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Feature #1242

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[B][DE] brainjo — Markus Wensauer (co-founder); Christian Michael Gnerlich (co-founder) (tech)

Feature #1242: [B][DE] brainjo — Markus Wensauer (co-founder); Christian Michael Gnerlich (co-founder) (tech)

Added by Redmine Admin about 1 month ago. Updated about 1 month ago.

Status:
Design
Priority:
Normal
Assignee:
-
Start date:
06/25/2026
Due date:
% Done:

0%

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Description

**Country:** Germany (Regensburg, Bavaria)
**Founder:** Markus Wensauer (co-founder); Christian Michael Gnerlich (co-founder) — Co-Founder, "CEO & Organizational Development" (per official team page; one trade-press profile lists Wensauer as Co-Founder & CTO)
**Background:** tech | verified: True — Both founders of brainjo GmbH (Regensburg, Bavaria) have technical backgrounds. Markus Wensauer (Co-Founder / managing director-representative) holds expertise in electrical and information technology (Elektro- und Informationstechnik) and occupies a developer role described on the team page as "Backend to Frontend" — squarely a tech/engineering profile (one trade-press item lists him as Co-Founder & CTO). Christian Michael Gnerlich (Co-Founder, CEO) is a Wirtschaftsingenieur (industrial/business engineer) and certified neurofeedback trainer, also listed on the official team page with a VR-Entwicklung (VR development) function alongside marketing — a hybrid engineering/business profile rather than pure business. So the "tech" classification holds: at least one founder (Wensauer) is purely technical/engineering, and the other (Gnerlich) is a business engineer with a development role. The official team page heading near Gnerlich lists "CEO & VR-Entwicklung" rather than "CEO & Organizational Development"; the company itself (brainjo GmbH, HRB 18882, Amtsgericht Regensburg) builds VR + brain-computer-interface digital therapeutics (DiGA/DTx) for ADHD, a deep-tech product.
**Stage / fundraise:** Seed. Founded 2022; ~10-person interdisciplinary team. Pre-market (market/regulatory approval targeted for 2028). Clinical study with ~100 children with ADHD already underway. / Closed a 2M EUR seed round in April 2026, led by High-Tech Gruenderfonds (HTGF), with better ventures (Munich) and angels incl. Andreas Weinhut. Capital earmarked explicitly to advance the clinical study and DiGA regulatory approval.
**Regulatory trigger:** DiGA pathway (BfArM listing for reimbursable digital health app) requiring MDR conformity + IEC 62304 software lifecycle evidence. Clinical study ongoing; market approval targeted 2028. This is precisely the compliance-evidence milestone ahead (SaMD requirements-to-code-to-test traceability + SOUP register) that OmDev's pipeline produces.
**Email:** (confidence high) — is published directly on the official brainjo team page (https://brainjo.de/team), alongside the confirmed pattern (e.g. s.reiprich@, a.pilling@). Generic also published on the homepage. Gnerlich is listed under on the team page; his personal address would by pattern be (inferred, not published).
**LinkedIn:** https://de.linkedin.com/in/markus-wensauer-664238206 (Wensauer); https://www.linkedin.com/in/christian-michael-gnerlich-61a64a145/ (Gnerlich); company: https://www.linkedin.com/company/20527786 **Website:** https://brainjo.de
**Score:** 10 -> Tier B
**Hook:** Congratulate Markus on the April 2026 HTGF/better ventures seed earmarked for the Hyperhero clinical study and DiGA approval. The angle is NOT "you can't build" (their team clearly can) but de-risking the regulatory file: with 2028 market approval gating reimbursement, OmDev can run alongside the in-house team as a dedicated CTO + senior squad whose pipeline auto-produces the IEC 62304/MDR evidence (SOUP register signed every build, requirements-to-code-to-test traceability) that BfArM/notified-body review demands - turning compliance documentation from a manual drag into a by-product of shipping, at a fixed monthly price ~3x cheaper than expanding the regulated-software team in-house, with brainjo owning all the code. References: CadSmile, SpeechLink.

---

## Founder & background
brainjo was founded in 2022 by Markus Wensauer and Christian Michael Gnerlich, both based in Regensburg. The official team page lists both as "CEO & Organizational Development" (a 2023 trade-press profile dubbed Wensauer "Co-Founder & CTO") ([brainjo.de/team](https://brainjo.de/team), [rocketeer.de](https://www.rocketeer.de/kaffeepause/markus-wensauer-co-founder-und-cto-brainjo/)).
Both founders carry an Electrical Engineering + AI background (Wensauer studied at Santa Clara University 2022-23; Gnerlich at OTH Amberg-Weiden + Santa Clara, with prior neurofeedback/AI roles) - a TECH founder profile, the weakest ICP signal; no finance/insurance/pharma-exec background found ([LinkedIn Wensauer](https://de.linkedin.com/in/markus-wensauer-664238206), [LinkedIn Gnerlich](https://www.linkedin.com/in/christian-michael-gnerlich-61a64a145/)).
**Why OmDev fits:** Technically literate founders buy a dedicated CTO + senior squad as leverage and compliance insurance, not as a crutch - the pitch is speed-to-approval, not capability.

