Feature #1238
open[A][CH] AERA Health — Tim-Ole Pek (finance)
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Description
**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
RA Updated by Redmine Admin about 1 month ago
- Status changed from Submitted to Design
DRAFT Email 1 (EN, outcome-sell):
To: Tim-Ole Pek — contact@aera.health (published). Likely direct-pattern firstname-based address for Tim-Ole; pattern unconfirmed. (confiance high) · Switzerland (Basel HQ) with operations in Munich, Germany · Redmine #1238
From: damien@omdev.tech
Objet: aeraos: shipping product and your mdr file in parallel
Hi Tim-Ole,
You're a finance-led founder steering AERA from a consumer app into AeraOS, clinical decision support that informs treatment. That lands squarely in SaMD territory under MDR, with EIC money earmarked for the regulatory work. So two hard, parallel builds: ship the product, and generate the IEC 62304 evidence the technical file needs. Without a named CTO in-house, that is a lot.
OmDev gives you a senior dev team plus a dedicated CTO at a fixed monthly price, about 3x cheaper than building the equivalent team, without dropping the norms (IEC 62304, MDR, ISO 13485). The pipeline produces evidence as a byproduct: a SOUP register signed at every build, requirements-to-code-to-test traceability feeding your file. We build the evidence, you certify. You own the code.
As a finance person, you'll appreciate auditable proof.
Worth 20 minutes? https://calendly.com/pollet-dam/discussion, or just reply.
Not relevant? Tell me and I'll close the loop.
Damien
OmDev, omdev.tech