ChloraSolv is regulatory approved for diabetic foot ulcers in New Zealand
RLS Global has received regulatory approval for ChloraSolv for treatment of diabetic foot ulcers in New Zealand. With this approval, RLS has established a first market presence in Oceania. The next step will be to broaden the indication in this market.
"RLS has a strategic regulatory plan which aims to give as many patients as possible the opportunity to be treated with ChloraSolv. New Zeeland is a small market, but the fact that the authorities have approved ChloraSolv indicated the patient benefit with the product and its mechanism of action", says Karin Fischer, CEO of RLS Global. "ChloraSolv with its unique properties will help many patients with foot ulcers due to their diabetes. This is a patient group with large healthcare costs. The fact that RLS has now received approval for ChloraSolv in one more market is very positive."
In December 2019, RLS submitted an application to TGA (Therapeutic Goods Administration), Australia. The process has been delayed. In May 2021 new guidelines* were presented, how TGA should streamline and shorten the process for products that have been approved under the new European legislation (MDR). RLS has decided to temporarily withdraw its application for ChloraSolv for diabetic foot ulcers in Australia to make clearer use of the MDR based approval for ChloraSolv in Europe. The aim is to speed up the process.
* https://www.tga.gov.au/comparable-overseas-regulators-medical-device-applications#.YSIBHAeyT9o.mailto
TRADING PLACE AND CERTIFIED ADVISER
RLS Global’s shares have been listed on the Nasdaq First North Growth Market since 17th May, 2017 and trading takes place under the short name RLS. Certified Adviser is Redeye Aktiebolag, phone: +46 8 121 576 90, email: certifiedadviser@redeye.se. During the period 2012 - 2017, the company was listed on Aktietorget.
CONTACT INFORMATION
Karin Fischer, CEO
E-mail: karin.fischer@rlsglobal.se
Telephone: +46 702-48 46 51
Eva Jagenheim, CFO
E-mail: eva.jagenheim@rlsglobal.se
Telephone: +46 31 780 68 20
About RLS Global AB
RLS Global AB is a medical technology company within Life Science. Based on the company's unique hypochlorite platform, RLS Global develop products for some of our most common illnesses in wound and oral care. RLS Global has a portfolio of strong brands, including ChloraSolv® and Carisolv®. The company is listed on Nasdaq First North with Redeye Aktiebolag, phone: +46 8 121 576 90, email: certifiedadviser@redeye.se. Read more at www.rls.global
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