Milu Labs Ltd

Preterm birth is a major global health problem: according to the WHO, preterm birth and its complications are the leading cause of death of children 5 years old and younger, responsible for 1 million deaths every year. Our solution is a sophisticated diagnostic test that can be used early in the pregnancy to determine the likelihood of preterm birth. With international reach, our diagnostic could transform the quality of women's health by empowering mothers-to-be and healthcare workers to monitor and treat pregnancies that exhibit a high risk of ending in preterm birth. We would be able to save the lives of mothers and their newborns, especially in countries in which women cannot access adequate healthcare service. 

We are attempting to solve the problem of preterm birth in developing countries across Asia. Preterm birth is a devastating challenge that impacts most the societies with the least healthcare resources to address it; while the average preterm birth rate is approximately 10%, in countries such as Indonesia, it is more than 15%. As mentioned above, the WHO concluded that complications arising from preterm birth is the leading cause of death for children aged five years and younger. Beyond that, preterm birth adversely affects the long-term health of both mothers and children: children born preterm suffer from an increased incidence of developmental, cognitive, and psychological challenges whereas mothers experience a greater risk of hypertension. 

Our solution is a diagnostic test, developed with the help of Dr. Thomas McElrath of Harvard Medical School, that can be used early in pregnancy to predict accurately the likelihood of preterm birth. Our technology is noninvasive so it poses no risk to the mother or child: a standard blood draw is all that is required. We then analyze the exosomes in the blood. Exosomes are tiny particles, microvesicles, that help intermediate the relationship between mother and fetus. Finally, we determine whether or not the pregnancy is at high-risk of preterm birth. Since our test is the only one that can be used at 10-12 weeks of pregnancy, we can have a massive impact on lowering preterm birth rates; detection needs to occur early enough for the treatment regimen to be effective. 

Our solution serves multiple populations, by far the most important of which is mothers and children living in countries with limited healthcare resources. We have conducted research with healthcare providers and mothers across Asia to understand the shape and scope of the problem so we can assist them in the development of effective care pathways. By offering a diagnostic test that is easy to administer, we can help prevent the occurrence of preterm birth by identifying high-risk pregnancies and treating them efficaciously. This, in turn, would save many lives and diminish other maladies associated with preterm birth. 

Doing our part to solve the problem of preterm birth is directly related to the Challenge of expanding access to high-quality care to mothers and newborns. Now, no diagnostic test exists that can detect the likelihood preterm birth early enough for the standard treatment pathway to be effective. Our product delivers care to treat a truly unmet need in healthcare, which is the prevention of preterm birth. 

Our solution is innovative because it resolves a truly unmet need: no other product can detect preterm birth early enough to treat it effectively. The closest competitor is Sera Prognostics, which raised $200 million to create a preterm birth test; their product, however, only can be administered at approximately 22 weeks of pregnancy, which is too late to do anything about it. 

Our core technology is exosome analysis. Exosomes are microvesicles, or floating particles, found in blood and that play a key role in the relationship between mother and fetus. Our technology analyses exosome levels and composition to determine the likelihood of preterm birth. 

Our technology is based on research done in conjunction with Dr. Thomas McElrath of Harvard Medical School and Dr. Zhen Zhang of Johns Hopkins Medical School. 

Circulating Microparticle Proteins Obtained in the Late First Trimester Predict Spontaneous Preterm Birth at Less Than 35 Weeks' Gestation: A Panel Validation With Specific Characterization by Parity

Evaluation of Proteomic Biomarkers Associated With Circulating Microparticles as an Effective Means to Stratify the Risk of Spontaneous Preterm Birth

Our theory of change is grounded in the historical impacts that other groundbreaking medical technologies have had. Countless healthcare products, from disease treatment to cancer therapeutics, have transformed societies by both extending lifetimes and increasing quality of life. By making our product available to low-income women in developing Asia, our preterm birth test will directly lead to lower levels of preterm birth. As explained earlier, this saves lives and produces other clear benefits for mothers and children. 

At this point, we are still conducting clinical trials. Within the next year, we plan to complete these trials and make our product available in China as a laboratory-designed test (LDT), serving approximately 50,000 pregnant women. Within five years, we hope to have tested almost 900,000 pregnant women, with a minimum target of testing close to 300,000 women per year. 

Within the next year, we plan to generate the requisite amount of data from clinical trials to clear regulatory requirements for LDT (laboratory-designed test) status. With this data, we will then form a collaboration agreement with a reputable distributor to deliver our test to clinicians. These developments would, at first, allow us to bring our test to low-income women in Asia. Within five years, we plan to have top-line NMPA (National Medical Products Administration) approval in China as well as approval in Southeast Asian markets. We will scale by forming strategic partnerships with hospitals and distributors to help the greatest number of women. 

The barriers we face are primarily regulatory, technological, and financial. On the regulatory front, we must generate enough data to show clinical effectiveness before we can bring our test to women. On the technological dimension, we must ensure that our cost of goods sold (COGS) are sufficiently low so that we may reach the largest number of pregnant women. On our financial requirements, we must maintain enough capital to pursue our activities without ending in bankruptcy. 

Regulatory solution - Complete all required clinical trials needed to enter each geography. This is a matter of time, management attention, and financial resources.

Technological solution - Build our engineering department and have them focus on low-cost design.

Financial solution - Raise capital from social impact and traditional investors. 

Full-Time Staff: Four

Scientific Advisory Board: Four

Our team is best-positioned to deliver impact because of deep experience in the healthcare sector as well as strategy and operations.

