Welcome to RLS Global Newsletter No. 02, 2020

Newsletter No. 02, 2020

Welcome to RLS Global Newsletter

March is approaching fast and a lot of activities has been put into motion. One of the focus areas of RLS Global is the long-term strategy of ChloraSolv to establish partnership on a regional and global level. During the fall, RLS has been very focused on the Swedish market. As of new year, the first initiatives have been taken in Denmark and Norway.

At the same time, RLS will initiate pre-clinical activities with the aim of broadening the product portfolio in areas such as burns and clinical indications outside Advance Wound Care during 2020. The R&D activities are based on the RLS Global’s Unique Buffered Hypochlorite Technology.

Effective as of May 25th, 2020, MDR (Medical Device Regulation) compliance is another important and necessary step for RLS. Decision was taken by the RLS board during 2019 to sell of the dental portfolio. To secure MDR compliance for PeriSolv and CariSolv would have required investments and resources in terms of more clinical data and improved documentation. Though with ChloraSolv we are very well prepared, and the process is in good condition to meet the new regulations.

With RLS focus on Advance Wound Care, I am very pleased that REGEDENT AG has decided to acquire PeriSolv and make the investments needed to secure the product is MDR compliance (announced on February 23rd). PeriSolv is an important component to the CLEAN & SEAL concept. To learn more about REGEDENT and the CLEAN & SEAL concept, please read below.


Karin Fischer, CEO
RLS Global AB

REGEDENT is a company based in Switzerland with almost 10 years of experience within the dental business. REGEDENT develops, manufactures and markets innovative solutions in regenerative and implant dentistry for optimized treatment and long-term patient care. The mission of REGEDENT is to supply professionals with smart regeneration products and solutions.

REGEDENT has developed the concept CLEAN & SEAL. It was developed based on scientific data, provides guidance and support for treatment and control of peri-implant mucositis. PeriSolv is an important component in the concept of CLEAN & SEAL. PeriSolv softening the extracellular matrix of the biofilm and enhancing bacterial removal by mechanical debridement.

Peri-implant disease is divided into two subgroups. Peri-implant mucositis, which is characterized by soft tissue inflammation without bone loss and peri-implantitis which is characterized by progressive loss of the supporting bone.  If mucositis is left untreated, it can progress into peri-implatitis, in worst case it can generated loss of the effected implant.

This problem is relatively new to the clinicians and dissatisfying for patients. It is of great importance to treat peri-implant mucositis, with infection control and extensive debridement being crucial for positive outcome.

More than 25% of the entire population undergoes a treatment of periodontal disease. A very small number represent surgical treatment. The periodontal market was valued to US$ 500 Mn in 2017. PeriSolv represents the chemical part in a chemo mechanical treatment of periodontal diseases.

To learn more about CLEAN & SEAL please use the link below:

http://www.regedent.com/en/professionals/concepts/clean-seal/


Welcome to RLS Global Newsletter No. 01, 2020

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


Welcome to RLS Global Newsletter No. 10, 2019

Newsletter No. 10, 2019

Welcome to RLS Global Newsletter

Watch the interview with Karin Fischer, CEO RLS Global, summarizing 2019 and presenting the focus areas of 2020.

 

Merry Christmas and Happy New Year!


Karin Fischer, CEO
RLS Global AB


Welcome to RLS Global Newsletter No. 9, 2019

Newsletter No. 9, 2019

Welcome to RLS Global Newsletter

Did you know that diabetes is a leading cause of amputation, blindness, heart disease, kidney failure and early death? Simple action can reduce the risk. World Diabetes Day became an official United Nations Day in 2006 with the passage of United Nation Resolution 61/225. It is marked every year on November 14th, the birthday of Sir Frederick Banting, who co-discovered insulin along with Charles Best in 2922.

As ChloraSolv is a very important treatment for diabetic foot ulcers, RLS Global wants to take this opportunity to recognize the World Diabetes Day.

Up to 70% of all lower limb amputations are related to diabetic foot ulcers. Every 30 seconds someone around the world is amputated due to a non-healing diabetic ulcer. Five-year mortality rate following amputation is reported between 47-70% and is higher among patients with major amputation.

Demand of wound care is increasing globally due to ageing populations and the development of lifestyle diseases such as obesity and diabetes. In 2017 about 425 million people were diagnosed with diabetes. Diabetes has a yearly growth on global level with about 8%. In 2045 the numbers will be closed to 630 million people. Up to 35% of people with diabetes will develop a diabetic foot ulcer in their lifetime.

