MedTrace Promised the EIC Accelerator 15O-Water PET: The Record

MedTrace Pharma A/S, founded in 2015 and based in Hørsholm north of Copenhagen, builds a machine that makes 15O-water, a radioactive form of water, next to a PET scanner and injects it into patients, plus software called aQuant that turns the scans into measurements of blood flow to the heart muscle. In the EIC Accelerator pilot's March 2020 cut-off it was selected with blended finance, grant plus equity, for a project called EU-CAD, according to the European Commission's list of selected companies, which names MedTrace as the only company on the project and gives its location as Lyngby. The grant was €2.5 million towards a total cost of €3,572,775, for a project that ran from 1 August 2020 to 31 July 2022, according to CORDIS.

The promise in the proposal was specific: mature the working prototype, validate it "in a small cohort of patients in three different EU sites, and obtain CE approval to operate in Europe", with the equity part paying for a US Phase III trial. Six years later, the record is mixed. The software was CE-marked in November 2025 and the disposable patient kits in March 2024. The tracer production system itself, called P3, carries no CE mark and "is not available for sale in any region or market", according to MedTrace's own product page. The US trial is still running.

Where MedTrace Stands Now

MedTrace is active and still raising money. It filed its 2025 accounts with the Danish Business Authority on 13 May 2026, and the company register shows its share capital rising from DKK 11.2 million in October 2025 to DKK 12 million in January 2026 and DKK 16.1 million in May 2026, along with new shareholdings by MedTravest IV and BankInvest in April 2026, according to North Data, which reprints the register entries. How much was raised in 2026 is not public.

The money matters because the cash is thin. The group ended 2025 with DKK 23.6 million in the bank after a net loss of DKK 35.1 million, and management wrote that its cash "will support operations into the second quarter of 2026". It said existing investors had agreed a term sheet for "EUR 8-12 million and later up to a total of EUR 30 million, including participation from a new external investor", according to the 2025 annual report. The 2026 capital increases in the register fit that plan, but no closing has been announced.

Leadership has turned over four times since the award. Chief executive Martin Stenfeldt stepped down in December 2022, when the company said the Phase III trial had "shown to be more comprehensive than first anticipated", according to Medical Alley. Ann Kristin Led, the finance chief, took over in January 2024 (Medical Alley) and left in June 2025 so the role could move closer to the US market, according to the company. After an interim spell by chief medical officer Nicholas Borys, board member and long-time shareholder Peter Juul Kristensen became CEO on 1 November 2025, according to MedTrace and the register entries on North Data.

The Technology: Water as a Heart Tracer

Coronary artery disease narrows the arteries that feed the heart. To decide who needs an invasive procedure, doctors scan how much blood reaches the heart muscle at rest and under drug-induced stress. Most of these scans use SPECT, which the EU-CAD proposal called a method "with poor accuracy and low throughput", or PET with other tracers. 15O-water is not metabolised and diffuses freely into tissue, so its signal tracks blood flow closely, and its half-life of about 122 seconds keeps radiation doses low, according to MedTrace's tracer page. CORDIS calls it "the undisputed gold standard tracer for blood flow assessment".

The same short half-life is the problem. The tracer must be made on site from a cyclotron's output and injected within minutes, and the images need specialised analysis, which is why 15O-water has stayed mostly in research. MedTrace's answer is a self-shielded, 150 cm tall unit that converts 15O-labelled gas into water and injects it as a timed bolus, and aQuant, software built only for 15O-water images. The software came from aQuant, a company MedTrace merged with in 2018, according to its company history.

What the EIC Project Promised, and What CORDIS Shows

The CORDIS periodic report names two milestones: recoding aQuant with testing and validation, and CE marking as a medical device. The listed deliverables add a clinical study ending at "last patient scanned" and regulatory approval in the EU "in the form a CEmark as medical device of the software and the medical device part of the hardware". MedTrace's investor page describes the grant more broadly, as money "to clear the regulatory pathway to market in five European markets".

The report is candid about delays. The software specification "took four month longer than planned", the company had to hire two people just for that work package, kit deliveries were "more challenging then expected due to redesign and technical errors", and most market access work was delayed by Covid-19 travel bans. Instead of buying data from a trial at Amsterdam UMC, MedTrace joined Dan-NICAD3, a 1,000-patient Aarhus University study comparing 15O-water PET with rubidium PET (ClinicalTrials.gov). It booked a slot with the notified body BSI, and Aarhus University Hospital scanned 1,000 heart patients between 7 December 2020 and 10 August 2021 under exemption permits from the Danish Medicines Agency.

