Martinez, Calif. – January 10, 2020 – ExThera Medical has commenced commercial sales in the European Union (EU) of its revolutionary Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) by establishing strategic distributors in Italy, Germany, and the Benelux countries.

In October, soon after receiving CE Mark approval in late July 2019, over 100 devices were shipped to Europe. The first post-CE Mark clinical treatment occurred in November 2019, with promising results. ExThera is now preparing for increased sales in anticipation of positive early results. “This is a monumental step in the company’s history” says Dr. Keith McCrea, Vice President Research & Development/CSO of ExThera Medical. “We look forward to more clinical results to be presented in upcoming medical congresses, in published case studies, and from our large company-sponsored Post Market Study”.

In 2019, ExThera established three new partnerships with TOP Medical, Burke & Burke, and Heinz Meise GmbH for exclusive distribution rights in Benelux, Italy and Germany, respectively. Agreements were signed shortly after ExThera’s CE Mark approval of Seraph 100 for the broad indication of pathogen reduction during bloodstream infections (BSI) in adjunction with antibiotic therapy.

With a shared interest in bringing breakthrough medical technology to patients in need, these commercial partners, TOP Medical, Burke & Burke and Heinz Meise GmbH have worked closely with ExThera to introduce a revolutionary therapy to address bloodstream infections, which affect over 1 million people in Europe every year.

The Seraph 100 blood filter provides a new option for treating bloodstream infections with its unique technology. Whereas, existing hemoperfusion devices remove only molecules, the Seraph 100 can also quickly lower the concentration of bacteria, viruses and fungi in whole blood. In pre-clinical and clinical testing, Seraph 100 was able to significantly reduce the bloodstream concentration of both drug-susceptible and drug-resistant pathogens, providing a long-awaited adjunctive therapy that addresses the severe problem of drug-resistance.

“We are excited to work with TOP Medical, Burke & Burke and Heinz Meise GmbH to bring Seraph to important EU countries. These organizations have long, established commitments to offering healthcare providers and patients quality options, and we’re happy to support their efforts to address a serious, global medical need,” commented Bob Ward, NAE President/CEO of ExThera Medical.

Headquartered in Maastricht, The Netherlands and founded in 2003, TOP Medical has a strong track record enabling new and breakthrough medical device technologies to enter the Benelux market to improve the quality of patient care. TOP Medical is ISO 13485:2016 certified.

Burke & Burke SpA is a private company established in 1967 with headquarters in Assago–Milan, and several regional offices throughout the country. They are a leader in ICU and NICU with a presence in all Italian hospitals and are recognized for their ability to introduce innovative Intensive Care products.

Heinz Meise GmbH Medizintechnik is based in Nordrheinwestfalen Germany and was established in 1983. The company, which is ISO 13485 certified, develops, manufactures and distributes sterile disposables and devices for acute dialysis, apheresis and transfusion medicine.

Additional distribution partnerships will be announced in 2020.

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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 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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