Today, at the World Diabetes day, RLS is attending a congress with close to 1000 participants from Sweden. Read more about the meeting below.

 

Best regards


Karin Fischer, CEO
RLS Global AB

The last three years, a Swedish Health Day for nurses has been arranged. This year it takes place in Örebro. The organizer is expecting between 800 to 1 000 delegates.  It is a day focus on future competences in different clinical areas such as advanced Wound Care. The day is organized with lectures, trade show and meetings/networking. It is a popular event for companies within advanced wound care. RLS will be present for the first time!

Attending meeting such as Swedish Health Day for nurses is an excellent opportunity to meet and share ChloraSolv to a wide range of potential users, such as nurse being experts on chronical wounds. In a context like this, most of the time it is a platform to meet and discuss with several of representatives from the same care giver.  Networking is key, and meetings like this always generate a lot of positive follow up work.

In Sweden, the nurses are the key contact person for patients with chronical wounds meeting the patients during a longer period. Among the nurses, there are always a request for new competence and new solutions for wound management.

‘Swedish Health Day have started and during the first two coffee breaks, the booth was full of interested delegates’, says Annika Nordström, Key Account Manager at RLS Global.

Annika continues…’It is very exciting to attend the Swedish Health Day and we will continue to share the story about ChloraSolv and share more highlights from the meeting’.


Welcome to RLS Global Newsletter No. 8, 2019

Newsletter No. 8, 2019

Welcome to RLS Global Newsletter

Market penetration is one of the key activities at RLS Global and our close collaboration with several of the Key Opinion Leaders are crucial. The partnership with OneMed is of course also very essential in order to accelerate the market penetration as rapidly as possible.

Our focus lies on Sweden at the moment and together with decision making bodies RLS have several clinical tests ongoing. The reference teams in the different country councils do evaluate and secure the clinical needs before any products or procedures are added to current or future contracts. The aim with the test is to educate and give the clinical staff experience of the new product or procedure. The outcome of the tests is coordinated in the individual country councils together with the clinical documentation and is the proof and argumentation for long-term reimbursement.

It is exciting to work in such close cooperation with experts within the clinical field. RLS makes learnings and receive very valid feedback which will be a part of our future development of ChloraSolv. Most exciting of all is when we receive all the positive feedback from many hospitals and clinics in Sweden.

Best regards


Karin Fischer, CEO
RLS Global AB

RLS has communicated the Go to Market Strategy for ChloraSolv. We strongly believe our home market is very essential and important. Why? Strong footprint on the home market is important for external stakeholders such as partners and clinicians. Also, Sweden is a well-developed country with strong reputation in the wound management environment. Moving on to new countries, the feedback from Sweden is important.

The total value of the Swedish market (Advanced Wound care market) is estimated to approximately 390 MSEK. The debridement market is close to 50 MSEK. However, since not all patients are treated with relevant debridement procedure the numbers are probably much higher. It is important to share the knowledge and research in regards of the importance of efficient debridement and the impact on wound healing.

In parallel, RLS is reviewing different options for the Nordic region as well as a few other markets in Europe. It is important to conduct a sustainable due diligence on the individua markets to ensure successful market entrance.

An important stakeholder for RLS is of course the societies driving the interest for the patients. RLS really appreciate that Stockholm Society of Diabetic acknowledge the fact that a new product has been CE approved for Diabetic Foot Ulcers.

Stay tune… more to come RLS the next couple of months.


Welcome to RLS Global Newsletter No. 7, 2019

Newsletter No. 7, 2019

Welcome to RLS Global Newsletter

I am very happy and proud that RLS Global announced September 25th the raising proceeds of SEK 50 million. It is an important contribution to the acceleration of the ChloraSolv strategy to establish a more sustainable growth at the market.

The reason to use preferential rights to further fund RLS was to diversify the shareholder base among institutional investors and at the same time take advantage of the opportunity to raise capital in a time- and cost-efficient manner. It is important to establish a strong base among institutional investors to secure long-term sustainability. The Directed New Share Issue was among a number of Swedish and international institutional investors. The book will be public in about 10 days.

The financial raise will be used to further invest in the Wound Care business segment. To build a sustainable business takes time and require resources. Our aim is to establish a long-term global partnership. In the meantime, the request is to further develop the product portfolio within Wound Care.

The net proceeds of the Issue intend to be used to the following focus areas:

1) Further develop and support the clinical program based on the company’s unique technical platform. The ChloraSolv 01 trial is ongoing and will be complied during Q1 2020. We are aiming to initiate new trails during 2020 to further develop the data supporting ChloraSolv. It will also be important to compile health economic data to support countries reimbursement systems.

