The most promising moment for a mental health intervention might be the one when a patient is least conscious. That is the core, quietly radical premise behind Wakez, a digital health startup from Cluj-Napoca that is attempting to turn the Apple Watch into a regulated therapeutic device. By delivering subtle, AI-guided vibrations during specific sleep stages, the company aims to modulate brain activity in a way that could alleviate symptoms of depression, all without waking the user up [WakeZ Use Cases, retrieved 2026]. It is a bet that places patient burden at near zero, but regulatory and clinical proof at an absolute premium.
Wakez’s journey began in 2017, founded by a group of five medical students [Adevărul, 2019]. The initial product was a smart alarm app focused on general sleep improvement. The clinical pivot came later, crystallizing around the concept of manipulating "REM pressure",a neurobiological mechanism linked to mood regulation. The company’s technical lead, psychiatrist and lecturer Zaki Milhem, now frames the platform as a tool for instant depression subtype diagnosis and real-time treatment via sensor fusion and AI [LinkedIn, retrieved 2026]. This evolution from wellness app to potential medical device defines their current challenge and ambition.
The Therapeutic Wedge
The product’s intervention is deceptively simple. Using a consumer smartwatch, it monitors sleep architecture in real time. Its proprietary AI then decides when to deliver precise haptic stimuli,gentle vibrations meant to alter sleep stages like REM or deep sleep. The claim is that these manipulations can produce an antidepressant effect, leveraging the brain’s natural recovery processes during sleep [Perplexity Sonar Pro Brief, Unknown]. For the patient, the experience is passive; the therapy happens in the background, sidestepping the adherence issues that plague many mental health apps requiring active daily engagement.
Financially, the model is a hybrid. Wakez plans a direct-to-consumer subscription priced between €7 and €10 per month, while also pursuing institutional contracts with mental-health clinics [ZF IT Generation, July 2025]. The recent €1.5 million (approximately $1.61 million) seed round from regional development agency ADR Nord-Vest is fueling this dual-track approach, with the company forecasting revenue of around €450,000 for the coming year (estimated) [ZF IT Generation, July 2025]. Recognition from programs like the EIT Health InnoStars Grand Final has provided early validation, but the path to scale runs squarely through medical device certification.
The Regulatory Hurdle
Wakez’s entire thesis hinges on a regulatory green light. The company has explicitly stated its aim is to register as a medical device in the European Union [ZF IT Generation, retrieved 2026]. This is not a casual formality. Achieving a CE mark under the EU’s Medical Device Regulation (MDR) for a mental health indication would require robust clinical evidence of both safety and efficacy, a process that is costly, time-consuming, and fraught with scrutiny. Without it, Wakez remains a sleep optimization app in a crowded market. With it, the company could unlock prescribing pathways and insurance reimbursement, fundamentally changing its market position.
The competitive landscape reflects this fork in the road. In the consumer sleep and wellness tracker space, giants like WHOOP and a host of other startups measure biometrics but stop short of claiming therapeutic treatment. In the digital therapeutic arena for depression, companies like Flow Neuroscience use transcranial direct current stimulation (tDCS), an active, wake-time treatment with its own clinical backing. Wakez is attempting to carve a unique niche between them: a passive, sleep-time intervention with therapeutic intent.
An Honest Counterfactual
The risks here are significant and layered. The most immediate is the clinical evidence gap. Publicly available, peer-reviewed data supporting Wakez’s specific method of haptic sleep modulation for depression treatment is not yet evident. The regulatory timeline is also a known constraint for early-stage biotechs; delays in certification can drain runway. Furthermore, the consumer subscription model at a low price point must achieve very high volume to become meaningful, especially before any insurance coverage is secured.
Yet, the team’s grounding in medicine is a deliberate asset. Having a practicing psychiatrist like Milhem deeply involved in product development suggests clinical realities are being baked in from the start, not bolted on as an afterthought. The choice to start in Romania, with its respected medical tradition and lower operational costs, may provide a more manageable environment to refine the protocol before tackling larger, more expensive markets.
For patients with major depressive disorder, the current standard of care often involves a difficult balancing act. First-line treatments include antidepressant medications, which can take weeks to show effect and carry side effects, and psychotherapy, which requires significant time, access, and financial commitment. For many, this combination is only partially effective, leading to a cycle of medication adjustments and persistent symptoms. A low-burden, adjunctive therapy that works autonomously during sleep would represent a profound shift in the treatment paradigm, if it can be proven to work.
The next twelve months for Wakez will be defined by a single, binary milestone: the progress of its medical device application. Success would transform a clever app into a novel therapeutic tool, validating its bet on sleep as a treatment vector. The journey from a student project in Cluj-Napoca to a regulated health technology is a long one, but it is a path that begins, quite literally, while the world is asleep.
Sources
- [Adevărul, 2019] Aplicaţia de smartphone menită să manipuleze creierul pentru un somn profund. Doi tineri români au lucrat la proiect
- [LinkedIn, retrieved 2026] Zaki Milhem - WakeZ - hack your sleep | LinkedIn
- [Perplexity Sonar Pro Brief, Unknown] Wakez company overview
- [WakeZ Use Cases, retrieved 2026] Use cases - WakeZ
- [ZF IT Generation, July 2025] Start-up pitch, Start-up-ul deep tech WakeZ a atras 1,5 mil. euro pentru a dezvolta o tehnologie de monitorizare a somnului în timp real
- [ZF IT Generation, retrieved 2026] ZF IT Generation. Start-up pitch, Start-up-ul deep tech WakeZ a atras 1,5 mil. euro pentru a dezvolta o tehnologie de monitorizare a somnului în timp real