The Danish Medicines Agency (DKMA) has authorised the "SBE-01" clinical trial on
medicinal products. The authorisation is given pursuant to § 88(1) of the Danish
Medicines Act.1. 

This rapid approval by DMA in less than 3 weeks is exceptionally fast and
demonstrates the completeness and quality of our documentation and proposed
study design, says Glenn Gundersen, Medical Director in SoftOx Solutions AS.
This is the first-in-man (phase I) study with our lead wound care product, SBE,
designed to treat infected chronic wounds. The study will establish a tolerable
dose and treatment schedule for SBE to be able to develop it into an effective
infection-treatment solution in problematic, non-healing wounds. 

This approval represents an important milestone for SoftOx Solutions AS and is
of crucial importance for the further development of an effective infection
treatment of problematic wounds, where there is an unmet medical need. It is
also an important step forward for the company's collaboration and funding
partners, such as University of Copenhagen, Bispebjerg University Hospital, US
Naval Medical Research Center (NMRC) under Medical Technology Enterprise
Consortium (MTEC) and The Research Council of Norway.

The SBE-01 study will commence as soon as permission has also been granted by
the relevant Scientific Ethical Committee.

SBE-01: EudraCT no. 2021-000314-42.

For further information, please contact:

Geir Almås, CEO of SoftOx Solutions AS, or
Glenn Gundersen, Medical Director in SoftOx Solutions AS
Mail: ir@soft-ox.com
Mobile: +47 977 59 071

About SoftOx Solutions AS
SoftOx Solutions AS (SoftOx, listed on Euronext Growth Oslo) is a Norwegian
MedTech company based in Oslo with the aim of helping 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