Business
FDA De Novo approval
FDA De Novo approval.
About this update from Tristel Plc
[{"type":"text","content":"\n\nTRISTEL plc\n(\"Tristel\" or the \"Company\")\n \nFDA De Novo approval\n \nTristel ULT approved by the FDA as a high level disinfectant for use on endocavity ultrasound probes and skin surface transducers\n \nTristel expects to gain significant market share in the world's largest ultrasound market\n \nTristel plc (AIM: TSTL), the manufacturer of infection prevention products utilising proprietary chlorine dioxide technology, announces that the USA Food and Drug Administration (\"FDA\") has completed its review of the Company's De Novo request for classification (Class II) of Tristel ULT as a high level disinfectant, and has granted its approval for immediate sale.\n \nTristel DUO, the Company's intermediate level disinfectant approved by the USA Environmental Protection Agency for use on the ultrasound console and the non-invasive parts of the endocavity probe, is now registered in all states of the USA.\n \nThe Company estimates that over 215 million ultrasound scans are carried out in the United States annually. Approximately 20% of these scans require high level disinfection and the remainder require low or intermediate level disinfection. With the FDA approval, Tristel has two products approved in the USA that can meet the disinfection needs for all ultrasound scans. This is a unique competitive position.\n \nThe United States nationwide launch of Tristel ULT will commence in October this year, following Tristel DUO's market introduction late last year. The Company has already established a manufacturing base with Parker Laboratories Inc., New Jersey, and will utilise Parker's national distribution network for the ultrasound market. Parker is the largest supplier of ultrasound transmission gels in the USA. As both a gel and an appropriate disinfectant must be used in every ultrasound scan procedure, the combination of Tristel and Parker products promises a powerful combination.\n \nWhilst Tristel is a new market entrant in the USA, the Company is very familiar with the competitive landscape which is almost identical in the other 40 plus countries in which Tristel operates. Approximately half of Tristel's global revenue is generated from the ultrasound market.\n \nFurther details of the Company's North American commercial strategy will be outlined to equity analysts and investo...