Meet the Entrepreneur: Carolyn Yarina and Gillian Henker, Sisu Global
At FINCA Ventures, we look for entrepreneurs leveraging market-based solutions to create large-scale, lasting social impact. In this series, “Meet the Entrepreneur,” we’ll be taking you into the minds of the intrepid leaders at our portfolio companies who boldly venture into markets in need of positive disruption.
Globally, there is a shortage of over 100M units of donor blood each year, which was made worse by COVID-19, which the WHO estimates reduced blood supply by 20 to 30 percent due to fewer blood drives, lockdown orders, and other infrastructure issues. Sisu Global, a medical device company, designed an autotransfusion product that allows patients to “donate” blood to themselves. During episodes of internal bleeding (both trauma and planned surgery), Hemafuse allows blood to be pulled through a filter to remove clots and particulates, it gets transferred to a blood bag and then re-transfused into the patient within five to eight minutes. In this interview, we spoke with Carolyn Yarina and Gillian Henker, co-founders of Sisu Global, to understand how they are meeting these challenges head-on with a comprehensive solution.
Both of you have extensive experience with medical device research and development. Take us through Sisu’s origin story and how you joined together to launch the Hemafuse device.
Carolyn: Sisu is a Finnish word that means “persevering in the face of adversity,” as we design medical devices for those that persevere. The origin of that dates to the invention of our portfolio of devices, and Hemafuse in particular.
Gillian: Hemafuse came about from a needs-finding trip when we traveled to Ghana in West Africa to observe OBGYN clinicians. We had the opportunity to watch an autotransfusion procedure while we were at the Komfo Anokye Teaching Hospital in Ghana, and we could see that there was a drastic need for blood. As a result, a few of us got together and decided to collaborate with the clinicians to develop a tool that would enable safer, more efficient autotransfusion. Soon after, we started the process of developing medical devices.
Hemafuse is an autotransfusion device that enables clinicians to salvage, filter, and recycle blood from patients with internal bleeding. Walk us through some of the challenges that healthcare systems in emerging markets face as it relates to donor blood shortages and how the Hemafuse device is tackling this challenge head on?
Carolyn: The need for blood is acutely felt all around the world. From a hospital in Kenya, where there is a shortage of over 50 percent of the blood that is needed, to one in the United States where we are seeing an all-time low of blood donations and even surgeries canceled as a result. We view this challenge from a standpoint of not only providing blood when it isn’t available but providing the highest quality of blood back to the patient during that surgery. The philosophy behind Hemafuse is that your own blood is better than someone else’s. Ultimately, if a patient loses blood from a trauma or a planned surgery and that blood is pooled internally in the stomach, chest or another body cavity we are able to capture that blood, filter it, and give it back to the same patient during the same surgery.
Imagine surgery after a car crash or with a ruptured ectopic pregnancy – a clinician reaches for a blood bag that isn’t there. We have seen instead that a clinician is able to reach for the Hemafuse device and re-transfuse that patient’s blood. This method not only leads to better outcomes for that patient but increases the overall blood supply. We have observed successful use of the device when there is a blood shortage and Hemafuse is the only choice to give a patient blood to save their life. We have also observed it in situations where there was blood available, but clinicians opted to give a patient their own blood instead.
Gillian: Essentially, it is all about adding blood into the healthcare system and empowering clinicians with the tools they need.
What distinguishes Sisu’s product from other autotransfusion devices?
Carolyn: We combine the safety and effectiveness of other autotransfusion devices used here in the United States with the simplicity and innovation of what clinicians perform using more manual techniques within emerging markets- Hemafuse is the only autotransfusion device that is completely infrastructure-independent. It can be easily assembled in less than five minutes, whether before or during a surgery, and it provides blood back to the patient. That includes not only packed red blood cells, but also platelets, plasma, and other components back to the patient during that same surgery.
Gillian: Additionally, nurses, doctors, and clinicians can be trained on this device. You do not need a specialist, like a perfusionist, to be able to operate it. Most theater clinicians can utilize this device with a brief training session and basic understanding, allowing it to move wherever surgery is being performed. This can be a tool in a toolbox to restore blood availability in a variety of settings.
