Industrial and commercial development of the digital therapy platform and technologies for monitoring and diagnosing sleep disorders

• Grant number: 25/04433-6
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: August 01, 2025
• End date: July 31, 2027
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Renata Redondo Bonaldi
• Grantee: Renata Redondo Bonaldi
• Associated researchers: Gabriel Natan de Souza Pires ; Iraciana de Lima Nobre Adriano ; Julia Ribeiro da Silva Vallim ; Ksdy Maiara Moura Sousa Werli ; Mariana Cardoso Melo ; Paula Villena Redondo ; Thábita Carneiro Maganete
• Associated research grant: 22/13130-9 - Wearable electroencephalogram band development and integration with a customizable therapeutic software for monitoring and remote treatment of sleep disorders and complaints, AP.PIPE

Abstract

This project aims to drive the industrial and commercial development of the solution created in phases 1 and 2 of PIPE, focusing on the digital therapy platform and technologies for monitoring and diagnosing sleep disorders, under the leadership of Dr. Renata Redondo Bonaldi, CEO and founder of SleepUp. SleepUp is an innovative digital platform that provides effective treatments and monitoring for sleep disorders. It offers digital therapy based on clinically validated protocols for insomnia, in addition to wearable sleep screening and monitoring technologies. The platform uses proprietary algorithms and artificial intelligence, as well as exclusive portable electroencephalogram hardware. Founded with the purpose of democratizing access to sleep health and mental health, SleepUp was the first platform to be registered and approved by ANVISA as a medical software in 2021. Since then, it has been internationally recognized for its high potential for impact and innovation. The proposed solution is widely applicable, offering home monitoring, remote diagnosis, and effective treatment for sleep disorders. With a digital and accessible approach, it addresses a problem that affects approximately 30% of the global population. This positions SleepUp as a disruptive technological innovation with great potential for intellectual property protection and global impact. The company received support in PIPE Phase 1 and is completing PIPE Phase 2. Additionally, it was approved for the FAPESP SEBRAE Supplementation Program for 2023 and 2024 and was selected for FAPESP WEEK ITALY, among other international events. During Phase 1, in 2021, SleepUp developed the technical-scientific proof of concept for the use of wearable technologies for sleep monitoring and staging. In Phase 2, the focus was to enhance the methodology and wearable technology for sleep staging, including the development of an electroencephalogram headband and other sensors, and integrate this technology into the SleepUp app. With more than 20 national and international academic publications, the company has already technically validated its proprietary algorithm and participated in over 15 acceleration and innovation programs, winning 10 awards and making 20 intellectual property filings (brand registrations, software, copyrights, and a patent). Furthermore, the company has excelled commercially, attracting customers both in Brazil and abroad, as well as investors interested in its potential. Now, with the support of PIPE Phase 3, SleepUp is ready to advance its internationalization strategy and complete the industrialization of its solution. The goal is to obtain the necessary regulatory approvals, register more intellectual properties, produce pilot batches, and ensure industrial viability for commercialization in Brazil and global markets. SleepUp aspires to become a global reference in disruptive innovation developed in Brazil, contributing to the training of the local hardware and software industry, while also enhancing local production and creating new employment and economic development opportunities. (AU)