MAMOME

In the US, approximately 9% of all pregnancies are complicated by gestational diabetes, but advances in maternal health has been very slow.  The current standard of care is to diagnose patients with material diabetes at week 24 - 28.  However, this is fairly late in the second trimester and may be too late to avoid many of the complications to the infant including heart disease, preterm birth, increased size and weight of the fetus which can result in injury to the baby at delivery, and post-partum complications such as postpartum depression or development of type 2 diabetes in the mom later in life.  The way gestational diabetes is diagnosed currently is through something called an oral glucose tolerance test, where the mom drinks some sugar and her sugar levels are monitored over time.  This test was developed in 1964 and no more recent advances have been made to identify patients at risk of gestational diabetes earlier in the pregnancy.  By the time the mom develops gestational diabetes, damage may have already occurred to the mom and baby.  An earlier, more sensitive test to identify patients at risk of developing gestational diabetes is needed to avoid these complications altogether.  This is especially true for lower income or minority populations who are at increased risk of pregnancy complications including gestational diabetes.

We are developing an AI-powered microbiome test to reduce the time of diagnosis of gestational diabetes from 24 weeks down to 12 weeks.  We use specific gut microbiome biomarkers to identify patients at risk of gestational diabetes.  Patient are given at-home testing kits around week 12 of pregnancy that is analyzed at a certified lab using shotgun metagenomics.  We then process the information through a propriety AI algorithm that combines patient demographic information and the results of the microbiome study to risk stratify patients at risk of gestational diabetes.

We then work with the obstetrics clinics to educate patients on their results, develop personalized interventions to improve maternal health, and avoid development of gestational diabetes later in the pregnancy.  Second and third trimester follow-up testing may be performed to track improvements to the microbiome as leading indicators of improved health from targeted interventions during the pregnancy.

There are approximately 3.66 million pregnancies per year in the US.  Yet,  approximately one-third of all pregnancies never get tested for gestational diabetes as many patients do not have the time or means to get tested.  This may be especially true in people of lower socioeconomic status and minority populations who are at increased risk of gestational diabetes.  The current oral glucose tolerance test takes at least 1-hour for the screening test and 3-hours for the confirmation test.  Both tests must be performed in a physician's office which creates barriers to patients.  By providing an at-home test that is easy to perform, we hope to improve access to testing for gestational diabetes to all patients.

Our goal is to develop an FDA-approved test that is covered by all insurance plans. For people that are uninsured, we aim to provide the cost at minimal cost to the patient or work with public health organizations to offer the test at no cost to the patient.  By improving access of this test and to intervene much earlier the pregnancy, we hope to reduce complications to the mother and baby, thereby improving the overall health of the community.

Our team is uniquely positioned to deliver our microbiome-based diagnostic solution to the target population. Led by CEO Nini Fan, an expert in clinical trials and collaborations with healthcare centers, our team is at the forefront of addressing maternal health challenges, particularly in GDM prevention and prediction. We work closely with local OB clinics, registered dieticians, and patients to provide a test that is easy to perform.  Our team provides logistics support and consultative services for patient to educate them on their results.  This diverse team ensures that our solution is not only scientifically robust but also technologically advanced. 

The design and implementation of our microbiome-based diagnostic test are meaningfully guided by the input and agendas of the communities we serve. We recognize that healthcare solutions must be collaborative efforts. We have actively sought out the insights of healthcare providers and researchers specializing in GDM, as well as pregnant women who are at the heart of this issue. Their perspectives have been instrumental in shaping the development of our diagnostic test, ensuring that it aligns with their expectations and requirements.

In summary, our team's strength is not just in our educational and professional qualifications but in our personal commitment and engagement with the communities we aim to serve. We actively seek to understand their needs, engage them in the solution's development, and incorporate their input into our design and implementation. By doing so, we are confident that our microbiome-based diagnostic test will be a solution that genuinely addresses the needs of pregnant women and healthcare providers in the context of GDM.

Maternal health is often overlooked.  We aim to provide a solution to this neglected space and modernize a test from the 1960s.  Our test has implications for other related conditions including diabetes mellitus and pre-diabetes.  Lastly, our initial target population is in the Unites States but our tests may be adapted with additional biomarkers in other countries.  We hope our test shines a light in the often overlooked category of maternal and fetal health, and inspires other people to develop new solutions in this field.

In regards to the science, we have identified propriety biomarkers in a pilot study (Clinicaltrial.gov registration number NCT#05265741) and are looking to improve the sensitivity and specificity of the test through additional studies.

