Press release content from Business Wire. The AP news staff was not involved in its creation.
Click to copy
MARTINEZ, Calif.–(BUSINESS WIRE)–Apr 21, 2022–
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.
About ExThera Medical Corporation
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 nosocomial and community-acquired infections as well as those caused by battlefield wounds and pandemics. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis and other severe 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 US, the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. The Seraph ® 100 is CE marked and commercially available in the EU. The Seraph ® 100 has FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in the USA.
For more information visit the company’s website at www.extheramedical.com.
About Seraph 100
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 subtracted from the bloodstream. Seraph 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 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.
For more news stories on the Seraph 100 click here.
All information contained in this news release derives from plausible reliable sources, which, however, have not been independently examined. There is no warranty, confirmation or guarantee, and no responsibility or liability is taken concerning correctness or completeness. As far as it is allowed by the relevant law, no liability whatsoever is taken on for any direct or indirect loss caused by the deployment of this news release or its contents. 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. The investment and/or the revenues that arise from it can rise or fall. A total loss is possible. Persons who are in possession of this news release are requested to obtain information concerning possible legal limitations and to observe them accordingly. We assume no responsibility to update or revise any forward-looking statements contained in this news release to reflect events, trends, or circumstances after the date of this news release.
View source version on businesswire.com:https://www.businesswire.com/news/home/20220421005190/en/
CONTACT: Galit Gelman
KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: MEDICAL DEVICES INFECTIOUS DISEASES HEALTH SCIENCE RESEARCH
SOURCE: ExThera Medical Corporation
Copyright Business Wire 2022.
PUB: 04/21/2022 09:00 AM/DISC: 04/21/2022 09:02 AM