ExThera’s Affinity Blood Filter Is Used to Treat COVID-19 Patients
Treatment of COVID-19 with ExThera’s Seraph®100 Microbind® Affinity Blood Filter (Seraph 100) has begun in hospitals in Germany and Italy.Seraph 100 treatments of COVID-19 are also expected to begin soon in France and the USA.
Seraph 100 is the only ‘hemoperfusion device’ approved for the reduction of pathogens in blood. In recent EU clinical cases improved lung function and rapid reduction of drug-resistant bacterial pathogens occurred with Seraph 100 treatment. Stabilization of blood pressure has also been observed, including during COVID-19 treatment. Another potential benefit of Seraph 100 treatment of COVID-19 is reduction in bloodborne virus/RNA, and the simultaneous treatment of bacterial and fungal ‘secondary infections’.
Clinical results and virus binding studies suggested that Seraph 100 treatment should help in the treatment of COVID-19, and in future epidemics, before vaccines are available. More clinical results are needed to confirm patient benefit in COVID-19, but lab studies with cytokines and other pathogens have accurately predicted Seraph 100 clinical results in other bloodstream infections.
One consideration is whether SARS-CoV-2 is present in the bloodstream of infected patients in measurable concentrations, and if so, at what stage of the infection. Very recent publications and clinician feedback confirm the presence of the virus (RNA) in the blood of critically ill COVID-19 patients. The measured binding capacity of a single Seraph 100 filter (about the size of a 12-ounce soda can) is huge in comparison to the amount of virus present in the bloodstream of critically-ill patients.
Lakhmir S. Chawla, MD, Chair of ExThera’s Scientific Advisory Board added, “In respiratory diseases caused by viruses, the onset of viremia (virus in the bloodstream) typically heralds severe disease. Reducing viral levels of COVID-19 may allow the body’s immune system to combat the deadly pathogen.”
President and CEO of ExThera Medical, Robert Ward NAE stated, “We are very pleased to confirm the feasibility of Seraph 100 treatment of COVID-19. Since Seraph 100 treatments have also consistently produced improved oxygenation/lung function, we believe that this feature together with virus reduction may be a useful combination for treating COVID-19, while simultaneously treating the dangerous secondary infections that can occur in COVID-19 patients.”
Seraph 100 has CE Mark approval in the European Union but is not currently approved by the FDA for use in the United States. ExThera has received clinician interest in individual emergency use of Seraph 100 in the USA and we expect COVID-19 treatments to begin here soon, when they meet the criteria outlined in the FDA Guidance. ExThera will report on ongoing EU COVID-19 cases and related case studies as soon as they are available, while adhering to HIPAA and GDPR requirements for patient confidentiality. Related peer-reviewed publications are in preparation or in press.
“We are excited about adding SARS-CoV-2 to the long list of bloodborne pathogens that Seraph 100 can target,” commented Keith McCrea, PhD. and Chief Science Officer of ExThera Medical. “This can open up a new treatment modality for this and future emerging diseases for which there are few if any treatments.” Seraph 100’s very broad-spectrum capability is based on its large biomimetic blood-contacting surface that imitates the binding sites disease-causing pathogens target once they find their way into the bloodstream.
The Seraph 100 blood filter provides a needed option for treating life-threatening bloodstream infections using new technology. Whereas first-generation hemoperfusion devices remove only molecules, Seraph 100 also quickly lowers the concentration of bacteria, viruses, and fungi in whole blood. Seraph 100 is able to significantly reduce the bloodstream concentration of both drug-susceptible anddrug-resistant pathogens, providing a long-awaited adjunctive therapy that addresses the severe problem of drug-resistance, and new and future bacterial, fungal and viral threats like COVID-19.
Professor Jan Kielstein, Director of Medical Clinic V, Academic Teaching Hospital Braunschweig, Germany who has performed many Seraph 100 treatments recently said, "When a pathogen like SARS-CoV-2 comes out of Pandora's Box we have to think outside of the box for a countermeasure. Seraph 100 is a disruptive technology that had been shown to eliminate infectious agents from the blood without side effects. Extracorporeal treatment with the Seraph100 could offer an added benefit to critically ill patients with severe COVID-19."
