Redsense receives TGA approval and market authorization for Australia and New Zealand

Redsense Medical today announces that the Therapeutic Goods Administration (TGA) has granted regulatory approval for the Redsense System. Redsense’s blood loss alarm is thus authorized to be sold in the Australian and New Zealand markets.

Redsense’s distributor will commence the introduction of the Redsense System in clinics as soon as the prevailing situation allows visits to perform demonstration tests. Considering Australia’s geographic extent, the Company also considers the country a key market for the future introduction of the Redsense Clamp accessory, which will increase patient safety even further.

“We are thrilled to achieve this milestone. There are close to 12,000 hemodialysis patients distributed across Australia and New Zealand, and following the market authorization disclosed today, this patient population will now be able to gain access to safer treatment. In addition, the extra layer of protection offered by the Redsense device will facilitate the adoption of more convenient home treatment and reduce the need to travel long distances to clinics,” says Patrik Byhmer, CEO of Redsense Medical AB.

Today’s announcement follows Redsense’s recently announced conclusion of a distributor agreement for Australia and New Zealand with Regional Health Care Group, which was disclosed on March 25, 2021.

About Redsense’s products

The Redsense Alarm is a patient safety device that monitors for blood leakage in conjunction with hemodialysis treatment. The Redsense Clamp is an accessory to the Redsense Alarm, which enables it to clamp the bloodline autonomously if blood leakage is detected. A clamped line ensures that the dialysis machine’s pump is stopped automatically, without the need for human intervention.

For more information, please contact:

Patrik Byhmer, CEO Redsense Medical AB (publ)

Phone: +46 35 10 60 30

info@redsensemedical.com 

www.redsensemedical.com

 

Redsense Medical is obliged to make the information contained herein public pursuant to the EU market abuse regulation. The information was submitted for publication through the agency of the contact person above at CET 09:00 on Tuesday, June 22, 2021

ABOUT REDSENSE MEDICAL

Redsense Medical is a corporate group with operations mainly in Europe and the United States. The company has developed the Redsense System, an innovationused for monitoring and alarm in the case of blood leakage in connection with a hemodialysis treatment. Redsense Medical solves one of the most serious remaining safety problems within hemodialysis – to quickly detect Venous Needle Dislodgement and catheter leakage to minimize blood leakage. The system consists of a patented fiber optic sensor, designed for either venous needle or central venous catheter, which is connected to an alarm unit. From the very start, the development of the company's technology has been based on the demands and safety requirements of healthcare providers in the dialysis sector.

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