Pharmaceutical and medical device company MedTrace has secured €10 million in funding to propel the next phase of its registrational Phase III clinical trial with the ambition to complete the study in 2026. Another capital increase is expected before completion of the study. The company will continue working to increase its investor base to enhance the development of its 15O-water technology and initiate work on new indications.
Pharmaceutical and medical device company MedTrace has secured €10 million in funding to propel the next phase of its registrational Phase III clinical trial with the ambition to complete the study in 2026. Another capital increase is expected before completion of the study. The company will continue working to increase its investor base to enhance the development of its 15O-water technology and initiate work on new indications.
The €10 million investment will accelerate the company’s clinical and regulatory objectives, while the future additional capital increase is expected to support the study, including completion of the NDA submission and prepare the company for the launch of the product in the USA. Furthermore, MedTrace plans to use these investments to fund additional studies in new indications such as oncology and neurology.
The financing round is led by a leading consortium of Danish and Swiss investment groups, including ATP, BankInvest, MedTravest, and EIFO from Denmark, as well as Swisscanto and Verve Ventures from Switzerland.
“We are incredibly grateful for the support of both our private and key investors, and for their belief in our mission to secure market approval for our complete 15O-water point-of-care solution”, says Ann Kristin Led, CEO of MedTrace. She continues:
“This funding enables us to accelerate our Phase III Clinical Trial, which is currently progressing according to plan, and to prepare the company for a successful submission for an NDA. Our ambition is to complete the trial in 2026. Our current estimates of the market for myocardial perfusion imaging is around 6 million procedures in the US”
Hospitals Adopt aQuant Software Ahead of CE Marking
In addition to accelerating patient enrollment, the company has made significant operational and regulatory progress. MedTrace recently submitted its first CE Mark application for approval of its proprietary software, aQuant, and has received positive feedback, including exemptions allowing it to be installed at two Danish hospitals — Aarhus University Hospital (AUH) and Gødstrup Hospital.
The aQuant software is specifically designed to be used for analysis of images from PET scans using 15O-water as a tracer to provide parametric images reflecting blood perfusion through the heart, along with actual measurements of blood flow to identify patients who may have coronary artery disease.
“This marks an important milestone for MedTrace and proves not only a demand for our solution but also that the Danish authorities consider our technology trustworthy with the recognition of the potential patient benefits”, continues Ann Kristin.
Exploring Expansion into New Indications Beyond the Heart
“We have carried out an efficient scale-up and see great potential to expand into additional indications beyond the heart. In the long term, our technology could be applied across multiple organs — an opportunity that will require further capital investment.”, says Ann Kristin.
The company has recently successfully completed two external regulatory audits, and its fully implemented Quality Management System (QMS) confirmed compliance with relevant safety authority requirements and supports high-quality product delivery for the patient kit used in 15O-water production and software development.
About MedTrace
MedTrace is an imaging technology company with a focus on advanced medical uses of radiopharmaceuticals with an ultra-short half-life such as 15O-water that can be made available for routine clinical practice.
The company’s Phase III clinical trial is currently enrolling in the USA, Canada and Europe. The study is designed to evaluate the diagnostic accuracy and safety of 15O-water as a tracer for PET scans in patients with suspected coronary artery disease.
MedTrace’s technology is already in use in clinical practice in Denmark at Rigshospitalet, Copenhagen, and Aarhus University Hospital, Aarhus, under magistral exemption and exemption from CE marking issued by the Danish Medicines Agency. To this day, Aarhus University Hospital has scanned 4,000 patients with 15O-water produced by MedTrace’s technology and medical devices.
Contact information:t:
Sandra Meersohn Meinecke
Press and communication
sandra@thecentral.dk
+45 53 56 51 61
