First trial in Humans shows positive effects in acute wounds

SoftOx Solutions’ (SoftOx) first-in-man clinical trial (SWIS-01) with its wound
rinsing product, abbreviated SWIS, has been successfully completed. The pilot
study which was conducted at the Department of Dermatology and Copenhagen Wound
Healing Center at Bispebjerg University Hospital, was designed to explore safety
and performance properties of SWIS in patients with split skin transplant donor
sites, serving as a model for surgically inflicted acute wounds.
 
Overall results show that SWIS has a very good safety profile, which was the
primary endpoint of the study. Performance-wise, the SWIS irrigation procedure
documents bacterial reduction, without impeding the epithelialization rate
(wound closure).  More information on this study can be found at
www.clinicaltrials.gov (NCT03742284).

A major milestone for SoftOx 
The clinical trial application for the company’s first medical device product
was approved by the regulatory authorities in Denmark late 2018, with a
subsequent recruiting period of approximately 9 months. 
“Today we can confirm that SWIS is safe in humans, and we are pleased to
announce that our product is tolerable when applied, and demonstrates favourable
rinsing effects in acute wounds”, says Glenn Gundersen, Medical Director of
SoftOx. Although, pilot studies in general are small in nature (12 patients),
the results are encouraging and serve as an important base for further product
development.

“This is an important milestone for both patients and SoftOx, as SWIS exerts its
effects without the use of antibiotics. This is ‘proof of concept’ of our
technology in the clinical setting, says CEO, Geir Almås. Ongoing dose-finding
studies in animals will further optimize the formulation to generate future safe
and effective medical products. We now look forward to continued development of
SWIS and bring it to the market without delay”, says  Almås.

A comprehensive and detailed publication on the results will be published in a
peer-reviewed Medical Journal. 

Contribution to solving the ever-increasing healthcare challenge of antibiotic
resistance
The development of SoftOx’ proprietary technology platform as well as product
leads have been completed in cooperation with The University of Copenhagen, more
specifically The Costerton Biofilm Center and Bispebjerg Hospital. The basis for
this technology is a combination of natural chemical agents well known to the
human body, which makes them well tolerated in use, and simultaneously highly
effective in killing bacteria and other microorganisms – without inducing
resistance. Laboratory experiments have shown outstanding microbicidal effects –
both on free-floating (planktonic) and biofilm embedded microbes, including
pathogens on WHO’s (World Health Organisation) list of bacteria resistant to
antibiotics. 


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About SoftOx:
SoftOx Solutions AS (SoftOx) is a Norwegian MedTech company established in 2012
and listed on Merkur Market, Oslo Stock Exchange (SOFTOX-ME) in 2017. The
company’s proprietary technology is focused on developing antimicrobial products
that do not contain classical antibiotics or induce microbial resistance, aiming
to prevent and treat biofilm-associated infections, either as medical device or
pharmaceutical products. SWIS, a medical device class III, is the Company’s
first product reaching clinical phase. For more information about SoftOx, see
www.soft-ox.com . 


For more information contact:
Geir H. Almås, geir.almaas@soft-ox.com, telephone 977 59 071