Written report October 2024 Salva Health 1. Women engaged Since we have finilized our AI training trials, we are no longer engaging with patients on a daily basis. Hover, we updated our landing page to include information about selfexamination for breast cancer and contact details for patients. This allows us to interact with patients directly and start building a community around Salva while providing information that can help early detection. Additionally, we’ve defined a proof of concept strategy to validate our product with patients outside of a controlled research environment. The purpose of this validation is to understand our potencial market without depending on insurance companies and our healthcare system in general. Due to political instability in Colombia, we want to focus on private clients and out of pocket payments as well. This validation will begin in late October and it will allow us to reach more women in the coming months. As part of Breast Cancer Awareness month, we are participating in a Forum by Semana Julieta: el revolucionario dispositivo colombiano para detectar el cáncer de mama en poblaciones remotas (semana.com), one of the most read magazines in Colombia. This allows us to gain visibility and continue to engage with our beneficiaries. We are also actively engaging with women via social media to generate awareness and brand presence. Commented [MOU1]: Link al artículo de Semana We were also featured in a Medical Innovation newspaper, we were interviewed on the national radio of education, and we were chosen as one of Tech Crunch’s Top 200 disrupters for their event in late October. This media presence allows us to continue engaging with the community and gain visibility with our key stakeholders. Commented [MOU2]: Link al artículo en la revista médica Next steps: For the next reports (monthly and pre-installment) we expect to quantify the number of women engaged in each initiative. Commented [MOU5R4]: https://techcrunch.com/2024/1 0/04/announcing-the-startup-battlefield-200-attechcrunch-disrupt-2024/ In November we will be featured in another Medical Innovation Newspaper. 2. Regulation approval We require two separate approvals before filling for commercialization approval from INVIMA (FDA equivalent in Colombia): Product validation approval and Medical Device manufacturing permit. For product validation approval we have been working with Sura, one of the biggest insurance companies in Colombia (our research ally and investor). This process requires an additional round of trials that must be preapproved by INVIMA. We are due to present our Commented [MOU3R2]: https://epicrisis.org/pdfviewer/e picrisis-33/ Commented [MOU4]: Link a este anuncio en la página de Tech Crunch most recent AI training results to Sura on the 17th of October for them to finish drafting our proposal of product validation for INVIMA’s approval. If Sura considers that our technology has reached a maturity level that is ready for regulatory validation, they will submit the request to INVIMA before the 25th of October. INVIMA will review our application in their next meeting which should be at the end of November to approve our validation trials. These will begin as soon as we receive the approval, either December or January. These trials evaluate our product’s technical function and usefulness in an unsupervised real clinical environment and should take about 3 months to complete. It is worth mentioning that this process might be delayed due to INVIMA’s current political status. On the other hand, we have made huge progress towards our Medical Device permit. We have already finished formalizing all the required documentation, processes definitions and negotiations with key suppliers. The permit will be issued after INVIMA visits our manufacturer on October 24th and 25th as they will evaluate the space that we have selected for our manufacturing. Once we have achieved both approvals, we will be able to file for a fast-track commercial approval to be issued. This fast-track grants us permission to sell our product/service to the public and only takes 15 business days to be granted. After that, they INVIMA will have 6 months to review our processes and, if they see necessary, cancel our approval. For this entire process we have hired a consulting firm that specialized in INVIMA regulations, and we have also been reviewing all the necessary documentation with Sura. Additionally, we have been researching the FDA’s Breakthrough Device Program that could allow us to fast-track our approval. Next steps: Commented [MOU6]: Link a esta información Commented [MOU7R6]: https://www.fda.gov/medicaldevices/how-study-and-market-yourdevice/breakthrough-devices-program#s3 Based on the INVIMA’s visit to our manufacturer, we will continue to improve our processes and negotiations with suppliers. Based on Sura’s review of our most recent results we will file for final product validation in November. 