Julieta

Our device is able to detect healthy and unhealthy tissues using AI as a way to identify women that may be at risk of breast cancer. With this tool, we can we offer all women an alternative screening that can truly be available everywhere. As a result, it will prioritize those women who are at risk of breast cancer so they can be properly diagnosed and treated.

We are extremely proud of this training and investigation process, it is a process that we carry out with one of the largest insurance companies in Colombia, Sura. Thanks to them we have been able to carry out research with more than 900 patients, in 4 different hospitals in two cities in the country and we have achieved an accuracy of our device of 92%.

Just as we have been rigorous in our research, we have been rigorous in our team formation because we understand the responsibility that our project has in our hands. That is why we have combined a research team, mechanical and electronic engineering and artificial intelligence to bring this solution to life.

It is with this team that we have been able to make a transition from a research project to a business model, because we are also aware that such a solution, if it is not profitable, will not be truly scalable or sustainable over time. So we have designed a business model in which we relieve our users of the burden of purchasing hardware and turn our device into a scalable service. Our innovative model is hardware as a service and we only charge for the readings performed. Rather than selling the device, these are lended to the healthcare providers, which allows us to maintain control of the devices to guarantee the quality of the operation and the readings, and also of the patient information that we also use to continue learning from them, improving our technology and developing alternative solutions.

Breast cancer has a survival rate of 90% when diagnosed in early stages, but despite this encouraging figure, it is the leading cause of death by cancer in women. This increase in mortality occurs mainly due to late detection due to lack of access to diagnostic tests that, despite being excellent detection alternatives, have high access barriers that limit their availability. Mainly the high costs of acquiring the devices, the requirements for infrastructure and specialized personnel to perform the readings, the fact that many emit radiation and therefore limit the population that can be exposed to them and that they are extremely uncomfortable and painful for women. The sum of these barriers is so great that in Colombia, for example, less than 5% of women end up having recurrent and preventive exams.

We designed a portable device, which eliminates all current access barriers to provide women with a test that can truly be performed from anywhere.

Our device is able to detect healthy and unhealthy tissues using AI as a way to identify women that may be at risk of breast cancer. With this tool, we can we offer all women an alternative screening that can truly be available everywhere. As a result, it will prioritize those women who are at risk of breast cancer so they can be properly diagnosed and treated.

We are extremely proud of this training and investigation process, it is a process that we carry out with one of the largest insurance companies in Colombia, Sura. Thanks to them we have been able to carry out research with more than 900 patients, in 4 different hospitals in two cities in the country and we have achieved an accuracy of our device of 92%.

Just as we have been rigorous in our research, we have been rigorous in our team formation because we understand the responsibility that our project has in our hands. That is why we have combined a research team, mechanical and electronic engineering and artificial intelligence to bring this solution to life.

It is with this team that we have been able to make a transition from a research project to a business model, because we are also aware that such a solution, if it is not profitable, will not be truly scalable or sustainable over time. So we have designed a business model in which we relieve our users of the burden of purchasing hardware and turn our device into a scalable service. Our innovative model is hardware as a service and we only charge for the readings performed. Rather than selling the device, these are lended to the healthcare providers, which allows us to maintain control of the devices to guarantee the quality of the operation and the readings, and also of the patient information that we also use to continue learning from them, improving our technology and developing alternative solutions.

Breast cancer is a formidable global health challenge, particularly prevalent in Latin America, where its impact is amplified by disparities in survival rates and limited access to early detection methods. In Latin America, the overall five-year survival rate for breast cancer stands at approximately 70%, a troubling statistic that falls below the European Union's benchmark of 80%. This discrepancy is predominantly atributed to the unfortunate prevalence of late-stage diagnoses, which substantially diminish the chances of successful treatment. Paradoxically, when breast cancer is identified early, the five-year survival rate for women in the region soars to an impressive 99%, underscoring the pivotal role of timely detection in mitigating the disease's impact.

