VCAST is a technology developed by the American company Kardiolytics, part of the Medicalgorithmics Group, enabling non-invasive, quick, and accurate diagnosis of coronary artery disease. The product is nearing commercialization. The CE certification process is in its final stage, the company has signed its first contract to use VCAST in a research project, and is in discussions with additional medical centers interested in collaboration.
VCAST (Virtual Cardiac Stress Test) is cloud software that uses proprietary artificial intelligence algorithms to convert cardiac CT scan data into three-dimensional models of coronary arteries. Additionally, VCAST performs a 3D model analysis to identify vessels with narrowing caused by atherosclerotic plaque. As a result, the physician receives information about the location of the plaque and the FFRsten parameter, which indicates how much the blood flow in the artery is reduced. This set of information assists the doctor in diagnosing and preparing a treatment plan for the patient.
“The VCAST product is an alternative to the current standard of care, the invasive coronary angiography procedure, which involves analyzing blood flow using a probe inserted into the heart’s arteries and assessing the presence of atherosclerotic plaque in the coronary vessels. A few years ago, regulators began favoring non-invasive alternatives, made possible by technological advances in AI and CT image processing. Currently, new guidelines in the USA, Europe, and Japan allow the use of non-invasive diagnostic methods for coronary artery disease. Public and private insurers have started reimbursing these procedures. These regulatory changes created a huge opportunity for us, and we believe in the commercial success of VCAST,” commented Przemysław Tadla, CTO of Medicalgorithmics and CEO of Kardiolytics, a subsidiary of Medicalgorithmics directly overseeing the VCAST project.
“Of course, we are not the only company seeking and introducing innovations in this area. From a business development perspective, this is good news because companies that introduced similar solutions to the American market have established reimbursement codes with insurers. We have been preparing for VCAST commercialization for some time, which will begin as soon as we complete the CE certification process,” added Jarosław Jerzakowski, COO of Medicalgorithmics.
American company HeartFlow Inc. was the first to offer non-invasive technology for analyzing blood flow in coronary vessels and received FDA approval for commercialization in the USA. The company has raised over $600 million for its development and market expansion and is actively working on establishing reimbursement codes. According to recent information, the company is valued at $1.5 billion. Cleary Inc., another American medtech company on the market, has raised nearly $300 million from investors, with a valuation approaching $1 billion (according to dealroom.co). Cleary also offers software for non-invasive coronary vessel analysis, specifically for atherosclerotic plaque analysis.
Our latest product, VCAST, already offers blood flow analysis in coronary vessels, and in the next version, planned for launch next year, it will allow for the identification and analysis of atherosclerotic plaque. Additionally, VCAST utilizes the latest technologies in AI algorithms and cloud technology, requiring less hardware, operating faster, and ultimately offering more advanced analysis and diagnostic parameters.
Last week, the company announced the signing of an agreement with the Multi-Specialty Hospital SPZOZ in Nowa Sól to use VCAST technology in a research project involving 200 patients. Under the agreement, Medicalgorithmics will provide the hospital with the technology for five years with an option to extend the collaboration. This will allow the hospital to use the VCAST product for commercially conducted coronary artery disease diagnostic procedures even after the research project ends.
“Completing the ongoing CE certification and subsequently obtaining FDA approval for the VCAST technology are milestones that will launch product commercialization in international 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 the CE certificate, we plan to offer VCAST in Scandinavia, the United Kingdom, Germany, France, Italy, Spain, Canada, and Australia. Additionally, we are interested in Japan and Southeast Asian countries,” added Maciej Gamrot.