OASIS Diagnostics

What OASIS Diagnostics does

OASIS Diagnostics S.A. is a Warsaw-based medical technology company that develops the ONIRY system for rapid, bedside detection of obstetric anal sphincter injuries (OASI). The company addresses the clinical problem that approximately 26% of women giving vaginal childbirth experience perineal injuries affecting the anal sphincter complex and that up to 80% of these injuries go undetected by standard postpartum digital rectal examination, leading to long-term fecal incontinence and quality-of-life complications. Its target customers are maternity hospitals, birth centers, urogynecology and pelvic floor specialists, and obstetric training programs, initially across Europe and the Middle East.

The ONIRY system comprises four components: ONIRY Spectrometer (the core impedance measurement device), ONIRY Probe (a patient-interface sensor with diameter no wider than a finger), ONIRY Stand (hardware mount), and ONIRY App (results visualization). The platform pairs electrical impedance spectroscopy with machine learning algorithms trained on a multicenter clinical dataset; in a pivotal trial of 152 postpartum women across Poland, the Czech Republic, Slovakia, and Spain, the device demonstrated sensitivity of 90.0 ± 1.2% and specificity of 90.0 ± 0.7%, with results published in Scientific Reports (Nature) in February 2025. Patents have been granted in Poland and Canada, with PCT international applications pending. The Spectrometer and Probe are Class IIa medical devices certified under EU MDR 2017/745, manufactured under an ISO 13485:2016-04 quality system.

OASIS operates a hybrid go-to-market combining direct enterprise sales to hospitals with regional distribution partnerships: Balmer Medical in Switzerland, DN FORMED Brno in the Czech Republic and Slovakia, Hueso Medical in Hungary, Kimal (Maternity by Kimal) in the UK, and Dimed in Italy. Revenue is generated through hardware sales with quote-based enterprise pricing, supplemented by replacement-probe recurring revenue; the company does not publicly disclose revenue. The most recent disclosed financing was a ~14 million PLN (~$3.46 million) private equity round from Vinci S.A. HiTech ASI S.K.A., a fund under Poland's Bank Gospodarstwa Krajowego, in August 2023. Headcount is in the 11–50 range across the Warsaw headquarters.

Name

OASIS Diagnostics

Legal name

OASIS DIAGNOSTICS spółka akcyjna

Website

https://oasis-diagnostics.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

Warsaw-based OASIS Diagnostics develops the ONIRY system, an EU MDR-certified Class IIa medical device that pairs impedance spectroscopy with machine learning to detect obstetric anal sphincter injuries within one minute of childbirth, sold to maternity hospitals across Europe and the Middle East.

Ownership category

akta.pro rank

Product category

Obstetric Diagnostic Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL)

akta.pro secondary industries

Remote Diagnostics & Point-of-Care (Connected Testing, Home Lab Devices) (HLACAPAK), Edge-Based Clinical Decision Support & Alerts (On-Device/On-Prem Analytics) (HLACAPAL)

Keywords

• Medical diagnostic devices
• Obstetric care equipment
• Impedance spectroscopy technology
• Postpartum care solutions
• Clinical medical devices

Headquarters

HQ city

Warsaw

HQ country

Poland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. Medical Device Sales: Sale of ONIRY system components including Spectrometer, Probe, Stand, and App. The system is classified as medical device Class IIa under MDR 2017/745.
2. Replacement/Accessory Sales: Ongoing sales of replacement probes and accessories through service and support channels.

Pricing tiers

Go-to-market motion3 records

Distribution channels6 records

Marketing channels7 records

Core offering

OASIS Diagnostics develops and sells the ONIRY system — a Class IIa medical device that uses machine learning-assisted impedance spectroscopy to detect obstetric anal sphincter injuries (OASI) at the bedside within one minute of childbirth. The system comprises the ONIRY Spectrometer (the main measurement device), the ONIRY Probe (a sub-finger-diameter patient interface), and the ONIRY App for results visualization. The company sells directly to hospitals and through regional distributors across Europe and the Middle East.

