast is one thing. The other is the commonly held myth that breast cancer is a greater risk for older women. Nothing could be further from the truth.
Research undertaken by the Breast Cancer Surveillance Consortium, published in the Journal of the National Cancer Institute, shows that younger women (from 40 to 49 years old) with a dense breast structure are 4 to 7 times more likely to experience malignant breast cancer, compared to older women with a fatty breast structure. According to 2020 data from the World Health Organization, around 26% percent of new instances of breast cancer around the world are detected in women under the age of 50. In some countries, this number rises to 47%. What’s worse, the vast majority of these diagnoses are during the advanced stages (III or IV) of the cancer’s progression. Stage I cancer, where the growth measures less than 2 centimeters, and the survival rates are between 92-99%, are very difficult to detect. It is this situation that AILIS can address. This is only augmented by the fact that the process of angiogenesis — which occurs before cancer cells are visible — can take several years before the cancer progresses.
“During our preclinical trials, which we conducted on 200 women, we saw instances where existing tests did not show any signs of illness,” said CEO Matuszewski. “A young woman, who goes for testing in March, comes back from her tests with a clean bill of health, but the AILIS machine is able to detect strong abnormalities consistent with malignant tumors,” he adds. “Unfortunately, our result is confirmed by a biopsy, and, in the few months between the two tests, the woman’s cancer had already metastasized,” he explains. “This shows how quickly the disease can develop and how difficult it is to detect it with a traditional examination.”
Leaving the system
First testing stations
Matuszewski admits that the entire approach to cancer diagnostics needs reprogramming. “We want to go beyond the system. We want to operate outside of hospitals, where women can sometimes wait in line for months to see a specialist,” he says. For him, accessibility is a key goal, as is “separating interventional diagnoses, such as biopsies, from preventative ones.” The company is also planning to release a mobile version of the AILIS machine, which they plan to set up in shopping centers. “The tests are short and non-invasive, so women can conduct them with ease while running errands,” he says. Surveys show that this could be a comfortable solution compared to conventional testing practices, he adds.
The first testing stations will be made available in Kraków, where the first trials will take place. A second test station is also planned for Gdańsk.
AILIS’s creators are convinced about the revolutionary role that the machine will play. “The cost of breast cancer treatment rises markedly as the disease progresses, and according to the WHO, almost two thirds of the world’s population does not have access to imaging diagnostics,” says Matuszewski. “According to 2019 research from Canada, the introduction of a personalized approach to breast cancer screening would reduce the number of more invasive tests performed and the costs associated with them by 21%,” he says. “On the global scale, this would save hundreds of millions of dollars.”
The imperfection of standard techniques results in an increase in false-positives
“What’s more, early screening based on personalized risk shows 50% higher effectiveness in detecting breast cancer,” Matuszewski adds. Currently, he is looking for practical solutions: “A large part of the world is struggling with a shortage of radiologists; some Asian countries have one radiologist per million inhabitants,” he says. “How can we think of a personalized approach under these circumstances?”
“In addition, the imperfection of standard techniques results in an increase in false-positive results and unnecessary, painful biopsies, which also increases health care costs … Thanks to AILIS, only those women who actually show signs of developing cancer will go for a biopsy,” he says.
Unknown future
Will AILIS be as effective as its creators say? Preclinical trials show promise, with successful detection rates of 94%.
The creators are now seeking certification and starting clinical trials involving 1,000 women, meant to teach artificial intelligence to distinguish healthy women from breast cancer patients — using ultrasound or mammography reference methods. At least another five years of retrospective studies are needed to see to what extent AILIS can detect breast cancer earlier than ultrasound or mammograms. This is a difficult task, because there are no reference studies, as this method is an absolute novelty. AILIS algorithms analyze thousands of breast examination results, learning to recognize and differentiate between healthy and diseased tissues.
More than 120 people collaborated on the technology’s development, including scientists, doctors, programmers, AI specialists and biomedical engineers. “They came to us from the best research centers: CERN, Gdańsk University of Technology, the Institute of Nuclear Physics of the Polish Academy of Sciences, the Medical University of Gdańsk and the University Hospital in Kraków,” says Matuszewski.
But, despite their success, clinical trials aren’t everything, and AILIS needs significant funding to implement the technology on a wider scale. The Kraków-based startup has already received more than €1 million of financial support from the National Center of Research and Development, but further funding is needed to build new machines and conduct further research.
The company is currently seeking investors but, so far, only international private investors are showing interest. But AILIS’s creators are determined that the technology should be an entirely Polish discovery and product. “We want not only to change the process of cancer diagnosis around the world, but also to bring attention to Poland, where uniquely advanced technological projects and innovations are taking place,” says Matuszewski. “We want to show that we are leaders of innovation, and that is why we are primarily seeking collaboration with Polish investors and firms.”
