Market Overview

ExThera Medical Presents Data Highlighting Key Clinical Results of Seraph® 100 Blood Filter at MHSRS


Presentation marks first time Seraph 100 data presented in the U.S.

ExThera Medical Corporation, a developer of therapies for removing
bacteria and viruses from blood, today announced results from a
prospective, non-randomized clinical trial evaluating the safety and
performance of the Seraph® 100 Microbind® Affinity
Blood Filter (Seraph) in renal replacement therapy patients who
developed bacteremia. The results were presented today in a session at
the Military Health System Research Symposium (MHSRS).

"These findings from the Seraph 100 trial support our belief that the
Seraph filter has the potential to change the landscape for treating
bloodstream infections, impacting a significant unmet need for new
treatment options," said Bob Ward, CEO, ExThera Medical. "In 2011, the
federal government first envisioned that such a technology could be
applicable to the military, and these efficacy and safety data support
that vision for the future treatment of bloodstream infections in a
multitude of settings."

In the study, patients on renal replacement therapy who developed
bacteremia had the Seraph filter included in the dialysis circuit for
four hours, with regular monitoring to measure the reduction of bacteria
in the blood passed through the filter (secondary outcome measure),
followed by a 14-day monitoring period to assess for adverse events
(primary outcome measure).

Interim safety and performance data showed that Seraph appears to be
safe and effective, and compatible with widely-used dialysis equipment
and procedures. In patients who exhibited measurable bacteremia at the
time of treatment, despite an adequate dose of antibiotics, a decrease
in bacterial count was observed by an increase in time to positivity
(TTP) measured by automated blood culture, comparing contemporaneous
post- to pre-Seraph blood samples. In addition, there have been no
device or treatment related adverse events reported during the entire
trial, with vital signs, including heart rate, blood pressure, and
cardiac output, all being stable and reproducible.

Preliminary data from the trial were presented on March 20, 2018 at the
International Symposium on Intensive Care and Emergency Medicine
Congress in Brussels, and MHSRS marks the first time these findings have
been presented in the U.S.

The U.S. Food and Drug Administration granted Seraph inclusion in its
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. On June 1, 2018, ExThera
announced the completion of the CE Mark registration trial evaluating
the safety of the Seraph® 100 Microbind® Affinity
Blood Filter (Seraph) in renal replacement therapy patients who
developed bacteremia. ExThera Medical expects to move forward with the
regulatory submission of CE Mark data in the European Union (EU) in the
fourth quarter of 2018.

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 may be useful in certain
bloodstream infections that progress to endotoxemia. The Seraph filters
have a blood-contacting surface that is anti-thrombogenic and

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

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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