Alarming statistics indicate that between 30% and 40% of breast cancer cases across Latin American countries are diagnosed at metastatic stages III and IV, signifying an urgent need for enhanced screening and diagnostic strategies. This urgency is exemplified in countries like Mexico, Colombia, and Peru, where the incidence of late-stage diagnoses escalates to a staggering 40-50%, according to data presented at a significant event in Sao Paulo, Brazil, attended by esteemed oncologists, healthcare experts, pharmaceutical leaders, patients, and prominent journalists from the region. Despite the well-established benefits of mammography in reducing breast cancer mortality, Latin America grapples with insufficient access to this gold standard screening method. The World Health Organization (WHO) recommends that 70% of the target population undergo mammograms for meaningful impact on mortality reduction. However, recent studies indicate that none of the Latin American countries examined even come close to this recommended threshold, with countries like Colombia, Chile, Costa Rica, and Argentina reporting alarmingly low screening rates, and Mexico facing particularly daunting challenges with a mere 22% coverage. Furthermore, this study highlighted a severe shortage of mammography equipment in Latin America, with up to 20% of existing machines requiring essential repairs. These limitations exacerbate the issue of accessibility, hindering the region's ability to provide timely and effective breast cancer detection.

This problem delves into the multifaceted challenges surrounding breast cancer in Latin America, emphasizing the critical importance of early detection and the pressing need for improved screening infrastructure. Despite the impressive 90% survival rate when breast cancer is diagnosed early, it remains the leading cause of death in women worldwide, underscoring the critical role of early diagnosis in saving lives. It also examines the barriers that impede women's access to screening, including factors like lack of facilities, long travel distances, prohibitive costs, limited information, misconceptions, discomfort, and pain. Collectively, these factors present significant obstacles between Latin American women and the potentially life-saving breast cancer screening tests they need. Access to screening exams is crucial for early detection and should not be limited to large cities, as it currently is.

Breast cancer is currently associated with highest number of mortalities for women by any cancer. According to theAmerican Cancer Society, aproximately 13% of women (1 in 8) will be diagnosed with invasive breast cancer during their lifetime.

Just as we have been rigorous in our research, we have been rigorous in our team formation because we understand the responsibility that our project has in our hands. That is why we have combined a research team, mechanical and electronic engineering and artificial intelligence to bring this solution to life.

● Valentina Agudelo Vargas – Co-Founder and CEO, leading the project's strategy.
● Cristina García – Co Founder and Chief of Staff. In charge of day-to-day operations at Salva and team coordination.
● Jorge Correa – CTO. Head of Technological Architecture.
● Ana Milena Herrera – Chief Medical Officer. Designs complete research protocols related to technological development (preclinical) and clinical performance evaluation studies of the device.
● Sergio Lopez – Biomedical Engineer. In charge of the medical validation of the device logic, supervision of regulatory processes, and definition of research scope.
● Juan Sebastián Uribe – Mechanical Engineer. Along with his team at HyS
Automation and Control SAS, responsible for the electronic design of the device and its firmware.
● Daniel Cano – AI Engineer. Designs the neural network for reading and interpreting device results. Additionally, responsible for programming the user interaction platform.
● Andrés Agudelo – Mechanical Engineer. Provides continuous support in the
development of the Julieta device.
● Santiago Moreno – Physical Engineer. Responsible for designing the structure of databases and ensuring information quality and security to meet ISO and Hippa Compliance standards.
● Simón Polanía – Product Engineer. Responsible for product design, assembly, and primarily design of the device.
● Tomás Gaviria – Product Engineer. Development of the device’s concept through 2D sketches.

Additionally, we have legal advice from the Gomez Pinzon firm, contracts for project development with Qara Medical regarding INVIMA sanitary registration, and BVS Lab for hardware quality certification.
The strategic direction of the project is led by Valentina Agudelo and a board of advisors, including three investors and the manager of Medicarte.

From the beginning, we have collaborated with Sura, one of the largest insurance companies in Colombia, for the research development, and more recently, for defining the business model. This partnership has allowed us to validate, firsthand, a significant portion of our idea with what will be one of our main clients (at least in the short term).

