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-adjuvant-therapy-for-severe-ards.pdf 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.

Om oss

BrainCool AB (publ) är ett innovativt medicinteknikföretag som utvecklar, marknadsför och säljer ledande medicinska kylningssystem för indikationer och områden med betydande medicinska mervärden inom sjukvården. Bolaget fokuserar på två affärsområden, Brain Cooling och Pain Management. BrainCool AB (publ) har sitt säte i Lund. Aktien är noterad på Spotlight Stock Market.

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