RLS

It is time to summarize a very different but interesting year, 2020.
2020 is the year when ChloraSolv was awarded on the first tenders in Sweden. The response and feedback have overall been very positive from the regions and the municipalities. The clinicians confirm the effect of the technology as well as the need of a more gentle method to support debridement. During the year the first commercial footprint was also established in Denmark and UK.
Today, most of the customer interactions are virtual due to the pandemic. RLS has arranged several webinars with relevant topics to drive the awareness about good debridement and ChloraSolv. RLS has close communication with most of the regions in Sweden with the objective to accelerate the number of tender awards. But we have to be honest, the current circumstances have of course an impact on the market penetration. There is strong hope, as of Q2 2021, the number of face-to-face activities will increase which will have a positive impact on the ChloraSolv uptake.

2020 was also the year when RLS’ second clinical trial, ChloraSolv01, was finalized. RLS is very pleased with the outcome and the first data were communicated at EWMA in November. The publication is under review and the aim is to publish the article in one high ranked journal early 2021. It is an important milestone and provides more, very interesting, data related to ChloraSolv.

In parallel, RLS has worked in close cooperation with researchers from Lund University. Additional pre-clinical data have been developed and will be published early 2021. This pre-clinical data and the data from ChloraSolv01, support significant changes which will improve the ChloraSolv claims. RLS has submitted the changes to the notified body, Eurofins. The objective is to broaden the indication to leg ulcers, improved biofilm claims as well as strengthen the debridement claims. Also, the shelf life has been extended from 12 to 24 months.

2020 is the year we submitted the approval dossier for Australia and Kuwait. There are no open questions from the authorities and RLS is awaiting the final approval, but the process has been delayed due to the pandemic. The authorities prioritize products and technology supporting the fight against covid-19. In the meantime, RLS together with local distributors, prepare for the launch. Key opinion leaders are approached and as soon as the product is approved the launch will start. Australia is a high-end market with strong focus on innovation. The stakeholders that are approached are ready to learn more about ChloraSolv as soon as the product is approved. The prevalence of patients with chronic wounds are high in the Middle East and is increasing rapidly every year. It is exciting that RLS is ready to launch ChloraSolv in two new regions hopefully early 2021.
The communication with FDA in USA is ongoing. RLS together with external consultants, are in the process to compile the documentation for a pre-IND meeting. The objective is to conduct the meeting during Q1 2021. The waiting line and respond time are extended these days due to the covid-19 situation.

Please spend some time and take part of the two new videos published on the website. There you will “meet” Annika Nordström, Key Account Manager, RLS Global, who makes an introduction to ChloraSolv. Hilde Ingebretsen, wound nurse at Danderyd hospital, is educating about the importance to conduct professional debridement as well as sharing patient cases with ChloraSolv. Watch the videos here.

I am very proud of the RLS team and the capacity to mitigate the business during such a challenging year as 2020. We all are looking forward to continuing the journey 2021, with more customer acceptance, launches in new regions and countries, many steps forward for the US market, further driving the long term business model for RLS and increase the focus on new indications.
I and the team wish you all a Merry Christmas and a Happy New Year!

Karin Fischer
CEO RLS Global

Three Regions in Sweden have awarded ChloraSolv on tenders, Kalmar, Stockholm and Skåne. And not to forget and to add on, about 10 different municipalities. From a population perspective, this represent a significant part of the Swedish market potential. More Regions are testing and evaluating the technology and RLS is expecting more positive awards going forward.

The last six months have been a challenging time for many different industries, as well as the healthcare sector. It is pending almost day by day how the industry can interact with the caregivers. However, there is a light in the tunnel and it is getting easier to reach out and “meet” with the different stakeholders.

RLS works in close collaboration with the wound nurses whom are responsible for these patients. Launching a new technology and product on the market demands a lot of insights and know-how from the users as well as from the patients. Recurring customer revenue is a comprehensive indicator that shows the extent to which we are retaining, expanding and growing our customer relationship value. It shows that the introduction of the technology is successful and ChloraSolv starts to become a standard treatment.

Shortly RLS will launch an updated website. The aim is to increase the communication with the care givers with more hands on experiences. Below is one patient case from Stockholm. It really shows the impact of ChloraSolv and the importance to establish a “clean wound” with the aim to support an efficient  wound healing process.   

New exciting pre-clinical data for ChloraSolv
RLS has also communicated about new, exciting data for Biofilm. Staphylococcus aureus and Pseudomonas aeruginosa are two common bacteria that form biofilms in chronic wounds. A biofilm is formed by a high number of bacteria that protect themselves through a secretion of a viscous barrier. A consequence is that the bacteria is protected from antibiotics and several antiseptics.

The purpose of the study was to investigate the effect of ChloraSolv on these two bacteria. The results show that ChloraSolv has a rapid effect on both bacteria. In Staphylococcus aureus biofilm, 33% of the bacteria were killed in 30 seconds and more than 81% in five minutes. The effect on Pseudomonas aeruginosa is more immediate and kills more than 95% after 30 seconds. After five minutes, 97% of the bacteria are gone from the wound model.

