Brighter’s pioneering diabetes management solution Actiste® receives market approval in the Kingdom of Saudi Arabia

Brighter AB (publ) is proud to announce that its pioneering solution for improved diabetes management – the Actiste® device and its associated digital platform – has received market approval from the Saudi Food and Drug Authority (SFDA). Some additional regulatory approvals for consumables included within the Actiste® Diabetes Management as a Service (“Actiste Service”) offering, as well as the cellular transmission approval from the Saudi Telecoms Authority, are still outstanding. However, they remain on track and are anticipated to be granted by Q1 2021.

On receipt of all required authorizations, Brighter will transition to the commercialization phase in the KSA by officially launching the Actiste Service via selected distributors and directly with the end users. Meanwhile, Brighter will work with preparatory sales activities.

“I am very proud of the work performed by our team and the appointed Authorized Representative in securing the market approval despite the current challenges posed by the Covid-19 pandemic. This allows Brighter to actively contribute to improving the quality of life of people living with diabetes in the KSA, and is a major commercial advancement,” says Henrik Norström, CEO of Brighter.

The Actiste Service will be sold through a mix of marketing channels including business-to-consumer (B2C), business-to-business (B2B) and business-to-government (B2G). Brighter’s ambition is to make a difference for at least 30% of the 4.3 million people living with diabetes in the KSA within the next five years.

Although the current COVID-19 pandemic causes some limitations in society, e.g. restrictions on physical interactions/travel and changes in healthcare authority’s immediate priorities, it also serves as an opportunity for digital healthcare initiatives. Designed for providing remote assistance and treatment, the Actiste Service can serve as an essential mean to help reduce exposure towards the virus, crucial for people living with diabetes due to their increased risk of developing severe illness from Covid-19.

Having a market approved product will strongly improve the prospect of Brighter reaching revenue generating agreements in KSA. However, we also respect the possibility that our market launch activities may be impacted by physical restrictions and shifting short-term priorities of healthcare authorities as a result of immediate response to the pandemic.

About Actiste
Actiste is the world's first complete IoT care solution for monitoring and treating insulin-dependent diabetes. The unit brings together and combines all the necessary functions for diabetes care – blood sampling, blood glucose measurement and drug injection – in a single connected device. 

The solution is based on patented technology for collecting data on specified biomarkers and injected volumes of drugs. With state-of-the-art eSIM technology, Actiste has global out-of-the-box connectivity, making it completely independent of other devices to utilize and share health and treatment data. Actiste received two CE-marks in September 2019 - one for MDD and one for IVDD.

The Actiste device is delivered as part of a subscription service. The service includes global connectivity, different levels of data sharing, continuous replenishment of consumables and enables coaching to optimize and improve treatment. https://actiste.com/.

For further information, please contact:

Investor Relations
IR@brighter.se

Henrik Norström, CEO
+46 733 40 30 45
henrik.norstrom@brighter.se

Certified Adviser
Brighter’s Certified Adviser is Eminova Fondkommission AB, +46 (0)8 – 684 211 10, adviser@eminova.se, www.eminova.se.

About Brighter AB (publ)
Brighter is a health-tech company from Sweden with a vision of a world where managing chronic diseases is no longer a struggle. We believe a data-centric approach is key to provide smarter care for chronic conditions. Our daily-care solutions facilitate the flow of real-life treatment data between chronic-disease patients, their loved ones and their care providers – improving quality of life, easing the burden on healthcare systems, and opening new opportunities for data-driven research. Brighter is certified under ISO 13485. In 2019 the company won the Swecare Rising Stars Award. The Company's shares are listed on Nasdaq First North Growth Market/BRIG.

This information is information that Brighter AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 15:23 CET on November 2, 2020.