Hemafuse: Increasing Blood Access

Hemorrhage is the leading cause of maternal mortality, 25% of which could be reduced with access to safe blood. Yet, for cases of internal bleeding, clinicians around the world are discarding the safe blood that pools internally that is available for re-transfusion. Hemafuse enables clinicians to salvage this blood, filter, and recycle it. This saves the life of a patient (ie ruptured ectopic), and conserves national blood resources. The blood conserved with Hemafuse is now available to save another patient, likely a mother who needs that blood to survive. Hemafuse has been used successfully across Ghana and Kenya, both in cases where there was no blood available and as the preferred option over donor blood. 

In light of COVID-19, the timing of scaling Hemafuse is critical. With blood drives being canceled and a reduction in blood donations, the situation around blood access has become even more dire.

There is a global shortage of over a 100 million units of donor blood per year, which means when a doctor reaches for a unit of blood it often isn’t there. In sub-Saharan Africa, ~26% of maternal hemorrhagic deaths are a direct consequence of the lack of blood, and globally up to 150,000 pregnancy-related deaths could be avoided each year if women had access to safe blood. 

Yet, for cases of internal bleeding (ie ruptured ectopic pregnancy), clinicians around the world are discarding the safe blood that pools internally and is available for re-transfusion.  If clinicians could capture that blood, filter, and recycle it, it could save the life of a patient and conserve national blood resources. The blood conserved would then be available to save another patient. This process is called autotransfusion, and it has the potential to provide that immediate and sustainable solution to prevent avoidable loss of life in Kenya, both during and long after the COVID-19 epidemic. 

Existing solutions for autotransfusion are insufficient. Innovative cl

Hemafuse is designed to salvage and recycle blood from internal bleeding for cases of ruptured ectopic pregnancy and other instances where “clean blood” is pooled in the abdomen or chest. Hemafuse is a handheld, mechanical device made to operate anywhere there is a surgeon, from a large city hospital to a rural surgical theater. As shown in the image below, (1) when the handle is pulled up, blood is retrieved from the surgical field and pulled through a filter. The specialized design of the filter removes clots and impurities. (2) When the handle is pushed down, the blood is then pushed through tubing into a blood bag to be (3) re-transfused to the same patient. Hemafuse is a semi-reusable device that is sterilized between surgeries and with disposable single use filters. The device can be reused up to 25 times and allows multiple units of blood to be salvaged in one surgery.

Hemafuse is a patented device that has been used across orthopedic, general, and maternal surgeries. The single most common use case for Hemafuse has been ruptured ectopic pregnancy. 

We have an opportunity to change the landscape of blood access. There are 20 Million cases viable for autotransfusion, including 2 million cases of ruptured ectopic pregnancy. If Hemafuse were implemented across Africa, imagine the difference that would be made in the blood supply, the impact would be multiplied as the blood from those cases was conserved for others.  

Sisu has a proven ability to execute and is prepared to build upon the success we’ve seen in Kenya and Ghana to scale rapidly throughout global emerging markets. Hemafuse has already been used successfully across 14 hospitals in cases ranging from ruptured ectopic pregnancies, aneurysms, and total hip replacements. Sisu has successfully trained over 1200 clinicians in Africa and has a global team ready to be deployed to support additional scale. Sisu has offices in Baltimore and Nairobi. We have a strong partnerships including Surgipharm, the largest medical distributor in Kenya, and Amref, the largest Africa-based healthcare NGO, are allowing us to quickly scale in Kenya and beyond.

Hemafuse is a solution for emerging markets, and more particularly for referral hospitals that see a large number of trauma cases and struggle with access to blood.

To improve maternal health outcomes, we need to improve access to blood. Hemafuse is a key solution to this fundamental challenge. 

Hemafuse is the only autotransfusion device on the market that is made specifically for the unique requirements in emerging markets. Hemafuse is used to save the lives of patients suffering severe internal bleeding across Kenya and Ghana. To date, no adverse outcomes have been reported, and the surgeons, anesthetists, and nurses that have used Hemafuse at least once have made it their standard practice in treatment of patients with severe blood loss. To quote one user “Autotransfusion is the best…It’s better than giving someone [else’s] blood to the patient. So, we are encouraging autotransfusion...Now that Hemafuse is here, we are advocating to get more in the system. Every theatre should have one, if not one, two.”

