BrainCool

Most research clinal studies that has established the neuro thrombectomy market have specifically excluded individuals with larger infarcts. Instead, the focus has primarily been on patients with mild to moderate stroke. That is with an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) 6 – 10. ASPECTS is a scale ranging from 0 to 10, with lower scores indicating a greater burden of infarction.

In the past nine months, three important clinical trials (RESCUE-Japan LIMIT [1], ANGEL-ASPECT [2], SELECT2 [3]) were conducted on patients with acute ischemic stroke caused by a large vessel blockage. These trials specifically focused on patients with larger infarcts (severe stroke), indicated by lower ASPECTS scores ranging from 3 to 5. The three trials showed strong significant data showing that endovascular thrombectomy also should be offered to patients with large strokes.

The robust and compelling data from these trials now suggest that endovascular thrombectomy should also be considered for patients with sizable strokes (ASPECTS score 3 - 5), a subgroup accounting for approximately 20% of all ischemic strokes.

The three clinical trials truly represents worldwide patients and will contribute to an even higher growth of implementation of thrombectomy in stroke. One trial involved Japanese patients (RESCUE-Japan LIMIT), another included Chinese patients (ANGEL-ASPECT), and the most recent trial, SELECT2, included patients from the US, EU, Australia, Canada, and New Zealand. SELECT2, in particular, was stopped early because it demonstrated remarkable effectiveness.

All three trials, despite differences in design, patient selection and geographic location, showed remarkably similar results, which clearly have confirmed the benefits of thrombectomy in severe stroke, were consistent across age, degree of neurologic deficit, imaging characteristics, time of treatment, and geographic location.

CEO Martin Waleij comments;

“Implementation of thrombectomy in severe stroke will contribute even further to the high growth of the neuro thrombectomy market, where the medical device markets using trombectomy in neurology was even before estimated to over SEK 7 billion in 2022.

Given the result of the Cottis 1 study [4] and objective of the Cottis 2 study [5], to show as big improvement in improved survival with good neurological outcome, as thrombectomy has previously shown, it is reasonable to expect a similar market potential and size for Neuro Chill® in stroke and that the market potential will grow with the expanding market for thrombectomy.”

References;
[1] https://classic.clinicaltrials.gov/ct2/show/NCT03702413
[2] https://www.nejm.org/doi/full/10.1056/NEJMoa2213379
[3] https://www.nejm.org/doi/full/10.1056/NEJMoa2214403
[4] MFN.se > BrainCool > BrainCool AB (publ): Utilization of BrainCell in Thrombectomy following Acute Ischemic Stroke: A Scientific Clinical Study" has now been released in the Journal of Stroke & Vascular Neurology
[5] MFN.se > BrainCool > BrainCool AB (publ): Ethical approval for the clinical study for stroke patients