Sisu Global Health Develops Donor Blood Recycling Device For Emerging Markets | Morten Bjorklund, BSc | RxEconsult

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Sisu Global Health Develops Blood Recycling Device (Hemafuse) For Emerging Markets Category: Pharmaceutical, Biotech, Medical Device Industry by - March 1, 2016 | Views: 12950 | Likes: 0 | Comment: 0  

Hemafuse For Donor Blood recycling

Sisu Global Health Develop Medical Technology For Emerging Markets

´╗┐There are over 10,000 different types of medical devices on the market, ranging from high-tech diagnostic and therapeutic equipment to basic technologies that help provide health care on a daily basis. In a market that is close to reaching $400 billion, four-fifths of revenue comes from sales in the Americas and Europe.

The reasons for this variable access to medical devices are many, including affordability and lack of capacity. In many areas, devices are not used to full effect because of erratic power supplies, shortage of health personnel and limited training capacity. To have a public health impact, the WHO highlighted the need for devices that are safe, affordable, accessible and appropriate.

The Baltimore-based startup Sisu Global Health develops medical technology that addresses critical needs in emerging markets. Their lead product, Hemafuse, is a handheld, mechanical device that can recycle a patient’s blood lost through traumatic internal bleeding. The device is meant to replace donor blood. Blood supply is limited, expensive, and is not readily accessible in developing countries. The device, which can be used in most situations of hemothorax and hemoperitoneum, including incidents of blunt trauma and early pregnancy complications, can be used up to 50 times with one-time-use disposable filters.

The startup is also in the phase of developing a centrifuge, called (r)Evolve, that separates blood in 3 minutes without electricity. The device is specifically designed to allow clinicians to travel and use it in rural settings. The inability to perform blood separation is a major barrier to using rapid diagnostic test’s (RDTs) which is one of the most common diagnostic tests in the rural developing world. These tests are used for diseases including HIV, malaria, hepatitis, syphilis and typhoid fever. Blood separation can extend the timeframe a clinician has to test a blood sample at room temperature from 2 hours up to 3 days.

Although it must be considered highly unethical to deliver a treatment or diagnosis with lower efficacy to the developing world than what is considered acceptable in high-income countries, Sisu Global Health is specifically designing devices for low-resource settings. While most medical devices are designed for use in developed countries, many of them will be less applicable in developing countries because of challenges in the public health system. 

Developing technology for low-resource settings is considered high importance because they require different solutions than what is already available and Sisu’s innovative and smart products could save millions of people. However, it is also important to highlight that while there is a market for such devices, we cannot simply stop investing in public health systems in developing countries. We still need to invest in more healthcare facilities and workers, improve training capacity, access to electricity and water, develop policies and partnerships with the goal of universal access to healthcare.

Sisu has successfully completed pre-clinical testing of the Hemafuse with pig and human blood, and manufacturing is underway. Supported by a consortium including USAID, UKAID, the Gates Foundation, Grand Challenges Canada, Government of Norway, they are expected to perform a statistically significant clinical study in Ghana this year that will lead to the first sales. Devices will be sold through wholesale distributors to hospitals, NGOs, and governments, and it is projected that the company will take in $25 million in revenue by its fifth year.


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