Kalia Health

Kalia Health (KH) is a health justice startup committed to improving reproductive health outcomes for conditions such as preeclampsia (PE). PE is the second leading cause of maternal mortalities in the US and worldwide and affects birthing people of color with greatest severity, despite the condition being straightforward to manage if detected early. Symptoms are subtle, often leaving expecting parents unaware of the developing complications unless they attend regular prenatal care checkups and receive quality care. Left undiagnosed, the condition becomes eclampsia, which leads to organ failure, seizure activity, and serious or fatal health effects for both parent and unborn child.

Our mission is to improve reproductive health outcomes through a home-based early detection of complications like preeclampsia. KH is currently developing a prototype for the Kal-PDx, an early preeclampsia detection strip to improve diagnosis, increase access to diagnosis, and create individual awareness about the developing complication.

Preeclampsia is the 2nd leading cause of maternal mortalities worldwide, despite being straightforward to manage if detected early. Symptoms are subtle, often leaving birthing people (BP) unaware of the developing complications unless they attend regular prenatal care checkups. Left undiagnosed, the condition becomes eclampsia, which leads to organ failure, seizure activity, and potentially fatal health effects for both parent and unborn child. The ongoing mortality from preeclampsia and eclampsia exemplify the health disparity between high-income settings where BP have access to adequate prenatal care and low-income settings where birthing people routinely die from preventable causes.

Diagnosis remains a challenge for two reasons: 1) Many BP are unable to access routine prenatal screenings due to a lack of transportation, hospital closures, a lack of medical infrastructure, and socioeconomic factors that limit opportunities to seek care; and 2) The current diagnostic protocol for preeclampsia (elevated blood pressure and proteinuria) is not specific to preeclampsia. Clinicians have informed us that they often find it challenging to accurately identify preeclampsia given clouding factors such as white coat syndrome (causing readings of elevated blood pressure) and other pregnancy complications, which are both challenging to distinguish from preeclampsia and also lead to protein in the urine.

KH is designing the Kal-PDx strip, which is a lateral flow assay. The Kal-PDx is a urine-based, point-of-care early detection test that measures elevated levels of protein biomarkers indicative of preeclampsia. Expecting birth parents can use the Kal-PDx, which functions like a home pregnancy test, at home to self-screen for the development of preeclampsia, so they know when the complication is beginning and can choose to seek preventative care before symptoms become severe. For those without routine prenatal care screenings, increasing individual awareness about developing complications is essential to reducing the burden of preeclampsia and eclampsia, and saving thousands of birth parents and babies from preventable harm.

Kal-PDx can also aid clinicians to identify preeclampsia with ease, even when there are no presenting symptoms and without the challenge of discerning white coat syndrome. Those assessed at higher risk may be asked to screen more often as prescribed by a physician. Expecting parents can take control of their health and test quickly and comfortably at home. Awaiting test results is stressful, and for many BP, both in the US and low resource countries, getting to a clinical appointment poses a huge burden. Early preeclampsia detection allows for a safer pregnancy.

Our team has completed the NSF I-Corps programs (national and site) for customer discovery to better understand our users and our market. We have completed 142 interviews of birthing people, clinicians, and others in the reproductive health ecosystem via the I-Corps programs as well as an additional 304 surveys and interviews conducted separate from the program. Interviews were completed in the U.S., Nigeria, and Uganda. Using this data, we have better understood user needs, redefined our customer in the U.S., planned to focus on the U.S. market first, and defined a preliminary pathway to commercialization.

Our solution will benefit both clinicians and expecting BP. Both physicians and expecting BP are primarily concerned with having a safe pregnancy and healthy baby. Clinicians find diagnosing PE challenging due to limited symptoms and signs, which may be confounded with other conditions. Early diagnosis can prevent severe PE and eclampsia, which requires surgical delivery and treatment with magnesium sulfate. BP who have received magnesium sulfate reported feeling cloudy and confused with limited memory of their deliveries. The costs of diagnosing and managing PE far offset the costs associated with severe PE and eclampsia, their complications, and required extended care. BP who have previously experienced preeclampsia have informed us that they are interested in a tool for self-diagnosis, especially when they are unsure if a pregnancy symptom is atypical and when they feel they are not being heard by their providers. Because it can be used at home rather than requiring routine visits to a clinical setting, the Kal-PDx will empower patients and increase access to care.

