Welcome to RLS Global Newsletter No. 5, 2020

Newsletter No. 5, 2020

Welcome to RLS Global Newsletter

The Annual General Meeting is always an important milestone during a business year. This year the meeting was organized via Zoom to meet the government’s recommendation due to Covid-19. Even if it is always more exciting to meet in person as it generates a more interactive dialog, it worked out very well.

Therefore, I would like to take the opportunity to say thanks to all of you whom dialed in and took part in our AGM meeting. It is very important for us to meet the shareholders on regular basis and share the latest updates and provide the answers to all the questions. I am already looking forward to meeting you in person 2021!

Pleased find below a short summary of the latest update regarding the current interest and request for CariSolv due to the Corona pandemic.

Please enjoy the reading.


Karin Fischer
CEO RLS Global

 

The dental industry is facing a major challenge due to the Corona pandemic. For more than three months, the entire business has been locked down and only open for emergency cases. Most countries in Europe are excepting the clinics to open in June/July.

The industry is now assessing how to manage the outcome of aerosol. Aerosol is produced from dental instruments like ultrasonic scalers, dental handpieces, and another high-speed instrument. It is also developing during the drilling and repair procedure. When aerosol is formed it radically increases the spread of infection during treatment. It is of course very important to secure safety of the dentist and the nurse during the procedures as well as make it as simply and gently as possible for the patient. The topic is on top of all national/international societies – how to develop the future guidelines to secure and limit the spread of infection as much as possible.

The last month RLS has been approached in regards of CariSolv. CariSolv contains of a gel and is based on the same unique buffered hypochlorite technology platform as other products in the portfolio. CariSolv is applied to the caries and with an instrument, the dentist scrapes away the damaged tissue. In other words, no (or minimal) drilling is required to minimize caries attack and aerosol formation is a very limit problem.

Drilling and filling are standard treatment for a dentist. In the past, the industry has had limit interest to change behavior.

It is of course very satisfying to be able to support in these challenging times. CariSolv has good potential and hopefully the product can be one solution for the dental industry to come across the challenges with aerosol.

However, in January RLS announced that the company made the strategic decision to focus on Wound Management with the focus on ChloraSolv. This is still the future strategy and priorities. But it is of course interesting to find out how the dental business will change and re-shape the next 6-12 months.

Find more information about CariSolv at https://rls.global/products-by-rls/carisolv/


Welcome to RLS Global Newsletter No. 4, 2020

Newsletter No. 4, 2020

Welcome to RLS Global Newsletter

“Business as usual” is hard to claim these days. All businesses and all companies including RLS Global are impacted of the current Covid-19 situation. The industry, as well has the healthcare sector, are in a transition process how to organize meetings and share information using new communication channels and tools such as WebEx, Webinars, telecon etc.

Spring 2020 was supposed to be a very busy time for RLS, attending several congresses, symposia, and meetings. These are important events reaching a broader audience to share the latest update about ChloraSolv. Due to the circumstances, most of the events are postponed to the fall. Individual meetings at the hospital or in the primary care are forbidden. Today we “meet” and educate through the new way of communicating with each other as mentioned above, WebEx and Webinars. It takes time to change behavior, but interaction between the industry and healthcare sector is still very important.

Region Kalmar signed a contract with RLS early March and as previously communicated, RLS is expecting several of these positive awards during Q2 & Q3. Due to the current situation, a few Regions postponed the tender process a few months, however we are confident that ChloraSolv will be awarded in several of the Regions during the year.

All companies are reviewing and re-allocating resources and activities these days. At RLS we increase our focus on R&D activities. We continue to drive new country registrations as well as reimbursement activities. Most important of all, we continue to interact with healthcare professionals who take care of “our patients”.

Despite the challenging situation, we will continue to work closely with current and future customers, and we will continue our activities and drive our agenda’s forward. The patients with chronical wounds still need our care!


Karin Fischer, CEO
RLS Global AB

Redeye published external analysis of RLS Global Redeye initiates coverage of RLS Global. The document is prepared for information purpose for general distribution and it is not intended to be advisory. The forward-looking information in the analysis is based on subjective assessments about the future, which constitutes a factor of uncertainty. Redeye is focused on technology and life science sector. They provide service within Corporate Broking, Corporate Finance, equity research and investor relations. Redeye’s is RLS’s Certified Advisory. The document is communicated via Redeye’s communication channel and the hit-rate is expected to be close to 2 million individual interest. The information contained in the analysis is based on sources deemed reliable by Redeye. The analysis is intended to be one of several tools that can be used in making an investment decision. In the executive summary Redeye highlights one of the unique benefits of RLS: “We think that RLS has a unique asset in its proprietary buffered hypochlorite platform, through which we believe that many interesting wound care products can be developed over the years to come. We believe that many investors are unaware of this and believe that it constitutes a hidden potential”. You can find the report via Redeye homepage and communication channels.

https://www.redeye.se/


Welcome to RLS Global Newsletter No. 3, 2020

Newsletter No. 3, 2020

Welcome to RLS Global Newsletter

These days are challenging for everyone, facing the situation all over the globe by the Covid-19 having an impact on all businesses. So far, at RLS we have good access to our customers, test centers and clinical trial sites. We continue to drive our projects and activities moving forward.

Last Thursday, March 12th RLS organized an educational meeting about ChloraSolv. More than 30 healthcare professionals from the Västra Götaland region participated. The focus of the meeting was to introduce the Debridement Method of ChloraSolv, present patient cases and together with the participants share the experience and learn from each other.

Many more of these meetings will be organized in several regions in Sweden during 2020. It is a good set-up to meet healthcare professionals (HCP’s) with long experience and good knowledge within Wound Management and to share experiences is the best way to increase awareness and interest among HCP’s.

It has been mentioned before, RLS receives such great feedback from all the test centers in Sweden. The need of efficient debridement and to get control of bacteria is key to achieve fast healing. Ease of use is also very important. We are expecting positive feedback from several of the country councils in the near future which will give RLS the opportunity to accelerate our footprint more rapidly.

RLS Global AB / Neongatan 5 / SE 431 53 Mölndal / Sweden Customer@rlsglobal.com / www.rls.global Phone +46 31 780 68 20 / VAT SE556726349501

The number of activities in Denmark has increased a lot the first quarter this year. Our new Danish colleague has established a footprint in all four regions. It is the same procedure in Demark as in Sweden, the clinicians are keen to test to get clinical experience of a new technology. ChloraSolv has been presented to the major KOL’s in

Denmark in order to initiate clinical testing. One of the main centers in Demark is Bispebjerg Hospital located in the Capital Region. The hospital is a teaching hospital for medical students and has the country’s largest wound care center. A lot of research and development is coming from Bispebjerg and there is a great interest of new


Karin Fischer, CEO
RLS Global AB


Welcome to RLS Global Newsletter No. 2, 2020

Newsletter No. 2, 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. 1, 2020

Newsletter No. 1, 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