marketing-medtech

**Country:** Switzerland (Basel HQ) with operations in Munich, Germany
**Founder:** Tim-Ole Pek — Co-Founder & CEO
**Background:** finance | verified: True — Finance / Strategy. Tim-Ole Pek is Co-Founder and Co-CEO of AERA Health, where his explicit functional remit is "Strategy and Finance" — he heads up finance and strategy within the founding team. He studied at Lund University School of Economics and Management. This is consistent with the claimed "finance" background.
**Stage / fundraise:** Early-stage, founded 2022 in Basel. Pre-seed (€4M, Mar 2023) then Seed (€3M, Feb 2025). Still seed-stage and actively scaling/raising via EIC blended financing. / €4M pre-seed (Mar 2023, led by Evoleen, Korify Capital, Neworld; angels incl. ex-Amazon CEO Jeff Wilke and Logitech CEO Bracken Darrell). €3M seed (Feb 2025, led by Speedinvest and Nucleus Capital). Additionally selected for the EIC Accelerator with up to ~€11M in blended financing (grant + equity) to advance regulatory work and market expansion. Actively scaling/raising.
**Regulatory trigger:** AeraOS is an AI-powered clinical decision support / treatment-plan platform for physicians (predictive "Digital Twin" health modeling). Clinical decision support that informs treatment is squarely SaMD under EU MDR Rule 11 (likely Class IIa+), requiring IEC 62304 software lifecycle evidence, clinical evaluation and CE marking. AERA explicitly earmarked EIC funds to advance regulatory work - a concrete MDR/IEC 62304/CE milestone ahead, plus reimbursement pathways (e.g. DiGA-style) for B2B clinical adoption in Germany.
**Email:** contact@aera.health (published). Likely direct-pattern firstname-based address for Tim-Ole; pattern unconfirmed. (confidence high) — contact@aera.health is published on the company's own About page (https://www.aera.health/about). General inboxes hello@aera.health, welcome@aera.health and partner@aera.health also appear across the site/Crunchbase. No personal address for Tim-Ole Pek is published, so it is not asserted.
**LinkedIn:** https://www.linkedin.com/in/timolepek/ (company: https://www.linkedin.com/company/aera-health) **Website:** https://www.aera.health
**Score:** 13 -> Tier A
**Hook:** Tim-Ole, you're a finance-led founder steering AERA from a consumer app into AeraOS - an AI clinical-decision-support platform that lands squarely in SaMD/MDR territory, with EIC money earmarked for regulatory work. That's two hard, parallel builds (ship the product, generate the IEC 62304/MDR evidence) without a named CTO in-house. OmDev gives you a senior dev team plus a dedicated CTO at a fixed monthly price ~3x cheaper than hiring that team, you own the code, and our pipeline produces the compliance evidence your technical file needs (signed SOUP register per build + requirements-to-code-to-test traceability feeding IEC 62304/MDR) - we build the evidence, you certify. Lets you convert seed + EIC capital into shipped product and a regulatory file in parallel.

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## Founder & background
Tim-Ole Pek, Co-Founder & CEO, leads finance and strategy at AERA and was educated in finance at Lund University School of Economics and Management - the top-priority ICP signal (finance, not tech) ([tech.eu](https://tech.eu/2023/03/20/preventative-measures-as-aera-health-raises-4-million/), [ffnews](https://ffnews.com/newsarticle/funding/p4-healthtech-startup-aera-health-raises-e4m-in-pre-seed-round-and-launches/)).
Co-founders are Dr. Andrea Gartenbach (CMO, medical) and Judy Okten (Co-CEO); no technical co-founder or CTO is publicly named, suggesting a thin in-house engineering bench ([LinkedIn](https://www.linkedin.com/in/timolepek/)).

## Funding & momentum
€4M pre-seed (Mar 2023, Evoleen/Korify/Neworld + angels Jeff Wilke ex-Amazon and Bracken Darrell of Logitech), then €3M seed (Feb 2025, led by Speedinvest and Nucleus Capital) ([tech.eu](https://tech.eu/2023/03/20/preventative-measures-as-aera-health-raises-4-million/), [siliconcanals](https://siliconcanals.com/aera-health-secures-4m/)).
Also selected for the EIC Accelerator with up to ~€11M blended financing earmarked to advance regulatory work and market expansion - founded 2022, still early and actively scaling.

## Product & regulatory
AeraOS is an AI-powered P4 preventive-health and clinical decision-support platform: unifies medical + lifestyle data, builds dynamic treatment plans, and runs "Digital Twin" predictive modeling for physicians and clinics ([aera.health](https://www.aera.health)).
Clinical decision support that informs treatment is SaMD under EU MDR Rule 11 (likely Class IIa+), demanding IEC 62304 lifecycle evidence, clinical evaluation and CE marking - and AERA explicitly tagged EIC funds for regulatory advancement, so the MDR/IEC 62304/CE milestone is live and ahead.

## Pain & buying signals
Finance-led CEO + medical CMO, no named CTO = likely thin dev capacity facing two simultaneous hard builds: ship a regulated AI platform AND produce the regulatory technical file.
Fresh seed + EIC blended capital creates pressure to convert money into shipped product and compliance evidence fast, without the time/cost to recruit a senior team and CTO in-house.

**Why OmDev fits:** OmDev supplies a senior dev team plus a dedicated CTO at a fixed monthly price ~3x cheaper than building it in-house (client owns the code), and the pipeline generates exactly the compliance evidence AeraOS needs - a SOUP register signed at every build plus requirements-to-code-to-test traceability feeding the IEC 62304/MDR technical file (OmDev builds the evidence; AERA certifies). That turns seed + EIC funding into shipped product and a regulatory file in parallel. References: CadSmile, SpeechLink.

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**Sources:** https://tech.eu/2023/03/20/preventative-measures-as-aera-health-raises-4-million/ · https://ffnews.com/newsarticle/funding/p4-healthtech-startup-aera-health-raises-e4m-in-pre-seed-round-and-launches/ · https://siliconcanals.com/aera-health-secures-4m/ · https://www.crunchbase.com/organization/aera-health · https://www.aera.health · https://www.aera.health/about · https://www.linkedin.com/in/timolepek/ · https://www.linkedin.com/company/aera-health · https://es.linkedin.com/in/timolepek