3. Commercial launch Sura (insurance company) is allowing us to go through a “sales process trial” with them in order to gain experience of how to sell our product directly to insurance companies and healthcare providers. This experience allows us to further understand the technical and commercial requirements of our customers and to gain experience in how long the process of gaining a big client can be. Our first meeting was held with the director of product acqusitions from Sura’s healthcare provider centers. Commented [MOU8]: Adjuntar presentación comercial Additionally, in September we held two meetings with publishers for our research. We want to write articles about the research that we have done on our device in order to gain validation from the medical sector which will help us gain trust and traction with key stakeholders. Next steps: In the next months, following our regulatory advancements due in October, we will begin building our commercial pipeline with potential clients that have already shown interest in our service. Keep in mind that these conversations have been very high level and there has been no formal commitments from any institution, we require INVIMA approval to formalize any commercial agreements. Potential clients that have shown interest: • Sura o Insurance: 2.500.000 women affiliated o Healthcare centers: 215.000 mammogram screenings annually • Profamilia: 60 healthcare centers in Colombia • Comfama: 49 healthcare centers in Colombia • Alianz Salud Insurance: 1.840.000 women affiliated • Colmédica Insurance: 115.000 women affiliated • Town Hall of Cundinamarca: 20.000 women Additionally, we will continue our “sales process trial” with Sura, based on the most recent training results that we will present in October, we will define the product’s usefulness in the market which will allow us to resize our market opportunity and define the selling strategy further. We will also continue exploring alternatives to publish our research, both independently and with Sura as our research ally. 4. Product development a. AI Algorithms We are creating a “risk assessment” variable that takes into account other information from the patient (age, sex, breast cancer personal history, family history, breast size, menopause, time of your first pregnancy, obesity (estrogen level), etc). This variable allows us to add a “probabilistic” factor to our interpretation of the screenings done with our device. We are also working on identifying the location of the detected anomalies and whether they are have any indicators of malignancy. This will allow our screening result to be even more precise and usefull for patient priorization in a rural environment. Commented [MOU9]: Verificar variables categóricas que está usando Maria en el evaluador de riesgo Commented [MOU10R9]: Validar con Sergio si habría forma de “mostrar” algo de esto Commented [MOU11]: Foto del diseño del mapa de calor que había hecho Andrés para ubicar las anomalías b. Software Our User interface is now available online and offline which improves it’s usability in remote areas. We have also created user profiles on our interphase to store additional patient data directly, instead of depending on external applications. Commented [MOU12]: Foto de la info de contacto de usuarios que estamos guardando en la PWA We also made general improvements in our data transfer from the device to our user interphase and we were able to reduce our screening time from 5 minutes to 2.5 minutes. Currently we are working on a dashboard that allows our clients to view the screening results of their patients directly in our interphase which will facility monitoring of our devices. Commented [MOU13]: Foto del dashboard que mandé c. Hardware We made improvements on the case of our device have been made to make it more resistant to falls and minor alterations as well as adapting it to our new printed circuir board design that we received recently and are currently testing as well as with a new battery that will improve it’s usability and durability. Additionally, we are making some changes on our accessories which include shortening the cables so they don’t get tangled, resizing of our calibration test, improving our placement board, finishing our user manual and evaluating new materials for our electrode distribution systems. Next steps: In the next months we will be focused on developing our user interface to include more profiles for administrators and dashboards. We will also focus on error validation during screenings and visual inspection of the durability of our devices. Finally, we will be evaluating if there are any compatibility issues with our device and pacemakers to determine if we can include patients with heart conditions in our screenings. Continuous improvement of our algorithms and results presentation. Commented [MOU14]: Foto de la nueva PCB Commented [MOU15]: Foto de la caja de distribución y del bicho completo en la caja plástica Commented [MOU16]: Foto de la tarjeta de validación Commented [MOU17]: Foto de las estrellas que estamos probando
