A solution for cGMP compliant production for 15O-water

IMPORTANT NOTICE: MedTrace’s products are not currently cleared for routine use in any markets, including both the US and Europe. In the US, 15O-water is currently under investigation as an investigational drug in a Phase 3 clinical trial. In Europe, its use is in compliance with approvals granted by national drug authorities, in accordance with the specific legislation of each member state.

We are developing an advanced Point of Care chemistry laboratory (referred to as P3) that adheres to cGMP standards. This innovative facility seamlessly integrates both the production of 15O-water and its administration to the patient in a fully automated process. Linked to a cyclotron, the P3 transforms 15O-gas into 15O-water. A unique injections system delivers the tracer to the patient through a venous catheter.

Stand-alone system

P3 has a height of approx. 60 in/150 cm.

Easy to operate

P3 can be operated from the machine itself or in the control room.


P3 is shielded with 2 in/5 cm of lead.


Full cardiac examination consisting of both a rest and stress scan with two identical doses can be completed within 30 minutes1

Due to the short half-life of only 122 seconds, the patient can stay on the scanner bed between scans removing the hassle of repositioning.

The P3 (A) is placed next to a PET-CT scanner (B) and connected to an onsite cyclotron (C). Both proton and deuteron cyclotrons are applicable. The cyclotron needs to be within certain distance to the P3.

Four easy steps to 15O-water PET scanning

Step 1

Once the patient and the PET scanner (B) are ready, the P3 (A) will call for 15O- gas from the connected cyclotron.

Step 2

The P3 will convert the 15O-gas (C) into 15O-water under cGMP conditions, prepare the desired dose, and inject it into the patient in one automated process. Dose turnaround time can be less than 4 minutes1.

Step 3

For cardiology, the procedure is repeated after a stress agent is injected. Due to the short half-life of 15O-water, the repeat scan can start only 10 minutes1 after the initial scan has started.

Step 4

Once the scan procedure is completed, the aQuant software can analyze the image data and provide the physician (D) with absolute cardiac flow images, values per cardiac segment to be used for aiding clinical interpretation.