Medical technology company BrainCool has been carrying out a joint clinical development program with the University Hospital in Freiburg for the past two years, sponsored with 3 million Euros by the EU.
The studies, Cottis 1 and Cottis 2 (“Combination of Targeted temperature management and Thrombectomy after acute Ischemic Stroke”), aims to establish a new treatment for stroke patients by combining cold therapy with thrombectomy.
Results from the first study were presented in October 2022 and showed a doubling of the number of patients surviving with good neurological function at hospital discharge. Next up is the larger, upcoming randomized pivotal clinical trial, Cottis 2.
Reperfusion injuries associated with thrombectomy
After a stroke has been identified and the blood clot blocking blood flow to the brain has been mechanically removed through a catheter (thrombectomy), blood flow is restored to save the affected part of the brain. However, permanent damage can still occur, which occurs when blood returns to the brain, known as reperfusion injury.
The BrainCell concept aims to rapidly cool the brain before reperfusion, to reduce the damage associated with thrombectomy. Specifically, this process begins with BrainCool's portable, battery-powered cooling device. RhinoChill. This is then followed by continuous cooling with the unit BrainCool System.
University of Maryland joins Cottis-2
BrainCool was able to announce last week that, in consultation with the University Hospital of Freiburg, it has concluded an agreement with the trauma hospital affiliated with University of Maryland, for participation in the Cottis 2 study. Dr. Neeraj Badjatia will be the main responsible for the hospital's participation. Maryland has previous experience in clinical studies in thrombectomy and has also participated in projects with cooling and thrombectomy.
BrainCool's CEO comments
To learn more about what it means that the University of Maryland will now participate in Cottis-2, BioStock contacted BrainCool's CEO Martin Waleij.
Martin, how did the collaboration with the University of Maryland come about?
– We have previously collaborated with Dr. Badjatia and have a joint grant in neurological fever. He is also the first author of the 2017 American guidelines for cooling neurological fever. He has recently been involved in another study in this area, and when he has completed his participation in this one, we saw him as particularly suitable to lead our study.
– He is one of the leading opinion leaders in the establishment of cooling of neurological fever, but also TTM and studies in thrombectomy. He is also an experienced resource who has participated in several FDA processes,
– The goal of a clinic in the USA is primarily to facilitate the process with the FDA and “market access”, i.e. a rapid establishment of insurance reimbursement for combined cryotherapy with thrombectomy.
How important is it that an American university is now joining the study?
– For patient recruitment and establishment of the concept in international guidelines, it plays a minor role, but it is clearly something of an insurance policy to ensure faster processes with the FDA and Medicare.
Does their participation potentially affect how the FDA views Cottis-2?
– Yes, we make that assessment. But we have shown previously that we can obtain FDA approval based solely on EU studies (Cooral System with a Nordic study), but it is positive and that it will be favorable for the possibilities of obtaining rapid insurance reimbursement.
Finally, you have raised SEK 60 million in a private placement. Can you tell us a little more about this?
– The capital not only facilitates the expansion of the company, but we have now brought in institutional owners with Carnegie funds as lead investors, which strengthens us against the capital market and various stakeholders.