Halmstad, Sweden, November 7, 2025 - Redsense Medical AB (publ) ("Redsense" or "the Company") announces that the Redsense Clamp System has been granted regulatory approval from the Australian Therapeutic Goods Administration (TGA), allowing the product to be sold and marketed in Australia. With the registration now in place, Redsense and its local distribution partner, Regional Health Care Group (RHCG), are initiating preparations for sales, training, and education activities in the market.
RHCG was appointed as Redsense's distributor for Australia in anticipation of the Clamp, and has been awaiting approval before starting commercial activities. With the Redsense Clamp now registered by the TGA, the companies can begin coordinated preparations to introduce the system to dialysis clinics across the country.
"This registration allows us to take the first concrete step toward establishing Redsense in Australia and we can now begin working closely with our partner RHCG to prepare for market introduction and support improved patient safety in dialysis care." says Sebastien Bollue, CEO of Redsense Medical AB.
RHCG is an established distributor of medical technology across Australia and New Zealand and was acquired by Henry Schein, Inc. in 2023. Henry Schein is also one of Redsense's key distribution partners in the United States, and the connection strengthens the collaboration framework for Redsense's expansion into new markets.