marketing-medtech

**Founder:** Séverin Benizri — Co-founder & CEO (Président)
**Background:** serial_entrepreneur | verified: True — Séverin Benizri is a serial digital/tech entrepreneur. Before co-founding Apneal (legal name MITRAL SAS, SIREN 893531509) in 2021 as CEO, he founded and led at least three prior companies: Helia.fr (Founder, 2006-2009), Paris Labs (Founder & CEO, 2010-2012), and 7Circles / Seven Circles (Founder & CEO, 2013-2020), a French startup focused on performance optimization via innovation, big data and collaborative solutions. He has a technical/business education (INSA Lyon Master in Computer Sciences, University of Jyväskylä Master in Business/Marketing/Strategy, HEC Master in Management & New Technologies) and a 2021-2022 DIU in Sleep Medicine from Université de Paris. Founding 4 companies over ~20 years supports the 'serial entrepreneur' label.</actual_background>
<parameter name="evidence">Crunchbase person profile ("Séverin BENIZRI - ... @ 7Circles") and RocketReach list him as Founder/CEO across multiple ventures: Helia.fr (2006-2009), Paris Labs (Founder & CEO 2010-2012), 7Circles/Seven Circles (Founder & CEO 2013-2020), and currently Founder/Co-founder & CEO of Apneal (2021-). His prior digital ventures served doctors and the pharmaceutical industry. Note: the Apneal about-us page, the Notre-Siècle interview, and the PSL startup page confirm his Apneal co-founder/CEO role but do not themselves describe his earlier companies; the serial-entrepreneur evidence comes from Crunchbase/RocketReach career history.</evidence>
<parameter name="source">https://www.crunchbase.com/person/sverin-benizri ; https://rocketreach.co/severin-benizri-email_93401225 ; https://psl.eu/en/startup-des-laboratoires/apneal ; https://www.apneal.ai/about-us/
**Stage / fundraise:** Early-growth, ~5 years from incorporation (created 2021-01-01 per Annuaire), 10-19 employees (tranche 2023). Past the pure-MVP stage: live beta, pivotal clinical study running, corporate partnership signed. Still pre-CE-clearance and scaling. / Heavily non-dilutive funded and momentum-rich: i-Lab 2023 national laureate (data.gouv.fr Lauréats I-LAB); selected for EIT Health Flagships, a >€2M program to accelerate the app. Commercial traction via innovation partnership with Air Liquide Healthcare. No confirmed priced equity round found in public sources; a raise to fund regulatory clearance + scale-up is the natural next step but is not publicly confirmed.
**Regulatory trigger:** Software as a Medical Device (SaMD), CE Class IIa certification process in progress (per apneal.ai). Pivotal European validation study underway: ~1,000 patients across ~20 centers in France, Germany, Spain, benchmarked against polysomnography, explicitly to support CE marking. This is the IEC 62304 / MDR / clinical-evaluation crunch point.
**Email:** contact@apneal.ai (confidence high) — contact@apneal.ai is the published general company inbox (surfaced via RocketReach company profile and consistent with the apneal.ai domain / website contact page). Séverin's direct address is masked publicly as s******@apneal.ai (RocketReach), implying a first-initial/first-name pattern, but the full personal address is NOT published, so only the general inbox is given as high-confidence. A plausible (unconfirmed, medium) direct guess would be severin@apneal.ai or s.benizri@apneal.ai.
**LinkedIn:** https://www.linkedin.com/in/severinbenizri/ **Website:** https://www.apneal.ai/
**Score:** 10 -> Tier B
**Hook:** Open on the i-Lab + EIT Health Flagships + Air Liquide momentum, then name the real squeeze: a CE Class IIa file means IEC 62304 lifecycle evidence, a signed SOUP register and requirements-to-code-to-test traceability — exactly while you're running a 1,000-patient FR/DE/ES pivotal study and an Air Liquide integration on a thin dev bench. OmDev plugs in a senior dev team plus a dedicated CTO at a fixed monthly price (~3x cheaper than hiring that team in-house), you own the code, and our pipeline auto-produces the compliance evidence (SOUP signed at every build + full traceability) that feeds your MDR/IEC 62304 file — so Guillaume can stay on the algorithm and clinical science while we carry delivery and the audit trail. References in regulated/health builds: CadSmile, SpeechLink. (Note: they already have a co-founder CTO and a QA/RA manager, so pitch added capacity + a compliance engine, not a CTO replacement.)

