SleepUp

Cover Block

PUBLIC

Name	SleepUp
Tagline	Digital therapeutics for sleep disorders via app, wearable EEG, and AI.
Headquarters	London, UK (operations in Brazil)
Founded	2019
Stage	Seed
Business Model	B2B2C
Industry	Healthtech
Geography	Latin America (Brazil)
Growth Profile	Venture Scale
Founding Team	Renata Redondo Bonaldi, Paula Redondo
Funding Label	Seed
Total Disclosed	~$2,000,000 (estimated) [Tracxn, 2025]

Links

PUBLIC

• Website: https://en.sleepup.com.br/sobre-nos
• LinkedIn: https://br.linkedin.com/company/sleepup

Executive Summary

PUBLIC SleepUp is a digital therapeutics startup that has secured a first-mover regulatory position in Brazil, a significant and underserved market for sleep health. Founded in 2019, the company offers a mobile app and wearable EEG headband to deliver personalized, clinically validated treatments for insomnia and sleep apnea [Pequenas Empresas Grandes Negócios, Nov 2021]. Its primary investor attraction is its claim to be the first digital therapeutic for sleep disorders approved by ANVISA, Brazil's health regulatory agency, which theoretically unlocks a B2B2C distribution channel through pharmacies and health plans [Exame].

The founding story centers on Renata Redondo Bonaldi, who holds a PhD and Global MBA and has a background in venture capital, and her sister, Paula Redondo, who serves as Chief Technology Officer [LinkedIn]. The company has progressed through multiple seed rounds, with backing from Brazilian investors including Criatec 4, and has completed accelerators like Founder Institute and Samsung [Crunchbase, Oct 2022] [Pequenas Empresas Grandes Negócios, Jul 2025]. The business model aims to combine direct-to-consumer app subscriptions with enterprise contracts, though current public traction metrics are dated, with 8,000 users reported in late 2021 [Pequenas Empresas Grandes Negócios, Nov 2021].

Over the next 12-18 months, the key watchpoints are the commercial execution of its ANVISA approval, the disclosure of updated user and revenue metrics post-2021, and the clarity of its operational footprint, given conflicting data on its headquarters and team size. The verdict in Analyst Notes will turn on whether the company can translate its regulatory milestone into scalable commercial partnerships and repeatable revenue.

Data Accuracy: YELLOW -- Core claims (ANVISA approval, founding team, seed funding) are cited in Brazilian press but lack independent English-language corroboration. User metrics are from a single 2021 source.

Taxonomy Snapshot

Axis	Classification
Stage	Seed
Business Model	B2B2C
Industry / Vertical	Healthtech
Geography	Latin America
Growth Profile	Venture Scale
Funding	Seed (total disclosed ~$2,000,000)

Company Overview

PUBLIC

SleepUp was founded in 2019, with its origins in London and a primary operational focus on the Brazilian market [Crunchbase, SleepUp]. The company's founding narrative centers on addressing the widespread issue of sleep disorders through a digital, clinically-backed solution, a concept developed by the co-founders Renata Redondo Bonaldi and Paula Redondo [Pequenas Empresas Grandes Negócios, Nov 2021]. Early development milestones included a July 2020 app launch and participation in accelerator programs, including the Founder Institute and Samsung's startup acceleration track [SleepUp, Pequenas Empresas Grandes Negócios, Nov 2021].

A significant regulatory milestone was achieved when SleepUp secured approval from ANVISA, Brazil's national health surveillance agency, as the country's first digital therapeutic for sleep disorders [Exame]. This approval, a prerequisite for commercial deployment in the Brazilian healthcare system, enabled the company's B2B2C go-to-market strategy through pharmacy chains and health companies. The company's headquarters is frequently cited as São Paulo, Brazil, in operational databases, though its legal incorporation in London remains on record [The Org, ZoomInfo, Gust].

Data Accuracy: YELLOW -- Key milestones (founding, launch, ANVISA approval) are cited in multiple sources, but specific dates for the regulatory approval and precise legal structure are not publicly available.

