MARTINEZ, Calif. – ExThera Medical and Asahi Kasei Medical, a core operating company of the Asahi Kasei Group, have entered into an exclusive distribution agreement in Japan for ExThera’s Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100). Per the agreement structure, ExThera Medical and Asahi Kasei Medical will collaborate to obtain regulatory approval of Seraph 100 for commercialization in Japan.

“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.”

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 USA 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 FDA Emergency Use Authorization (EUA).

“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.

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

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About Asahi Kasei and Asahi Kasei Medical
The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 40,000 employees around the world, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of 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.

For more information, visit www.asahi-kasei.com and www.asahi-kasei.co.jp/medical/en/.

For more information, please contact:
Asahi Kasei Corp.
Corporate Communications
Phone: +81-(0)3-6699-3008
Fax: +81-(0)3-6699-3187

ExThera Medical Corporation
Corporate Communications
Phone: +1-925-839-2060
[email protected]

About ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100) for removing a broad range of pathogens from the bloodstream of patients. Seraph 100 can be used in hospitals, clinics, on battlefields and in other austere environments to address nosocomial and community-acquired infections as well as those caused by battlefield wounds, pandemics, and biological warfare agents. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and many other severe bloodstream infections. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the U.S., the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. 

The Seraph 100 Microbind Affinity Blood Filter (Seraph 100) attained CE Mark in 2019 and is commercially available in the EU for the treatment of blood stream infections. The Seraph 100 device has neither been cleared nor approved by the U.S. Food and Drug Administration (FDA) for any indication. The Seraph 100 has been authorized by FDA under an Emergency Use Authorization (EUA) to treat patients with COVID-19 infection. The Seraph 100 is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph 100 device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

For more information, visit the company’s website at https://extheramedical.com/.

About Seraph 100 and the ONCObind Procedure
As a patient’s blood flows through the Seraph^® 100 Microbind^® Affinity Filter (Seraph 100), it passes through a bed of small beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Many harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream. Seraph 100 adds nothing to the bloodstream. It 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 proprietary 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 circulating tumor cells, bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis.

ExThera Medical is currently developing the ONCObind Procedure Hemoperfusion Filter (ONCObind) to support cancer treatment. ONCObind is part of the same platform technology as Seraph 100.

For more news stories on Seraph 100 and ONCObind, click here.

Disclaimer
All information contained in this news release derives from plausible, reliable sources, however they have not been independently examined or verified. There is no representation, warranty, or guarantee provided herein. Except as otherwise required by appliable law, all liability for any direct or indirect claims, damages or losses are hereby disclaimed whether or not foreseeable. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Accordingly, the investment and/or the revenues that arise from it can rise or fall or fail entirely. We assume no responsibility to update or revise any statements contained in this news release, including forward-looking, to reflect events, trends, or circumstances that might arise after the date of this news release. Results from case studies (reviews) may not be predictive of future results.

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