PuriBlood’s FDA-approved leukocyte reduction filter hits the market — marching into the 30-billion blood transfusion medical device market

6 Dec

Blood transfusion can be considered a form of organ transplant. It can sustain the life of the recipient, but there are many risks. Most of the adverse reactions to blood transfusion are related to the infusion of allogeneic white blood cells. Therefore, in recent years, the global medical community has begun removing or reducing white blood cells from blood components. This market exceeds 1 billion US dollars a year. But due to its high technical threshold, several major European and American companies have long dominated it. The Taiwanese medical startup “PuriBlood Medical” has been toiling for years, breaking through technical limitations and developing a series of “anti-coagulation Leukocyte Reduction Filter” products. These products are faster and more precise at removing white blood cells than existing filters on the market. They have also received FDA market approval at the end of 2018 and are about to enter the blue ocean market of blood transfusion.

PuriBlood was founded by Yung Chang, the director of the CYCU Research and Development Center for Membrane Technology, and has received guidance from the MOST germination program. Its leukocyte filter uses selective cell adhesion that captures white blood cells with polySBMA. In short, it means to “separate the positive and negative charges of SBMA, control its charge bias, and use the specific affinity generated by hydro-electrostatic field to allow adhesion of white blood cells and red blood cells to pass through.” Yung Chang stressed that the key is how to precisely capture white blood cells: “There is around one white blood cell for every thousand red blood cells in our blood. That is why the screening rate must be high.” According to clinical trials, PuriBlood’s leukocyte filter has a 99.99% reduction effect.

Filtration duration is also a competitive advantage of PuriBlood’s products. In the past, the United States was the best at this, taking 15 to 20 minutes to finish filtering one bag of blood. But clinical trials show that PuriBlood’s leukocyte reduction filter only takes half the filtration time of existing products on the market. Compared to other companies, PuriBlood’s leukocyte reduction filter can process the same amount of blood in a short period of time. The product is also unaffected by temperature and is applicable in any non-glaciated region.

PuriBlood was founded by Yung Chang, the director of the CYCU Research and Development Center for Membrane Technology. PuriBlood has developed a series of “anti-coagulation Leukocyte Reduction Filter” products that have received FDA market approval and is about to enter the blue ocean market of blood transfusion.

 

How leukocyte reduction is related to blood transfusion safety

Approximately 100 million people need a blood transfusion in the world each year, so safety is of great concern. Most of the adverse reactions to a blood transfusion are related to the infusion of allogeneic white blood cells. White blood cells are key immune cells in the human body that attack foreign substances, including allogeneic white blood cells. In general, the number of white blood cells in the recipient is higher than allogeneic white blood cells. Theoretically, no problems should arise if the foreign white blood cells are completely removed from the body, but there will still be side effects. For example, almost every recipient will have a fever due to the febrile nonhemolytic transfusion reaction. For recipients with very weak resistance, like cancer patients undergoing chemotherapy, the infused foreign white blood cells may be higher in number or more aggressive than their own, resulting in alloimmunization. In severe cases, it may even lead to death.

Another problem is that white blood cells carry viruses that can infect the recipient, and the incubation period is very long. Therefore, reducing white blood cells before blood transfusion can also prevent long-term chronic diseases. Side effects due to allogeneic white blood cells after transfusion include transfusion-related acute lung injury, platelet refractoriness, increased risk of bacterial infection after surgery, and viral infections such as CMV, HIV, and EBV.

“Why have many countries implemented leukocyte reduction? The goal is to reduce medical costs after transfusion.” Yung Chang pointed out that this is the main reason why many advanced countries have passed relevant laws and regulations. “Medical costs far exceed complete leukocyte reduction before every blood transfusion in the nation.” At present, around 28 countries including the United Kingdom, Germany, France, parts of the United States, the United Arab Emirates, Canada, and Japan have legislated complete leukocyte reduction as a necessary procedure for blood transfusion.

Currently, only specific diseases undergo leukocyte reduction in Taiwan. Around 800 thousand of the 2 million blood transfusions per year undergo pre-transfusion leukocyte reduction. To implement complete leukocyte reduction, it will cost around NT$ 300 to 600 million Taiwan dollars a year. But without leukocyte reduction, the medical costs for subsequent disease management will be around NT$ 3 to 6 billion. This is a huge burden for both the health care system and the individual. Therefore, the purpose of developing leukocyte reduction products is for preventive medicine, which is also one of the main missions of the Taiwan Blood Services Foundation.

Global market conditions

The global market demand for leukocyte reduction filters is around 5000 to 6000 sets per year. There are three major competitors in the global market. The largest company is Germany’s Fresenius, with a turnover of 1 trillion Taiwan dollars a year and ranks among the Fortune 300 companies. The Leukocyte reduction filter is one of the mainstream products, with an annual market share of almost 2000 sets.

The second largest is the US medical giant Haemonetics. In 2012, it purchased a leukocyte reduction technique from Pall, another leader in medical devices, for 15 million Taiwan dollars and gained access to the global market. Currently, Haemonetics has a global market share of 1000 sets. The third is a Japanese company, but its technique has not progressed in recent years.

Luke Chen, general manager of PuriBlood, said he hopes that after the new generation of high-performance leukocyte reduction products are launched, they will win over the market with superior user experience, high-quality filtration, and reasonable prices. PuriBlood aims to become the fourth-largest company in the world. Currently, PuriBlood has established a complete blood laboratory and factory that produces filters. The factory has an annual capacity of 1.2 million and 10,000 test orders from the American blood blank. In addition to leukocyte reduction filters, PuriBlood is also actively investing in cutting-edge product development to create next generation products that can transform blood preparation based on a comprehensive collection of evidence.

The key to the leukocyte reduction technique is the circular filter in the middle. Whoever can filter the blood the quickest and most smoothly has the greatest competitive advantage. According to tests, PuriBlood’s leukocyte reduction filter only requires half the filtration time of existing products on the market.

 

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