ExThera Medical, Asahi Kasei Medical Forge Distribution Pact

ExThera Medical and Asahi Kasei Medical are teaming up to broaden the availability of treatment for critically ill patients.

The two companies are working to obtain Japanese regulatory approval of ExThera’s Seraph 100 Microbind Affinity Blood Filter (Seraph 100) and have also hammered out a distribution agreement. The Seraph 100 adsorber is the first blood purification device capable of removing a wide range of pathogens from the blood and has been used with more than 800 U.S. and European Union patients in over 70 hospitals. It has demonstrated reduced mortality and ICU length of stay in severe/critically ill COVID-19 patients in preliminary clinical studies.^1,2 The device received European CE mark in 2019 for the treatment of bloodstream infections, and was granted use in 2020 for use in critically ill COVID-19 patients under U.S. Food and Drug Administration Emergency Use Authorization (EUA).
 
“The agreement with ExThera Medical is of great significance for the further expansion in the intensive care business field, positioned as one of our growth drivers,” said Shugo Sumiyoshi, president of Asahi Kasei Medical. “We believe the Seraph 100, with its unique adsorption capability, will add new value to our healthcare solutions and contribute to more lives saved.”

As a patient’s blood flows through the Seraph 100 filter, it passes over beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby removed from the bloodstream. Seraph targets the pathogens that cause the infection, while it also binds and removes harmful substances generated by the pathogen and by the body’s response to the infection. Seraph’s adsorption media (the beads) constitute a flexible platform that uses immobilized (chemically bonded) heparin for its well-established blood compatibility and its unique ability to bind bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis. 
 
“ExThera’s partnership with Asahi Kasei Medical is an important milestone in our collaborative ongoing fight against life threatening pathogens. We are pleased to partner with the Japanese market leader in extracorporeal therapeutics who is motivated to commercialize Seraph 100 and join our global pursuit of saving lives of those suffering from severe sepsis/septic shock,” said Robert Ward, ExThera Medical chairman and CEO.
 
Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei Group has consistently grown through the proactive transformation of its business portfolio. With more than 40,000 employees around the world, the company operates three business sectors: Material, Homes, and Health Care. Asahi Kasei Medial is a core operating company in the Health Care sector that develops and markets devices and systems for dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics.
 
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph 100 Microbind Affinity Blood Filter for removing a broad range of pathogens from the bloodstream of patients. Seraph can be used in hospitals, clinics, or field hospitals to address infections caused by battlefield wounds or pandemics. 
 
References 
¹ Chitty et al, A Multicenter Evaluation of Blood Purification with Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19: A Preliminary Report, (2021)
² Schmidt et al, Interim-analysis of the COSA (COVID-19 patients treated with the Seraph® 100 Microbind® Affinity filter) registry, NDT, 2021; gfab347