marketing-medtech

**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:** m.wensauer@brainjo.de (confidence high) — m.wensauer@brainjo.de is published directly on the official brainjo team page (https://brainjo.de/team), alongside the confirmed pattern first-initial.lastname@brainjo.de (e.g. s.reiprich@, a.pilling@). Generic info@brainjo.de also published on the homepage. Gnerlich is listed under info@brainjo.de on the team page; his personal address would by pattern be c.gnerlich@brainjo.de (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/