Multicenter findings suggest Seraph 100 can be safely deployed to meet COVID-19 variant threats

MARTINEZ, Calif. – ExThera Medical announces the publication of clinical study data further demonstrating safety in the treatment of critically ill COVID-19 patients with the Seraph^® 100 Microbind^® Affinity Blood Filter. The device was investigated under the PURIFY OBS multicenter observational study facilitated by the Henry Jackson Foundation for the Advancement of Military Medicine and the Uniformed Services University of the Department of Defense.

“This study shows that Seraph 100 was safely deployed during the COVID-19 pandemic as a medical countermeasure,” said Retired COL Kevin K. Chung, MD, principal investigator of PURIFY OBS. “As COVID-19 variants have demonstrated potential immune escape from both vaccines and monoclonal antibodies, a pathogen-agnostic device that removes viral particles directly from the bloodstream is an attractive potential therapy.”

The study includes analysis of 106 patients admitted to the ICU, 53 treated with Seraph 100 vs. 53 controls. Final results were similar to interim results published as a pre-print last year:

• Mortality was lower in the Seraph 100 treated group compared to controls in both univariate and multivariate analyses: 32.1% vs. 64.2% (p=0.001)
• 3 of 4 analysis methodologies yielded improvements in survival: Odds ratio of 0.26 (95% CI 0.09-0.79, p=0.016), 0.27 (95% CI 0.10-0.73), and 0.31 (95% CI 0.12-0.80) respectively: Nearly 4X improvement in survivability odds when severely ill COVID-19 patients are treated with Seraph 100
• The Seraph 100 therapy was safe and well tolerated.

“We are very pleased that, compared to contemporaneous controls, there was a strong signal of survival benefit for COVID-19 patients treated with the Seraph 100,” said ExThera Medical Chairman and CEO Robert Ward. “We are now focusing on the prospective interventional multicenter PURIFY RCT trial to provide a more thorough clinical understanding of the Seraph 100’s impact to outcome for broad pathogen-induced shock patients.”

“We are encouraged that these results show that the Seraph 100 therapy is safe and well tolerated,” said ExThera Medical Scientific Advisory Chair Lakhmir Chawla, MD. “These results justify multicenter randomized controlled trials to study the Seraph 100 in various critically ill patient populations suffering from sepsis.”

PURIFY RCT, began enrolling last month for the treatment of pathogen associated shock. Click here for the full study.

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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 http://www.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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