Because KH’s primary mission is health justice we strive for continued health activism and local community engagement. This work keeps us engages with potential users and allows us to understand their changing needs. For example, during COVID, we noticed that many birthing people were unable to access perinatal supplies. Kalia Health partnered with MAAME (maameinc.org), a non-profit here in Durham, and we worked to safely collect and distribute maternity clothes, vitamins, diapers, pack-n-plays, etc. to low-resource and underserved birthing people in the greater NC triangle area. Working with MAAME, not only allowed us to relieve the immediate needs of new and expecting parents, but it connected us to a community full of resources and activists, to which we now contribute.

Access to the Kal-PDx (along with communication with a clinician via telehealth or via community health workers) among underserved demographics (e.g. rural populations, uninsured and underinsured, undocumented, low and middle income countries, etc.) would provide an added level of care, which would not typically be received due to an inability to reach, qualify for, or afford sufficient prenatal care. Populations with high risk of preeclampsia or those that tend to be highly affected, such as birthing people of color, need to be closely monitored for development of the condition. These patients can screen more frequently at home using the Kal-PDx in between prenatal care visits and communicate the results (e.g. via a photograph of the test results or selection of a positive/negative response) via telehealth and mHealth platforms.

The typical prenatal care visit frequency beginning at 20 weeks of gestation (when preeclampsia can onset) is once per month up till 28 weeks, 2 times per month up till 36 weeks, and every week up till 40 weeks. Routine monitoring of PE development is essential to stopping disease progression.

The experiences of pregnant people have changed over the past year due to the COVID-19 pandemic. The value of home-based diagnosis has become more apparent than ever. Many patients with low-risk pregnancies had safe and healthy deliveries despite having visited their care provider less frequently as a safety precaution. The use of home-based diagnostic tools would facilitate delivery of essential, quality care when circumstances do not allow for in-person clinical appointments. It is important that such tools be used in parallel with telemedicine so that patients are under the care of a provider. It is critical that patients can follow up rapidly with positive diagnostic test results and begin treatment. 

We have built a proof of concept lateral flow assay, which can detect both of our biomarkers of interest from a fresh urine sample. We have also completed a small (n = 80)  background study proving the diagnostic capacity of our biomarkers. This study allowed us to identify a diagnostic window, however we need to conduct further clinical research precisely defining our diagnostic thresholds so we can optimize our device and begin clinical validation. Our next steps are to complete a larger clinical trial to determine the exact diagnostic threshold, finalize prototype development, begin clinical validation, seek FDA approval, and launch.

The Kal-PDx provides non-invasive, rapid, point-of-care diagnosis of preeclampsia, early in pregnancy for increased access to healthcare. It is the only non-invasive, home use diagnostic for PE in development. It is the only diagnostic utilizing our biomarkers of interest in urine. There are currently no other preeclampsia diagnostics tests available in the US market, though many are in development. The Kal-PDx is among few urine-based tests in development, and the only test being designed for home use. Because our test can be used by patients in a home environment rather than administered by a healthcare provider in a clinical setting, Kal-PDx provides the added value of patient empowerment and can reach patients with limited access to healthcare. Additionally, KH acknowledges that a technical solution alone cannot solve a social problem. As such, we take a holistic approach in building our company and delivering solutions (e.g. partnering with regional NGOs to provide the Kal-PDx at cost and utilize midwife training programs to deliver care). 

 Number of people currently served by Kal-PDx: 0

Number of people served by Kal-PDx in one year: 0

Number of people served by Kal-PDx in five years: 5 million

The Kal-PDx is at technology readiness level 4. The Kal-PDx is early in development, but the technology has been de-risked through the development of a proof-of-concept prototype and validation of our biomarkers of interest. We do not currently have a minimum viable product, and therefore do not have any users. In one year, our finalized prototype will undergo clinical validation testing and regulatory approval. During this stage, our products will be used by study participants, but will not be available for the larger population. Our anticipated time to product launch is 2.5 years. Though the Kal-PDx will not be available during this time, we intend to continue serving our local community (particularly birthing people of color) and fighting for health justice.