2) Prepare the FDA submission. The US is a big and attractive market. However, it takes time and resources to get market access. RLS will initiate the process during the fall 2019.

3) Product portfolio development within Wound Care

4) Secure market penetration in selected international markets. Europe is the focus for 2020-2021. Important, strong market penetration in a few countries are more successful compared to limit market acceptance in several countries. Therefore, RLS will select a few strategic countries in Europe. In parallel we have initiated the registration process in a few selected regions.

5) Intellectual properties. We will continue to work on our patent strategy.

It is also very exciting that the Swedish leading Financial Newspaper, Dagens Industri, DI, reached out for an interview to further share the message about RLS and ChloraSolv. Please take part of the interview via the link below:

https://www.di.se/nyheter/nyemission-ska-fa-fart-sarvardsportfolj/

Last but not least, I want to send a thank you to our current as well as our new shareholders. RLS has a very exciting journey going forward and we will continue sharing news about our business development.

Have a nice weekend!

Best regards


Karin Fischer, CEO
RLS Global AB


Welcome to RLS Global Newsletter No. 6, 2019

Newsletter No. 6, 2019

Welcome to RLS Global Newsletter

It was communicated Thursday 12th of September that RLS Global signed a cooperation agreement with OneMed AB. OneMed is the leading distributor in the Nordic region and will act as a distributor for ChloraSolv to the municipalities and country counties whom they have agreements with. This is of course an important first step of the startup phase of the commercialization of ChloraSolv.

OneMed is present in several European markets where the Nordic region is the most prominent. They are supplying medtech products, medical equipment and providing services support system to the healthcare sector. RLS have a great opportunity together with OneMed to build up a structured training program with the aim to providing an efficient debridement method to the patients – ChloraSolv.

Below is a short summary describing the aim and processes to secure access of products into the tender based healthcare system. These processes apply to all suppliers introducing new products and innovations to the market. 

I hope the summary below will provide some general understanding about the obligations and purposes with regulated reimbursement processes.

Best regards


Karin Fischer, CEO
RLS Global AB

The purchase structure for the European countries are designed and governed under the law of Public Procurement Act. For any supplier, it is key to get into the public procurement lists, in order to have their products accessible for use.

The aim with public procurement is to secure the tax money are used cost efficiently, the purchase structure is covers measures taken in order to procure supplies, services or works through contract award. But most important of all, secure the health care system is offering the best products and procedures to the patients.

The RLS team has moved very rapidly in Sweden. Clinical tests are initiated in several of the country councils. The aim with the tests is to educate and give the clinical staff experience of the new product or procedure. The clinical tests coordinated in the individual country councils are together with the clinical documentation the proof and argumentation for long-term reimbursement.

As been communicated in the past, ChloraSolv will open a new category within debridement, chemical mechanical debridement, which makes the product unique. It is not competing with any other products in the tender agreements today. We will focus on adding ChloraSolv on the tenders that are ongoing.  In parallel, a few country councils will announce the public tenders for advanced wound care during the fall which gives RLS the opportunity to participate in the bid.

OneMed is an important supplier to several of the country councils and homecare districts in Sweden and the rest of the Nordic. The partnership with OneMed will give RLS access to many important stakeholders as well as decision making bodies for new products and innovations. RLS will as well establish training and educational program with OneMed with the aim to increase the knowledge and understanding of efficient debridement method. A common goal is to treat more patients in a much more efficient way.

To learn more about OneMed please use the link below:

www.onemed.com


Welcome to RLS Global Newsletter No. 5, 2019

Newsletter No. 5, 2019

Welcome to RLS Global Newsletter

With the holidays behind us, the team is back, rested and ready to take on the business during autumn. At RLS we have very exciting and busy months ahead of us which will have good impact on our future business.

As of August 1st, RLS Global has a new team member onboard – Annika Nordström. Annika has the position as Key Account Manager and will drive the commercialization process for the Swedish market. I am thrilled to extend the Swedish team and I know with Annika’s background and long experience within wound management, ChloraSolv will be well taken care off and introduced to our customers. To learn more about Annika and her view of the wound care market in Sweden, please continue to take part of the newsletter below.

I am looking forward to continuing to share our journey and news during the fall. We are also aiming to open our Facebook account during the fall and share on a more regular basis our daily work within RLS Global.

Best regards


Karin Fischer, CEO
RLS Global AB

Annika Nordström, Key Account Manager

Annika, welcome to RLS Global! Why did you decided to join RLS Global and be part of our journey going forward?