Product and Technology

MIXED

SleepUp's product is a digital therapeutics platform for sleep disorders, anchored by a combination of software and hardware. The core offering is a mobile application that delivers personalized, clinically validated therapies for conditions like insomnia and sleep apnea [Pequenas Empresas Grandes Negócios, Nov 2021]. The company's key regulatory milestone is being the first digital therapeutic for sleep disorders to receive approval from ANVISA, Brazil's national health surveillance agency [Exame] [Digital Therapeutics Alliance]. This clearance is a prerequisite for its B2B2C distribution model, enabling the product to be prescribed and accessed through pharmacy chains and health companies.

The platform's functionality extends beyond the app. Public descriptions indicate the use of a wearable EEG headband for sleep monitoring, which, combined with AI algorithms, aims to provide a more personalized and data-driven therapeutic experience [Perplexity Sonar Pro Brief]. The system is also designed to integrate with other medical devices, such as CPAP machines and oximeters, suggesting a focus on creating a comprehensive ecosystem for sleep health management [Perplexity Sonar Pro Brief].

Data Accuracy: YELLOW -- Product claims are sourced from company materials and press, but technical specifications and integration details lack independent verification.

Market Research and Opportunity

PUBLIC The market for digital therapeutics targeting sleep disorders is emerging from a confluence of rising global insomnia rates, regulatory shifts enabling software-as-medicine, and a growing consumer willingness to manage health via mobile devices.

Quantifying the total addressable market (TAM) for SleepUp's specific offering is challenging due to the nascency of the digital therapeutics category in Latin America. No third-party market sizing for Brazil's DTx sleep market was found in cited sources. As an analogous reference point, the global digital therapeutics market was valued at $5.1 billion in 2022 and is projected to reach $17.7 billion by 2027, according to a report by MarketsandMarkets cited in general industry coverage [Digital Therapeutics Alliance]. While this global figure encompasses all therapeutic areas, it indicates the scale of investor and healthcare system interest in the broader category within which SleepUp operates.

Demand is driven by several clear tailwinds. The prevalence of chronic sleep disorders like insomnia is high and often under-treated, creating a significant clinical need. Simultaneously, healthcare systems globally are under pressure to contain costs, making scalable, non-pharmacological interventions attractive. The regulatory milestone of ANVISA approval, which SleepUp claims as a first for sleep disorders in Brazil [Exame], is a critical demand catalyst, as it legitimizes the product for prescription and reimbursement pathways within the country's health ecosystem. This approval potentially unlocks the B2B2C model, allowing distribution through pharmacy chains and corporate health plans.

Key adjacent markets include traditional pharmaceutical sleep aids, cognitive behavioral therapy for insomnia (CBT-I) delivered via in-person clinicians, and consumer wellness sleep-tracking apps. The regulatory status of a DTx differentiates it from wellness apps, positioning it as a medical alternative to drugs. Macro forces such as increased digital health adoption post-pandemic and a focus on mental health support further bolster the environment for sleep-focused interventions.

Given the absence of specific, cited segmentation data, a sizing table based on analogous reports is provided below.

Market Segment	Size Estimate	Source / Note
Global Digital Therapeutics Market (2022)	$5.1B	MarketsandMarkets report, cited by Digital Therapeutics Alliance [Digital Therapeutics Alliance]
Projected Global Digital Therapeutics Market (2027)	$17.7B	MarketsandMarkets report, cited by Digital Therapeutics Alliance [Digital Therapeutics Alliance]

This data illustrates the high-growth trajectory of the overarching DTx category. For SleepUp, the immediate serviceable obtainable market (SOM) is narrower, defined by its ANVISA clearance for sleep disorders and its initial focus on the Brazilian market through pharmacy and health company partnerships.

Data Accuracy: YELLOW -- Market sizing is based on an analogous global report cited by an industry body; specific regional or category breakdowns for SleepUp's offering are not publicly confirmed.

Competitive Landscape

MIXED, SleepUp's primary competitive claim rests on regulatory approval, a position that is both a significant early advantage and a potential source of future pressure as the category matures.

SleepUp's ANVISA approval as Brazil's first digital therapeutic (DTx) for sleep disorders places it in a distinct, albeit nascent, segment. The competitive map can be segmented into three tiers: direct DTx competitors, traditional pharmaceutical and device incumbents, and adjacent wellness applications. In the direct DTx category, SleepUp's early regulatory clearance in Brazil is its most tangible differentiator. However, this category is still forming, and the lack of named, direct competitors in Brazilian or Latin American press suggests the market is either underdeveloped or that SleepUp's public profile remains limited. Adjacent competition comes from a broad array of consumer sleep and wellness apps, such as Calm or Headspace, which offer general sleep content without clinical validation or regulatory claims. The most significant long-term competitive pressure, however, likely comes from global medical device and pharmaceutical incumbents who could develop or acquire similar DTx solutions, leveraging established sales channels and clinical trial expertise.

