Mama Ope is an automated pneumonia diagnostic aid that determines and interprets pneumonia signs to complement health worker assessment skills, so that we can improve the accuracy of pneumonia diagnosis, facilitate early treatment initiation, and also inform the design of implementation programs aimed at reducing the global pneumonia mortality. So why this is important is because the early diagnosis of pneumonia is vital for improved treatment outcomes. However, most health workers fail to correctly determine and interpret the signs and symptoms for the diagnosis of pneumonia. This is one of the reasons as to why it is the leading infectious cause of morbidity and mortality globally. As of 2016, the death rate was at 880,000 deaths worldwide, according to UNICEF. And, of course, the under five mortality from pneumonia is highest in Sub Saharan Africa and Asia according to the World Health Organization. Some of the most affected countries include Nigeria, India, Pakistan, Democratic Republic of Congo, and Ethiopia.
We have accomplished some key R&D milestones such as proof of concept, a first working prototype that works effectively in a bench model, and then a prototype that works safely and effectively in humans, which we are currently validating through an accuracy study using multiple sites in Western Uganda. These results are going to be important to support our regulatory approval and entry into the market. So, finally, we can see the long journey to market closing in and we expect to launch into the market soon.
One of the biggest challenges has to do with the regulatory landscape. It took us some time to get clearance for this clinical study and then, also, as of now, there is no harmonisation for medical devices across Africa, even just in East Africa. And even on a national level, the medical device regulation area is quite gray since most of the regulation is to do with drugs. Our regulating body, the National Drug Authority mostly deals with drugs. And we are one of the first people in the space of local medical device development since most of the devices used in the country are imported.
Also, a lack of harmonisation for medical devices in East Africa, let alone Africa, makes it hard for us to access those other markets at once. This means you have to also go through the regulatory bodies of Kenya, Nigeria, Ethiopia individually. But when there is harmonisation, it becomes easy because you only have to go through the regulatory process once. Apparently that is in the pipeline in the East African Community. So what that means for us right now is that we have to overshoot for a CE or FDA clearance for us to be able to access these other markets outside of Uganda. That is one of our biggest challenges so far.
Over the past six years of operating this business, I think the biggest lesson for me has been building a strong team. I would advise someone to take their time and get a complimentary, strong team that can stand the test of time. At some point, the journey will become a roller coaster and you will need to draw strength from one another. And then also the fact that the budgets of startups are limited, and startup paychecks at the start can be minimal. Self motivation and people who buy into the vision is a very important aspect of growing and keeping on. And then also, obviously, to keep learning and connecting to the network, how other people are doing it, how they're doing it faster, where they are fundraising from. Keep learning, asking questions, and staying connected to those on a similar path.
This is an exciting part to talk about. We met Villgro in 2017 or 2018 and it's been a journey! First of all, they funded us at a critical stage when we were on the journey of proving our concept. That was big because most funders were looking out for startups that were already past that stage. So they provided funding at a critical stage and then provided business development support that has been invaluable. Those weekly meetings are magical. They have helped us define and refine a lot of things.
Additionally, Villgro has opened many doors. When I look at most of the follow-on funding that we have received, Villgro opened those doors. And also in connection to investment readiness, they have availed us with training opportunities, they have helped us to understand and meet specific needs and expectations of investors, helping us to get ready for that stage. They also provided connections in the overall ecosystem, including suppliers, support for clinical studies, principal investigators, partners to help secure specific areas of funding. They were able to make connections within the ecosystem that have been very fundamental for us.