Beskrivning
Land | Norge |
---|---|
Lista | Euronext Growth Oslo |
Sektor | Hälsovård |
Industri | Medicinteknik |
2021-06-23 11:00:27
SoftOx Solutions AS (SoftOx) is pleased to announce that the results of the
clinical investigation SoftOx Wound Irrigation Solution for acute wounds (SWIS)
have been completed. The study, which has been conducted at Bispebjerg
University Hospital in Copenhagen, is a confirmatory clinical investigation to
document safety and performance of SoftOx Wound Irrigation Solution (SWIS)
compared to Normal Saline (NS) in a human wound model.
The study showed both significant improvement in wound healing and reduction in
bacterial burden compared to Normal Saline (NS), positioning the product as
superior towards today's market leaders. Finishing the clinical development
program strengthens the SoftOx platform for further product development. The
results from the study "SWIS-02" confirm the excellent safety profile of the
SoftOx technology platform, also strengthening the documentation of SoftOx hand
disinfectant technology with regards to skin friendliness being superior to
today's alcohol-based hand disinfectant. The company now prepares to file their
wound irrigation SWIS for final approval as a Medical Device in Europe.
SoftOx Wound Irrigation Solution (SWIS) will become a Medical Device intended
for wound rinsing and moistening to prevent infections in all types of acute
wounds, such as abrasions, cuts, burns and surgical wounds. SWIS has the
potential to become a favoured alternative to the current wound irrigation
solutions on the market which have challenges related to safety (side effects,
resistance development) and effect. According to market reports from The Insight
Partners, the global market size for wound irrigation solutions was estimated at
USD 1.6 billion in 2018, and yearly 190 million wounds is treated in hospitals.
Finalization of the SWIS-02 study concludes the clinical evaluation part of the
SWIS documentation package. SWIS is expected to be the company's first CE-marked
product for the European market.
Regarding the wound healing capabilities, the study meets its primary endpoint
of re-epithelialization (non-inferior to NS) by day 10 with high significance
(p<0.0001). Furthermore, early re-epithelialization at day 4 was significantly
better than normal saline (mean 57% versus 43%, p<0.0001). Also, overall
usability aspects of SWIS handling were reported to be satisfactory.
Once again SWIS demonstrates and confirms previous findings (from SWIS-01) to be
safe and well tolerated as a wound irrigation solution for acute wounds and not
associated with any major risks. Performance outcomes demonstrate antimicrobial
properties with excellent wound healing (re-epithelialization) observations.
"This has been a highly successful study with respect to implementation, conduct
and outcome and clearly confirms the favourable properties of SWIS as an
excellent wound irrigation solution," says Glenn Gundersen, Medical Director of
SoftOx.
For further information, please contact:
Geir Almås, CEO of SoftOx Solutions AS, or
Glenn Gundersen, Medical Director 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 vision 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.