## Funding & momentum
Closed a 2M EUR seed in April 2026 led by High-Tech Gruenderfonds, with better ventures (Munich) and angels incl. Andreas Weinhut ([EU-Startups](https://www.eu-startups.com/2026/04/brainjo-raises-e2-million-to-develop-vr-based-solutions-that-complement-traditional-therapy-where-it-falls-short/), [HTGF](https://www.htgf.de/en/brainjo-seed-funding/)).
The capital is explicitly earmarked to advance the clinical study and DiGA regulatory approval - a regulation-driven raise, the highest-intent moment to engage ([TechFundingNews](https://techfundingnews.com/brainjo-2m-seed-vr-adhd-therapy-children-germany/)).
**Why OmDev fits:** Fresh seed + a hard regulatory deadline = budget and urgency aligned to OmDev's fixed-price, compliance-producing delivery model.

## Product & regulatory
Flagship "Hyperhero" is a VR digital therapeutic (DiGA) for ADHD in children aged 8-13, built with pharma partner MEDICE; market approval targeted for 2028 with a ~100-child clinical study already running ([BioM](https://www.bio-m.org/en/media-center/news/news/regensburger-start-up-brainjo-erhaelt-2-mio-euro-fuer-vr-therapie-speziell-fuer-kinder-mit-adhs)).
A reimbursable DiGA requires MDR conformity and IEC 62304 software-lifecycle evidence for BfArM listing - the exact technical-file milestone ahead.
**Why OmDev fits:** OmDev's pipeline outputs that evidence as a build by-product (signed SOUP register per build + requirements-to-code-to-test traceability feeding the IEC 62304/MDR file); OmDev does not certify but de-risks the review.

## Pain & buying signals
Regulatory approval + clinical validation is the stated use-of-funds and the gate to reimbursement revenue; no CTO is formally named on the team page ([brainjo.de/team](https://brainjo.de/team)).
Counter-signal: founders are technically deep and there is already an in-house bench (Lead VR Dev, Full-Stack Dev, two Game Devs, a Product Owner) plus active Unity/C# hiring - so "can't build" is weak; the real lever is regulated-software throughput and audit-grade documentation.
**Why OmDev fits:** A dedicated CTO + senior squad alongside the existing team accelerates the 2028 approval path and industrializes the compliance evidence, at a fixed monthly price ~3x cheaper than scaling regulated-software headcount in-house, with brainjo owning all code (refs: CadSmile, SpeechLink).

---
**Sources:** https://www.eu-startups.com/2026/04/brainjo-raises-e2-million-to-develop-vr-based-solutions-that-complement-traditional-therapy-where-it-falls-short/ · https://www.htgf.de/en/brainjo-seed-funding/ · https://techfundingnews.com/brainjo-2m-seed-vr-adhd-therapy-children-germany/ · https://www.bio-m.org/en/media-center/news/news/regensburger-start-up-brainjo-erhaelt-2-mio-euro-fuer-vr-therapie-speziell-fuer-kinder-mit-adhs · https://brainjo.de · https://brainjo.de/team · https://de.linkedin.com/in/markus-wensauer-664238206 · https://www.rocketeer.de/kaffeepause/markus-wensauer-co-founder-und-cto-brainjo/ · https://www.linkedin.com/in/christian-michael-gnerlich-61a64a145/ · https://ai.ur.de/en/interview-with-christian-gnerlich-brainjo/

RA Updated by Redmine Admin about 1 month ago Actions
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  • Status changed from Submitted to Design

DRAFT Email 1 (EN, outcome-sell):

To: Markus Wensauer (co-founder); Christian Michael Gnerlich (co-founder) — (confiance high) · Germany (Regensburg, Bavaria) · Redmine #1242
From:
Objet: congrats on the seed, one thought on the diga file

Hi Markus, hi Christian,

Congratulations on the April seed from HTGF and better ventures, earmarked for the Hyperhero clinical study and DiGA approval.

Your team can clearly build. The angle here is de-risking the regulatory file ahead of 2028 market approval, where evidence gates reimbursement.

OmDev can run alongside your in-house team: a senior dev squad plus a dedicated CTO at a fixed monthly price, about 3x cheaper than building the equivalent team in-house, without dropping IEC 62304 or MDR. The pipeline produces the evidence as a byproduct: a SOUP register signed at every build, requirements-to-code-to-test traceability feeding your IEC 62304 and MDR file. You own all the code; CE marking stays with you.

Similar work: CadSmile, SpeechLink.

Worth a look? https://calendly.com/pollet-dam/discussion or just reply.

Not relevant? Reply "stop" and I won't follow up.

Damien
OmDev, omdev.tech

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