Clinical verification of LundaTex System - compression product for treatment of venous leg ulcers

Purpose and goal

The aim of the project was to clinically verify our product LundaTex System. A compression product consisting of a bandage that delivers a w ell-defined pressure invariant of who applies or the size of the leg, which is used together with the so-called ´Patches´ (Press Patch) made in a hook and loop material, which are applied outside the bandage to provide a higher, more effective working pressure. A patient study was initiated. Preliminary data from the study helped us to sign the first agreement with an international distributor.

Expected results and effects

During the project, we developed our product which is intended for patients with chronic venous leg diseases such as leg ulcers. The product was CE-marked and a patient study together with a national and an international leg ulcer clinic was initiated. Preliminary data from the study shows promising results. Presentations at international conferences have resulted in new business contacts.

Planned approach and implementation

The project has to a large extent followed the planned process stated in the application. 1. The product was improved after feedback from clinical expertise. 2. The product was CE marked. 3. A patient study was initiated. Feedback from international key-opinion leaders was used during all steps. The product has been presented at several major international conferences.