Fre 14 jun / År 42 / Nr 1 2024

A cool approach to preventing tissue injury

BrainCool, based in Medicon Village, is using controlled temperature management technology to create portable and local cooling systems for fast treatment and prevention of neurological and other tissue injury.

In hypothermia, as the body temperature falls, everything slows down, including breathing, heart rate and cellular metabolism. While that process is dangerous for someone who has been exposed to uncontrolled temperature changes, for example falling into cold water, targeted temperature management can be used to prevent injury to the brain following an ischemic event such as stroke, cardiac arrest, traumatic brain injury or birth injuries, and can protect tissues against injury, for example during chemotherapy. This could save lives, reduce costs and improve patients’ quality of life

How cooling helps
Therapeutic cooling has a number of mechanisms of action. Cooling the body by one °C reduces cell metabolism by 5-8%, cutting the cell’s need for oxygen.Temperature reduction may also stabilise the cell membrane, which could reduce damage during oxygen deprivation. Once the blood flow is restored, low temperatures may also reduce reperfusion injury, by reducing free radical production, and in the case of brain injury, reducing intracranial pressure.
Because therapeutic cooling doesn’t involve drugs, it could be initiated on clinical diagnosis alone and before any imaging takes place, for example in the field at the location of the injury or ischemic episode, in the ambulance, and during the wait for other diagnostic procedures. The BrainCool System is an advanced surface cooling system that offers selective brain cooling and three different temperature zones, along with shivering detection. When shivering, which can be a side effect of cooling, is imminent the BrainCool System can alert healthcare professionals and/or or slow down the coolant capacity of the system, keeping patients just above their shivering trigger point.
Studies published back in 2002 have shown the positive effects of cooling after cardiac arrest, and its use is now incorporated into a number of guidelines from organizations including American Heart Association, European Resuscitation Council, and The International Liaison Committee on Resuscitation, in order to prevent neurological damage. In a Phase 3 trial of medical cooling within six hours of a stroke patients (EUROHYP-1), the first stage of the study has shown the hypothermia approach to be safe, and the ongoing stage is now looking at efficacy. The BrainCool System was added into the study in July 2016.
PolarCap: Cooling in concussion
In the US alone, there are somewhere between 1.6 million and 3.8 million sports-related concussions yearly, a mild form of traumatic brain injury. BrainCool’s PolarCap cools the scalp and neck to reduce the brain temperature and could be used in the field for immediate treatment. BrainCool is carrying out a clinical trial in collaboration with nine teams from the Swedish Hockey League. BrainCool has created a subsidiary that will focus on sports medicine.
“We are currently evaluating the use of PolarCap within ice hockey, and there is also potential in other sports such as rugby, martial arts, horse racing, and American football,” said Martin Waleij, BrainCool CEO.

RhinoChill Nasal brain cooling
RhinoChill is a portable, non-invasive battery operated medical device that provides early-stage and rapid cooling by spraying coolant liquid into the nasal cavity. It can be used in the field by rescue services, and while patients are in ambulances and the emergency room. Because the effect lasts for a few hours, patients can be chilled rapidly to the target temperature, and then the BrainCool System’s precise management of body temperature can keep the patient’s temperature within a precise range through the full treatment period of 72 hours or more. RhinoChill can also be used at the same time as the BrainCool System for an enhanced cooling effect, allowing the target temperature to be reached much faster.
“This rapid cooling can be crucial, and the ability to use the two systems together gives us an important competitive edge,” said Waleij.
BrainCool is assessing RhinoChill for ‘at home’ use in medication overuse headache and migraine, following a UK hospital-based study that showed reduction in pain and other migraine symptoms during and up to 24 hours following treatment.

Preventing painful chemotherapy side-effects: Cooral
Oral mucositis as a result of cancer chemotherapy is painful and distressing, and leads to increased healthcare spending on painkillers, total parenteral nutrition and infection. Cooral cools the mouth in chemotherapy and head and neck ration, reducing damage to the soft tissues in the mouth. Cooral has De Novo 510 k and Early Access Pathway designation and priority review, and the Food and Drug Administration in the US will accept the ongoing Swedish trial as a submission for approval.