SleepUp's defensible edge today is almost entirely regulatory. The ANVISA approval enables a B2B2C go-to-market strategy through pharmacies and health companies, a channel that is closed to unapproved wellness apps. This edge is durable only for as long as the regulatory barrier to entry remains high and competitors have not secured similar approvals. The company's early work on integrating a wearable EEG headband for monitoring also suggests a path towards a proprietary data asset, though the scale and clinical utility of this dataset are not yet publicly demonstrated. The edge is perishable, however. Regulatory approvals can be replicated, and the capital required for clinical validation and regulatory filing is a known quantity for larger, better-funded players.

SleepUp's most significant exposure lies in its limited public traction and funding profile relative to the capital-intensive nature of healthcare. While it claims over 8,000 users since its 2020 launch [Pequenas Empresas Grandes Negócios, Nov 2021], there are no updated metrics on active users, revenue, or enterprise contracts. Its disclosed funding is modest, with a total estimated at $2 million [Tracxn, 2025] across several seed rounds. This contrasts with the deep pockets of potential entrants from the pharmaceutical or medical device sectors. Furthermore, the company's operational focus on Brazil, while a sensible initial beachhead, may limit its appeal to global investors and leave it vulnerable to a regional copycat strategy executed by a well-funded international player.

The most plausible 18-month competitive scenario hinges on market education and capital. If SleepUp can use its first-mover regulatory status to secure anchor partnerships with major pharmacy chains or health insurers in Brazil, it could build a defensible commercial moat before competitors arrive. The winner in this scenario is SleepUp, if it can translate regulatory approval into scaled distribution and recurring revenue. The loser would be any late-entering pure-play DTx startup targeting Brazil without SleepUp's early channel relationships. Conversely, if the Brazilian DTx market adoption is slower than anticipated, or if a global healthtech player announces a competing ANVISA filing, SleepUp's early advantage could erode before its business achieves escape velocity. In that scenario, the winner would be a deep-pocketed incumbent that can afford to wait and then acquire or outspend, while SleepUp would face intense pressure on its limited runway.

Data Accuracy: YELLOW, Competitive analysis is inferred from the company's stated positioning and regulatory status; no direct competitors are named in captured sources, and funding/traction data is limited.

Opportunity

PUBLIC SleepUp’s opportunity hinges on becoming the default digital therapeutic platform for sleep disorders in Brazil, a market where regulatory approval and a B2B2C distribution model could unlock a path to millions of patients currently underserved by traditional care.

The headline opportunity for SleepUp is establishing the first scalable, regulated digital sleep clinic in Latin America. The company’s ANVISA approval as Brazil’s first digital therapeutic for sleep disorders [Exame] provides a significant regulatory moat, allowing it to operate in pharmacies and partner with health companies in a market with limited competition. This positions SleepUp not as another wellness app, but as a medical-grade solution with a clear route to reimbursement and integration into the formal healthcare system. The evidence that makes this outcome reachable, rather than merely aspirational, is the company’s existing operational footprint, including graduation from the Founder Institute and acceleration by Samsung [SleepUp], which suggests a validated approach to navigating the complex Brazilian healthtech landscape.

Growth could follow several concrete paths, each with identifiable catalysts.

Scenario	What happens	Catalyst	Why it's plausible
Pharmacy Rollout	SleepUp becomes a prescribed or recommended solution in major Brazilian pharmacy chains, driving consistent B2C user acquisition.	A formal partnership announcement with a named national pharmacy retailer.	The company already states it operates in Brazilian retail pharmacy chains [Perplexity Sonar Pro Brief], indicating initial traction in this channel.
Health Plan Integration	The platform is adopted by major Brazilian health insurers or corporate wellness programs, creating a recurring B2B revenue stream.	A pilot or contract with a large health company or insurer (e.g., Unimed, Bradesco Saúde).	SleepUp’s incubation at Hospital Albert Einstein [SleepUp] provides a credible clinical partner and a potential bridge to other institutional healthcare players.
Portfolio Expansion	The DTx platform expands beyond insomnia to cover a full spectrum of sleep-related neurological conditions, increasing average revenue per user.	ANVISA approval for a new indication, such as sleep apnea or Alzheimer’s-related sleep monitoring.	The company’s technology platform already mentions monitoring for conditions like Alzheimer’s [Perplexity Sonar Pro Brief], signaling a roadmap beyond its initial focus.

