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].
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].
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]. 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 [ZF IT Generation, July 2025].
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]. 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. 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.
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. 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. The next twelve months for Wakez will be defined by a single, binary milestone: the progress of its medical device application.