BrainCool and KI conduct major cardiac arrest study
BrainCool will deliver its products RhinoChill and BrainCool System to Karolinska Institutet for a large international clinical study pre-hospital cooling of cardiac arrest patients. In a comment to BioStock, CEO Martin Waleij says that the deal value of 3 million SEK is secondary to the fact that RhinoChill can become central in the future treatment of cardiac arrest.
Barely a week has passed since the medical technology company BrainCool announced that it is investing in establishing the company’s product RhinoChill – a portable, battery-powered cooling device – for the treatment of stroke in connection with thrombectomy. Thrombectomy involves mechanically removing the clots in the brain using a catheter, which re-establishes blood flow to save the affected part of the brain after a stroke.
An approval of stroke as a medical indication, the company’s CEO Martin Waleij says, would mean a major breakthrough similar to an approval of a new drug.
Read more: BrainCool wants to reform stroke care (March 23, 2023)
RhinoChill in the treatment of cardiac arrest
Following the announcement of the stroke initiative, the next focus area has now been announced; the treatment of cardiac arrest with RhinoChill. In connection with this, the company has received an order from Karolinska Institutet (KI) worth 3 million SEK. In both the RhinoChill projects BrainCool hopes to develop a new standard treatment in both stroke and cardiac arrest care, i.e. two therapies.
KI is responsible for and sponsors the cardiac arrest study, while BrainCool, together with researchers from KI, will jointly analyse data for future regulatory approvals that are to be based on the clinical study with RhinoChill. The plan is to recruit 970 patients to several European centres in the coming quarter and the study is to last for three years.
Treatment in the home
The goal of the study is to increase survival after cardiac arrest by 20 per cent, with full neurological function. A key to achieving this very ambitious recovery is that the treatment can be initiated already in the patient’s home or at the latest during the ambulance ride. According to BrainCool, RhinoChill lowers body temperature to the target temperature about 6-8 hours faster than when cooling is initiated in the hospital.
The CEO comments
BioStock contacted BrainCool’s CEO Martin Waleij to find out more about the study and the choice of two new indications in a very short time.
Martin, in a press release, you state that the conditions are very good to quickly implement the treatment as a standard method in ambulance care and in the early phase of hospital care around the world. What speaks for this, in your opinion?
– There are several different factors that support the hypothesis for the study. In the new study, a proprietary and further developed RhinoChill-product will be used. Inclusion of patients will only occur within 20 minutes of cardiac arrest and the majority of patients will be included in the study through dedicated physician cars. That is, large educational efforts by many ambulance nurses in different ambulance systems will not be needed as primarily physician cars will be used in the study. This reduces the risk of not being carried out optimally but also ensures that the rapid inclusion and randomization of the patient can be carried out.
– Clinically, the study will only be performed on patients with ventricular fibrillation as they have a reasonable chance of survival, thus excluding non-shockable patients where the majority of these die before arrival in hospital regardless of which interventions are used.
– Already in the Princess-1 study, a clear significance for shockable patients for CPC 0 – 1 / mRS 0–1 was reached in a subgroup analysis of only 273 patients. The results showed not only a 20 percent improvement in survival with full neurological function, but a (relative) improvement of over 60 percent.
– Digging even deeper into the results, the improvement in patients enrolled within 20 minutes of the cardiac arrest showed even stronger results. The patients who were included within 20 minutes showed that the proportion with complete neurological function was 47.4% versus 21.1% (p-value = 0.008). This means not only an improvement of 20% but more than a doubling (about 120%) of the number of survivors with full neurological function. That is, if you assume that the outcome in the control group, survival with full neurological function is 35%, you reach significance if the active group reaches 42%. It shows that the study design of 970 patients rests on a strong foundation, but also that there is a good basis to establish a strong signal already at an interim review in the study of 400 patients.
– Strengthened by these results and with implemented quality improvements of the product and implementation of the treatment and protocols, it indicates that we have created a strong foundation.
– Last but not least, another detail is worth mentioning: In the Princess 1 study, the active group was compared with a control group that was cooled down to the same target temperature (below 34 degrees) and even in the control group, the target temperature was reached within 180 minutes versus 101 minutes in the active group. The control group in Princess 1 also reached target temperature several hours before the active group in other TTM studies. The Princess 2 study will compare against a control group that only treats patients with fever control.
How do you envision that the study results would be received within cardiac arrest care if you manage to reach the goal of full neurological recovery?
– As I said, our goal is not only to change the guidelines in the area, we also intend to take this a step further to establish a well-defined therapy and treatment form for all cardiac arrest patients. By adapting the outcome measure to the mRS scale, all available health economic evidence in the field will be applicable to our studies. That is, follow the same route as our stroke project, and we have of course established our strategy in cooperation with both the FDA and corresponding authorities in the EU.
– However, the products will be launched not only as two different therapies but as two different products and brands. We will get back to the stock market with more information once the studies start.
How would you describe the interest in the technology among the international study centres that have so far announced interest in participating in the project?
– Study centres have not yet been published by KI, but we can conclude that a very strong steering group is being established within the study of leading centres in several EU countries.
What would it mean financially for BrainCool if new requirements to use your treatment concept were to be introduced in the healthcare system?
– The project is of course facilitated by our successes in stroke and by the collaboration with the cardiac arrest centre at KI. It is a bit too early to speculate in financial terms, instead our focus is on building a solid foundation, after which the outcome of the study will define the future.
Finally, you have chosen two new medical indications in a very short time period. Can you say anything about expected timeframes to reach market within these indications, under optimal conditions?
– The goal is to start the studies in the coming quarter. Within the stroke project, the goal is for the study to be completed within 2024. For the project in cardiac arrest, BrainCool is not a sponsor of the study and I can therefore not speculate about this, but I can state that the goal is for the recruitment of patients to take place within three years.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.