Advanced Sterilization Products (ASP) Announces CE Mark for ULTRA GI™ Cycle for Duodenoscopes in Partnership with FUJIFILM Healthcare Europe

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ce mark regulatory

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

New cycle for the STERRAD™ 100NX Sterilizer introduces a validated sterilization method for complex endoscopes, promoting patient safety through innovation.

SCHAFFHAUSEN, Switzerland--(BUSINESS WIRE)-- ASP International GmbH (“ASP”), a division of Fortive (NYSE: FTV), in collaboration with FUJIFILM Healthcare Europe GmbH, proudly announces that the ULTRA GI™ Cycle has received CE mark approval. The ULTRA GI™ Cycle is the latest innovation for the STERRAD™ 100NX Sterilizer with ALLClear™ Technology.

The ULTRA GI™ Cycle’s receipt of the CE mark represents a pivotal advancement in elevating patient safety across healthcare facilities and addressing the complex challenges associated with traditional reprocessing methods. “This is a meaningful step forward in our mission to make duodenoscope reprocessing safer across Europe,” said Chad Rohrer, President, ASP. “By bringing hydrogen peroxide gas plasma sterilization into routine practice, we’re giving clinicians greater confidence to focus on what matters most – their patients.” ASP’s immediate focus is to work with medical device manufacturers to ensure that new duodenoscope models are designed to be compatible with hydrogen peroxide. The partnership with FUJIFILM Healthcare Europe is the latest example of this.

Pierre Emeric, Vice President, R&D at ASP, continued, “The addition of the new FUJIFILM duodenoscope models ED-840T and ED-840XT to the ULTRA GI Cycle further expands the breakthrough technology platform and demonstrates ASP's commitment to innovation and partnership with FUJIFILM Healthcare. Most importantly, current ASP customers who already have a STERRAD 100NX Sterilizer with ALLClear Technology can access the benefits of the ULTRA GI Cycle via a cycle upgrade on their existing equipment and can continue maximizing the value of their investment.”

“Duodenoscopes have historically posed infection control challenges due to their contamination rates,” said Ivan Salgo, MD, VP & Chief Medical Officer at ASP. “The partnership between ASP and FUJIFILM Healthcare has resulted in a sterilization approach that exceeds current industry benchmarks, providing healthcare professionals with an advanced solution to elevate patient safety standards.”

Visit this webpage for more information on the ULTRA GI™ Cycle.

About Advanced Sterilization Products (ASP)

Advanced Sterilization Products (ASP) has a long track record of designing and delivering innovative infection prevention solutions that dramatically raise the level of health care and safety for those who matter most. Our pioneering technology, global distribution and established leadership position enable us to simplify the process of buying and operating infection prevention products and services every day for thousands of medical facilities around the world. This enables our customers to focus on what they do best – preventing infection and saving lives. For more information, please visit www.asp.com.

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MEDIA CONTACT:

Nuno Azeredo

Vice President, Global Brand Marketing

Advanced Sterilization Products (ASP)

asp-communications@asp.com

INVESTOR RELATIONS:

Christina Jones

Vice President, Investor Relations

Fortive Corporation

investors@fortive.com

Source: Advanced Sterilization Products