Our solution directly addresses UN Goals of improving maternal health,  reducing pregnancy related complications, and improving childhood well being.  By identifying and intervening on patients at risk of gestational diabetes earlier in the pregnancy, we aim to avoid the complications of gestational diabetes entirely.  Children of gestational diabetes have complications at the time of delivery including increase birth weight which may result in shoulder and nerve injury at the time of delivery, preterm birth, cardiac disorders, and metabolic disorders.  Long-term complications to the child include higher risk of type 2 diabetes, obesity, and neuropsychiatric development.  For women who have gestational diabetes, they have a higher risk of developing type 2 diabetes mellitus, kidney diseases, postpartum depression, heart disease, and cancer.

By improving the overall health of the mother and child, we hope to improve overall health equity, health disparities, and public health. 

MaMome's AI health solution harnesses cutting-edge artificial intelligence technology and relies on a wealth of comprehensive data sources to drive its microbiome-based diagnostic tests for gestational diabetes mellitus. Our AI components are central to our solution's success, as they enable the identification of microbial biomarkers associated with GDM, early prediction, and improved patient outcomes.

The cornerstone of our AI-driven solution is the microbiome data collected from expectant mothers. This data encompasses microbial compositions, genetic profiles, and various metabolic markers relevant to GDM. To maintain data quality, we have developed proprietary data collection protocols and procedures, ensuring standardized and consistent sample handling across the cohort. We work closely with healthcare institutions, clinics, and research partners to acquire high-quality, curated data, focusing on pregnant women in various stages of pregnancy.

In addition to our proprietary data sets, MaMome also leverages publicly available genomic and clinical data, enabling us to conduct extensive cross-referencing and validation of our findings. This approach ensures that our AI models are not only based on novel and proprietary data but are also validated against external sources, enhancing the robustness and reliability of our diagnostic tests.

Our plan for acquiring good, curated data is multi-pronged. We continue to collaborate with healthcare institutions and researchers to expand our data sources, increase sample sizes, and enhance the diversity of the data. Additionally, we are actively engaged in partnerships with clinics and healthcare providers to streamline the data acquisition process and ensure that data collected from expectant mothers are representative and comprehensive.

Our company follows strict HIPAA compliance.  All future clinical studies will go through the rigors of the Institutional Review Board (IRB) process.  This is critical as our goal is to have an FDA-approved test and will be subject to additional scrutiny for how our data is collected and processed.  As our technology scales, we will have processes in place for HIPAA compliance to ensure the privacy and security of our data.

MaMome's impact goals for the coming year are to collaborate with local clinics and healthcare providers to enhance the diagnosis and management of patients at risk of gestational diabetes. By working closely with these institutions, we aim to refine our diagnostic processes and provide more effective tools for healthcare professionals to identify and support expectant mothers with GDM risk.

Over the next two to three years, our focus shifts towards improving the accuracy of our diagnostic tests and achieving full FDA approval. This step is crucial to ensure the reliability and effectiveness of our solution, meeting rigorous regulatory standards, and gaining the trust of the healthcare community.

Looking ahead to the next five years, our overarching goal is to expand our testing platform nationwide. We aspire to make our microbiome-based diagnostic test accessible to expectant mothers across the country, contributing to improved maternal and fetal health outcomes on a larger scale. To achieve this, we will continue to collaborate with healthcare institutions, researchers, and healthcare providers, ensuring our solution's integration into standard maternal care protocols.

By pursuing these impact goals, MaMome aims to have a transformational impact on people's lives, particularly expectant mothers at risk of gestational diabetes. We are committed to driving innovation in maternal health, improving early diagnosis and management, and ultimately contributing to healthier pregnancies and improved healthcare outcomes.

4 people:

• Nini Fan MBA/M.S., Founder, and CEO - Full-time

• Norihiro Yogo MD Co-Founder, and CTO - Part-time till fundraise

• Stephanie McClellan MD, Co-Counder, and CMO Part-time till fundraise

• Yanjiao Zhou, MD/PhD, Scientific Director - Part-time till fundraise

Our accomplished leadership team, led by CEO Nini Fan MBA/M.S., excels in microbiome and healthcare startups. Dr. Norihiro Yogo, with medical and machine learning expertise. Dr. Stephanie McClellan is an OB/GYN and women's health influencer. Dr. Yanjiao Zhao specializes in machine learning and translational microbiome. MaMome pioneers AI healthcare solutions.

