February 8, 2019

Welcome to RLS Global Newsletter

Issue 1, 2019

It is very exciting to kick off a new year for RLS Global. 2019 is the year when we will launch our new product, ChloraSolv, within advanced wound care. It is also the year when we accelerate our partnership with Straumann and open new markets for CariSolv. It is the year when we will improve our “external focus” and establish many new partnerships, which will have a significant importance in the future development of RLS Global.

I do hope you all have had the possibility to navigate and learn more about our new website, www.rls.global. As a team we are very proud that we now can reach out with our message and services to the global environment. The long-term goal is that our website is the platform to learn and understand about our two clinical fields, oral- and wound care.

Our aim is to continue to provide newsletter on regular basis. In parallel we will publish notifications on our LinkedIn profile, RLS Global. In August we will open our Facebook account which will improve our communication with the patient and the families. Enjoy the reading!

Karin Fischer, CEO RLS Global

The status of CE Approval for ChloraSolv

The question these days are of course, when is ChloraSolv finally CE approved and ready for commercialization? 

To register and get a medical device product approved is a regulatory, complex, process. The aim with the regulation is to secure safety and efficient products to the market. ChloraSolv is a unique patented product within debridement which will help many patients with chronical wounds in the future.

As been communicated, RLS submitted the technical file to the notified body, Llodys, in the beginning of 2018. Given the challenging European situation with the implementation of the new Medical Device Regulation, MDR, as well as a potential of a hard Brexit, the process has taken much more time than expected. At this point we are slightly more than one month late according to the outlined plan communicated in May 2018 (target date end of December 2018).

Despite the challenging situation, RLS has close communication and dialogue with Lloyds. At this point RLS is very busy keeping up with the tight deadlines and complex situation Lloyds are facing at this point.

In parallel, the team is working intensively to prepare the go to market strategy for ChloraSolv. One big event RLS will attend is the European Wound Management Association Meeting (EWMA) in Gothenburg in June 2019. EWMA is a non-for-profit umbrella organization, linking national wound management organizations, individuals and groups with interest in wound care.

Central to EWMA’s objectives is to support implementation of interdisciplinary and cost-effective wound care of high quality. EWMA works to reach its objectives by being an educational resource, organizing conferences, contributing to international projects related to wound management, actively supporting the implementation of existing knowledge within wound management and providing information on all aspects of wound management.

This year EWMA is organized in Gothenburg, June the 5th – 7th. This is the event when RLS will promote and share the story and come across with the message about ChloraSolv to the broader European audience. At the event more than 4,500 participants are attending from more than 80 countries. It is in important milestone for the team.

RLS will attend in different meetings and symposiums during the exhibition. These days are a great opportunity to meet potential customers and distributors. But most important of all, take part of scientific presentations and meetings focusing on the importance to drive the science forward, says Karin Fischer. Three intensive days to meet colleges from the same area of interest is very important and much appreciated.