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SoftOx Solutions är ett norskt medicintekniskt bolag. Bolaget har utvecklat en egenpatenterad lösning baserad på ättiksyra för behandling av kroniska sår hos patienter. Lösningen används för att eliminera infektioner i samband med biofilmer, vilket består av olika kluster av bakterier. En del av läkemedelsutvecklingen sker i samarbete med övriga forskningsinstitut. SoftOx Solutions etablerades under 2012 och har sitt huvudkontor i Oslo, Norge.
2021-03-29 14:32:30
With reference to the stock exchange announcement from SoftOx Solutions AS
("SoftOx") on December 11th, 2020, when SoftOx received information from the
Swedish Chemicals Agency that the application for SoftOx Disinfection Products
was sufficiently complete to proceed to the final decision-making. Contrary to
this statement, the Swedish Chemicals Agency changed its initial position by
rejecting SoftOx application with reference to its latest request for additional
testing data.

This implies an estimated six-months delay for SoftOx's major launch in the
European markets, notwithstanding, the Swedish decision does not affect
continued sales and marketing in Norway, Sweden and Denmark.

"Based on the information received in December we were confident that our data
was sufficient to approve our products. We are surprised by the decision and the
justification when the Agency now ask for additional tests", says CEO Geir Almås
of SoftOx Solutions AS.

The request for additional test concerns certain impurities in the formulated
disinfectants. SoftOx fundamentally and scientifically disagrees with the
Swedish Chemicals Agency's assessment and request for additional tests for this
data. During the evaluation process, SoftOx submitted a series of test data,
generated by the accredited third-party laboratory "Sintef", in which it was
confirmed that the concerned impurities does not impact adversely the SoftOx
disinfectant products. In support of this, SoftOx has also undertaken additional
tests to verify its initial conclusions presented to the competent authorities
during the evaluation process. These confirmatory tests (including requested
tests) are anticipated to be finalized in November 2021.

Notwithstanding, SoftOx is committed to defend its scientific position and
pursue its biocides submission before the national competent authorities. On
advice from its scientific experts, SoftOx intends to contest and submit an
administrative appeal in Sweden, and to undertake additional regulatory measures
to ensure a scientifically viable and sustainable implementation of EU's
biocides regime on SoftOx products.

"SoftOx feels confident that when the requested documentation is available, the
application will be duly recognized." Says Almås.

For further information, please contact:

Geir Almås, CEO of SoftOx Solutions AS
Mail: ir@soft-ox.com
Phone: Front Desk: (+47) 948-59-599

About SoftOx Solutions AS
SoftOx Solutions AS is a Norwegian BioTech company listed on Euronext Growth
Oslo. Our Vison is "Helping the world fighting infections - developing new ways
of eradicating infections and fighting antimicrobial resistance". We are working
to combat major threats to human health, namely the emergence of antimicrobial
resistance (AMR), biofilm infections in chronic wounds and the spread of
viruses. For more information on SoftOx, visit www.soft-ox.com.