30 months

We are a women-founded, women-led team.  We feel the mission to improve the lives of women should likewise be represented in our leadership team.  We work closely with providers from all backgrounds who likewise care for patients from all cultural and socioeconomic circumstances. Our goals are to ensure our company represents those values and for us to hire, promote, and advocate for our team members based on their merits.

MaMome's operational model and plan revolve around a well-structured approach to deliver impact in the field of maternal health, specifically in the early diagnosis and management of gestational diabetes mellitus (GDM). Our model is built on collaboration, innovation, and a deep understanding of the healthcare ecosystem.

Team Organization: MaMome boasts a multidisciplinary team with expertise in microbiome research, healthcare, and technology. The leadership team includes our full-time CEO and Founder, Nini Fan MBA/M.S., an experienced entrepreneur in the microbiome and healthcare startup space. We also have Dr. Norihiro Yogo MD, our part-time CTO, a Harvard Medical School graduate with strong credentials in machine learning and medical informatics. Dr. Stephanie McClellan MD, an OB/GYN and part-time CMO, brings extensive healthcare experience and influence in women's health. Dr. Yanjiao Zhao, MD/PhD, our part-time Scientific Director, is an expert in machine learning and translational microbiome. Additionally, Wenxin Zhao, our Data Scientists Lead, is responsible for the technical aspects of our AI solution.

Engagement with Stakeholders: We have established partnerships with local clinics and healthcare providers to ensure seamless integration of our microbiome-based diagnostic solution. This collaboration is essential to understand the real-world needs of healthcare professionals and expectant mothers. By actively involving these stakeholders, we aim to fine-tune our solution to align with their expectations and clinical workflows.

Access to Tools: Access to cutting-edge tools and technologies is fundamental to our solution. We have leveraged state-of-the-art machine learning and AI technologies to develop our microbiome-based GDM test. MaMome's team works in close collaboration with data scientists, ensuring that we have the necessary tools and expertise to create a robust and accurate solution. Additionally, we have a strong network in the healthcare and research community, providing access to clinical data and resources for validation and clinical trials.

Impact Delivery: 

Our strategy for delivering impact involves three key phases:

• Local Engagement: In the initial phase, we collaborate with local clinics to implement our solution and gather insights. This engagement helps us understand the dynamics of clinical practice and enables us to tailor our offering to meet the specific needs of healthcare providers and patients.

• Clinical Trials and Validation: To substantiate the scientific validity of our microbiome-based GDM test, we plan to conduct clinical trials. These trials will be instrumental in seeking FDA approval, a critical step in the journey toward widespread adoption.

• Expansion: Once we achieve FDA approval, we aim to expand our testing platform nationally. This expansion will be supported by our growing network of healthcare partners and stakeholders, ensuring that our solution reaches a broader audience and positively impacts maternal and fetal health outcomes.

Our operational model and plan are rooted in collaboration, innovation, and the relentless pursuit of scientific excellence. We are committed to delivering a transformational impact on the lives of expectant mothers and healthcare providers by revolutionizing the early diagnosis and management of GDM.

To ensure financial sustainability, MaMome has devised a comprehensive strategy that encompasses various revenue streams. We aim to secure government funding and contracts, including NIH SBIR and support from the New York State Venture Fund, to kickstart our operations. Sales will play a pivotal role, with subscription services and products offering a B2B2C model. We intend to seek reimbursement agreements with payors to enhance the adoption of our services. Additionally, we plan to raise capital through a seed round with venture funds.

Our long-term goal is to obtain FDA approval for our diagnostic test, making it eligible for insurance reimbursement. To achieve this, we will actively apply for grants to conduct clinical trials, laying the foundation for FDA clearance. Simultaneously, we'll engage with angel investors and initiate a seed round to secure the necessary capital for development and regulatory compliance.

We recognize that the path to FDA approval and insurance reimbursement is a journey that requires time and resources. While we work on establishing our product, we will collaborate with local clinics for utilization and explore opportunities for a direct-to-consumer option. This multifaceted approach allows us to extend our financial runway and progress toward an FDA-approved test. Furthermore, we have a counseling service that is billable by insurance, providing an additional revenue stream and bolstering our financial sustainability.

MaMome's current operating costs are $88,000 per month. These costs encompass various aspects of our operations, including research and development, clinical trials, data analysis, and administrative functions. Additionally, our current operating costs cover the compensation of our multidisciplinary team, which includes microbiome researchers, data scientists, clinical experts, and administrative staff.

