Newsletter No. 01, 2020

Welcome to RLS Global Newsletter

January has been a very busy month for RLS in a good manner. The company has accomplished two audits with good outcome, and we are well prepared for the new Medical Device Regulation, MDR, which will be implemented in May.

It has also been very busy from a go to market perspective. A few more contracts are signed by municipalities in Sweden. RLS is in several interesting negotiations with country councils in Sweden. As mentioned before Christmas, we expect some good outcome the first six months due to all market activities and interactions with our potential customers during the fall last year.

We also took the opportunity to attend the Advanced Wound Care symposium in Stockholm. The theme for the symposium was Trends within Wound Management. More than 200 nurses from Sweden were present.

I am very excited to kick-off a new year with the RLS team. Market penetration is of course the focus area for 2020 and we will open new markets during the year. We will take the next step and broaden the indication for ChloraSolv. New clinical trials will be initiated, and the team will grow. Welcome 2020!


Karin Fischer, CEO
RLS Global AB

 

January 21-22, more than 200 nurses met in Stockholm to learn more about future trends within Advance Wound Care. The passion and dedication to improve current standard treatments are encouraging.

One of the main speakers at the conference was Christina Lindholm, Senior Professor at Sophia hemmet Högskolan/Karolinska University. According to her presentation, trends within research and development and product development are very much on Biofilm and debridement.

Biofilm is a consortium of microorganisms in which cells stick to each other and often also to the surface. These adherent cells become embedded with a slimy extracellular matrix that is composed of extracellular polymeric substances (EPS). Because they have three-dimensional structure and represent a community lifestyle of microorganisms, they have been metaphorically described as “cities for microbes”.

A chronical wound with Biofilm will never heal. Due to the microorganisms and how they act and are organized, the epithelial cells cannot act and close the wound.

ChloraSolv is based on a unique hypochlorite technology platform consisting of a two-component system. The two components, mixed upon application onto the would bed, generate a step increase in pH that facilitates removal of devitalized tissue and biofilm, preserving health, viable tissue during debridement and helps loosen up the devitalized tissue. Also, very important to efficient would healing is to get control of the bacteria. ChloraSolv contains broad-spectrum anti-microbiological agent that reduces the microbiological load. It is very encouraging to provide the market with a technology that meets several of the needs to secure efficient wound healing for the patients.

A lot of questions are asked these days in regards of the new Medical Device Regulation, MDR, which will be implemented 26th of May 2020. The aim with the new directive is to secure safety and efficiency of current and future products within medical device. If you want to learn more about MDR, please use the link:

https://ec.europa.eu/growth/sectors/medical-devices_en

RLS did all the MDR preparation during the fall last year. In January two audits have been completed, MDD and 13485:2016, with very good outcome. RLS is well prepared to implement MDR and the audit will take place during this year. Eurofins is RLS new notified body.

Annika Nordström
Key Account Manager, RLS Global
presenting the benefits of ChloraSolv
in the RLS Global booth