Enzymatica comments on article in Dagens Medicin
Dagens Medicin is critizing in an article on February 10, 2021 one of the clinical studies, the so called ColdPrev I, which is part of the clinical evaluation data supporting the benefits of the product, that Enzymatica uses in the marketing of ColdZyme®. Enzymatica refuses the criticism and gives the comment below.
ColdZyme is a very well-documented product, whose effect on common cold has been verified in both in vitro studies as well as in vivo studies. An in vitro study from 2017 showed that ColdZyme could deactivate over 90% of the known viruses that cause common colds. The ColdPrev I study, two German multicenter studies and lately a British study of endurance athletes display the clinical benefits of ColdZyme.
In the study that Dagens Medicin addresses, ColdPrev I, the scientists together with experienced statisticians have performed explorative analysis based on data from the study. These analysis, and the criterias for the analysis that were used, have been reviewed and approved by the principal investigator for the study. These results show that for those participants, which had common cold symptoms, the duration of the common cold was reduced by up to 3.5 days. Enzymatica considers that data and criterias for the analysis have been communicated in a clear and transparent way. In the latest British study on endurance athletes it was also shown that the duration of the common cold could be shortened by up to 3.5 days.
ColdZyme was recertified in 2020 according to MDD (Medical Device Directive) by the notified body Eurofins Product Testing. ColdZyme can thereby be sold as class III medical device product within the EU. ColdZyme and its documentation have been reviewed by Eurofins, which is a notified body for medical device products appointed by a competent authority within the EU. Eurofins have reviewed the full documentation, which includes safety, efficacy and product claims.
ColdZyme has contributed in a positive way to the common cold category in Sweden and internationally by adding a large group of loyal consumers. We look forward to continuing our effort to create value within the category by marketing of a safe, efficient and well-documented product.
For more information, please contact:
Claus Egstrand, Chief Operating Officer Enzymatica AB
Phone: +44 7780 22 8385 | E-mail: email@example.com
Ann-Christine Provoost, Director of Regulatory Affairs Enzymatica AB
Tel: +46 (0) 702-74 37 31 | E-post: firstname.lastname@example.org
Carl-Johan Wachtmeister, Communication manager Enzymatica AB
Phone: +46 (0)701-88 50 21 | Email: email@example.com
About Enzymatica AB
Enzymatica AB is a Swedish life science company that develops and sells health care products for primarily conditions of the ear-nose-and-throat region. The products are based on a barrier technology that includes marine enzymes. The company’s first product is the medical device ColdZyme®, a mouth spray against common cold. The product has been launched in about 30 markets on 3 continents. The strategy is to continue to grow by developing more health care products and strengthening the company’s position in existing markets and expanding into new geographic markets through established partners. The company has its headquarters in Lund and is listed on Nasdaq First North Growth Market. For more information, visit: www.enzymatica.com and www.enzymatica.se/en/section/media/press-releases
Enzymatica’s certified adviser is Erik Penser Bank. Phone: +46 (0)8 463 83 00. Email: firstname.lastname@example.org
Enzymatica AB Ideon Science Park, SE-223 70 Lund, Sweden Telefon +46 46-286 31 00