The training process we conducted was carried out with one of the largest insurance companies in Colombia, Sura. We have been able to conduct research with over 900 patients in four different hospitals in two cities in the country, achieving a device accuracy of 92%.
● Specificity: 92%
● Sensititivity: 91%
● Outcomes: “Healthy” or “At risk”

We have utilized this data to understand how we can continue improving our design to provide a better experience for patients. The value of Sura’s investment in our research is estimated at $ 200.000 USD at the moment and will be doubled in the coming months with a new study that we will launch in February 2024.

This agreement in no way gives Sura intelectual property rights over our developments, all copyrights, patrimonial rights and ownerships are property of Salva Health and Julieta.
In our first year of commercialization, we estimate conducting 60,000 tests in
collaboration with Sura as part of a previously agreed-upon commercial pilot.
During this training stage, we have been able to validate the need for the device in the market. This is due to our interaction with patients who have shown significant interest in the presented device, as it offers a completely different experience compared to the one they undergo during any type of screening.
Having the firsthand perspective of our client (insurance company) and our beneficiary (patient), we have affirmed the viability of our business.

We are applying to MIT Solve to leverage its comprehensive ecosystem and diverse network in addressing challenges inherent in our breast cancer screening solution. Beyond financial assistance, MIT Solve offers a wealth of resources including expert guidance, capacity-building workshops, and access to a wide array of partnerships. By collaborating with Solve, we aim to enhance the technical robustness of our solution, navigate intricate regulatory landscapes, and ensure cultural resonance across diverse communities.

Through partnership with MIT Solve, we envision fortifying our technological infrastructure, fostering regulatory compliance, and deepening our understanding of cultural nuances. Solve's extensive network and expertise provide an unparalleled opportunity to propel our solution forward, enabling us to overcome barriers and realize our goal of equitable access to breast cancer screening worldwide.

We are aware that breast cancer is a public health priority worldwide and because of it, there are other startups developing alternative solutions for early detection. However, this is not a source of worry but of pride for us. The way we see it, when it comes to health, the more the better.

Our competitive advantage is our mission of reaching women in remote and rural areas. This mission comes with it's own challenges, but we were able to develop a device that is fully automated and doesn't require internet connection. At the moment we aren't aware of any other initiatives that have developed a device and a business model that can successfully reach remote rural areas in this same way.
What we understood about the business that other don’t is that this is a global problem of public health and that our device had to be developed in a way that is could be available for everyone, anywhere. This is not a premium product, this is a global product.
Furthermore, the competitive edge of our product lies in its cost effectiveness in production and the ability to provide automatic readings for real-time results. Unlike current competitors in the market, our device is cost-effective to manufacture, painless, easy to transport, install, and use. It does not emit radiation and features automatic result interpretation powered by artificial intelligence.

The population of female in Latin America is 251 million people. Out of that population, there were 210,000 cases of breast cancer in 2020. Among those cases, 126,060 were detected late, and since the mortality rate is 70% when detected late, there were 88,242 deaths of women in Latin America who were diagnosed late. This final figure represents the potential number of women we can save with Julieta through early detection of abnormalities in breast tissue.

Strengthen the capacity of all countries, in particular developing countries, for early warning, risk reduction and management of national and global health risks

Electric bioimpedance is one of the methods developed to estimate body composition. It is based on the resistance of cells, tissues, or body fluids to the passage of an electric current.

We fed our algorithm with an extensive database of impedance measurements compared to a mammogram, resulting in the identification of different patterns between healthy and unhealthy tissues. What experimental data (if any) do you have showing that this would work?

Our device has been trained and validated with over 900 patients in 4 hospitals across 2 different cities in the country, and currently, we have a 92% accuracy in detecting anomalies in breast tissue.

