The first PET scans with 15O-water generated with a novel production and administration system from the Danish company MedTrace Pharma A/S (MedTrace) have been performed in patients at Aarhus University Hospital (AUH). AUH has become the first hospital in the world to utilize, under a magistral exemption, a clinical system that makes the use of 15O-water PET practical and efficient. As many as 1500 patients suspected to have coronary artery disease (CAD) pr. year are expected to be imaged at AUH with this approach in a rest/stress scan protocol.
15O-water (radioactive water) has been the gold standard in measuring heart muscle perfusion since the 1980s. However, it has not been practically applicable to routine clinical use due to the ultra-short decay time of the tracer. MedTrace has developed a system that automatically produces and administers 15O-water to patients undergoing PET myocardial perfusion imaging (MPI). This approach may revolutionize cardiac imaging standards in terms of diagnostic accuracy and patient throughput.
“In the past, you literally had to lace up your running shoes and run with the 15O-water in a lead container from the production lab to the patient in the PET scanner in order to use it before it decayed. This obviously is not a solution we can use in practice”, says Lars Christian Gormsen, MD, chief physician in charge of research, Department of Nuclear Medicine & PET Center, Aarhus University Hospital. “This problem has been solved with MedTrace’s equipment, and right now there is no one else in the world who is capable of making clinical 15O-water scans at the same volume we are. Roughly speaking, it is a simple plug-and-play solution that makes it possible to deliver the radioactive tracer easily and safely every 10 minutes. And that is a great relief for the many professional groups involved.”
“Research throughout the years has shown that 15O-water is the best tracer for quantifying myocardial blood flow (MBF), but 15O-water has not been practically available in the past. With our technology, the use of 15O-water is expanding, so that it is no longer only reserved for research but may soon come into routine use for the benefit of patients and the hospital systems. Aarhus University Hospital’s clinical commissioning is a very big milestone for MedTrace”, stated Martin Stenfeldt, CEO of MedTrace.
“This initial clinical experience with 15O-water is showing all the potential benefits of this approach for both patients with suspected coronary artery disease and the overall healthcare system”, said Cesare Orlandi, MD, member of MedTrace’s Board of Directors. “While the accuracy of 15O-water for the quantitative assessment of perfusion abnormalities has been undisputed for decades, the installation and implementation of MedTrace’s system for routine clinical use at AUH is proving to be a practical, reliable and efficient approach, also leading to unsurpassed patient throughput and resource utilization.”
About 15O-water and Coronary Artery Disease
15O-water is a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET). Due to its free diffusibility, 15O-water is considered the non-invasive gold standard for quantitative MBF studies and has been used as reference standard for validations of other MBF quantification techniques, such as single-photon emission computed tomography (SPECT), cardiac magnetic resonance imaging (CMR) and dynamic computed tomography (CT). PET imaging with 15O-water allows for accurate assessment of patients with known or suspected coronary artery disease (CAD). CAD is the most common form of heart disease, affecting approximately 16.8 million people in the United States1. CAD is the leading cause of death in the United States for both men and women, with more than half a million Americans annually dying from CAD2.
About PET myocardial perfusion imaging (MPI)
Unlike computed tomography (CT) or magnetic resonance imaging (MRI), which primarily shows anatomy and structure, positron emission tomography (PET) is an imaging procedure that provides information about the blood flow of an organ. MPI is a non-invasive test that utilizes a small amount of radioactive material (radiopharmaceutical) injected into the body to assess the distribution of blood flow to the heart. MPI is used to identify areas of reduced blood flow (perfusion) to the heart muscle. The test is typically conducted under both rest and stress conditions, to allow physicians to evaluate and compare the two scans and predict whether the patient has obstructive coronary artery disease that requires intervention. While SPECT is most commonly used for MPI, PET imaging has gained considerable support and is used in the field of cardiovascular imaging, as it offers many advantages over SPECT, including higher spatial and contrast resolution, improved diagnostic accuracy, accurate attenuation correction and improved risk stratification. Several PET tracers are used for MPI and quantification of blood flow, including 82Rb, 13NH3 and 15O-water. However, 15O-water has a 100% extraction rate, which makes the tracer superior to 82Rb and 13NH3 as no flow-dependent extraction corrections are required.
About MedTrace:
MedTrace Pharma A/S was founded in 2015 by Martin Stenfeldt, Rune Wiik Kristensen and Peter Larsen. The company has developed a hardware solution that enables the production of 15O-water in clinical practice. In 2018, MedTrace merged with a software company that has developed a unique analytical software platform only for 15O-water. With this, the company’s overall solution became complete and has since moved 15O-water from the lab and research to practical use.
Previously, 15O-water could not be used in practice because its ultra-short half-life makes it useless only 10 minutes after it has been produced. In other words, production has to be nearby and on-demand. This challenge has been solved by MedTrace. With the so-called P3 equipment, which is placed directly by the scanner in the hospital, it has become practically possible to produce and use the safer and more accurate 15O-water tracer in diagnostic scans of heart patients.
MedTrace is thus a pharmaceutical company with a platform technology consisting of two elements: an automated hardware system, P3, which both produces and injects 15O-water into the patient, and the software, aQuant, which automates the analysis of the scan images based on 15O-water.
MedTrace is currently collaborating with university hospitals in Europe, Japan and the US, including the world’s leading hospital: Mayo Clinic, headquartered in Rochester, Minnesota.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that may be described from time to time in filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the data hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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For more info:
Martin Stenfeldt, CEO MedTrace Pharma A/S, +1 (617) 620-4531, martin@medtrace.dk/us
