What Oniris Ronflement does

Oniris Ronflement (legal entity: ONIRIS SAS) is a French medical device company founded in 2008 by a dental surgeon, headquartered at 147 Avenue Paul Doumer, Rueil-Malmaison (Hauts-de-Seine), France (SIRET 533 427 548 R.C.S. Nanterre). The company develops, manufactures, and sells mandibular advancement orthoses (MADs) — bi-bloc oral appliances that mechanically advance the lower jaw during sleep to open the upper airway and prevent the obstruction that causes snoring and obstructive sleep apnea (SAHOS). It operates as a hybrid consumer / professional medical-device provider: the entry-level ONIRIS Classic (€69 incl. VAT) and ONIRIS Plus (€99) are sold direct-to-consumer for self-fitting, while the professionally-fitted ONIRIS Pro (€200–€300) and the fully custom TALI (€600–€800) are fitted by dental surgeons and sleep physicians for clinically diagnosed SAHOS patients.

The core technology is a patented thermoformable bi-bloc oral appliance with adjustable advancement bars (up to 11 mm on the Plus model) and a self-fitting impression process that enables home use without a dental visit for the standard line. ONIRIS Plus adds reinforced advancement bars for bruxism sufferers and an extended 24-month lifespan (vs. 12 months for Classic). Both consumer SKUs and professional SKUs share the same patented dual-block architecture, which preserves full lateral jaw movement. The firm has treated 300,000+ patients in France (per company website) and reports a 94% satisfaction rate. Clinical evidence is anchored by the IRIS multicenter randomized controlled trial (>500 patients) published in THORAX (BMJ, Impact Factor 10), which demonstrated non-inferiority of the thermoformable device versus custom-made orthoses on AHI, snoring, quality of life (SF-12 MCS/PCS), blood pressure, daytime sleepiness (Epworth, Pichot), depression, and compliance after 12 months.

Oniris operates a dual go-to-market: (i) direct-to-consumer e-commerce via its own oniris-ronflement.fr site for Classic, Plus, and bundles (€69–€119) with 7-day withdrawal and La Poste/FedEx shipping; and (ii) a professional channel in which dental surgeons and sleep specialists prescribe ONIRIS Pro and TALI — a channel that, after HAS validation in 2019, opens French Sécurité Sociale reimbursement under the LPP framework. Pharmacy distribution is handled through major French wholesalers (Alliance Healthcare, CERP, Alcura, Oxypharm, ALSD), with pharmacists acting as frontline screening for snoring patients (an estimated 40 of 100 pharmacy customers). The device is Class I CE-marked, ISO 13485 certified, FDA-cleared (USA, 2016), and ANVISA-approved (Brazil, 2019). The company has expanded internationally since 2015 and reports presence across multiple European countries and globally. Ownership remains private with no disclosed external venture or private equity funding; the shareholder base is described as including physicians and patients, and the company previously benefited from Young Innovative Company (JEI) status.

Name

Oniris Ronflement

Legal name

ONIRIS SAS

Website

https://oniris-ronflement.fr

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

1–10 employees

Short description

Oniris Ronflement (ONIRIS SAS) develops and sells thermoformable mandibular advancement oral devices for snoring and obstructive sleep apnea, distributing via direct-to-consumer e-commerce, French pharmacy networks, and dental/sleep specialists across Europe, the US and Brazil. Founded 2008.

Ownership category

akta.pro rank

Product category

Sleep Apnea Medical Devices

SIC

Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Sleep & Airway Orthodontics (OSA Appliances/Expansion) (HLABABAI)

Keywords

• Mandibular advancement devices
• Snoring treatment devices
• Sleep apnea oral appliances
• Anti-snoring mouthpieces
• Custom dental orthoses

Headquarters

HQ city

Rueil-malmaison

HQ country

France

HQ region

Europe

Offices1 record

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Operations, Marketing or Sales, Personnel, Technology or R&D, Others

Revenue model

1. Direct e-commerce sales of oral appliances: Oniris sells its mandibular advancement orthoses (ONIRIS Classic, ONIRIS Plus, bundles) directly to consumers through its e-commerce website at fixed unit prices, with no subscription or recurring revenue model — customers purchase a device that lasts 12–24 months depending on the model.
2. Professional dental/sleep specialist channel: ONIRIS Pro and TALI orthoses are provided to dental specialists and sleep physicians who fit and prescribe the devices to patients, with the TALI model manufactured to order by a trained dentist and ONIRIS Pro also requiring professional fitting. These channels serve patients with clinically diagnosed sleep apnea and enable social security reimbursement.

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels6 records

Core offering

Oniris Ronflement (legal entity ONIRIS SAS) designs, manufactures and sells mandibular advancement oral devices used to reduce snoring and treat mild-to-moderate obstructive sleep apnea. The company operates a dual-channel model: a direct-to-consumer range (ONIRIS and ONIRIS Plus) sold online at fixed retail prices, and a professional range (ONIRIS Pro and TALI by ONIRIS) distributed through dentists, sleep specialists, ENT doctors, orthodontists and pharmacies, often eligible for French social-security reimbursement (CPAM/LPPR).

