Medical technology company BrainCool specializes in early, rapid medical cooling (hyperthermia) with controlled temperature regulation in areas such as stroke and sudden cardiac arrest. The company is also active in oncology – read more here.
The area that has made the most progress is stroke. With the product RhinoChill first an early and rapid cooling is obtained, which is followed by a continuous cooling with BrainCool System, which is marketed in the US as IQool SystemThe concept has attracted a lot of interest lately.
Thrombectomy for stroke
In a stroke, a blood clot blocks blood flow in the brain. Today, the most effective treatment is to mechanically remove it using a catheter (thrombectomy). However, permanent damage can still occur when blood flow returns to the brain – so-called reperfusion injury. With BrainCool's products, the brain's temperature is quickly cooled before the return flow, to reduce damage.
EU-funded stroke studies
Interest in BrainCool's stroke treatment concept in conjunction with thrombectomy has increased recently. This is partly due to the initial results from the EU-funded Cottis 1 study, which were presented in October 2022. They showed a doubling of the number of patients surviving with good neurological function at hospital discharge. Read more about the latest scientific findings here.
Next up is the larger, upcoming randomized pivotal clinical trial, Cottis 2, to which University of Maryland recently joined. Read more here.
BrainCool's collaboration with ZOLL
BrainCool signed a contract this spring cooperation agreement with the American medical technology giant INCH, valued at at least SEK 100 million. The agreement initially covered the US, Germany, Switzerland and Austria. This was recently expanded to seven countries in Asia. ZOLL now markets and sells BrainCool's products for temperature control of intensive care patients in the indications cardiac arrest and neurological fever. Watch Martin Waleij tell us more in a studio interview with BioStock here.
Comments from the CEO
Last week, BrainCool announced that ZOLL had placed an order for 25 IQool Systems for the American market. The order value was close to SEK 9 million. It also received an order for 20 BrainCool Systems for the Asian market, with an estimated order value of SEK 6 million. As recently as today, September 4, the company announced another order for 10 IQool Systems from ZOLL, for the US market.
In addition to orders placed at the signing of the agreement for 350 systems, with quarterly deliveries starting in the second quarter of 2024, BrainCool has thus taken an additional order for 55 systems with delivery in 2023.
BioStock contacted Martin Waleij for his view on future developments.
Martin, what do you think the US market will look like in the near future?
– Our original plan was to be in a pre-launch phase until the second quarter of 2024, before initiating quarterly orders. However, our distributor has prioritized a rapid market establishment of our product. This has resulted in a robust pipeline and we have already received orders for over 50 systems for the US market, which are in addition to the order that was concluded in connection with the agreement.
– We have had a very good start to the collaboration. It is obvious that we have been integrated into an organization with extensive expertise and networks within Targeted Temperature Management (TTM) and that there is a full-scale investment in our product.
How big is the potential in the US for BrainCool?
– The main goal in 2023 is to create a good foundation with a very large ramp-up of volumes in line with the agreement. Our first priority is then to achieve milestone 1, which means implementing 400 systems in this market annually in the near future. This would in turn enable care for approximately 12 patients (assuming we reach the point of an installed base of 000 systems, and then reach 400 per year) and generate annual sales of approximately SEK 400–160 million.
– According to what is known, competitor Arctic Sun sold over 650 systems in 2022 in the US. Therefore, our second interim goal is to surpass this and establish ourselves as a market leader in the sector, with a completely new technology that has been clinically validated.
You valued the agreement at at least SEK 100 million this spring. How do you view this figure today?
– The order refers to a minimum order divided per quarter over 18–24 months. We have already received a number of orders and our goal is of course to sell more.
You have recently expanded the agreement with ZOLL to Thailand, Malaysia, Singapore, Indonesia, Philippines, Taiwan and Pakistan. What is the background to this?
– The reason for expanding our cooperation agreement with ZOLL to include seven countries in Asia is based on the successful start of our partnership. It is strategically advantageous to broaden the agreement in regions where our partner has an established market presence. It is also worth noting that our partner is owned by a Japanese company, which gives further importance to our presence in Asia.
How is the agreement structured?
– I cannot go into more detail about the contract structure due to confidentiality agreements. However, the structure follows the same structure as our basic agreement. It includes an initial order, followed by annual purchase commitments specified per country.
Finally, can you briefly tell us about the agreement with your new partner Wallaby Medical in China, which you also commented in our studio recently?
– The partnership with Wallaby Medical in China was signed to conduct clinical trials combining our TTM solution in combination with thrombectomy. We see great potential in this collaboration, which is one of six significant players in neuro-thrombectomy. It is worth noting that they had a collaboration regarding a product called Thermoguard in cooling, but which has been terminated as they have not achieved sufficient clinical results.
– The aim is to prepare for market registration of our products in China, which has the fastest growing neurology market in the world. Based on the results of the clinical trials and Cottis-2, the final distribution terms will then be hammered out.
– We plan to conduct the clinical study in collaboration with three leading Chinese university hospitals, led by Beijing Tiantan Hospital. This hospital is prominent and has published the ANGEL-ASPECT clinical study on thrombectomy in severe stroke in the New England Journal of Medicine earlier this year. We have thus established a collaboration with some of China's most prominent researchers in the field of neurothrombectomy.