1. Specificity: 92%
2. Sensititivity: 91%
3. Outcomes: “Healthy” or “At risk”

Valentina Agudelo Vargas – Co-Founder and CEO- Full time

●Cristina García – Co Founder and Chief of Staff - Full time
● Jorge Correa – CTO. Head of Technological Architecture. Contractor
● Ana Milena Herrera – Chief Medical Officer. Contractor
● Sergio Lopez – Biomedical Engineer. Contractor
● Juan Sebastián Uribe – Mechanical Engineer. Contractor
● Daniel Cano – AI Engineer. Full time
● Andrés Agudelo – Mechanical Engineer. Full time
● Santiago Moreno – Physical Engineer. Contractor
● Simón Polanía – Product Engineer. Contractor
● Tomás Gaviria – Product Engineer. Contractor

● Santiago Jaramillo - Mechanical Engineer- Full time

● Alejandra Yepez - Biomedical Engineer - Full time

For over 5 years, our project evolved from research to business development. Initially, we focused on validating our device during three years of intense research. Two engineers and an epidemiologist supported Sura during clinical trials, while a nurse assisted patients full-time. Despite a 2-year hiatus due to COVID challenges, we completed research by 2022. Our team expanded to include a medical surgeon with expertise in epidemiology and pathology, mechanical and physical engineers, an AI engineer, a UX-UI designer, and a biomedical engineer.

Our team is the ideal choice for our innovative solution due to multidisciplinary expertise in engineering, biology, and AI. Technical proficiency spans mechanical and biomedical engineering, physics, and AI, ensuring a well-rounded approach. What sets us apart is our healthcare-experienced advisory team, including FDA-approved serial entrepreneurs. Our CEO, experienced in business transformation at PepsiCo and pursuing an MBA at INSEAD, adds commercial expertise. The Chief of Staff contributes vital skills in people and operations management.

Although the purpose of our startup is to have a great social impact, we are aware that our solution will only be scalable and sustainable in the long run if it is backed with a profitable business model.

With this in mind, we have designed a business model that eliminates the costs of acquiring fixed assets for our clients and instead offers our hardware as a service. Our devices are lended to the institutions and we only charge them for the amount of screenings that are done.
The device is placed on loan at the Health Service Providing Institutions, which allows us to maintain control of the devices to guarantee the quality of the operation and the readings, and also of the patient information that we also use to continue learning from them and improving our solutions.
We will start by leveraging insurance companies; currently, we are forming an alliance with Sura in Colombia to use their network of affiliates as a distribution channel. Starting off with a commercial pilot in 3 cities: Bogotá, Barranquilla and Medellín.
Simultaneously, we are seeking to solidify partnerships with various healthcare institutions and NGOS. Entities such as the Colombian Civil Air Patrol and the Red Cross have expressed interest in becoming distribution channels for Julieta to reach places where no entity has been able to establish a presence.
Additionally, we will be reaching out to the high-cost line in Colombia to be categorized as an alternative examination to mammogram when it is not available.
On an international scale, we will be seeking FDA approval by leveraging on our pre-approved INVIMA sanitary registration. With the FDA approval we will expand our registration process throughout LATAM.

To define the price, we analyzed the cost of performing a mammogram in Colombia as a reference point for the willingness to pay for these services. Prices for these services range from $ 25 USD to $ 100 USD and they vary depending on the service contracts that insurance companies have with both healthcare centers and the government.

Given such a broad range, we again decided to leverage our proximity with Sura to narrow our analysis. In their case, providing a mammogram service costs about $ 45 USD.
Taking into account that Sura does over 150k screenings per year, their annual costs can be estimated at $ 6.750.000 USD.
Our starting price is $ 20 USD and can vary with negotiable terms like length of contract and estimated screenings per month.

Comparing their current cost with our price per screening their expense would go from $6.750.000 USD to $ 3.000.000 USD for preventive screenings.
If we were to estimate the real savings for Sura after implementing Julieta we would need to add the expense of the diagnostic mammograms that would be done on the population that we identify as “at risk”. Statistically, this shouldn’t be more than 25% of the population which means they would assume an additional $ 1.687.500 USD on diagnostics mammograms.
In summary, if we take into account the cost of our screening and the cost of further mammogram screenings for the patients successfully identified, the total annual cost of Sura after implementing Julieta would be reduced to $ 4.687.500 USD or 70% of their current expense.