Development Project

We are now in the final phase of the development project of ChloraSolv.

A clinical program is ongoing. ChloraSolv has been evaluated in an open randomized controlled study where safety and tolerability were assessed as well as a beneficial outcome on wound size reduction and wound closure. The result of the study was published in Clinical Diabetes and Endocrinology 2016 (12).  We have initiated our second trial together with six sites in Sweden.

The product has been submitted for registration in Europe and we look forward to presenting our unique product to the market in 2019 after receiving regulatory approval.

We are using our proprietary buffered hypochlorite technology to create a new and innovative product ChloraSolv to assist clinicians to effectively debride and clean the wounds to support natural wound healing.

ChloraSolv has been designed to meet the following objectives and customer needs:

  • To facilitate removal of necrotic tissue and biofilm preserving healthy, viable tissue during debridement.
  • The de-vitalized, necrotic tissue shall be is easy to remove by using a blunt instrument and may re-place or reduce the need for sharp debridement
  • Easy to use in primary care and in patients’ homes by a health care professional.
  • It shall only require a short application time to enable an efficient wound treatment procedure.
  • The Product shall contain sodium hypochlorite that is a broad-spectrum anti-microbiological agent that reduces the microbiological load as shown in vitro (pH Eur 5.1.11).

Our overall goal has been to provide a gentle and effective debridement method that result in improved wound care reducing the suffering for patients and   the overall cost for the society in treating complicated wounds.

Product

1. K. Sen et al., Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy, Wound repair and regeneration, 2009 Nov–Dec; 17(6): 763–771.

2. International Diabetes Federation. IDF Diabetes Atlas, 8th edn. Brussels, Belgium: International Diabetes Federation, 2017. http://www.diabetesatlas.org

3. Armstrong et al. Diabetic Foot ulcers and their recurrence. N Eng J Med June 2017

4. Clinical Practice Recommendations on the Diabetic Foot: A guide for health care professionals. International Diabetes Federation; 2017.

5. Diabetic foot problems: prevention and management. National Institute for Health and Care Excellence, UK; 2015.

6. Strohal R. The EWMA document: debridement. J Wound Care. 2013;22(1):5.

7. Gould L, Stuntz M, Giovannelli M, Ahmad A, Aslam R, Mullen-Fortino M, et al. Wound Healing Society 2015 update on guidelines for pressure ulcers. Wound Repair Regen. 2016;24(1):145-62

8. Lavery LA, Davis KE, Berriman SJ, Braun L, Nichols A, Kim PJ, et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines. Wound Repair Regen. 2016;24(1):112-26.

9. Marston W, Tang J, Kirsner RS, Ennis W. Wound Healing Society 2015 update on guidelines for venous ulcers. Wound Repair Regen. 2016;24(1):136-44.

10. Flanagan M. Principles of Wound Management. In: Flanagan M, editor. Wound Healing and Skin Integrity: Principles and Practice. First edition ed: John Wiley & Sons, Ltd; 2013. p. 66-83.

11. Schultz GS, Sibbald RG, Falanga V, Ayello EA, Dowsett C, Harding K, et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003;11 Suppl 1:S1-28.

12. Bergqvist K, Almhojd U, Herrmann I, Eliasson B. The role of chloramines in treatment of diabetic foot ulcers: an exploratory multicentre randomised controlled trial. Clin Diabetes Endocrinol. 2016;2:6.