Seraph^® 100 Microbind^® Affinity Blood Filter Deemed First-In-Class Medical Device by U.S. FDA

Martinez, CA – ExThera Medical Corporation, a company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100).  The Seraph 100 is a patented blood filter containing a biomimetic surface, similar to that found in the human circulatory system that removes pathogens that could otherwise overwhelm a patient; a common source of severe/critical illness. 

“Multiple Seraph Breakthrough Designations represent a formal identification by the US FDA that Seraph development should be expedited for patient access because of its promise for providing more effective treatment for life-threatening and debilitating diseases associated with antibiotic resistant sepsis, as well as severe SARS-CoV-2 [COVID-19] infection,” said Sanja Ilic, M.D., M.S., RAC & Chief Regulatory Officer for ExThera.  “It additionally signals that the FDA is already thinking about future pandemic preparedness, something we are keen to partner on with them and the medical community.”

“I am very pleased that we are also making impressive progress toward USA regulatory approval and commercialization,” said Robert Ward, Chairman and President of ExThera Medical.  “In addition, a Breakthrough Device Designation allows for immediate coverage through Centers for Medicare and Medicaid Services (CMS) via New Technology Add-On Payment (NTAP). This allows for additional line-item procedural reimbursement of Seraph 100 during initial commercialization and is an important health economic driver for commercial adoption.”  

ExThera Medical continues to make progress in the PURIFY RCT bloodstream infection clinical study, a prospective interventional multicenter randomized controlled trial, sponsored by the Department of Defense, as part of the pivotal work required by the FDA.  Breakthrough Device Designations are an important addition to this ongoing activity, along with future pandemic preparedness.

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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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