Martinez, Calif. – March 11, 2019 – ExThera Medical Corporation (ExThera) today announced the formation of its Scientific Advisory Board (SAB). Led by chairman Lakhmir (Mink) Chawla, MD, current Chief Medical Officer of La Jolla Pharmaceutical Company, the SAB will include several esteemed medical professionals from both the U.S. and Germany. Professor Dr. Herwig Gerlach, Director of the Clinic for Anesthesiology, Critical Care Medicine and Pain Management at Vivantes Klinikum Neukoelln Berlin Germany, and Stuart Goldstein, MD, Director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center, will join the ExThera SAB immediately. ExThera, an early-stage device company in the San Francisco Bay Area, is a developer of novel therapies for reducing bacteria and viruses in blood.

As ExThera innovates to improve the treatment of bloodstream infections and sepsis globally, the three SAB appointees bring comprehensive medical and research expertise to the company, including direction of ExThera’s U.S. and European clinical trial programs.

Prior to joining the board, Dr. Chawla was a Professor of Medicine at the George Washington University Medical Center in Washington, D.C. where he directed research efforts for the Division of Critical Care Medicine. He previously headed the Division of Intensive Care Medicine at the Washington DC Veterans Affairs Medical Center, and currently serves as a Clinical Professor of Medicine at the University of California, San Diego Medical Center. With a focus on critical care and nephrology, Dr. Chawla has led and supported several grants and research projects centered on acute kidney injury, renal disease, extra-corporeal therapies, shock, and sepsis.

Professor Gerlach brings expertise in anesthesiology and critical care medicine as a board-certified physician and professor. A widely published researcher, he has investigated issues pertaining to intensive care, critical care and emergency medicine, post-operative care, and the treatment of sepsis, which are highly relevant to ExThera’s mission of developing new therapies for the treatment of bloodstream infections. In addition to his several roles throughout Germany, Prof. Dr. Gerlach also previously served as a research fellow at Columbia University in New York. He previously served as President of the German Sepsis Society and is now Vice President.

Dr. Goldstein contributes expertise in nephrology and brings to the board a unique perspective from his background in pediatric care. In addition to his current role at Cincinnati Children’s Hospital Medical Center, he holds a faculty position as a professor of pediatrics for the University of Cincinnati School of Medicine. Dr. Goldstein has also led and contributed research support for several research investigations focused on device therapies, including those with emphasis on renal failure and end-stage renal disease, for various institutions.

“I am delighted to be working with ExThera and Professors Gerlach and Goldstein. Despite progress in the treatment of many infectious diseases there remain many pathogens for which there are no effective anti-microbials. The ExThera technology brings cutting-edge material science to the bedside allowing clinicians to treat bacterial and viral diseases that do not have adequate treatments available. It is an exciting opportunity to bring a new weapon to fight these infectious diseases.” said Lakhmir ‘Mink’ Chawla, MD, Chairman of the SAB.

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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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