Carolyn: Ultimately, we are solving that gap to make autotransfusion accessible to everyone.
The majority of Hemafuse use cases to date have been for ruptured ectopic pregnancies. How do you think about the maternal health impact that the Hemafuse device has on end patients?
Carolyn: The main factor in first-trimester maternal deaths is ruptured ectopic pregnancies, particularly in countries with higher STD rates or less-adequate prenatal care. Ectopic pregnancies pose a significant threat to maternal mortality, especially if you do not have access to blood. They can occur in three percent or even five percent of births in some countries.
Gillian: OBGYNs and other staff in that department are the biggest recognizers of the need for blood. Whenever we talk to the lab, OBGYNs order the most blood. They understand more than almost anyone that blood is their most valuable resource for preventing hemorrhage.
What has been the most valuable lesson you’ve learned from working with Sisu’s medical partners on the continent?
Gillian: I believe that the clinicians were crucial in helping us grasp how the hospital or medical systems operate. Getting their perspective was essential in the design process and the device’s development heavily incorporated user and customer feedback.
Carolyn: At Sisu, Gillian often uses the phrase “We don’t save lives, we enable clinicians to save lives.”
Sisu obtained U.S. FDA clearance for the Hemafuse device towards the end of 2021, opening over 80 new countries for distribution. How does this impact your geographic sales strategy going forward?
Carolyn: At the start of the COVID-19 pandemic, Kenya was the only nation we had marketed to. We then made the decision to pursue U.S. FDA approval to provide additional options to other nations that need regulatory permission from their home countries to scale. We have been able to sign new contracts or MOUs to allow for additional nations to utilize Hemafuse since receiving that U.S. FDA certification. We are also in broader discussions to open other markets, and we’re very thrilled to have the chance to introduce Hemafuse to India. As a result, Hemafuse can reach a wider audience and achieve greater scale, financial success, and impact.
Sisu has benefitted from various types of capital to scale its business. What has been the strategic role of blended finance in your company’s growth?
Carolyn: Blended finance has been influential in our growth. When Gillian and I founded the company, we were working side jobs to supplement our primary line of work. Medical device companies focused on emerging markets within Africa are less funded than in some other markets. We won competitions and awards; received different backing to build our credibility, our traction, and to prove our determination. Different types of capital serve various purposes. When it comes to investment, the goal is to make money and then offer investors a significant return. With grant or non-dilutive capital, the goal is to demonstrate impact outcomes. By having blended financing, we have been able to ensure strong economic and impact outcomes for our funders which helps to build a stronger, scalable organization that both does good and does well.
Imagine it’s five years from now and Sisu is making international headlines. What would that headline be and why is this important to you?
Carolyn: Our goal has been to change the way that medical devices are designed and commercialized for emerging markets. The headline would be two-pronged. One of them would say, “Hemafuse: Now Your Own Blood Can Save You,” to demonstrate that Hemafuse is the accessible, go-to device for autotransfusion. The second aspect is that, when we consider our broader goal, 80 percent of medical gadgets are being produced for 10 percent of the world’s population. In addition to mentioning Sisu, the headline would emphasize the importance of designing medical devices for under-resourced settings.
What are some of the barriers Sisu faces in achieving the vision in that headline?
Carolyn: We are introducing a product and business model that is not commonly funded or recognized. A class 2 device like Hemafuse typically costs $31 million in the medical device industry. With less than $5 million in funding, we have now launched this product and brought it to market, but often we need to accomplish more before receiving support. At Sisu, we are determined to ensure those commercial outcomes are fulfilled to get the strongest return.
Why were you excited to have FINCA Ventures come on-board as an investor?
Carolyn: FINCA Ventures checked the boxes of having the connections, background, and expertise, while also having a vision of doing good. Having their support has opened doors and facilitated conversations and connections, and we are grateful to have FINCA Ventures as an investor and partner on this journey.