When compared to other autotransfusion devices, Hemafuse has three distinct advantages; low cost, simple design with manual operation, and ability to provide immediate whole blood transfusions. Hemafuse is substantially cheaper than other Cell Salvage Machines currently available. Because the Hemafuse is manually operated and requires neither electricity nor a specialized healthcare professional for operation, it can be used anywhere from a large urban hospital to a combat zone. Additionally, Hemafuse gives patients back whole blood which includes plasma, platelets and clotting factors in addition to red blood cells. The above mentioned autotransfusion devices provide patients with only red blood cells. From the work Sisu has done to date in Africa, we have found that while units of donor red blood cells are often scarce, units of donor plasma are extremely rare and expensive.

Hemafuse has two issued US utility patents. The unique and proprietary nature of this patent is around the general features of the device, filtration aspects, and the particular location of the modules for the method of blood filtration with a focus on maintaining laminar flow. Other products of similar form and function mainly exist in the water filtration landscape; however, these patents promote turbulent flow where the design of Hemafuse is particular to laminar flow. Prior art with regard to autotransfusion has been identified and uses configurations involves electrical components and additional systems for cell separation and washing. Hemafuse had a second patent also issued around the Hemafuse filter, as well as international patent filings. The patents and intellectual property associated is entirely owned by Sisu Global Health. 

This is a novel device and even Medtronic has showcased Hemafuse in slide decks shown in Africa as "technology that leapfrogs their own" in comparison to their US-focused autotransfusion device. 

Launch video including product demo: https://www.youtube.com/watch?v=yiTcUwSEPyo

Articles Demonstrating Success: 

• Press Release: https://www.cnbcafrica.com/africa-press-office/2020/02/05/now-your-own-blood-can-save-you-autotransfusion-device-hemafuse-will-revolutionize-blood-access-across-africa-now-available-in-ghana-and-kenya/
• Kenyan Feature on Hemafuse https://www.standardmedia.co.k...
• Kenya First Lady donates Hemafuse https://newsroom.amref.org/new... 
• Solution to Kenya's blood shortage: https://www.devex.com/news/ken...

The theory of change is that with greater blood access the lives of women with ruptured ectopic pregnancy and persons with trauma incurring internal bleeding could be saved. Autotransfusion is a viable option to provide this blood access. Blood is the difference between life and death and by providing access to safe blood, Hemafuse enables life-saving surgeries. If there is an insufficient amount to treat all patients, donor blood “saved” by Hemafuse can now be used to save another patient's life i.e. an anemic child with malaria. The Hemafuse will minimize blood exposure and risk to the clinician by maintaining a closed system to transport the blood. Clinicians will have a reduced risk of contracting diseases carried by the blood of the patient with this closed system.

Through access to blood more hospitals will perform more surgeries and save more lives but also will have an increased revenue stream to grow their hospitals. Distributors will also be financially compensated and will grow their staff. Through the commercial model of Sisu Global Health, Hemafuse will not only save lives, it will grow the economy.

Sisu’s business model is one in which the value is placed entirely on the filters and the reusable pump portion of the device is marketed as “free” within the packet. The device is sold in either an intro pack with 5 filter and accessory kits to one pump or a full pack of 25 filters and one device. This intentional business model design discourages overuse of the main device past its life of 25 uses. If the device is overused, there becomes higher risk of cracking or crazing which could increase risk of blood-born pathogen transfer. Filters are not sold separately to discourage overuse of the pump.

The sale of Hemafuse and proper business partnerships incentivizes proper design and use of the device in a sustainable model. Scaling the availability of the device across medical systems and countries leads to greater access to clean blood sources. This will create a global decrease in maternal mortality and mortality from trauma.

Sisu has been used across 14 hospitals in Ghana and Kenya and has saved dozens of lives (an impacted far more). 

Sisu is ready to scale and looks forward to scaling our impact to over 40,000 lives in the next 2 years and 600,000 lives in the next 5 years. The role of Hemafuse is even more important at our current juncture as COVID-19 changes the landscape for public health. The blood shortage was already severe, and we’ve watched it get worse as blood drives are cancelled and patients stay home. Even the World Health Organization has allocated funding in their country aid deployments to help strengthen blood systems. Sisu is currently building on the foundation built so far and is seeking partners to scale Hemafuse rapidly during this current crisis to help save lives.

Sisu is ready to scale and looks forward to scaling our impact to over 10,000 lives in the next year, 40,000 lives in the next 2 years and 600,000 lives in the next 5 years.  The role of Hemafuse is even more important at our current juncture as COVID-19 changes the landscape for public health. The blood shortage was already severe, and we’ve watched it get worse as blood drives are cancelled and patients stay home. Even the World Health Organization has allocated funding in their country aid deployments to help strengthen blood systems. 