The Biofilm data is really encouraging for ChloraSolv. All new data, customers feedback, new tenders as well as stronger footprint on the market provides the confidence in ChloraSolv drive our market penetration.

Not to forget…  ChloraSolv 01. RLS has submitted an Abstract to EWMA (European Wound Management Meeting) and the plan is to share data already at the annual meeting in November. It is the first time a few data points will be communicated to the wound care community.

Below, one patient treated with ChloraSolv the last months:

As mentioned before, an efficient debridement method is key to stimulate an efficient healing process. The combination with antimicrobial effect as well as softens of devitalized tissue are unique with ChloraSolv.

It is a very exciting moment for us at RLS Global despite a very challenging time on the market. Stay tune… more to come!

Karin Fischer
CEO RLS Global

RLS had the pleasure to attend Redeye investor meeting taking place in Gothenburg. Please take part of the executive summary of RLS Global’s coming activities.

You will find the presentation here: https://redeye-3.wistia.com/medias/fv548n6uv4

Karin Fischer
CEO RLS Global

Back in business… it has been really encouraging to get a few weeks off, time to reflect on a very unusual spring but also taking the time to get some perspective of all the activities we have accomplished during this strange period of time.  We can look to an exciting fall and winter with confidence, full of energy and motivation.

As of this week, we will start up with ChloraSolv® in Region Stockholm. Worthwhile to mention is that this is the largest Agreement which has taken place in Sweden within Wound care. ChloraSolv is now available to all healthcare providers in the region – Inpatient- and Outpatient Care, Primary Care and Private Care Providers. RLS has a new team member in place who has long experience within Wound Care, who will take the lead and drive the market penetration in the region.

It is the same procedure as in any other region, meeting with Wound Care experts at each institute, introducing the Unique Hypochlorite Technology by RLS Global which ChloraSolv consist of. Drive the process to provide the Healthcare Professionals the experiences of the ChloraSolv and to support continuously. During the fall RLS aims to attend several local meetings and exhibitions to introduce the Unique Hypochlorite Technology by RLS Global. Let’s cross our fingers that the events still will take place.  Due to our clinical trial, ChloraSolv01 and local test of ChloraSolv, the region already had some experience of ChloraSolv. This is of course very good when you enter a “new” market.

Another Region which is really encouraging to follow is Region Kalmar and the development going on there. Several of the clinicians are trained and have experience of ChloraSolv and we are seeing for the first time in the history of RLS Global, recurrent revenue for ChloraSolv and overall, the feedback is very good from the region. RLS will, during fall organize Educational Webinars to reach out to as many as possible. These Webinars will be live and will be announced on our Website in time for you to register. The Webinars will be recorded and will be available on the RLS website after the session.

In parallel, RLS are in close contact with several of the regions in the country. There is a strong confidence in RLS and that ChloraSolv will be accepted in a few more regions during 2020. A new Clinical test has also been initiated to a few smaller regions who are interested in the technology.

Due to the pandemic, most of the countries in Europe has been locked down. However, as of September there is light in the tunnel and RLS is expecting to re-initiate several of the activities in the pipeline.

R&D is always an area of high priority at R&D. Together with the University of Lund pre-clinical activities are initiated focusing on biofilm. It is a very “hot” topic within the global Wound Care Management community. It is an important key component in our further development of our Unique Technical Platform and ChloraSolv. All pre-clinical activities are extremely exciting and important for RLS Global. It gives us so many new insights about the technology and the product which will generate new future possibilities for RLS. More to come within this topic.

The outcome of ChloraSolv01 is of course a key component to increase the value of ChloraSolv and a key asset to broaden the indication for ChloraSolv. The database was closed by end of June and RLS has received the first statistical report and the results are according to the expectations. The study endpoints includes for example the reduction of devitalized tissue (necrotic tissue) and reduction of wound size. The clinical report is aiming to be finalized in September and then next step is to compile the publications. RLS work in close cooperation with the principal investigator, Senior Consultant Associated Professor Jan Apelqvist, through this process. In parallel to the publication in a medical journal, RLS will present part of the results at an international conference during fall 2020.

The fall of 2020 will generate several new opportunities for RLS and ChloraSolv. New milestones will be reached. Stay tuned and continue to follow our exciting journey.

Yours sincerely,

Karin Fischer
CEO RLS Global

Friday, July 17^th RLS Global published the Q2 Interim Report and at the same time Karin Fischer, CEO at RLS Global was interviewed by the Certified Advisor of RLS Global, Redeye Aktiebolag. The aim of this interview was to summarize the first six months of 2020 and look into the strategic plan of Q3 and Q4, 2020.

Via the link below you will get access to the interview (please note: the interview is in Swedish).

Interview with Karin Fischer, CEO RLS Global

The Team of RLS whish you a nice summer!

Karin Fischer
CEO RLS Global

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/

“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/

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/

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.