Seraph 100 received CE Mark approval for the broad indication of pathogen reduction during bloodstream infections in adjunction with antibiotic therapy. Seraph 100 distributors in the EU include Heinz Meise GmbH in Germany, Burke & Burke in Italy, and TOP Medical in the Benelux countries. Distributors have recently been named in several other regions. Working with Gorta, Ireland’s oldest NGO, ExThera has also entered a public-private partnership designed to strengthen public health systems in developing countries by making world-class medical devices available at affordable prices.
About the Seraph® 100 (Seraph) Microbind® Affinity Blood Filter
As a patient's blood flows through the Seraph filter, it passes over tiny 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 removed from the bloodstream. Seraph does not add anything to the blood, which is returned to the patient with blood cells and proteins intact. Seraph 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. The ‘anti-thrombogenic’ heparin media can be combined with other ExThera-proprietary media to tailor the capability of future Seraph products for the treatment of specific diseases, or to further broaden Seraph’s capability.
About ExThera Medical
Based in Martinez, California, near San Francisco, and in Vaals, The Netherlands, ExThera Medical Corporation is a privately held medical device company developing innovative blood filters capable of removing a broad range of harmful substances from the blood. The company develops therapeutic products to treat patients in the hospital or clinic, during epidemics, or on the battlefield. Led by an accomplished management team with decades-long experience in the development and manufacture of blood-contacting implants, devices, and enabling biomaterials technology, the company has strong patent protection and a growing body of data from independent laboratory studies, from its participation in DARPA’s Dialysis-Like Therapeutics program, and from successful clinical use in the EU.
For more information and an instructive video please visit our website:www.extheramedical.com
Seraph 100 is not currently approved for use by the US FDA
Disclaimer: 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.
Galit Gelman & Mandy Van Haaren
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
British Firm BitePRO Claim Mental Health Care Professionals Are At Risk Of Being Bitten26.2.2020 17:12:00 CET | Press release
According to British firm BitePRO, mental health care and special educational needs professionals are at increased risk of being bitten by patients or pupils. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200226005697/en/ Healthcare nurse wearing BitePRO® Bite Resistant Clothing (Photo: Business Wire) Many nurses, care workers and teachers retire on medical grounds. They walk away from the profession they were once extremely passionate about, partly because medical experts have been able to identify that they suffer from real trauma and severe stress. Others, like Minnesota based Special Education Assistant Erin Gonzales are keen to continue and state: “I work at a school where human bites are a daily occurrence, but I work with kids with special needs. But honestly, I wouldn’t trade it for the world.” Oklahoma based Psychiatric Nurse Practitioner Miranda Hagan shares her desire and refuses to give up: “I have permanent sca
BIOCORP: Marketing Partnership on Mallya with iSage Rx in the Field of Digital Diabetes19.2.2020 17:00:00 CET | Press release
Regulatory News: BIOCORP (Paris:ALCOR) (FR0012788065 - ALCOR / Eligible PEA PME), a French company specialized in the development and manufacturing of medical devices and smart drug delivery systems, today announced an alliance with US-based iSage Rx, LLC., a digital therapeutics company, focused on insulin dose optimization. In detail, the two companies are committed to integrating their respective technologies to simplify insulin dose capture and optimization. The integration of Mallya (a CE-marked connected device dedicated to insulin pens) into the iSage app (a clinically validated insulin titration platform cleared by the FDA) should enable patients with type 2 diabetes to simplify their insulin management. This will allow patients with diabetes to seamlessly capture, record, and store information about their insulin injections and while receiving automated guidance on how to adjust their insulin dose overtime ("titration"). Ryan Sysko, President and CEO of Amalgam Rx, Inc, said:
