First CE Mark for Patient Kits as Medical Devices Obtained by MedTrace
CEO Ann Kristin Led and CTO Lars Trolle in front of MedTrace’s automated manufacturing system (P3 MT-100) that produces, doses, and injects 15O-water. The now CE marked Patient Kits connect the P3 MT-100 to the patient via a venflon.
MedTrace recently gained its first CE mark for two of its medical devices less than12 months after submitting the technical file. Obtaining the European CE mark demonstrates the company’scommitment and ability to successfully and in a short timebring a product from research and development to a commercial launch, says Senior Director of QA&RA at MedTrace, Maja Damby Carøe.
With great anticipation, MedTrace reveals today that the company has obtained the MDR Certification and its first CE mark for its patient kits.
The medical devices are part of MedTrace’s automated manufacturing solution for producing, dosing, and injecting 15O-water to patients during PET exams.
Senior Director of QA & RA at MedTrace, Maja Damby Carøe, says:
“I am immensely proud of our achievement. Receiving the MDR Certificate and the first CE mark proves that MedTrace has the team and processes in place to generate extensive technical documentation, solve complex uncertainties in due time, and finally achieve market clearance for medical devices.”
“As a young pharma and medical device company, the first CE mark is a major advancement for us and the groundwork is now laid for the market clearance of our entire 15O-water solution,” says Maja Damby Carøe.
The now CE marked Patient Kits connect the company’s automated manufacturing system (P3 MT-100) to the patient via a venflon. The Patient Kits along with the P3 MT-100, are currently in use at several university hospitals in the U.S. and Europe as part of the company’s phase III clinical trial.
Market Clearance of aQuantis Expected Next
MedTrace is also in the final stages of developing its evaluation software, aQuant. It is expected that this software will offer analysis of the quantitative myocardial blood flow during PET exams with 15O-water. MedTrace anticipates celebrating aQuant as its next market clearance achievement.
About MedTrace
Pharma and medical device company MedTrace focus on radiopharmaceuticals with an ultra-short half-life and is currently working to make 15O-water available in clinical practice. The company has an ongoing phase III clinical trial that seeks to evaluate the diagnostic accuracy and safety of 15O-water as a myocardial perfusion PET imaging agent.
MedTrace recently celebrated that it had activated four new U.S. sites, bringing the total number to six activated sites across Denmark and the U.S.
The company has offices north of Copenhagen, Denmark, and in Minneapolis, Minnesota, USA.
Forward-Looking Statement
This news release by MedTrace Pharma A/S (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. The company offers no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those outlined in the forward-looking statements.
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