‘I believe it is a unique situation, to be part of such a great team and bring a new technology to the market. As we all know, wound debridement is the mechanical removal of dead, damaged or infected tissue. To improve the healing potential of the remaining tissue plays a very important role in wound management. Today, there is a gap when it comes to efficient debridement. I have a strong believe that ChloraSolv will close part of this gap, says Annika Nordström.’

What kind of properties do you believe are important to secure a successful launch with ChloraSolv?

‘Annika Nordström continues…we must keep in mind, the daily work in the healthcare sector is extremely busy with high pressure on the healthcare professionals. To change a current working procedure takes time and the benefits of the product must have strong evidence.  You can read in the newspaper daily how the healthcare sector is suffering due to lack of resources and money. I believe benefits such as ease of use, cost efficiency and gentle to the patients are extremely important.  But of course, most important of all, safety and good outcome. When I did my due diligence before joining RLS Global I found out that ChloraSolv can meet these expectations. ChloraSolv is a product that can be used both in the healthcare sector and in homecare. It is very easy to use. The clinical outcome impresses me.

Annika, you have spent almost your entire career within wound management. You have more than 10 years of research experience. The last 15 years within the industry. Why wound management?

‘You are right, I have such a passion and dedication to the patients suffering of chronic wounds. It is a big patient group, growing yearly by 8-10% on a global level. Despite increasing focus on research and development there is still a lot to do to improve the quality of life for this patient group. It is important the healthcare sector together with the industry continue to drive the research and development forward. Better and more efficient treatments are a must to change this negative trend. But of course, on a higher level, we need to change our lifestyle and take care of our health to prevent diseases such as obesities and diabetic, says Annika Nordström.’

What will be your strongest and most important contributions to RLS Global and the launch of ChloraSolv?

‘Annika conclude, with more than 25 years of experience within wound management I have a unique network. I have already met several key opinion leaders introducing ChloraSolv. In general terms, there is a need and a great interest for new and efficient debridement products. I am impressed that RLS Global already have several test sites in Sweden. My first task is to secure the outcome of these test sites as well as driving the procurement process forward in our main councils in Sweden. I strongly believe that we will have a few contracts in place by the end of the year. I will also work in close collaboration with the R&D team to secure that the market experiences will be part of the next generation of ChloraSolv. The technical platform is very interesting, and I believe the future is bright. I am very much looking forward to share patient stories and ChloraSolv experiences with all of you.


Welcome to RLS Global Newsletter No. 4, 2019

Newsletter No. 4, 2019

Welcome to RLS Global Newsletter

During June 5-7, the EWMA Conference (European Wound Management Association) took place in Gothenburg, Sweden. 3 700 delegates from more than 81 countries visited Gothenburg and EWMA. All with one common interest – how to improve the patient treatment of chronic wounds. The congress was a very important milestone for RLS Global with the launch of ChloraSolv.

Attending EWMA was tremendously inspiring. But it was also connected with a lot of proudness. When the RLS team left Congress at Gothia Tower it was with a strong, happy and successful experience. The number of people whom we shared the story of ChoraSolv, the new connections that was established, and the number of people showing interest in a more efficient debridement treatment, cannot be counted. Now the exciting work task takes on, to evaluate and continue the conversation with several very, interesting leads.

EWMA – a Very Important Milestone for RLS Global

RLS Global decided in early 2019 to attend EWMA with a strong present. Despite that RLS Global is a small company, it was decided to be present with a booth and take the opportunity to expose ChloraSolv. Below you can see pictures of the design of the booth and the team. It was a lot of traffic at the booth during the three days of the Conference. Our communication focused on the benefit and usage of ChloraSolv but also the current and future clinical program. For the team it was good learning to receive questions and feedback on the first generation of ChloraSolv and we also got quite a few tips how the product can be further developed.

EWMA together with RLS also organized a focus group meeting represented by 10 key opinion leaders from seven different European countries. The aim with the focus group meeting was to invite representatives with various background and receive direct feedback on the product it’s claims and benefits. At the meeting both physicians and nurses were present. A lot of very valuable feedback but one very important take away was how to further develop the clinical program for ChloraSolv. The RLS technical platform has a lot of new, interesting, opportunities and sharing ideas with a group of experience people is of course very encouraging.

