MedTrace Announces First Subject Scanned in Phase 3 Clinical Trial

MedTrace Pharma Announces First Subject Scanned in the Company’s RAPID-WATER-FLOW Phase 3 Clinical Trial First Subject Scanned in RAPID-WATER-FLOW Trial at Aarhus University Hospital, Denmark Multiple Sites Involved Across the United States, Denmark, Sweden, and The Netherlands The Global Trial is Expected to Continue for 12 Months MedTrace Pharma A/S, a pharma and device company […]

MedTrace announces IND approval of RAPID-WATER phase 3 clinical trial

MedTrace Pharma announces IND approval with the initiation of RAPID-WATER phase 3 clinical trial MedTrace Pharma A/S announced today the FDA approval of the company’s Investigational New Drug (IND) application and the approval to commence the RAPID-WATER clinical trial to evaluate the use of 15O-water PET in diagnosing Coronary Artery Disease (CAD). The global trial […]

MedTrace Pharma takes step towards CE marking

MedTrace Pharma takes step towards CE marking A notified body has signed a contract to review MedTrace Pharma’s aQuant software and patient kit products with an eye to CE marking. The notified body, BSI, is based in the Netherlands. “We’re encouraged that BSI has agreed to audit our products,” says Rune Wiik Kristensen of MedTrace […]

MedTrace Installs P3 System at Sahlgrenska University Hospital

MedTrace Installs P3 System at Sahlgrenska University Hospital MedTrace Pharma A/S has signed a contract with Sahlgrenska University Hospital in Gothenburg, Sweden for the installation of a new P3 production and infusion system providing up to 1000 doses of 15O-water per year for the next five years. The Gothenburg-based hospital, one of the largest in […]

First patient imaged with MedTrace technology

First patient imaged with MedTrace technology The first PET scans with 15O-water generated with a novel production and administration system from the Danish company MedTrace Pharma A/S (MedTrace) have been performed in patients at Aarhus University Hospital (AUH).  AUH has become the first hospital in the world to utilize, under a magistral exemption, a clinical […]

MedTrace to partner with Mayo Clinic in oncology study

MedTrace to partner with Mayo Clinic in oncology study As part of the recently closed equity fundraising, MedTrace also signed a know-how license agreement with Mayo Clinic (Rochester, MN, USA) embarking on the already installed P3 prototype and the aQuant software. The scope of the agreement is outlined in the press release below. Press Release […]

Putting the low radiation dose of 15O-water in perspective

Putting the low radiation of 15O-water in perspective Tracers are radioactive compounds that doctors inject into patients to diagnose various diseases by, for example, following the flow of blood or use of sugar in organs. All tracers come with a radiation dose, but the dose of 15O-water is much lower than all other tracers used […]

Manufacturing Partnership

Manufacturing Partnership with A/S Kurt Hansen In preparation for our future production of hardware systems, we have partnered with A/S Kurt Hansen from Svendborg, Denmark to manufacture the next five P3 prototype systems. Planned delivery for the first system is first week of December whereas the last unit is planned to be delivered in early […]

First Production of 15O-water

First Production of 15O-water using the MedTrace bedside P3 system It was a moment of great joy, when MedTrace Pharma, together with local staff at Aarhus University Hospital, this Saturday (March 2nd, 2019) produced the first test-dose of 15O-water using the new MedTrace 15O-water generator, the P3 system. The testdose was 1,669 MBq (volume: 2ml) […]

First Prototype Installed

First Prototype Installed We are proud to announce that we, with support from Kapacitet A/S, this weekend successfully installed our first fully functional prototype – the P3 system – at Aarhus University Hospital in Denmark.  The P3 system is capable of converting 15O gas from the cyclotron into 15O-water and inject it into the patient undergoing […]