This year, Sisu is also focused on achieving a $1M run rate. An upcoming Series A will be the last investment round that Sisu needs to raise in order to  achieve financial sustainability. Sisu may raise additional investment to fund scale or introduction of new products. 

We’ve executed with a small, dedicated, core team and a broad network of partners. Sisu has 16 team members: 

10 Full Time Employees in Sisu or partners dedicated to Hemafuse

6 part-time contractors that are closely involved and considered part of the team

We’ve executed with a small, dedicated, core team and a broad network of partners. Our unique commercial model has allowed us to be efficient with our capital. We consider the core team to be the glue that holds these amazing partnerships together. ­While the credentials of our team and partners are impressive, our success speaks for itself. We outperform our peers in execution, taking Hemafuse to market on less than 10% of the average cost to take a medical device through regulatory in the US. Our top-tier partnerships with Surgipharm, the largest medical distributor in Kenya, and Amref, the largest Africa-based healthcare NGO, are allowing us to quickly scale in Kenya. 

Sisu's management team consists of three global health experts with a collective 34 years in management positions in emerging market companies. Our team’s strengths include extensive experience launching and operating medical device companies in the U.S. and emerging markets like India and Ghana. Sisu’s managers have leveraged their expertise in building lasting relationships, recruiting and maintaining top talent, and negotiating to develop strong public-private partnerships throughout Africa. Sisu has successfully developed vibrant partnerships for each stage of our development (see next question).

Sisu’s advisors also bring a wide range of expertise and are members of African governments, and medical industry, international operations, and clinical development experts. 

Sisu has successfully developed vibrant partnerships for each stage of our development. We partner with experienced design firms that have a successful track record of supporting cutting edge medical devices, and world-class manufacturers that operate under gold-standard procedures like ISO 13485 certification to bring our products to life. We’ve engaged accomplished regulatory consultants and established distributors like VIA Global and Surgipharm that are committed to delivering high quality logistics. Our internationally renowned training and marketing partner, Amref Health Africa, is the largest African-based international non-governmental health organization. 

Sisu has a robust revenue model. Hemafuse is sold through distributors to hospitals in a packet of one device, reusable for up to twenty-five times, and twenty-five single-use filter and accessory kits. The cost of one packet of the Hemafuse System to the hospitals is $5,000 USD, which provides the equipment necessary for use on 25 patients. This translates to $200 for a single use of Hemafuse, during which up to 3 units of blood can be salvaged and returned to a patient. The cost to collect and process a single unit of donor blood in many emerging markets is ~$100 (source: Kenya & Tanzania NBTS) or $250 per unit of donor blood in the US. Hemafuse saves hospitals money, improves operating room efficiency, and conserves precious blood resources so they can be used for other patients that aren’t candidates for autotransfusion. Autotransfusion is proven to reduce recovery time with no risk of disease transfer or rejection. 

Hemafuse is sold through wholesale distributors to hospitals, governments, and NGOs. After assessing >40 distributors, Sisu has signed both global and Kenyan distribution contracts for Hemafuse.  Sisu will scale Hemafuse, initially by establishing distribution, and training/marketing partners in each new country, as we've done in Kenya. At later stages, we will scale through regional distributors to help with the adoption and implementation of Hemafuse. Sisu also has a global distribution partner, VIA Global. Additional revenue streams include  impact project wherein foundations, governments & NGOs pay Sisu in exchange for impact and impact measurement. 

Blood access in Africa is a $3B market, and the total addressable market for Hemafuse is $2B, based on wholesale pricing. Due to the state of blood access in the African market, some lifesaving and elective surgeries are not able to be performed due to lack of available blood supply. Therefore, Sisu has further narrowed its focus to a serviceable addressable market (SAM) based on surgeries currently performed that are viable for Hemafuse, with percent population in poverty removed.

Hemafuse has an annual SAM of $0.6B in its three target regions in Africa and $1.2B when including SE Asia and India, based on wholesale pricing. This is an under-estimate, as increased access to blood would increase access to surgery. For context, the national guidance across most countries is to have 2 units of blood on hand before surgery, but with a severe shortage of over 50% across emerging markets, clinicians must decide whether to risk surgery with a low chance of success, delay, or send patients to another hospital with the hopes they will have blood.  Based on initial calculations, which will be refined with more in-depth research, this $1.2B serviceable addressable market translates to a potential of millions of lives saved and tens of millions of lives impacted.

After raising a $3M Series A, Sisu will achieve financial sustainability. This will be the last investment round that Sisu will need to raise; however, Sisu may raise additional capital to fund scale or additional products.