There are over 200 million annual pregnancies globally, including 4 million live births in the US. In 5 years, we anticipate that our product will impact 5 million birthing people, assuming strong adoption in the US (i.e. device is used for 50% of pregnancies) and initial success in low and middle income countries (LMICs). 

We will measure our social impact with both long- and short-term monitoring and evaluation of device usage and health outcomes. 

Short-term success will be measured by adoption of the device (i.e. sales numbers and the number of clinics and physicians prescribing the diagnostic to their patients). To measure short-term impact, we will track changes to the number of preeclampsia diagnoses and correlationg gestational age, follow up to care by birthing people using the Kal-PDx, monitor if PE treatment begins earlier, changes to the number of adverse outcomes (including seizures, emergency deliveries, and fatalities), and changes to gestational age at birth among preeclamptic patients. 

To measure long-term impact, we will look for reduction in rates of maternal, fetal, and neonatal mortalities attributable to PE, long-term morbidity due to PE, and penetration of Kal-PDx availability and accessibility (e.g. cost, distance to purchase).

We will measure user and provider satisfaction and perceived outcomes, such as ease-of-use, accessibility, convenience, health seeking behaviors, etc. Social impact will also be gaged by quality of partnerships and the outcomes of the work conducted (e.g. an NGO could purchase strips and provide them directly to clinics or implement distribution with community health workers).

For both long- and short-term metrics, access to Kal-PDx and treatment received among key underserved and highly affected demographics (e.g. rural populations, birthing people of color, uninsured and underinsured, undocumented, etc.) will be measured. These metrics provide a high-level overview of interest areas and are not exhaustive. 

Total: 12 (6 actively engaged, 6 as needed)

Full-time: 1

Part-time: 5

Consultants: 1

Advisors: 5

Co-founders Denali Dahl (Ph.D. Candidate in Biomedical Engineering) and Happy Ghosh (M.Sc. in Global Health, B.S. in Biomedical Engineering) have backgrounds in biomedical engineering and global health research. Denali, Chief Executive Officer, has experience developing women's healthcare diagnostics and drug delivery technologies and has run clinical studies to test women's health diagnostics in the U.S. and globally. Happy, Chief Product Officer, has experience in developing technologies for low resource settings, including a novel, low-cost, corn-starch based ultrasound gel and a traumatic brain injury diagnostic (using an LFA format). Both have completed the Advanced Lateral Flow Development course and built the prototype for their diagnostic. 

Though we are not yet mothers, Denali and I (Happy) are both women of color that have experienced poor quality care. I have long been engaged with the healthcare system due to the long-term illness of an immediate family member and have had challenges accessing health coverage while working full time on KH.  I have experienced implicit and explicit bias, microaggressions, gas lighting, and outright discrimination. Like those in our community, I’ve experienced these all due to my race, gender, color, and weight. I have been forced to confront the reality of injustice and am determined to reform the system. Our team is largely comprised of women and people of color who understand the challenges of navigating a health system that was not designed for their benefit. We work to create a safe space for all team members by listening first and protecting our shared values.

As a startup, we have the opportunity to build an equitable organization at our origin rather than course-correcting later on. KH has created educational content and shared stories on our blog and social media platforms on issues that affect BP (e.g the racialized history of healthcare).  We developed an anti-racism guide for startups and advocated for better justice practices within the NC startup ecosystem. We center our community and continually work to hear them and serve their needs.

Despite our early stage, it is important to keep our ethics and justice (including DEI) goals at the forefront.  Our next step are to find an ethical bank (ideally owned by people pf color and focused on community investment) and evaluate investors with which we have value alignment. As we go through clinical validation and regulatory approval, we will grow our team. During that time, we will build transparent hiring and diverse candidate recruitment and interview practices to ensure fairness. As we commercialize our technology and begin to generate revenue, we plan to implement CEO wage caps because CEO wages are big contributor to wealth and income inequality, and we value labor equity. These steps are likely to change as our company develops, but it is important to plan and include checkpoints to evaluate progress and adherence to justice values as this is an iterative process. KH will benefit from guidance in developing policies, practices, and checkpoints as we work to integrate a culture of justice into our business.

