MedTrace was founded with the belief that we can improve diagnostic accuracy in PET perfusion examinations. Our first ambition has been to focus on cardiac diseases, and to make [O-15]-H2O practically available. We want doctors around the globe to have access to the gold standard perfusion tracer which is [O-15] H2O and to help usher in a new era in diagnostic medicine.
We have developed a Point-of-Care GMP-compliant chemistry lab (MT-100) that combines the production of [O-15]-H2O with the infusion of the tracer into the patient – in one automated process. This will allow for unprecedented patient throughput. Furthermore, we have also developed a novel diagnostic software to evaluate myocardial perfusion in an absolute quantifiable way and given the nature of water we will be heightening the bar of diagnostic accuracy from PET scans.
How it works
A full patient procedure consisting of a rest and stress scan with two injections can be completed within 30 minutes. With the short half-life of [O-15] of only 122 seconds, the patient can stay on the scanner bed while the initial injection decays awaiting the second scan.
The MT-100 (A) is placed next to a PET-CT scanner (B) and connected to an onsite cyclotron (C). Both proton (p,n) and deuteron (d,n) cyclotrons are applicable. The cyclotron can be placed up to 1600 feet/500 meters away from the PET scanner.
|1)||Once the patient and the PET scanner is ready, the MT-100 will call for [O-15] O2 gas from the connected cyclotron.|
|2)||The MT-100 will convert the [O-15] O2 gas into [O-15] H2O under GMP conditions, prepare the desired dose, and inject it into the patient in one automated process.|
|3)||The procedure is repeated, allowing for injection of a suitable stress agent. Due to the short half-life of|
|4)||Once the scan procedure is completed, the doctors can diagnose the patient using the aQuant analytical software (D), and compare the myocardial blood flow at rest and under stress conditions. Read more about aQuant here|
Pathway to market
MedTrace is currently preparing for a pivotal Phase III clinical trial evaluating [O-15] H2O PET scans towards invasive coronary angiogram and current best practice SPECT scans. The trial will be conducted under FDA approval and include patients from EU, US and Japan. Several US hospitals are involved coast-to-coast accompanied by three European hospitals and one Japanese.