Focus, Health Care, and Small Business & Startups

Medical device startup lands $250K grant

Sisu Global Health’s Hemafuse can replace soup ladles in surgery in Africa.

October 3, 2014
| By Pete Daly |
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Sisu Global
Sisu Global Health’s leadership includes, from left, Gillian Henker, Carolyn Yarina and Katherine Kirsch. Photo by Johnny Quirin

A Grand Rapids startup that is developing a manual auto-transfusion device to treat ruptured ectopic pregnancies and internal hemorrhages in Sub-Saharan Africa will receive a $250,000 grant from a global competition whose sponsors include the Bill and Melinda Gates Foundation and USAID.

Sisu Global Health, currently housed at the GR Current business incubator, is hoping to make its first shipment of the Hemafuse in about two years, after it has been cleared in clinical trials and received regulatory approvals.

Right now the three partners who founded Sisu Global Health in March are its sole employees, and their work these days is focused on raising capital and finding an injection-molding manufacturer to produce the Hemafuse, among other things.

As noted by Sisu CEO Carolyn Yarina, 80 percent of medical technology today is designed for only 10 percent of the world. Sisu has a design process and a humanitarian commercial business model intended to reach the other 90 percent of the world — the less-developed regions where surgery is more challenging due to factors such as little donated blood and an inconsistent supply of electricity, which complicates using electric-powered devices in surgery.

Katherine Kirsch, chief marketing officer of Sisu, said that, compared to Sub-Saharan Africa, there is no shortage of donated blood in the U.S. that would lead to demand for the Hemafuse.

Yarina, who has a BSE from the University of Michigan in chemical engineering, was previously CEO of CentriCycle and led its development for the past four years from its start as a class project involving 22 U-M students. Ultimately, it evolved into a nonprofit organization.

Yarina has worked in India on product design for Embrace Innovations and was in supply chain management with Halliburton.

A native of Chassell in the Upper Peninsula, Yarina was the recipient of the RPM Ventures Entrepreneur of the Year and the Harry E. Benford Entrepreneurial Award. She has been featured in Business Insider and will be in the October edition of Entrepreneur. She speaks three languages, including Turkish and Hindi.

Another co-founder of Sisu is Gillian Henker, chief technology officer, who heads product development. After spending a year working with clinicians in Kumasi, Ghana, Henker and others founded DIIME — Design Innovations for Infants and Mothers Everywhere. She was president and CEO of DIIME for three years, during which time she participated in Hub Ventures Accelerator program (now Better Ventures) in San Francisco.

Henker has previously done field research in Ghana as a device design student fellow for the Global Health Specialization program at the University of Michigan. She was featured in an article about DIIME in Forbes and has presented at the Appropriate Healthcare Technologies for Developing Countries Seminar in London. She holds a BSE from the University of Michigan in mechanical engineering and a minor in multidisciplinary design.

Kirsch focuses on fundraising, partnership development and marketing. A previous member of CentriCycle, Kirsch drove business operations and the education aspect of CentriCycle’s holistic model. She recently returned from a Fulbright English-teaching assistantship in Rwanda where she taught classes at INATEK University in Kibungo, Rwanda, and managed the first published literary journal with students at the National University of Rwanda, called INGANZO. Kirsch also wrote reports and grants as an intern at the U.S. Embassy in Paramaribo, Suriname. She has experience working with government agencies and NGO’s in Cameroon, where she did research around cultural ideas of nationalism and globalization. A native of Schoolcraft, she graduated from Albion College with a degree in English literature and French.

The Hemafuse functions like a large syringe to pull blood through a filter and into a blood bag in a closed system for autotransfusion back into the patient. The patient’s blood must be reintroduced because of the lack of donated blood.

According to an abstract on Sisu Global Health presented at the MichBio Expo last week, in Sub-Saharan Africa, doctors are forced to use kitchen soup ladles and gauze to recover and filter blood in the patient during an internal hemorrhage. Over 500 soup ladle procedures are performed for pregnancy complications alone each year in Ghana’s largest hospital, Korle Bu.

The procedure using a ladle may take 30 minutes and require assistance from up to nine hospital staff. Use of the Hemafuse is a 10-minute procedure with fewer staff assisting.

The grant just awarded to Sisu is its largest capital infusion yet, and is from Saving Lives at Birth, A Grand Challenge for Development, aimed at reducing maternal and infant deaths in less developed areas of the world. Other support for the program is from the government of Norway, Grand Challenges Canada (funded by the Canadian government), and the U.K.’s Department for International Development.

Yarina said the grant “gives us a little bit of a runway” for launching Sisu Global Health.

Sisu has a current target of $800,000 in seed funding to advance the Hemafuse to market and continue development of a second medical device it has in the pipeline.

According to the information provided to MichBio Expo, Sisu Global Health is targeting a $2.1 billion medical device market in Sub-Saharan Africa, which has an estimated compound annual growth rate of more than 13 percent.

The Hemafuse has an estimated annual market of $150 million in Sub-Saharan Africa and a $20 million market in Sisu’s five-year target market in Ghana, Rwanda, Kenya, Tanzania and Ethiopia. The market in Ghana, where Sisu plans to begin sales, is $1.5 million. Ghana has a shortage of more than 40 percent of the donor blood it needs.

Sisu plans to expand its product portfolio starting in its second year and has already identified new product needs.

According to Sisu documents, Hemafuse combines cost effectiveness, safety and low labor usage to create a more viable alternative that can save lives. It is reportedly less than 1 percent of the cost of the Haemonetics Cell Saver, a sophisticated blood recovery system used in procedures where medium- to high-volume blood loss occurs.

Sisu Global Health has letters of support from three hospitals in Ghana, including the largest hospital in West Africa, where it is anticipated that use of the Hemafuse will create demand.

The Ghanaian National Blood Service already has written a letter of support for autotransfusion and devices such as the Hemafuse.

The main body of the Hemafuse is semi-reusable and will be purchased by hospitals directly, projected to cost $50 retail for 50 uses. Each attachable filter is designed to cost $5 retail and is disposable after each patient.

Two of Sisu Global Health’s advisory board members are Sajju Jain, the past COO of Embrace Innovations, and Dr. Nichodemus Gebe, head of Biomedical Engineering in the Ghanaian Ministry of Health. He is advising on implementation in Ghanaian hospitals.

The company is anticipating costs over the next three years of $2.1 million, with potential sales revenue of $2.5 million.

According to the company information provided to MedBio, Sisu may be of interest to major Western medical device companies that are beginning to shift their focus to global health needs and emerging markets.

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