THE COMPANY

BrainCool AB (publ) is a Swedish medical device company, listed since May 2014 on Aktietorget
The business idea is to develop and market patented medical cooling technologies with an initial focus on brain cooling and prevention of oral mucositis.
The vision is to create The Medical Cooling Company with a clear focus on bringing products with high innovation and medical needs to the market. These products will create a de facto standard in their field.

Therapeutic Hypothermia

Therapeutic hypothermia, or cooling, lowers a patient’s body temperature to help reduce the risk of injury to the brain following a period of insufficient blood flow due to an ischemic event, such as cardiac arrest, stroke or traumatic brain injury. Cooling begins after the patient is admitted to the hospital.
Two landmark human studies published simultaneously in 2002 by the New England Journal of Medicine demonstrated the positive effects of mild hypothermia applied following cardiac arrest. In response to this research:

 

• The International Liaison Committee on Resuscitation (ILCOR) released a special advisory statement recommending the use of therapeutic hypothermia following cardiac arrest.
• This recommendation was incorporated into the 2005 updates to the American Heart Association (AHA) and European Resuscitation Council (ERC) guidelines for care following cardiac arrest.
In the 2010 Guideline updates, ERC added the statement “Therapeutic hypothermia is now an established therapy that greatly contributes to improved survival with good neurological outcome.” In the 4th link of the Chain of Survival AHA guidelines recommend that patients resuscitated from cardiac arrest be transported only to centers that practice therapeutic hypothermia.

The products

Brain Cooling

•A brain hypothermia device,  for the stroke marketThe BrainCool System

•A brain hypothermia device for the cardiac arrest market – The BrainCool System ( the same product with a different configuration )

Both product offers a cash flow driven business model.  With the accessories BrainCool Pads® which is used for not more than 1 – 2 patients on a weekly basis.

The BrainCool™ system for Stroke

An estimated worldwide market potential of $3 billion annually. 

The BrainCool™ system for Cardiac Arrest

Current annual sales by three major players (Bard / Medivance, Asah Kasei / Zoll and Philips Healthcare) $ 150 million* with an annual growth of 30–40% with a similar market potential as stroke.

The PolarCap™ System , for treatment of concussion

With 3.8 million sports-related cases annually in the US.

The PolarCap® System is a portable cooling system with high effect, which will be used to reduce the temperature of the brain in ice hockey players by cooling the scalp and neck via circulating cold fluid in a cap complete with collar.

The product is now being evaluated in a first clinical study in which Malmö Redhawks and yet another Swedish ice hockey team are participating.

In the first quarter of 2016 a subsidiary has been created, IQool Technologies, with a focus on sports medicine with the first business area, treatment of concussions, with the product The PolarCap System.

 

Medical cooling of oncology

Prevention of oral mucositis (OM), a major severe side effect of cancer treatment – The Cooral™ System

• In 2009, Medicare reimbursed over $40,000 per patient with ulcerative mucositis lesions.

http://www.cancertherapyadvisor.com/oral-mucositis-in-cancer-patients-treatment-update/article/240497/

• GlobalData estimated that the oral mucositis therapeutics market was valued at $813.2m in 2010. Further, the oral mucositis therapeutics market is expected to grow at a compound annual growth rate (CAGR) of 5.2% from $813.2m in 2010 to $1,156.0m in 2017. The growth would be primarily due to the increase in cancer patients, increased rate of chemotherapy and increase in awareness among patients about oral mucositis.

The market for prevention of Oral Mucositis is valued at more than $1 billion annually

The COORAL™ system for prevention of Oral Mucositis

The Cooral™ product is a single-use cooling oral device, used every time a patient undergoes chemotherapy (or radiation to head and neck) connected to a portable cooling system.
The product has received De Novo 510 k designation and has also now received an EARLY ACCESS PATHWAY with priority review (the strongest fast track in medical devices) and the current Swedish trial is accepted as base for approval by the FDA.

Indications

Stroke

A stroke is the rapid loss of brain function resulting from an impeded blood supply to the brain. This can be due to lack of blood flow (ischemia) caused by an embolism or other thrombosis or it can be caused by a leakage of blood (hemorrhage). As a result of the lack of blood flow, the affected area of the brain is unable to function and this can lead to brain damage and cell death.
A stroke is a medical emergency that can cause permanent brain damage and even death. It is the leading cause of adult disability in the United States and Europe and it is the number two cause of death worldwide.
Because stroke incidence rises exponentially with age, the social and economic burden of stroke will rise further with the aging of the population.
In Sweden alone with a nine million population, 30,000 persons every year will experience a stroke and another 35,000 become victims of a cardiac arrest.
The products are needed because considerable neuroprotection can be achieved through hypothermia, resulting in saved lives but also significantly improved quality of life for the surviving patients.
Even small medical advantages in these two patient groups will give large health economic gains for society. There is also the potential for necessary technologies to be adopted at all hospitals with emergency care programs for these patients.

Ischaemic stroke

Ischemic stroke is currently considered the largest challenge in the area of cardiovascular disease, due to the very limited number of treatments available to the victims. Intravenous thrombolysis with alteplase is the most prominent treatment strategy, but is available only for a small minority of patients. In addition, about half of the stroke patients remain dependent or die despite thrombolysis. Because stroke incidence rises exponentially with age, the social and economic burden of stroke will rise further with the ageing of the population.

