Lodgement of CONNEQT Pulse Device with the TGA

Key points

• Cardiex has formally lodged application with TGA for inclusion of CONNEQT Pulse device in Australian Register of Therapeutic Goods
• TGA registration process expected to take 3-6 months
• Follows recent finalization of Market Agreement with manufacturing partner Andon

Full summary

Cardiex Limited (ASX: CDX) has announced the formal lodgement of its application with the Therapeutics Goods Administration (TGA) for the inclusion of the FDA-cleared CONNEQT Pulse device (Pulse) in the Australian Register of Therapeutic Goods (ARTG). This follows the recent finalization of a Market Agreement between Cardiex and its manufacturing partner, Andon, to complete the necessary regulatory requirements in Australia. With the TGA lodgement now complete, the Company is well positioned to achieve inclusion in the ARTG. Cardiex CEO Craig Cooper commented that with FDA clearance in the United States and now a formal TGA lodgement in Australia, the company is establishing a strong global footprint for the CONNEQT brand and is excited to bring its transformative cardiovascular technology to new markets to help drive better health outcomes worldwide. The Company will continue to keep shareholders informed as further regulatory and commercial milestones are achieved. The TGA registration process is expected to take approximately three to six months.