Tristel plc announced that Health Canada has approved Tristel ULT as a Class II Medical Device for endocavity ultrasound probes and skin surface transducers. The timing of this regulatory approval comes well ahead of the Company's original aim for gaining approval before the end of H1 Fiscal Year 2025 and allows commercial launch during fiscal 2024. Health Canada approval, alongside approval from the US Food and Drug Administration received in June 2023, means that Tristel ULT can now be manufactured and sold throughout the whole of North America by Tristel's commercial partner Parker Laboratories Inc. as a high-level disinfectant for ultrasound instruments.

Parker completed its first production run of Tristel ULT in October 2023 and is actively introducing the product to its United States distribution network. This activity will now be extended to the Canadian market. The first hospital users in the United States are trialling and purchasing the product.

Tristel will provide a more detailed update in its interim results on 26 February 2024. Tristel is preparing its dossier for Tristel OPH, a high-level disinfectant For use on ophthalmic instruments, for submission to the FDA and has requested a pre-submission meeting with the agency. The review meeting date is scheduled for early March 2024.

The Company anticipates completing its submission seeking 510(k) approval in the summer and receiving FDA approval by the end of the year. Tristel OPH was approved by Health Canada in June 2021. Tristel OPH were launched into the Canadian ophthalmic market as a high-level disinfectants for ophthalmic instruments including re-usable tonometers and lenses that contact the cornea during the Company's last financial year.

The product is being distributed throughout the country by Innova Medical Ophthalmics Inc., Toronto, a subsidiary of Advancing Eyecare, Jacksonville, Florida. Tristel OPH is being used by public health authorities in all the major Canadian provinces.