Article about ColdZyme acquitted from suspicions of research misconduct
11 April 2022
Non-regulatory press release
Article about ColdZyme acquitted from
suspicions of research misconduct
The Swedish National Board for Assessment of Research Misconduct (Npof) has acquitted the two researchers who had been reported by Region Skåne for an article about an Enzymatica financed scientific study. According to Npof, there is no basis for the suspicion of falsification or fabrication of data.
Region Skåne filed a complaint to Npof in December 2021 regarding the article from 2017 about Enzymatica’s study Coldprev 1. The board acquits the researchers from the suspicion of research misconduct and states in its decision:
“The board is of the opinion that if you read the article in its entirety, it is clear how the experiments have been carried out and how the calculations have been made. Thus, there is no basis for the suspicion of falsification or fabrication of data” (Npof, Dnr 3.1-21 0177, Enzymatica’s translation from Swedish)
”We are not surprised. These are well-reputed researchers who have no reason to push any boundaries. For their and our sake, I hope that Npof’s decision now puts an end to this issue”, said Claus Egstrand, CEO of Enzymatica.
The study was financed by Enzymatica and results from the study, together with results from a number of other studies, have been used in many regulatory application processes around the world when ColdZyme has been approved by local authorities for new markets. Results from the study were part of the collective clinical data that was assessed when ColdZyme was approved as a class-III medical device in the EU. The three most recent markets where the product has been approved by regulatory bodies are Canada, Mexico, and Turkey.
“We have an effective product with good scientific documentation. This leads to very smooth and fast approval processes for new markets, which allows for us to expand internationally at a good pace”, said Claus Egstrand.
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