Wound cleansing & irrigation
Development for wound cleansing, irrigation, debridement and prevention. Ukraine pilot studies are planned for early 2027, with registration targeted for Q4 2026–Q1 2027 and national launch in H2 2027.
In development
Science in service of healing
Next Generation Antimicrobial
Advancing a new approach to biofilm in infected and chronic wounds. Helping create the conditions for healing.
The unmet need
Biofilm protects bacteria and can keep wounds in a persistent state of inflammation. For patients living with chronic wounds, this remains a significant barrier to healing.
Bacteria within biofilm are difficult to address with conventional antimicrobial approaches.3
Unhealed wounds account for about two-thirds of wound care costs and today's antiseptics and antibiotics do not adequately address biofilms.
TECHNOLOGY - Our solution
SoftOx WoundCare Biofilm Eradicator (SBE) combines stabilised hypochlorous acid with acetic acid in an optimised antimicrobial formulation. The SBE delivers clinical efficacy against infections and biofilm with superior outcome.
A molecule also produced by the body's immune cells.
Combined with HOCl in our optimised formulation.
Early first‑in‑human results in chronic leg ulcers indicate accelerated wound healing and activity against WHO‑priority resistant bacteria and biofilm.4
One formulation / Two development paths
Development for wound cleansing, irrigation, debridement and prevention. Ukraine pilot studies are planned for early 2027, with registration targeted for Q4 2026–Q1 2027 and national launch in H2 2027.
In developmentPharmaceutical development for infected, hard-to-heal wounds, with venous leg ulcers as the lead indication. Phase 1a/1b is complete with early positive signals and positive FDA pre-IND feedback; US Phase 3 is planned for late 2027.
Clinical developmentFewer weeks of dressing changes and nursing visits, fewer wounds becoming chronic, fewer amputations and admissions, and less systemic antibiotic use.
Source: SoftOx MedValue decision model (Markov VLU/DFU sheets). USD per patient, discounted 3%/yr; SoftOx price not included. Modelled, not clinical results.Clinical Evidence
Completed Phase 1a/1b studies in chronic leg ulcers provide early wound-healing signals, a dose-response pattern and an encouraging safety profile. Ukraine pilot studies are intended to support progression to a US Phase 3 trial.
Across the Phase 1a and Phase 1b studies (n=28), as reported in the company material.1
98%After a 20-minute soak, compared with 49% for saline.1 An early microbiological endpoint—not a wound-closure result.
Five days of treatment · follow-up at day 7
Group medians; small exploratory comparison (n=4 per arm). 500 ppm HOCl + 2% acetic acid. The negative placebo value indicates an increase in wound area. Source: SBE-01.4
After a 20-minute soak (%)
Compared with saline in a biofilm wound model. An early microbiological endpoint, not a wound-closure result.1
SBE is investigational. These early findings do not establish clinical efficacy or regulatory approval.
Company
SoftOx WoundCare is an independent medical company focused on developing a new class of antimicrobial for infected and chronic wounds. Built on 15 years of product development, we bring together specialist expertise as needed in a lean organisation, with patent protection until 2043.
Purpose
Locations
SoftOx WoundCare AB
Holding company · Malmö
SoftOx WoundCare Commercial
& Management AG
Commercialisation & management
Planned 2027SoftOx Wound & Skincare AS
Global support office
People
CEO · Chief Business Development Officer
Outgoing CEO · until end of 2026CEO
Planned · from 2027CFO · Finance, IR, Communication & Operations
Chief Commercial Officer
Chief Medical Officer
Head of IT
Chemistry Manufacturing Control Officer
QA Officer
Chairman
Outgoing · until end of 2026Chairman
Planned · from 2027To be announced
To be announced
Board member
Planned CEO · from 2027The 2027 CEO and chairman appointments are planned leadership transitions.
Timeline
From a patented idea to early clinical research, our development is guided by a clear goal: addressing the needs of hard-to-heal wounds.
Founded in Oslo on patented antimicrobial technology.
Start of collaboration with University of Copenhagen (Prof. Thomas Bjarnsholt).
Listed on Merkur Oslo Stock Exchange (SOFTOX-ME).
Sponsor contract established with the US Navy (wound care).
SWIS-02 wound study: faster early healing than saline.
SIS Phase 1 completed – safe to inhale.
EU COUNTERACT defence grant (CBRN) signed.
Safe in human with 98% bacterial reduction, 36% wound closure.
Restructuring; R&D to University of Copenhagen; wound care spin-out announced.
SoftOx Wound & Skin Care demerged to shareholders (1:1).
Successfully kills pathogens within the biofilm.
Sponsor contract established with the US Navy (wound care).
Faster early healing than saline.
Safe in human with 98% bacterial reduction, 36% wound closure.
Publication of stabilised hypochlorous acid in chronic leg ulcers.
SoftOx WoundCare demerged, becoming independent and developing SBE.
First medical-device registration ongoing in Ukraine; industrial partnership with local partner.
Equity partner with additional financing. New management. Ukraine MD proof of concept.
Commencing US Phase 3 Adaptive Design Clinical Trials. Considering listing in the US.
Detailed planning of commercialisation SBE US. Launch of MD RoW.
Market launch of SBE US and Europe.
Trials and launch of new product areas.
End of existing patents.
Planned milestones are estimates, not commitments, and depend on financing, clinical results and regulatory decisions.
Contact - Get in touch
For commercial partnerships and company enquiries.
SoftOx WoundCare AB
Slottsgatan 20
211 33 Malmö, Sweden