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2020-06-02

BrainCool: BrainCool AB (publ) is conducting a study with covid-19 patients

BrainCool AB, in collaboration with intensive care unit (ICU) clinics
at Södersjukhuset ("SÖS") in Stockholm Sweden, will conduct a small
study (case series) in which covid-19 patients are to be treated for
severe fever. Approximately 15 patients will be treated with the
BrainCool? System.

SÖS has taken the initiative to carry out the study after promising
results with the BrainCool? System. The products have been
successfully used to treat four covid-19 patients with severe and
recurrent fever, where drugs have been shown to be ineffective in
treating these fever peaks.

In addition, France's and Switzerland's health ministries have issued
warnings that the commonly used fever-reducing drug ibuprofen, which
also goes by the name Ipren in Sweden, could worsen the prognosis of
patients with covid-19 (ref
https://www.thelancet.com/action/showPdf?pii=S2213-2600%2820%2930116-8)

The results of the study will be presented in collaboration with three
leading hospitals as early as September, in connection with a
scientific satellite meeting in New York, USA for healthcare
professionals in the region.

CEO Martin Waleij comments:

Covid-19 is a new disease with many factors yet to investigate.
However, we can conclude that we see a direct value of our products
in treating fever, for example within neuro-care in the United States
where it is preferred to avoid drugs and instead treat the fever with
advanced TTM systems, similar to the cases we have experienced at SÖS
where drugs have not been effective. BrainCool is positive to
contributing to finding solutions during the ongoing covid-19 crisis.

Furthermore, it is becoming increasingly clear that covid-19 is not
merely a respiratory disease. Blood-clot complications are part of an
inflammatory state which increases the risk of stroke and brain
damage with subsequent significant needs for rehabilitation. For
these patients, the BrainCool System can play an important role to
reduce brain damage. BrainCool closely follows and monitors all new
findings and publications that indicate brain damage, rehabilitation
needs and risk of stroke, all in which our products can help bring
value to patients. BrainCool will also continue to explore all
possibilities to contribute with relevant treatment to benefit
patients.

The current study at SÖS in Stockholm does not entail any costs for
the company. However, BrainCool will donate the disposable items to
treat the fifteen (15) covid-19 patients included in the study. The
four already treated patients will be included retrospectively in the
study.

The primary purpose of the study is to evaluate advanced fever therapy
but also to make observations regarding patients with acute lung
failure, a condition also called ARDS (Acute Respiratory Distress
Syndrome), but also neurological refractory fever patients will be
observed.

Nearly one-third of patients undergoing mechanical ventilation at ICU
suffer from ARDS, which is a serious condition with around 40 percent
mortality. ARDS is also a condition that often affects the severely
ill covid-19 patients, with even higher mortality rates.

Clinical studies suggest that therapeutic hypothermia (TH) has shown
improved clinical outcomes as a lung protective approach in patients
with ARDS. There are documented patient cases where temperature
treatment in patients with ARDS has led to positive outcomes, such as
ventilator free days and shortened hospitalization and ICU
length-of-stay, which is also in line with BrainCool's experience
from Germany and the US.

See attached publication
https://www.alliedacademies.org/articles/hypothermia-therapy-as-an-adjuv...
as well as an ongoing clinical trial at the University of Maryland,
USA. Ref: https://clinicaltrials.gov/ct2/show/NCT03376854.

CEO Martin Waleij closes:

- The study at Södersjukhuset is mainly focused on advanced fever
treatment, but from BrainCool's perspective it is of interest to
evaluate our products for potential treatment for ARDS patients as
well. This also applies to patients where the condition is not a
direct consequence of covid-19.

This information is information that BrainCool (publ) is obliged to
make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of the
contact person set out herein, on June 2, 2020.

For more information

Martin Waleij - CEO
+46 - 733 -93 70 76
E-mail: martin.waleij@braincool.se

About BrainCool AB (publ)

BrainCool AB (publ) is an innovative medical device company that
develops, markets, and sells leading medical cooling systems for
indications and areas with significant medical benefits within the
healthcare sector. The company focuses on two business segments,
Brain Cooling and Pain Management. BrainCool AB (publ) is based in
Lund, Sweden, and its share is listed on Spotlight Stock Market.

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https://news.cision.com/se/braincool/r/braincool-ab--publ--is-conducting...
https://mb.cision.com/Main/11624/3126229/1257887.pdf

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