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Beskrivning

LandNorge
ListaEuronext Growth Oslo
SektorHälsovård
IndustriMedicinteknik
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.
2021-09-22 09:34:19
Update regarding the ongoing application process for national approval of
biocidal products (disinfection products) in Norway (with reference to the stock
exchange announcement from SoftOx Solutions AS (SoftOx) on March 29 and
September 17, 2021).

The Ministry of Climate and the Environment has not upheld the postponed
implementation of whether there should be a deadline in Norway for SoftOx to
suspend sales by 3 October 2021, for SoftOx disinfection based on active
chlorine released from sodium hypochlorite.

-We do not understand this decision. It is important to emphasize that this has
nothing to do with the quality of and clinical documentation of the product,
says CEO Geir Almås in SoftOx.

The notice concerns the application for disinfection based on active chlorine
released from sodium hypochlorite, where there has been an ongoing appeal
process in the Ministry of Climate and Environment regarding the approval of
SoftOx disinfection. This application was rejected by KemI in Sweden, and has
been appealed to the Land and Environmental Courts in Sweden. Pending a decision
from Sweden, SoftOx has applied to the Ministry of Climate and Environment in
Norway to remain in the market with the product in question. The current
deadline for SoftOx to suspend sales is by October 3, 2021, with the possibility
of continued use for a period of six months thereafter. SoftOx has now received
a rejection of the request for deferred implementation of decisions. It is
pointed out, however, that when SoftOx is upheld in Sweden, the product will be
able to be put back on the market in Norway.

The Ministry justifies its refusal on the grounds that: "It is therefore only a
question of a temporary loss of revenue" and further writes: "The consequences
of the decision are reversible, in the sense that the product can be relaunched
on the market."

- The Ministry has based their decision on process and unfortunately shows
little understanding of the importance of keeping the product in the market. The
positive is that the Ministry states that the processing of our application will
be prioritized, says Almås

SoftOx is now taking a thorough review of the letter from the Ministry of
Climate and the Environment and continues the active dialogue with both KemI in
Sweden.

- We perceive the dialogue with KemI as very constructive and good, and are
optimistic about a positive outcome, says Almås.

For further information, please contact:
CEO Geir Almås of SoftOx Solutions AS, or
Mail: ir@soft-ox.com
Mobile: (+47) 948 59 599

About SoftOx Solutions AS
SoftOx Solutions AS (Softx, listed on Euronext Growth Oslo) is a Norwegian
BioTech 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