Image: Tristel Duo ULT offers high-level disinfection for all parts of an ultrasound transducer (Photo courtesy of Tristel)
Parker Laboratories Inc. (Fairfield, NJ, USA) and Tristel plc (Newmarket, UK) have entered into a commercial partnership in which Tristel will manufacture and distribute its high-level ultrasound probe disinfectants.
Tristel is a UK-based manufacturer of infection prevention products. Ultrasound probe disinfection is one of Tristel's most important areas of focus within the hospital infection prevention market, accounting for approximately 40% of the company's global revenues. Parker is a leading manufacturer in the US market for the conductive gels and sheaths that are used in all ultrasound procedures, with a nationwide distribution network.
Tristel has submitted its De Novo request for approval to the US FDA for Tristel Duo ULT, a high-level disinfectant foam that can be used on ultrasound probes used for intra-cavitary and skin surface diagnostic procedures. To Tristel’s knowledge, Tristel Duo ULT is the first disinfectant to make a De Novo request to the FDA, reflecting the novelty of the product. Duo ULT is widely used throughout Europe, the Middle East, Asia, and Australasia. During the company's current financial year, the product will have been used in over eight million disinfection procedures of ultrasound probes worldwide.
The FDA's De Novo review and approval process stipulates a 150-day decision timeframe. Additional data requests are commonplace, and the FDA website states that the average duration for review and approval is approximately 11 months. Tristel is also proceeding with the state registration of another version of Duo which has been approved by the US EPA for the disinfection of general medical surfaces. The company has received 24 state approvals and anticipates that all others will have been received by the end of 2022. Tristel will manufacture and distribute both Duo products via its commercial partnership with Parker.
"After five years of testing and data generation we are very pleased to have finally submitted our De Novo request for approval to the FDA. We have made an investment of GBP 2.8 million in the project which has all been expensed," said Paul Swinney, Chief Executive of Tristel plc. "The United States is the largest ultrasound market in the world and our competitors will be the same as those we compete with in all our other markets worldwide. To our knowledge no new high-level disinfectant has been approved by the FDA and introduced into the United States since 2011, other than variants of previously approved products. Duo ULT is recognized as a leading high-level disinfectant throughout the rest of the world, and our entry into the United States market will be a significant inflection point for the company."
Parker Laboratories Inc.