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Biotech / Medical : NanoViricides - Nanobiotechnology
NNVC 7.520+2.6%May 29 4:00 PM EDT

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To: donpat who wrote (736)1/5/2018 1:16:19 PM
From: donpatRead Replies (3) of 1214
 
FDA Grants ExThera Medical’s Seraph® 100 Blood Filter Expedited Access Pathway (EAP) Designation

The EAP should make Seraph available to clinicians more quickly, satisfying the ‘unmet need’ for improved treatments for drug-resistant infections

Martinez, CA. – August 30, 2017 – ExThera Medical Corporation, the leading developer of innovative filtration devices for removing pathogens from whole blood, today announced that the U.S. Food and Drug Administration (FDA) has granted ExThera’s Seraph® 100 Blood Filter (Seraph) the agency’s Expedited Access Pathway (EAP) designation. Seraph’s initial indication for use will be ‘as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is a heparin- or heparan sulfate-binding bacteria, including antibiotic resistant bacteria MRSA, VRE, ESBL, CRE, and MRSE.’

extheramedical.com
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