RLS Global’s Chief Technology Officer, Mats Ahlenius, was attending and presented ChloraSolv at a satellite symposium focusing on new innovations. RLS was one out of five companies speaking at this session. It was interesting to listen to other companies with similar journey as RLS but also to share ChloraSolv with the audience with strong interest of new innovations. We did a lot of pre-marketing about the event and the conference room was filled during the presentation.

Walking around the exhibition and learn about all the companies and their portfolio, it is obvious that the market is seeking for efficient debridement treatments. Of course, ChloraSolv has a few competitors, however, ChloraSolv stand out providing a chemo-mechanical debridement with antimicrobial properties. It is also unique that ChloraSolv is used as a debridement procedure, it is not a gel you keep between the dressing changes. The fact that ChloraSolv is easy to use, a lot of our visitors thought that the product is very appropriate both in primary- and homecare. Most of the patient suffering of chronic wounds are treated in the homecare sector.

If you want to learn more about EWMA – please visit www.ewma.org

I want to take this opportunity and highlight the company presentation that took place May 28th. We had close to 60 participants attending the webcast. If you missed the presentation, please use the link below and you can take part of the team presentation: www.rls.global

May 29th the Annual Meeting 2019 took place. I want to thank the shareholders attending the meeting. A lot of good questions and input related to RLS Global go to market strategy. I highly appreciate the opportunity to share our success and challenges in this kind of setting.

Finally – I want to wish you all a wonderful summer. See you in August!

Best regards


Karin Fischer, CEO
RLS Global AB


Welcome to RLS Global Newsletter No. 3, 2019

Newsletter No. 3, 2019

Welcome to RLS Global Newsletter

At the beginning of May, RLS participated in the Symposium of Advanced Wound Care (SAWC) which took place in San Antonio, Texas, May 7th-11th. The meeting serves as a forum to connect the entire wound care team; physicians, nurses, physical therapists, researchers, scientists, podiatrists and dietitians. The aim and purpose are to share the latest news within research and development which will improve patient outcomes through education.

Attending meetings such as SAWC is tremendously inspiring, to learn about the future research trends, new product innovations and finally – the great networking opportunity. Below you can read about a few “hot topics” discussed during SAWC.

Trends and Learnings from SAWC

I had the pleasure to attend several of presentations talking about the importance of good debridement to secure efficient wound healing. It is all about how to manage biofilms to stimulate the healing process. Biofilms are the collective name of one or more types of microorganisms that can grow on many different surfaces and cause infection. According to the research, this is one of the most important aspects for an efficient wound care. Biofilms can have a significant negative impact on wound healing by contributing to bacterial infection and inflammation and hence cause a delay of the wound healing process. And managing biofilms is exactly what ChloraSolv is all about!

ChloraSolv is a unique gentle method for easy wound debridement. It facilitates gentle removal of devitalized/necrotic tissue which can include biofilm. It is very encouraging to listen to the researchers and review the latest data that really supports ChloraSolv’s mode of action.

Another hot topic during the meeting was the future development of Biomarkers within the diagnosis and personalized treatment of chronic wounds. The science is moving rapidly, and in the future, biomarkers can be used to optimize treatment of chronic wounds. Biomarkers play a vital role in the development of new inventive therapies. The more understanding and information the clinicians can get about the wound and its conditions, the better treatment can be offered. This will drive the awareness of the importance of efficient debridement to optimize the wound healing.

Attending SAWC is also an excellent opportunity to further build a clinical- and business network relevant for RLS Global. The interest for RLS and our debridement product is definitely much stronger now when ChloraSolv is CE approved. A lot of interesting discussions took place in regards of our journey going forward. As we know, several of the global players have a gap in the portfolio when it comes to efficient debridement products.

The European Wound Management Association (EWMA) annual conference takes place in Gothenburg in about three weeks’ time. The conference will bring 2500 delegates. The objectives of EWMA is to support implementation of interdisciplinary and cost-effective wound care of high quality. On top of that, this year RLS Global will officially launch ChloraSolv during the conference!

Attending meetings such as SAWC and EWMA are tremendously inspiring, to learn about the future research trends, new product innovations and of course the great networking.

Last but not least – Dental 24 accepted a debate article written by RLS last week. It is about the importance to learn and implement the philosophy about Minimal Invasive Treatment. You can reach the article via the link below:

https://dental24.se/petra-blogg/vavnadsbevarande-tandvard-for-battre-munhalsa-och-farre-patienter-med-tandlakarskrack/

I want to take the opportunity to welcome our shareholders to the annual meeting taking place the 29th of May. You will find the invite via the link below:

https://rls.global/investor/calendar/


Karin Fischer, CEO
RLS Global AB