The software work then went wrong. In its 2022 accounts, MedTrace said it had insourced aQuant development and spent "significant time and resources re-evaluating the technical solution and design to solve technical problems experienced late in the project development stage", which led to an extraordinary write-down of DKK 17.2 million on the analysis platform, according to filings with the Danish Business Authority. The project closed in July 2022 without a CE mark.

1. Recode and validate aQuantLateRebuilt in-house after a DKK 17.2M write-down in 2022; CE-marked in November 2025.
2. CE mark for the softwareDeliveredaQuant CE-marked for coronary artery disease, three years after the project ended (MedTrace).
3. CE mark for the hardware's device partsPartlyPatient kits CE-marked in March 2024; the P3 system is not for sale anywhere.
4. Clinical study at three EU sitesNot shownAarhus data and one Uppsala installation reported; no three-site study result or "last patient scanned" announced.
5. Market access in EuropeNot deliveredAll 2025 revenue came from Denmark, under exemption permits.

The patient kits, the single-use tubing that connects P3 to the patient, received their CE mark under the EU Medical Device Regulation in March 2024, according to Medical Alley, after the company gained ISO 13485 certification in June 2023 (Medical Alley). aQuant followed in November 2025; MedTrace's announcement and its 2025 annual report both report it, and no notified body statement is public. The company's own regulatory notice still lists only "Patient Kit and aQuant" as CE-marked components in the EU.

What It Has Achieved Since the Award

The equity side of the award did happen. MedTrace says the European Innovation Council joined Swisscanto, ATP, BankInvest and Vækstfonden in a Series B of about DKK 180 million in 2021, according to its investor page, and the company appears in the EIC Fund portfolio under the EU-CAD project title. The size of the EIC Fund's stake is not public; North Data lists a change in the EIC Fund's shareholding in October 2025. IPE reported the round in May 2021 as DKK 180 million, with an IPO as ATP's long-term hope; MedTrace's 2022 accounts put it at DKK 182 million, paid in two tranches.

Further rounds followed: €18.2 million in September 2023, led by ATP, MedTravest, Swisscanto and Verve Ventures (Medical Alley), and €10 million in May 2025 from the same group plus BankInvest and the Danish state fund EIFO (MedTrace). The 2025 cash flow statement shows DKK 66.6 million from that capital increase.

The commercial footprint is still small. Revenue has stayed between DKK 1.5 million and DKK 2.7 million a year since 2021, all of it in Denmark in 2025, from hospitals using the system under exemption permits. More than 4,000 patients have been scanned in Denmark this way, the 2025 annual report says. Most spending is capitalised as development: DKK 61.6 million of research and development in 2025 went onto the balance sheet, which is why equity stood at DKK 302.6 million despite the losses.

The bigger prize is the US. The Phase III trial RAPID-WATER-FLOW started on 8 May 2022 and is "active, not recruiting", with completion estimated for October 2026, at 13 sites in the US, Canada, Denmark, Germany, the Netherlands and Sweden, according to ClinicalTrials.gov, last updated in August 2026. The registry lists an estimated 215 patients; the company's 2025 annual report gives a target of 182 and 131 enrolled at the end of 2025, with the last patient expected in the second half of 2026 and a New Drug Application to the FDA "shortly after". No result has been published.

Why It Matters for Europe

Cardiovascular disease is the leading cause of death in the EU, at 1.7 million deaths a year, and the Commission's first EU-wide plan for it, the Safe Hearts Plan of 16 December 2025, puts early detection among its flagships, according to the European Commission and the World Heart Federation. Nuclear medicine also has a supply angle: the Commission's SAMIRA action plan of February 2021 makes securing medical radioisotopes a priority, noting that many source materials are imported and many isotopes come from ageing research reactors. A tracer made on site from a hospital cyclotron's output, as P3 does, sidesteps those chains, though MedTrace has chosen the US, not Europe, as its first commercial market.

The Verdict

Credit is due: the company kept its investors, grew from 5 to more than 30 staff, put its system into routine use at Danish hospitals and brought a regulated software product to market. But the EU-CAD goal of operating in Europe with a CE-marked solution has not been met, and the company itself describes the full system as investigational. MedTrace and the EIC were not asked for comment; this article is based on public records and published statements, linked throughout.