Company
In development · Pre-CE · Targeting Class I DiGA

A clinical company building the part of recovery
nobody does.

We are building a DiGA designed around the addiction therapy waitlist — a population no other listed product treats as its primary user. We work with the institutions that set the standard, and hold ourselves to the same bar.

How we work

Working with the institutions
that set the German standard.

Our collaborators span academic psychiatry, affective science, digital health methodology, and regulatory affairs. We will name them when the formal partnerships are in place.

Academic psychiatry
Validation study design and clinical oversight
Affective science
Emotion regulation and intervention methodology
Digital health research
Outcome measurement and trial methodology
Regulatory affairs
MDR pathway and the DiGA-Verzeichnis listing process
Principles

Three commitments
that decide every product call.

Clinical mechanisms, not engagement tricks

Affect labeling. Urge surfing. Cognitive restructuring. Problem-solving. Social action. Each module is grounded in published evidence with effect sizes we can name.

Determinism over autonomy

A state machine controls flow. The LLM is a delivery interface, not a clinical reasoning engine. Every output passes regex, keyword, and semantic safety checks.

Evidence over storytelling

A controlled validation study against the current standard of care for the addiction therapy waitlist — which is nothing. Primary endpoint: depression and anxiety. Secondary: percent days abstinent.

Regulatory

Designed as Class I under MDR.
Self-certifiable. By design.

Fixed-schedule psychoeducation and self-help skills — identical content for all users in the same week. No adaptive clinical logic, so the Class I self-certification path is open to us with no Notified Body required. CE marking and the BfArM DiGA listing are work in progress; neither is in place today.

Status
In development
Pre-CE · Pre-DiGA listing
Target classification
CE Class I (MDR)
Target reimbursement
DiGA pathway · §33a SGB V · all GKV
Safety architecture
Deterministic orchestration with layered clinical guardrails.
Talk to us

If your work touches this gap,
we want to know you.

Get in touch