There are a number of different avenues through which one can get entrepreneurial support and education, and I have even had the opportunity to take advantage of some of these. However, there were a couple things missing from those experiences. Firstly, I'm seeking community, particularly from other founders that both prioritize impact and are from the communities they are serving, who may not share my exact experiences, but understand my journey. Additionally, I am trying to run a venture that, despite being a biotech company, is foremost focused on health justice. I need support and guidance in building a company that is thoroughly ethical, has a sustainable business model, but also had the ability to attract investors or the alternative resources necessary to build and launch our product. KH also needs help navigating a commercialization plan with consideration to reimbursement, regulatory strategy, and access to care. Solve is the ideal opportunity to grow as a founder and build my business without losing its integrity.

We look forward to connections to those that provide expertise on our high need areas, such as developing a US reimbursement strategy and engaging regional partners for a global launch. We feedback and support on refining our impact metrics and implementing an iterative approach to developing them. Lastly, we are excited for education that is specific to impact focused organizations and prioritizes people over profit. 

We are interested in mentorship for business and financial development (i.e. navigating medical reimbursement in the US and planning for a global launch), resources for R&D (e.g. financial resources, access to clinical centers, partnerships with clinicians and manufacturers), and access to an experienced network for support in developing impact metrics and seeking FDA approval. 

We intend to partner with clinicians to conduct the clinical validation of our product as a part of the regulatory process. Partnership with a reproductive health center can aid us in achieving this goal. We would like to reach additional physician-users through partnerships with these key opinion leaders and the support of organizations such as the American College of Obstetrics and Gynecology and the Preeclampsia Foundation.

We have been able to utilize many university networks to advance our work both by providing internships and experiential course projects and via general entrepreneurial support. We are interested in additional university partnerships.

We intend to partner with the Diagnostic Consulting Network for support in optimizing our prototype.

If there are MIT faculty members of Solve Member working in overlapping problem area, we are interest in partnering to amplify our impact when there is project or organizational fit. 

Preeclampsia is the second leading cause of maternal mortalities globally and in the US and it affects Black people more often and birthing people of color with greatest severity. Though KH is designing a health tech product, our work and values align best with those of impact organizations. We want to integrate building a product into the big picture of developing a health justice organization. We aim to create a company that is holistically just and ethical. 

We want develop a health justice company that leverages technology to improve access to care and health outcomes, esp. for people of color. We work to move society towards a world where people can exist freely and have all of their needs met rather than one in which life is good for a few at the expense of the vast majority of others. 

Our team is dedicated to making our product and our vision a reality because of our core beliefs. We are eager to learn and coachable, but our commitment to health equity means that we won’t compromise our values. We are aware of our strengths and the gaps in our knowledge and are comfortable turning to those more experienced for guidance. The Robert Wood Johnson Foundation Prize will not only support our product development efforts but will be used towards ensuring people have access to both the Kal-PDx and a healthcare network. Our team is the right team for the RWJ Foundation Prize because we are diligent and conscientious.

Kalia Health is uniquely positioned for the Innovation for Women Prize, as we are developing a tool for women and birthing people made by women.

Preeclampsia is the second leading cause of maternal mortalities globally and in the US and it causes over 800 maternal deaths every day. Though our company is designing a health tech product, our work and values align best with those of impact organizations. We want to integrate building a product into the big picture of developing a health justice organization. We aim to create a company that is holistically just and ethical. We want to develop a health justice company that leverages technology to improve access to care and health outcomes, esp. for women and birthing people of color.

Our team is dedicated to making our product and our vision a reality because of our core beliefs. We are eager to learn and coachable, but our commitment to health equity means that we won’t compromise our values. We are aware of our strengths and the gaps in our knowledge and are comfortable turning to those more experienced for guidance. The Innovation for Women Prize will support the development of our life-saving reproductive health product, and it will be used towards ensuring that both high risk and vulnerable populations of women have access to the Kal-PDx and a provider with whom they can follow up. Our team is the right team for the Innovation for Women Prize because we are diligent and conscientious.