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BrainCool AB (publ) comments on international clinical trial efforts with targeted temperature management ("TTM")

2021-11-11

 

Two major TTM clinical studies are underway in Germany and the US, the core markets of BrainCool. Both clinical studies are in-hospital studies only.

 

  • The ICECAP study in the US, which already has started with funding from NIH of MUSD 20. (See more detail about this trial in Appendix 1.)
  • The "Jena" study in Germany, which is not yet initiated. An ethical submission has been made with University of Jena as main site along with a total of 17 major cardiac arrest centres, as well as an application for funding from the German research council of MEUR 3. (See more detail about this trial in Appendix 2.)

Martin Waleij CEO comments:

There is continued research underway in the TTM space, with considerable research funding, which will lead to new knowledge and leverage further interest in the market. BrainCool is neither funding nor have been part of the design of either of these trials.

The feedback BrainCool has received from key opinon leaders/healthcare professionals in both of these core markets is that cooling to a lower target temperature is still of great importance. The feedback was gathered through a market review performed by BrainCool, subsequent to the results of the TTM-2 trial[1]. The results of the recent TTM-2 trial did not demonstrate any significant difference in mortality rates or intact neurological survival when comparing the two main strategies of targeted temperature management (delayed initiation of cooling at the ICU to 33°C vs. normothermia including early treatment of fever). This study suffers from the same problems as the previous TTM-1 study: Firstly, it did not include a control group without any temperature control. Additionally, it could be argued that the patients in this study do not represent the patients in general practice accurately. Compared with most North American – and German – hospitals, the TTM-2 study had twice as many witnessed cardiac arrests, twice as many cases of bystander-initiated CPR, three times the frequency of shockable rhythms and about three times the rate of survival to hospital discharge. Particularly, patients in the TTM-2 trial experienced a higher percentage of bystander-initiated CPR (80%) relative to previous clinical trials (49% to 58%).[2],[3] Thus, it remains to be clarified if the TTM-2 trial results can be widely applied to US and German speaking communities with a longer time to resuscitation. The TTM-2 trial added a target temperature of 37.5°C in addition to 33°C and 36°C, for clinicians to choose for sudden cardiac arrest patients to implement high quality TTM.

 

However, based on the market feedback received, there is strong support for cooling at lower target temperatures and also for the importance of the time window of the TTM therapy. A common denominator of both the Jena and ICECAP trials, which are described in more detail in Appendices, is the exclusive use of high quality TTM systems at the ICU and the need for strategies of implementing cooling earlier.

 

In the German and Austrian multi-centre trial effort (Jena trial), three high quality TTM systems are included for implementation of the therapy at the ICU – one of the three is the BrainCool System. For adaption of early cooling, only one medical device is included – The RhinoChill System, the only device for implementing cooling therapy directly in the emergency room ("ER") and until the patients arrive in the ICU. Both clinical trials share a common factor: the intent to apply cooling earlier.

 

Martin Waleij CEO adds:

Obviously, we have been in communication with the leadership of both clinical trials. BrainCool’s official view is that TTM should be applied already at the scene of the cardiac arrest – even in out-of-hospital situations. That said, we are of course monitoring the developments of clinical trials in our space closely.

 

Although the two efforts are "in-hospital" studies only, it is evident that there is a need for the use of the BrainCell concept – implementing cooling as early as possible with the RhinoChill System and maintenance cooling with the IQool system – for out-of-hospital cardiac arrests as well as for in-hospital patients.

 

In the case of the US trial, we have not pursued for participation before we could actively offer the BrainCell concept, that is  post a market clearance for RhinoChill System. It might be difficult reaching the prerequisite of inclusion, reaching time to target from cardiac arrest to target temperature without implementing our concept. In the case of the German effort, we have presented clinical material for both of our devices to be approved for use in the trial.

 

 

 

 

 

[1] https://www.nejm.org/doi/full/10.1056/NEJMoa2100591

[2] Bernard SA, Gray TW, Buist MD, et al. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med 2002;346:557-63.

[3] The Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med 2002;346:549-56.

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 Oncology. BrainCool AB (publ) is based in Lund, Sweden, and its share is listed on Spotlight Stock Market.