|The team behind Sisu Global Health, from left: CMO |
Katie Kirsch, CEO Carolyn Yarina, and CTO Gillian Henker.
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 reason 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 highlight the need for devices that are safe, affordable, accessible and appropriate.
The Baltimore-based startup Sisu Global Health develop medical technology that address 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, which can be both limited and expensive, not to mention far away, in developing countries. The device, which can be used in most situations of hemothorax and hemoperiteneum, 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 that separate blood in 3 minutes without electricity, called (r)Evolve. The device is specifically designed to allow clinicians to travel with it to rural settings. Inability of performing blood separation is a major barrier to using the most common diagnostic test in the rural developing world, rapid diagnostic test’s (RDTs). These tests are used for diseases including HIV, malaria, hepatitis, syphilis and typhoid fever, and blood separation can extend the timeframe a clinician has to test a blood sample in room temperature from 2 hours up to 3 days.
Although it must be considered highly unethical to deliver a treatment or diagnostic 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 would have low efficacy in developing countries due to low capacity of the public health system. Developing technology for low-resource settings is considered of 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.