A systematic review of animal studies modeling stroke suggests that therapeutic cooling is the most promising intervention identified to date. In these animal studies, cooling to 35 °C reduced infarct size by about one third, and cooling to 34 °C by around 45%. Moreover, several prospective observational studies in stroke have shown an association between raised body temperature and poor outcome, and between low body temperature and good outcome. Finally, cooling improves outcome in patients with hypoxic-ischemic brain injury after cardiac arrest. Hypothermia is therefore the most promising treatment for patients with acute ischemic stroke.

Cardiac Arrest

Cardiac arrest occurs when the heart stops beating and prevents the circulation of blood in the body, which results in loss of consciousness and breathing. If this is unexpected it can be termed a sudden cardiac arrest or SCA. Brain injury is likely if cardiac arrest goes untreated for more than five minutes. Sudden cardiac arrest usually results from an electrical disturbance in the heart and is different from a heart attack. However, a heart attack can sometimes trigger an electrical disturbance that leads to sudden cardiac arrest.
Cardiac arrest is a severe medical emergency that, in certain situations, is potentially reversible if treated early. With fast, appropriate medical care, survival is possible.

Unconscious survivors of out-of-hospital cardiac arrest have a high risk of death or poor neurologic function. Therapeutic hypothermia is recommended by international guidelines

 

Concussion

A concussion is a type of traumatic brain injury (TBI) caused by a bump, blow, or jolt to the head that can change the way the brain normally works. Concussions can also occur from a fall or a blow to the body that causes the head and brain to move quickly back and forth.
Health care professionals may describe a concussion as a “mild” brain injury because concussions are usually not life-threatening. Even so, their effects can be serious.
With stronger recommendations from the American Heart Association in 2010, 24 hours of hypothermia has become the standard for some patients who don’t wake up after cardiac arrest. No one cooling method has been proven better than any other – although new devices to specifically target the brain rather than the entire body are being developed
Each year in the US approximately 10–15% of athletes who participate in contact sports suffer a concussion. While those who participate in football, basketball, soccer and cheerleading activities are particularly vulnerable, a number of people suffer concussions from everyday activities, such as riding bikes, skateboarding or rollerblading.
In Sweden, the problem is familiar in the Swedish Hockey League (SHL) where almost every week a new incidence of a concussion occurs. Several famous players have been forced to stop playing prematurely, and the area has been highlighted in different high-profile research at Sahlgrenska Academy.
Several different mechanisms can explain the beneficial effects of cooling. For each degree by which the brain temperature is lowered, its metabolism decreases by roughly 6%. Less oxygen and glucose is thus consumed, which reduces the risk of cell death. The risk of cerebral edema (accumulation of fluid in the brain) is reduced, and consequently also the pressure in the skull.

Oncology – prevention of oral mucositis (OM)

OM significantly affects the quality of life for cancer patients in terms of pain, ability to eat, swallow and talk. The symptoms are often of such severity as to require an interruption or curtailment of therapy or lead to dose reduction of the cancer therapy or a treatment delay. In some cases these patients require hospitalization.
OM has a direct and significant effect on the duration of the disease remission and cure rates due to the dose limiting toxicity but also in some cases affects survival because of the risk of infection, and it has a significant impact on quality of life and cost of care. It is clear that the presence of OM is a major driver of health-care cost.
A common complication of a number of cancer therapeutic procedures such as chemotherapy, radiotherapy but also in the condition of before bone marrow transplantation (HCST).
Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes. We believe any treatment that accelerates healing and/or diminishes the rate of appearance of mucositis would have a significant beneficial impact on the quality of life of these patients and may allow for more aggressive chemotherapy.
It has to be pointed out that it appears that the most effective interventions for OM will be those that mitigate/prevent the activation of the initiation phase of mucositis. Once the damage occurs, it is very difficult to stop or reverse.
There are a number of medical device (formulas and liquids) and pharma projects in the area but all with limited results, and a tolerable medical cooling product that acts preventively in an initial phase will be a highly competitive tool to improve QoL and treatment results for many cancer patients.
Of the currently available products ice cubes have the strongest clinical evidence, not taking into account radiotherapy, where cryotherapy seems to be unable to prevent but only give relief.
However, the use of ice cubes seems be limited on a few markets and carries with it a number of disadvantages that can be offset by a tolerable cooling products that can prevent patients in the two other main groups from being affected by OM.
It is reported that OM can occur in at least 40% and up to 70% of standard chemotherapy regimens; see appendix 1 for a table of reagents. From feedback from medical doctors the problem seems to be very high with 5 FU.
Within the gastrointestinal cancer group the drug 5 FU is administered, which results in many severe cases of OM. Within the adjuvant setting only in Germany 65,000 new cases annually are treated with 5 FU. Bone marrow patients are fewer but with many severe cases where patients’ cancer treatments are affected negatively.
One should also take into consideration that OM is a side effect of cancer that in many markets has obtained reimbursement for both pharma and medical device products, which is an upside in entering an already established market. And the presence of OM is a driver of healthcare cost.