Looking ahead to the next year, our projected operating costs are estimated to be $847,000. This projection includes an allowance for the expansion of our team to support the growth of our microbiome-based diagnostic solution. The majority of these costs are attributed to human capital estimates, as we anticipate hiring additional personnel to strengthen our clinical research, data analysis, and sales efforts. We aim to bolster our clinical trials, further develop our AI technology, and expand our user base, which necessitates the inclusion of new team members.

The breakdown of our projected operating costs for the next year includes salaries, benefits, and other human capital expenses for current and anticipated team members. It also encompasses costs associated with clinical trials, research, development, marketing, and administrative functions. These projections align with our strategic plan to enhance the accuracy and reach of our microbiome-based GDM test, as well as the pursuit of FDA approval and expansion to a national scale.

MaMome is seeking funding of $100,000 to drive significant advancements in our mission to revolutionize maternal health through our microbiome-based GDM diagnostic solution. This funding will be meticulously allocated to ensure a direct and rewarding impact on our objectives for 2024.

• Clinical Trials and FDA Approval (40%): The largest portion of the funding, $40,000, will be dedicated to conducting comprehensive clinical trials. This investment will significantly enhance the clinical validation of our microbiome-based GDM test, bringing us closer to obtaining FDA approval. By expanding the clinical evidence, we not only increase the test's accuracy but also pave the way for its integration into clinical practice.

• Research and Development (25%): Approximately $25,000 will be channeled into research and development efforts. This includes refining our AI algorithms, advancing data analysis capabilities, and exploring new microbial biomarkers to boost the precision of our diagnostic test. By investing in cutting-edge technology and research, we ensure that our solution remains at the forefront of innovation.

• Team Expansion (20%): We will allocate $20,000 to grow our team, hiring additional experts in microbiome research, data science, and clinical domains. This expansion is crucial to meet the increasing demands and challenges of developing an accurate and clinically validated diagnostic solution.

• Marketing and Outreach (10%): To extend our reach and engage with more healthcare providers and expectant mothers, $10,000 will be devoted to marketing and outreach initiatives. This investment will help us expand our presence in the maternal health ecosystem, fostering greater adoption of our solution.

• Administrative and Operational Costs (5%): A portion of the funds, $5,000, will cover essential administrative and operational expenses, ensuring the smooth functioning of our daily activities.

By deploying the $100,000 funding in this manner, MaMome will achieve a transformative impact. We'll be one step closer to delivering an FDA-approved microbiome-based GDM test, enhancing maternal and fetal health outcomes, and solidifying our position as leaders in AI-driven healthcare solutions. This funding directly supports the development and validation of our solution, ensuring that it reaches its full potential and makes a meaningful difference in the field of maternal health.

The Cure Residency represents a remarkable opportunity for MaMome, and we are tremendously excited about the possibilities it offers. This initiative aligns perfectly with our mission to transform maternal health through our AI-powered microbiome-based GDM diagnostic solution. The diverse support elements provided by the Cure Residency will be instrumental in advancing our work and achieving our vision.

Seed Funding: The financial support is pivotal as it will enable us to accelerate our medical device, refine our AI algorithms, and expand our commercialization efforts. This funding will directly impact our ability to move closer to our ultimate goal of delivering an FDA-approved diagnostic test that enhances maternal and fetal health outcomes.

Mentorship: The guidance and mentorship from seasoned experts in the field will be invaluable. Their insights, experience, and strategic direction will help us navigate the complex landscape of healthcare innovation more effectively. With their support, we can refine our strategy, ensure robust clinical validation, and maximize our impact.

Lab Space: Access to a dedicated lab space will provide us with a conducive environment for conducting experiments, data analysis, and research. This will significantly enhance our research and development capabilities, enabling us to stay at the cutting edge of microbiome-based diagnostics.

Educational Programming: The educational components of the Cure Residency are a fantastic resource. They will empower us with the latest knowledge and best practices in healthcare, AI, and entrepreneurship. This knowledge will be directly translated into improving our solution, making it even more effective and impactful.

Networking Opportunities: Connecting with like-minded innovators and potential partners in the Cure Residency program will broaden our horizons. Collaboration with fellow healthcare visionaries and experts can open doors to new insights, technologies, and opportunities for growth.

The Cure Residency is not just an opportunity; it's a pivotal turning point for us. It will empower us to move forward with greater momentum, enhancing our solution and making it a reality for expectant mothers everywhere. We are excited about the potential for synergy and collaboration within the program and look forward to leveraging these resources to accelerate our mission. We are deeply committed to improving maternal health and believe that the Cure Residency will play a pivotal role in achieving this goal.