Chairman: Dr. Daniel Chai is a serial entrepreneur and investment manager with over 25 years of experience in the healthcare sector. He understands healthcare industry dynamics - ranging all the way from clinical trials to product commercialization. He has served as a healthcare sector portfolio manager at major investment houses such as Neuberger Berman and UBS. Dr. Chai graduated as an Angell Scholar from the University of Michigan and received his M.D. from Columbia University.

CEO: Dr. Wilson Zhang is a leading figure in China’s diagnostics industry with over 20 years of experience. Dr. Zhang’s expertise in China’s diagnostics sector provides us the best ability to build and scale an Asia-centric diagnostics firm. He formerly served as the Lead of Strategy and Corporate Development at Zhejiang Dian Diagnostics, one of the largest diagnostic labs in China and is publicly traded on the Shenzhen Stock Exchange. Dr. Zhang holds an M.D. from Shanghai Jiaotong University.

CFO & CSO: Matthew G. Badalucco has over a decade of business experience across developed and emerging markets. His global experience has provided him with a deep understanding of startup economics; he most recently was the Director of Investment Strategy at Catcha Group, one of the largest venture builders in Asia, where he advised the CEO. He holds an A.B. with Honors from Dartmouth College, an M.B.A. from MIT, and an M.P.A. from Harvard University.

We have partnered with two major entities in the diagnostics and healthcare space. First, we are working with the Hangzhou Biopharma Town to house our laboratory and China office. Second, we have a collaboration with Thermo Fisher Scientific, a global medical instrumentation maker, to devise protocols and procedures for our preterm birth test.

Our business model follows a straightforward process used by many other diagnostics companies: we will partner with labs, hospitals, and distributors to sell our product directly to physicians. We want to use our financial resources in the most prudent and most impactful way so we will not build our own sales force, which would extremely expensive. Instead, we will collaborate with our partners to inform doctors of the benefits of our test. Similarly, we will not market directly to pregnant women because of challenges in educating mainstream customers about esoteric medical knowledge. Financially, our business model entails the production of kits and sales to clinicians; distributors will receive a fraction of the price that clinicians pay. 

We plan to raise capital via grants, social impact investors, and traditional investors to sustain us until we reach break-even. Our break-even point is expected in late 2021 as we commence sales of our preterm birth test in China. From that point, we will be fully self-sustaining and require no outside capital to function. 

Besides the much-needed financial assistance, becoming a Solver would help accelerate our growth plans by furthering connecting us to the MIT community. One of our co-founders, Matthew G. Badalucco, is an MIT alum and his time at the Institute had a transformational effect on this thinking and outlook. Solve's mentors, workshops, and media exposure will most definitely help us at Milu try to deliver a major social impact for low-income women across Asia. 

Being a member of the Solve community would help us overcome obstacles to our growth even more quickly. We would have access to researchers and practitioners who understand the issues that efforts like ours face, including finding advisors and other talent that could assist in our regulatory approval efforts across Asia. Opportunities to access capital are very necessary at this moment as we build towards organizational sustainability and our break-even point. Finally, media exposure would certainly help us establish legitimacy when trying to collaborate with large, established healthcare institutions and government entities across the world. 

We are most interested in partnering with Solve members and MIT researchers and/or faculty to learn about how to grapple with problems that might emerge from commercializing state-of-the-art medical technologies in low-income countries. 

We are qualified for this prize because our very mission at Milu Labs is to increase the quality of low-income women’s health across Asia. Our core product is the world's first preterm birth test that can be administered early enough in pregnancy to do something to treat preterm birth. Since preterm birth is a major global challenge that leads to deaths of 1 million infants every year as well as long-term health problems for both women and children, we believe we can have a major impact on women's lives. We would use the prize to continue our clinical and commercial development. 

Our goal is to increase the quality of low-income women’s health across Asia. To accomplish that, we introduce a truly new tool that healthcare workers can use to help pregnant women: a sophisticated diagnostic test that can be deployed early in the pregnancy to determine the likelihood of preterm birth. According to the WHO, preterm birth is a major global challenge that leads to deaths of 1 million infants every year as well as long-term health problems for both women and children. If detected early enough, pregnant women can be placed on a care pathway that will dramatically reduce the probability of preterm birth. Currently, no other product can be used early in pregnancy to detect an elevated risk of preterm birth. Because no other tools exist that can do this, our product can have a profound impact on women in developing Asian countries. 

Our goal is to increase the quality of low-income women’s health across Asia. To accomplish that, we introduce a truly new tool to help pregnant women: a sophisticated diagnostic test that can be deployed early in the pregnancy to determine the likelihood of preterm birth. According to the WHO, preterm birth is a major global challenge that leads to deaths of 1 million infants every year as well as long-term health problems for both women and children. We have worked in conjunction with public sector entities, most importantly the Hangzhou government's Biopharma Town, to devise our strategy, understand the needs of local clinicians, and implement our regulatory pathway. We have found that, if detected early enough, pregnant women can be placed on a care pathway that will dramatically reduce the probability of preterm birth. Currently, no other product can be used early in pregnancy to detect an elevated risk of preterm birth. Because no other tools exist that can do this, our product can have a profound impact on women in developing Asian countries. 

 Our goal is to increase the quality of low-income women’s health across Asia. To accomplish that, we introduce a truly new tool to help pregnant women: a sophisticated diagnostic test that can be deployed early in the pregnancy to determine the likelihood of preterm birth. According to the WHO, preterm birth is a major global challenge that leads to deaths of 1 million infants every year as well as long-term health problems for both women and children. If detected early enough, pregnant women can be placed on a care pathway that will dramatically reduce the probability of preterm birth. Currently, no other product can be used early in pregnancy to detect an elevated risk of preterm birth. Because no other tools exist that can do this, our product can have a profound impact on women in developing Asian countries.