Systematic to help medtech comet onto the world market

MedTrace Pharma A/S has developed what is so far the only solution worldwide that can accurately show tissue damage and stenosis in the heart and lungs. Systematic is now going to gear and quality-assure the solution so the prototype can be prepared for the world market.

The Danish company MedTrace Pharma’s invention 15O-water PET and aQuant analysis software provide the sharpest and most accurate scanning images so far of tissue and blood flow in the heart and lungs, thus enabling doctors to identify serious sclerosis and stenosis with unprecedented precision.

The invention is expected to be very significant for the diagnosis and treatment of heart and lung patients, but 15O-water PET also holds considerable interest because it can be used to examine lungs which have been damaged as a result of COVID-19.

Exacting quality assurance requirements for products for the global market
The solution has already been used on a trial basis in Japan, the USA and Denmark, but in order for 15O-water PET to be sold on the global market, the imaging diagnostic software, aQuant, which processes and displays the razor-sharp images of the tissue, needs to be thoroughly quality-assured. This task will be performed by the Danish software company Systematic.

“The requirements regarding documentation, safety and infrastructure are extremely exacting when commercialising and approving a medical product for the US and European markets. Against this background, external consultants have been helping us find the best possible partner for the task, and the choice fell on Systematic due to the company’s extensive global experience with healthcare solutions, its methodical approach and, not least, its focus on transparency,” explains CEO Martin Stenfeldt from MedTrace Pharma.

Planning for European launch in 2023 – followed by the US market
In other words, Systematic will help to draw up the relevant documentation for the aQuant software, optimise the code and build a robust infrastructure to pave the way for scaling of the prototype and integration with healthcare systems worldwide. In addition, Systematic will ensure that scanning images are displayed in a user-friendly interface that supports doctors’ routines.

“For us, it’s an incredibly exciting project as it brings together everything we’re good at with a completely new business area. We have shown that we can develop well-functioning infrastructures and record systems for the public health service. Now, we also need to make sure that a medical product can be integrated with hospital infrastructures and obtain the approvals that are required for medical equipment on the global market,” says Dina Myrup Raabjerg, Business Development at Systematic.

Once everything is in place, Martin Stenfeldt expects MedTrace to be ready for approval and launching in Europe in 2023. After that, the goal is FDA approval for the US market. The company is aiming for DKK 1 billion in revenue after ten years on the market.

For Systematic, the future perspectives are also interesting:

“It’s a completely new market that we’re entering. Based on this solution, we can create a generic platform for medtech companies working with image diagnostics. At the same time, we will be able to support product maturation and the final development of medical products from project to CE approval and sale,” she explains.

Great success with the prototype at AUH – more pilot projects in the pipeline
Aarhus University Hospital (AUH) is one of the hospitals that is helping with the development and testing of the prototype. The prototype has been used for diagnosing heart patients at the hospital since January 2021. Lars Christian Gormsen, a consultant doctor, told the Danish Broadcasting Corporation dr.dk that by using the solution it is possible to conduct 20 times more examinations than anywhere else worldwide. He also reckons that the chances of being able to identify sclerosis and stenosis in the heart with an ordinary CT scanning are 40-60%, whereas it is an impressive 90% using the MedTrace solution.
After the summer holidays, similar pilot projects are being launched in Sweden, the Netherlands and the USA.

Facts about 15O-water PET

The Danish company MedTrace Pharma has developed a unique method of recording scanning images of tissue and blood flow in the heart and lungs.

The prototype is already in use at Aarhus University Hospital, and the feedback is positive.

15O-water PET and aQuant analysis software are:

1. A machine that produces radioactive water which is injected into the body of the patient so that a positron emission tomography (PET) scan is able to produce very precise images.
2. A software platform for analytical image processing, which enables doctors with unprecedented precision to identify tissue damage in the heart and lungs.

Systematic’s contribution to the solution:

1. An integration platform and infrastructure which makes it possible to scale and integrate the solution with IT systems at hospitals worldwide.
2. Quality-assuring the software and a user-friendly interface for displaying the scan images.
3. Optimising the code and preparing documentation with a view to obtaining CE approval.