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## Founder & background
Séverin Benizri — Co-founder & CEO of Apneal (legal entity MITRAL SAS, SIREN 893531509). Repeat/serial founder: previously Founder of Paris Labs and Founder of Seven Circles (7Circles) before launching Apneal in 2021 ([Crunchbase](https://www.crunchbase.com/person/sverin-benizri); [LinkedIn](https://www.linkedin.com/in/severinbenizri/)).
Business/management profile (HEC Paris; INSA Lyon CS; Jyväskylä), reinforced by a 2021-22 DIU in Sleep Medicine — a non-technical, domain-deep CEO. Tech is held by co-founder/CTO Guillaume Cathelain (PSL researcher); Bruno Sicre co-founder/board ([about-us](https://www.apneal.ai/about-us/)). No documented finance/insurance role, so classed serial_entrepreneur.

## Funding & momentum
i-Lab 2023 national laureate (data.gouv.fr Lauréats I-LAB), and selected for EIT Health Flagships — a programme worth >€2M to accelerate the app ([EIT Health](https://eithealth.eu/news-article/apneal-eit-health-flagships/)).
Commercial traction via an innovation partnership with Air Liquide Healthcare for sleep-apnea screening ([Air Liquide](https://healthcare.airliquide.com/facts/sleep-apnea-innovative-partnership-improve-screening)). Created 2021-01-01, 10-19 employees ([Annuaire](https://annuaire-entreprises.data.gouv.fr/entreprise/mitral-893531509)). No public priced equity round confirmed; a clearance/scale-up raise is the logical next step but unverified.

## Product & regulatory
SaMD: a smartphone fixed to the chest uses accelerometer, gyroscope and microphone to capture breathing, heartbeat and sound overnight, with AI estimating the apnea-hypopnea index ([apneal.ai](https://www.apneal.ai/)). Bichat (AP-HP) pilot hit ~90% correlation vs polysomnography ([PMC study](https://pmc.ncbi.nlm.nih.gov/articles/PMC12413423/)).
Regulatory trigger: CE Class IIa in progress, with a ~1,000-patient pivotal study across ~20 centres in FR/DE/ES to support CE marking — i.e. the IEC 62304 / MDR / clinical-eval crunch is happening now.

## Pain & buying signals
Regulated-SaMD delivery overload: a Class IIa file demands IEC 62304 lifecycle evidence, a signed SOUP register and requirements→code→test traceability, all while running a multi-country pivotal trial and an Air Liquide integration. Public team shows only ~2-3 software devs + data scientists and a single Quality/Regulatory Affairs lead — a thin bench for that load.
**Why OmDev fits:** OmDev adds a senior dev team + a dedicated CTO at a fixed monthly price (~3x cheaper than in-house), client owns the code, and the pipeline auto-generates the compliance evidence (SOUP signed every build + full traceability) that feeds their MDR/IEC 62304 file — freeing the founders to focus on algorithm and clinical science. Pitch added capacity + a compliance engine, not a CTO swap (they already have CTO Cathelain + a QA/RA manager). Regulated/health references: CadSmile, SpeechLink.

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**Sources:** https://www.apneal.ai/ · https://www.apneal.ai/about-us/ · https://www.apneal.ai/contact-us/ · https://annuaire-entreprises.data.gouv.fr/entreprise/mitral-893531509 · https://www.crunchbase.com/person/sverin-benizri · https://www.linkedin.com/in/severinbenizri/ · https://eithealth.eu/news-article/apneal-eit-health-flagships/ · https://healthcare.airliquide.com/facts/sleep-apnea-innovative-partnership-improve-screening · https://pmc.ncbi.nlm.nih.gov/articles/PMC12413423/ · https://www.mpo-mag.com/breaking-news/ces-2025-apneal-unveils-the-worlds-first-ai-powered-app-to-detect-sleep-apnea/ · https://rocketreach.co/severin-benizri-email_93401225