New Phase 3b Interim Data from STARDUST Study Show Two-Thirds of Patients with Moderately to Severely Active Crohn’s Disease Achieved Clinical Remission After Two Doses of STELARA® (ustekinumab)14.2.2020 07:00:00 CET | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced interim data from the Phase 3b STARDUST study. At week 16, 79 percent of patients with moderately to severely active Crohn’s disease (CD) achieved clinical responsea and 67 percent were in clinical remissionb after receiving one ~6 mg/kg intravenous (IV) dose followed by one 90 mg subcutaneous (SC) dose of STELARA® (ustekinumab), open label.1 Intestinal ultrasound (IUS) responses were assessed and were detected as early as week 4.2 Week 16 data (digital oral presentation or DOP 13) and IUS response data (DOP 10) from STARDUST are being presented as part of a digital oral presentation at the 15th Congress of the European Crohn’s & Colitis Organisation (ECCO).1,2 The primary endpoint of the 48-week STARDUST study is comparative endoscopic responsec among adult patients with CD receiving ustekinumab maintenance therapy.3 At week 16, patients who achieved a ≥70 point decrease in Crohn’s Disease Activity Index scored
Edwards Launches New Compact Dry Vacuum Pump With the Highest Pumping Density on the Market13.2.2020 13:07:00 CET | Press release
Edwards launch the new nXRi high performance compact dry pump, with lower input power and zero maintenance, bringing real performance improvements and cost benefits across a range of applications. Initial variants will provide pumping speeds of either 60 and 90 m3h-1 , four times more pumping speed than a similar sized dry pump. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200213005447/en/ Edward nXRi Compact Dry Vacuum Pump (Photo: Business Wire) Designed with size in mind, the compact footprint and height allow the Edwards nXRi dry pump to fit easily under a benchtop saving valuable space in the laboratory; and at under 30kg offers a highly mobile vacuum pump for changing work flows and environments. The pump is maintenance free for up to five years, with no tip-seal or oil change, for maximum uptime and reduced maintenance costs. The nXRi's 40% smaller footprint, compared to alternative dry pumps, assures seamless integ
Interactive Brokers Launches Bond Scanner to Help Investors Find the Best Pricing on Wide Range of Fixed Income Products12.2.2020 15:00:00 CET | Press release
Interactive Brokers Group, Inc. (Nasdaq: IBKR) today announced it has created a Bond Scanner to help make finding the best prices on bonds easier and more transparent for clients and non-clients alike. “We believe we offer the lowest bond prices available. Investors should visit our Bond Scanner at ibkr.com/bonds, filter for bonds of interest, and then call their broker to compare,” said Steven Sanders, EVP of Marketing and Product Development at Interactive Brokers. “Clients benefit from our aggregation of price quotes from multiple electronic venues and institutional dealers,” he added. “We do not widen spreads nor are there hidden fees or markups. While some companies charge a large, hidden markup, we charge extremely low, transparent commissions. IBKR clients may provide liquidity to bond markets and improve pricing by entering their own pending orders into the book.” In addition to ultra-low, transparent pricing, the company offers a huge selection of fixed income products, includ
ADVA tackles GNSS jamming and spoofing with market’s first intelligent assurance solution11.2.2020 08:00:00 CET | Press release
ADVA (FSE: ADV) today launched the industry’s first centralized GNSS monitoring and assurance tool. Using artificial intelligence (AI) and machine learning (ML) for comprehensive predictive maintenance, it addresses the key concerns of GNSS users around the globe. The new customer-owned tool enables users to collect and analyze huge amounts of information from across the network to remotely identify issues and protect networks from GNSS vulnerabilities, including jamming and spoofing attacks. It also helps to identify GNSS obstruction issues, detect blind/poor spots that appear over time and enable optimal antenna positioning. Built into ADVA’s Ensemble Controller network management suite with Sync Director, the solution enables customers to detect potential problems in advance, maintain the highest quality of network synchronization and significantly reduce opex. By complementing today’s limited distributed approach to GNSS assurance with a centralized-global system, it offers a major