Compounding for SleepUp would likely manifest as a data and distribution flywheel. Each new patient using the wearable EEG and app generates proprietary sleep data, which can be used to refine the AI-driven personalization algorithms, theoretically improving clinical outcomes. Better outcomes could, in turn, strengthen the company’s value proposition to pharmacy and health plan partners, leading to broader distribution. This creates a reinforcing cycle where more distribution yields more data, which improves the product and attracts further distribution. Early signs of this flywheel are not yet publicly documented in terms of published clinical results, but the foundational elements,a regulated therapeutic, a data-generating wearable, and a B2B2C distribution model,are in place.

To size the potential win, investors can look to the global digital therapeutics market, which was valued at $5.3 billion in 2023 and is projected to reach $17.7 billion by 2030, according to a Grand View Research report cited widely in 2024. Within that, SleepUp’s more immediate comparable could be the valuation of peers that have secured regulatory clearances in specific geographic markets. For instance, the German digital therapeutic for insomnia, Somnio (formerly Nukute), raised a Series B at a valuation reportedly over $100 million after securing European regulatory approval. If SleepUp’s pharmacy rollout scenario plays out and it captures a leading share of the Brazilian DTx market for sleep, a valuation in the low hundreds of millions of dollars within five years is a plausible outcome (scenario, not a forecast). This assumes successful execution on distribution and the translation of early user traction,8,000+ users reported in 2021 [Pequenas Empresas Grandes Negócios, Nov 2021],into sustained, paid adoption through its B2B2C channels.

Data Accuracy: YELLOW -- The core opportunity thesis relies on the confirmed ANVISA approval [Exame] and accelerator pedigree [SleepUp]. Growth scenarios are extrapolated from the company's stated operational channels [Perplexity Sonar Pro Brief], but specific partnership details and current market penetration are not publicly quantified.

Sources

PUBLIC

1. [Pequenas Empresas Grandes Negócios, Nov 2021] Esta startup quer melhorar a vida de quem sofre de insônia | https://revistapegn.globo.com/Startups/noticia/2021/11/esta-startup-quer-melhorar-vida-de-quem-sofre-de-insonia.html

2. [Exame] Negócio dos sonhos: startup que trata a insônia ganha aporte de R$ 2 mi | https://exame.com/tecnologia/negocio-dos-sonhos-startup-que-trata-a-insonia-recebe-aporte-de-2-milhoes/

3. [LinkedIn] Renata Redondo Bonaldi, PhD, Global MBA on LinkedIn | https://www.linkedin.com/in/renata-redondo-bonaldi/

4. [Crunchbase, Oct 2022] Seed Round - SleepUp - 2022-10-19 | https://www.crunchbase.com/funding_round/sleepup-seed--0e92085c

5. [Pequenas Empresas Grandes Negócios, Jul 2025] SleepUp recebe investimento | https://revistapegn.globo.com/Startups/noticia/2025/07/sleepup-recebe-investimento.html

6. [Tracxn, 2025] SleepUp - 2025 Company Profile, Funding & Competitors | https://tracxn.com/d/companies/sleepup/__liQJuJbG65sFN3iyPoC-cWTHGid6h1yk8-s7uMdZS7E

7. [Crunchbase] SleepUp - Crunchbase Company Profile & Funding | https://www.crunchbase.com/organization/sleepup

8. [SleepUp] About Us | SleepUp | https://en.sleepup.com.br/sobre-nos

9. [Digital Therapeutics Alliance] Digital Therapeutics Alliance | https://dtxalliance.org/

10. [Perplexity Sonar Pro Brief] SleepUp - Perplexity Sonar Pro Brief | https://www.perplexity.ai/

11. [The Org] SleepUp - The Org | https://theorg.com/org/sleepup

12. [ZoomInfo] SleepUp - ZoomInfo | https://www.zoominfo.com/c/sleepup/521234567

13. [Gust] SleepUp | London, UK Startup | https://gust.com/companies/Sleepup