Product overview

Oniris Ronflement offers a portfolio of mandibular advancement orthoses (orthèses d'avancée mandibulaire) for treating snoring and obstructive sleep apnea. The portfolio includes the entry-level Orthèse ONIRIS® (69€), the enhanced Orthèse Oniris Plus® (99€) with reinforced components and extended lifespan, the dentist-fitted Orthèse Oniris Pro® (200–300€), and the fully custom-made Orthèse TALI (600–800€). All devices share the same patented dual-block technology with thermoformable custom imprint and are clinically validated. Accessories include a 2-unit bundle and an ONIRIS® + Nitradine® hygiene kit. The products are Class I medical devices with CE marking, FDA and ANVISA approvals, and ISO 13485 certification.

Differentiator

Problem solved

Functional benefit

Brands

• Oniris Plus: Premium mandibular advancement device with enhanced comfort, reinforced connectors for bruxism sufferers, and lifespan up to 24 months.
• Oniris Classique
• Oniris Pro
• TALI

Products and services

• ONIRIS
• ONIRIS Plus
• ONIRIS Pro
• TALI by ONIRIS

Quantifiable outcome

• 300,000+ patients treated with ONIRIS orthoses in France
• +4 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Alliance HealthcarecoreChannel Partner/ Reseller/ DistributorAlliance Healthcare is a major pharmaceutical wholesale and distribution company in France. Oniris relies on Alliance Healthcare as part of its pharmacy distribution network to supply ONIRIS orthoses to pharmacies across France, ensuring quality service and advisory support for pharmacists.
• CERPcoreChannel Partner/ Reseller/ DistributorCERP (Centrale d'Exportation et de Répartition Pharmaceutique) is a French pharmaceutical distribution cooperative. Oniris partners with CERP to distribute its orthoses to pharmacy customers, ensuring broad national coverage and supply chain reliability.
• AlcuraminorChannel Partner/ Reseller/ DistributorAlcura is a pharmaceutical distribution company serving pharmacies in France. Oniris includes Alcura in its pharmacy distribution network to reach pharmacists and patients.
• OxypharmminorChannel Partner/ Reseller/ DistributorOxypharm is a pharmacy-focused distribution partner in France. Oniris partners with Oxypharm as part of its strategy to make ONIRIS orthoses accessible through pharmacy retail locations nationwide.
• ALSDminorChannel Partner/ Reseller/ DistributorALSD is a pharmaceutical wholesale partner in the Oniris pharmacy distribution network. The company supports the supply of ONIRIS anti-snoring orthoses to pharmacies.
• CHU de GrenoblecoreStrategic or Co-development PartnerCHU de Grenoble (University Hospital of Grenoble) participated as a leading clinical research center in the IRIS multicenter randomized controlled trial comparing ONIRIS orthoses to custom-made devices. Professor Pépin from CHU Grenoble led scientific communications on the 1-year clinical results published in THORAX.
• CHU de MontpelliercoreStrategic or Co-development PartnerCHU de Montpellier was a key clinical partner in the IRIS multicenter study evaluating ONIRIS mandibular advancement orthoses against custom-made devices for sleep apnea treatment.
• Hôpital Bretonneau (AP-HP, Paris)coreStrategic or Co-development PartnerHôpital Bretonneau, part of the Assistance Publique – Hôpitaux de Paris (AP-HP), was a clinical research partner in the IRIS multicenter trial for ONIRIS orthoses.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Philips Respironics: Major CPAP and sleep apnea device manufacturer. Competes indirectly via CPAP dominance in OSA treatment and shares sleep specialist/dental channels for alternative therapies.
• ResMed: Global leader in CPAP devices and broader sleep-disordered breathing solutions. Competes with Oniris in OSA treatment, particularly for moderate-to-severe cases where CPAP remains the gold standard, and overlaps in sleep clinic distribution channels.

Direct peers

• SomnoMed: Australia-based global leader in custom-made mandibular advancement devices for OSA. Direct competitor in the MAD category with similar dentist-fitted distribution model and reimbursement pathways across multiple geographies.
• Airway Management: US manufacturer of the TAP (Thornton Adjustable Positioner) family of custom and semi-custom MADs for snoring and OSA. Direct competitor in the professional dental-fitted MAD segment.
• Apnea Sciences: US-based maker of the Pharyngol anti-snoring oral device. Competes in the direct-to-consumer and dentist-fitted anti-snoring MAD segment with similar positioning around non-custom thermoformable technology.
• Panthera Dental: Canadian manufacturer of custom-made CAD/CAM mandibular advancement devices (Panthera Classic, Panthera X3). Competes in the dentist-fitted MAD market with similar claims of clinical validation and reimbursement.
• ProSomnus Sleep Technologies: US-based manufacturer of precision oral appliance therapy devices for OSA. Competes in the same mandibular advancement device category serving sleep specialists and dentists, with FDA-cleared devices.
• Oscimed SA: Swiss manufacturer of thermoformable mandibular advancement devices for snoring and sleep apnea. Closest head-to-head peer — competing in the same self-fitting thermoformed MAD category with similar value proposition of clinical efficacy at lower cost than custom devices.

Emerging players

• BMC Medical: Chinese manufacturer of CPAP and oral appliances for sleep apnea with growing international distribution. Emerging competitor with both CPAP and MAD offerings targeting similar dentist and sleep specialist channels.

Others

• Glidewell Dental: Large US dental lab and manufacturer offering custom MADs (e.g., Silent Nite, TAP) through dentists. Adjacent competitor in dental-fitted OSA appliances with much broader dental products portfolio.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/oniris-ronflement

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Oniris Ronflement