Medicalgorithmics, a medtech company listed on the sWIG80 index, has completed the CE certification process for its VCAST software, which is used for the non-invasive diagnosis of coronary artery disease. Obtaining the certification allows the company to commercialize the technology in the EU and selected countries outside of Europe. The VCAST software, which uses artificial intelligence algorithms to analyze heart CT scan images, is developed by Kardiolytics Inc., Medicalgorithmics’ U.S. subsidiary. The company estimates that the commercialization of the VCAST technology could generate revenues of PLN 130 million by 2028.
The Virtual Cardiac Stress Test (VCAST) is a technology that enables the non-invasive assessment of coronary arteries for the diagnosis of coronary artery disease. The diagnosis is based on heart CT scan data, which are analyzed by the artificial intelligence algorithms developed by Kardiolytics. VCAST supports physicians in diagnosing coronary artery disease, offering a fast and non-invasive alternative to traditional, invasive diagnostic methods, such as coronary angiography.
Medicalgorithmics plans to commercialize VCAST in the European Union, the UK, Switzerland, and selected Southeast Asian countries, as well as in Australia. It is estimated that the number of people at risk or living with coronary artery disease in these countries exceeds 40 million. This is four times the population of potential patients requiring diagnostics using VCAST compared to patients with heart arrhythmia.
“Obtaining CE certification for VCAST is an important milestone and another step towards commercializing the solution in the European market. We are convinced that our software can help reduce the waiting times for patients awaiting CT scan results. By using artificial intelligence algorithms, the VCAST technology turns CT data into an interactive 3D model of coronary arteries in just a few minutes, providing doctors with a user-friendly way to assess their condition. Additionally, the software offers a complete blood flow analysis in the vessels, which is equivalent to the invasive measurement performed during a coronary angiography procedure,” said Przemysław Tadla, a member of the board at Medicalgorithmics and CEO of Kardiolytics Inc.
The CE certification allows Medicalgorithmics to begin the process of registering VCAST technology with the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products in Poland. This will enable the solution to be commercially used within the European Union. The CE certification also opens the door for the company to apply to national regulators in selected countries worldwide, such as the UK, Canada, Switzerland, and Australia, allowing VCAST to be offered to customers outside the EU. The company also plans to apply to the FDA (U.S. Food and Drug Administration) for approval to introduce the technology to the U.S. market under the 510(k) procedure.
The company estimates that after obtaining CE certification and FDA registration, VCAST technology could generate additional revenues of around PLN 130 million by 2028. These revenues will be equally generated from markets requiring CE certification or FDA approval. However, the U.S. market, in the company’s view, has greater potential and could eventually generate significantly higher revenues than those from countries requiring CE certification.
Medicalgorithmics already has its first partners using VCAST software for coronary artery disease diagnosis. In July, the company announced the signing of an agreement with the Multispecialty Hospital SPZOZ in Nowa Sól. In September, a second agreement was signed with the American Heart of Poland for the use of VCAST. Under both agreements, partners have access to the technology for clinical trials, and after certification is completed, they will be able to use the software in the diagnosis of coronary artery disease. Medicalgorithmics also has a letter of intent with Diagnostyka Group, the leader in the medical diagnostics market in Poland, and is negotiating additional agreements for the use of VCAST technology in coronary artery disease research. The company is also in regular contact with partners from 22 countries, some of whom operate cardiology departments where the product could be used.
“VCAST is a modern, non-invasive alternative to traditional coronary angiography, enabling a precise analysis of coronary vessels without the need for invasive procedures. Thanks to the rapid development of artificial intelligence technology and advanced CT image processing, new guidelines in the U.S., Europe, and Japan allow the use of such methods. The growing number of coronary artery disease cases and the aging population in developed countries create favorable market opportunities for VCAST. In the United States alone, this technology could support the diagnosis and treatment of up to 20 million people annually. We are excited that Medicalgorithmics and Kardiolytics can begin commercializing VCAST, which will benefit patients and contribute to building value for shareholders,” said Professor Paul Lewicki, a member of Medicalgorithmics’ supervisory board and a partner at BioFund Capital Management LLC, the company’s largest shareholder.
“The CE certification and subsequent FDA approval for VCAST software are milestones that will enable the commercialization of the product in additional markets. In the first phase of commercialization, we will focus on countries with the highest reimbursement rates and a large number of patients who can benefit from our product. Therefore, after obtaining CE certification, we want to offer VCAST in countries such as Scandinavia, the UK, Germany, France, Italy, Spain, Canada, and Australia. Additionally, we are interested in Japan and Southeast Asian countries,” added Jarosław Jerzakowski, COO, and member of the board of Medicalgorithmics responsible for sales.
“We expect to see revenues from the commercialization of VCAST technology in 2025, which will positively impact the generation of positive cash flows by the company,” added Maciej Gamrot, CFO, and member of the board of Medicalgorithmics responsible for finance.
“VCAST’s AI-powered, non-invasive approach to diagnosing coronary artery disease through CT scans eliminates the need for traditional invasive procedures, significantly reducing healthcare costs and risks. By providing rapid, detailed, and personalized 3D modeling of coronary arteries, it allows clinicians to make more precise diagnoses and treatment decisions, revolutionizing cardiovascular care,” says a Medical doctor, PhD Kris Siemionow, a member of Medicalgorithmics’ supervisory board and a partner at BioFund Capital Management LLC, the company’s largest shareholder.