BrainCool

·         The Cottis-1 study (1) has been accepted for publication in the highly regarded scientific journal 'Stroke & Vascular Neurology' (with an impact factor of 10, 2023). The journal has announced that it will publish the article in the September issue or present it online within a couple of weeks.
·         Furthermore, the Cottis-2 study (2), a randomized study of 400 patients, has recently received granted ethical approval, planning to start after summer. In addition, the University Hospital in Freiburg has completed a new scientific article based on the data generated through discussions with BrainCool and the FDA.
 
New clinical data with significant results
 
This forthcoming scientific publication is based on a so-called "matched-pair-analysis" performed on 650 patients (3), who during the period 2016-2021 were treated with thrombectomy, at the University Hospital in Freiburg.
 
At a group meeting for the Cottis-2 study, the results have been shared with a larger circle of people, which is why BrainCool now decides to share the results with the market.
 
The results from the feasibility study with 22 patients who underwent treatment with cooling therapy, have been compared with 44 patients with the same age, gender and the same type of brain damage (1).
 
A shift analysis shows statistically significant results (p < 0.05) with an increased stroke survival after three months of follow-up, from 34.2% to 68.2%, with a good neurological function (mRS 0-2).

CEO Martin Waleij comments:
 
Of course, the shift analysis does not replace the randomized trial. However, we can conclude that additional scientific publications strengthen our hypothesis. In fact, we can now show that Neurochill delivers the desired effect; chance is "eliminated". 
If the above results are generalized to a randomized trial, significance would already be obtained after 52 – 56 patients.
 
References
 
1.       MFN.se > BrainCool > Publication Acceptance of BrainCool's Thrombectomy Study in Stroke & Vascular Neurology
2.       MFN.se > BrainCool > BrainCool AB (publ): Ethical approval for the clinical study for stroke patients
3.       Matching was performed for patients previously treated in Freiburg (2016-2021) based on their age, NIHSS on admission, ASPECTS score on admission, and location of large vessel occlusion