ExThera Medical’s ‘Seraph’ Blood Filter Successfully Completes Pre-Clinical Testing in Final Phase of DARPA’s DLT Pro...
January 25 2018 - 8:21AM
Business Wire
Technology Could Address Significant Need for
Better Treatment of Bloodstream Infections Caused by Drug-resistant
Microbes
ExThera Medical Corporation, the leading developer of innovative
therapies for removing bacteria and viruses from blood, today
announced that the safety and effectiveness of its Seraph® 200
Microbind® Affinity Blood Filter (Seraph 200) has been demonstrated
in pre-clinical testing. The fourth phase of DARPA’s Dialysis-Like
Therapeutics (DLT) program was successfully completed in November
by Battelle scientists. This final phase of testing employed Good
Laboratory Practices to produce results for submission to the U.S.
Food and Drug Administration (FDA). The written report, which is
pending, confirms safety and efficacy of Seraph in the removal of
drug-resistant pathogens from whole blood.
Seraph is a unique production-ready device that is capable of
removing a broad range of sepsis-causing bacteria, viruses, toxins,
and pro-inflammatory cytokines from whole blood. Validated in
preclinical studies and currently under evaluation in a promising
European clinical trial, a related device (Seraph 100) promises to
address the significant unmet need for rapid treatment of
bloodstream infections caused by a long list of pathogens,
including many that are drug-resistant. Seraph 100 was recently
designated by FDA for inclusion in the Expedited Access Pathway
(EAP) program. EAP designation is granted to devices that have the
potential to satisfy unmet clinical needs in the prevention of
fatal or debilitating diseases.
Although similar in appearance, Seraph is very different from
other blood filters, which are offered for the treatment, but not
the prevention, of bacterial sepsis. Whereas other devices can
remove only cytokines or endotoxins, and in one case viruses,
Seraph quickly removes many bacteria, bacterial toxins, viruses,
fungi and cytokines simultaneously, using a blood-compatible
surface that does not injure the blood. As such, Seraph is designed
to treat bloodstream infections quickly to prevent their
progression to life-threatening sepsis and septic shock. Seraph 200
also binds endotoxins created by gram-negative bacteria.
ExThera Medical is focused on developing easy-to-use devices for
the rapid treatment of life-threatening bloodstream infections,
especially in the face of rising incidence rates and the spread of
drug-resistant pathogens worldwide.
“Effective treatments for preventing and treating sepsis are
critically needed, especially for members of our military for whom
risk of exposure is significant. We are pleased to have been chosen
for this important final phase of DLT testing, and to contribute to
the collective efforts to save lives and healthcare dollars,” said
Robert Ward, CEO of ExThera Medical.
About the Seraph® Microbind®
Affinity Blood Filter
As a patient's blood flows through the Seraph Microbind Affinity
Blood Filter, it passes over proprietary microspheres coated with
molecular receptor sites that mimic the receptors on human cells
that pathogens use when they invade the body. Harmful substances
are quickly captured and adsorbed onto the proprietary surface and
are thereby removed from the bloodstream without adding anything to
the blood, which is returned to the patient with blood cells
intact. The adsorption media is a flexible platform using
chemically-bound, immobilized heparin for its blood compatibility
and its unique binding capacity for pathogens. Seraph may be
configured with optional supplemental adsorbents to remove other
toxins and evolved pathogens. For example, Seraph 200 adds
endotoxin binding to Seraph 100, which will be useful in
bloodstream infections that progress to endotoxemia. The Seraph
filters have a blood-contacting surface that is anti-thrombogenic
and anti-inflammatory, and which has been demonstrated to be safe
in other medical devices and implants.
About ExThera Medical
Based in Martinez, Calif., ExThera Medical is a privately-held
medical device company developing innovative, single-use blood
filters capable of capturing and removing a broad range of
bacteria, viruses, parasites, toxins or other harmful substances
from whole blood. The company develops therapeutic products to
treat patients in the hospital or clinic, or on the battlefield.
Led by an accomplished management team with extensive experience in
blood-contacting devices and biomaterials, the company has strong
patent protection and a growing body of data from independent
laboratory studies, in addition to its participation in DARPA’s
Dialysis-Like Therapeutics program. For more information, visit
www.extheramedical.com.
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.
Caution: The Seraph®
Microbind® Affinity Blood Filter is currently
undergoing clinical evaluation and is not available for commercial
sale.
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version on businesswire.com: http://www.businesswire.com/news/home/20180125005619/en/
ExThera Medical Contact:Robert S.
Wardrobert.ward@extheramedical.comorMedia Contact:Sierra
Smith, 408-540-4296sierra@healthandcommerce.com