Product overview

OASIS Diagnostics offers the ONIRY system—a unified medical device platform for rapid, bedside detection of Obstetric Anal Sphincter Injuries (OASI) immediately after childbirth. The platform consists of ONIRY Spectrometer (the core measurement device) and ONIRY Probe (the patient-interface sensor), supported by ONIRY Stand (hardware mounting) and ONIRY App (results visualization). The system employs machine learning-assisted impedance spectroscopy to achieve 90% sensitivity and specificity in identifying injuries that frequently go undetected by standard examination, thereby improving postpartum care outcomes.

Differentiator

Problem solved

Functional benefit

Brands

• ONIRY: AI-based portable medical device system for rapid bedside detection of obstetric anal sphincter injuries (OASI) immediately after childbirth, comprising ONIRY Spectrometer, ONIRY Probe, ONIRY Stand, and ONIRY App, using machine learning-assisted impedance spectroscopy technology.

Products and services

• ONIRY System The complete ONIRY diagnostic platform for rapid bedside detection of obstetric anal sphincter injuries (OASI) immediately after childbirth. Combines machine learning-assisted impedance spectroscopy with a portable spectrometer, finger-diameter probe, and results app to achieve 90% sensitivity and specificity in under one minute. Targeted at maternity hospitals, obstetric departments, and urogynecology clinics.
• ONIRY Spectrometer The main diagnostic device of the ONIRY system that performs impedance spectroscopy measurements on perineal tissues. EU MDR Class IIa certified medical device designed to detect obstetric anal sphincter injuries through electrical impedance analysis with integrated machine learning for immediate signal interpretation.
• ONIRY Probe A purpose-built diagnostic probe with diameter no wider than a finger for patient comfort during postpartum examination. Performs impedance measurements on perineal tissue, completing the measurement process in less than one minute. EU MDR Class IIa certified and sold both as part of the ONIRY system and as replacement units through service channels.

Quantifiable outcome

• 90% sensitivity and specificity in detecting obstetric anal sphincter injuries
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature4 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Hueso Medical KftcoreChannel Partner/ Reseller/ Distributor · 16 January 2026New distribution collaboration in Hungary. Shared goal of strengthening postpartum care and giving clinicians tools for accurate assessment after vaginal delivery.
• Balmer MedicalcoreChannel Partner/ Reseller/ Distributor · 30 April 2025Official ONIRY distributor for Swiss market. Major milestone in DACH region expansion. Presented ONIRY at SGGG 2025 Congress at Basel, Switzerland.
• DN FORMED Brno s.r.o.coreChannel Partner/ Reseller/ DistributorDistribution partner in Czech Republic and Slovakia. Presented ONIRY at SGPS 2025 Conference in Košice, Slovakia. Organized seminar for midwives in Brno with over 40 participants.
• KimalcoreChannel Partner/ Reseller/ DistributorUK partner (Maternity by Kimal) representing ONIRY at RCOG World Congress 2025. Claire Nicholson coordinating engagement.
• GynZoneminorGTM or Marketing PartnerGlobal e-learning platform with 35,000+ medical professionals across 180+ countries. Collaborated on webinar about impedance spectroscopy in OASI detection with Prof. Carlo Ratto and Prof. Stefano Salvatore as speakers.
• DimedminorChannel Partner/ Reseller/ DistributorItalian partner enabling hands-on ONIRY demonstration at AIUG National Congress in Florence, Italy.
• Scientific Advisory BoardcoreStrategic or Co-development PartnerDistinguished international experts including Prof. Antonino Spinelli (Chairman), Prof. Carlo Ratto, Prof. Stefano Salvatore, Prof. Abdul H. Sultan, Dr. Stephan Kropshofer, and others from institutions across Europe, USA, and Middle East. Provides clinical guidance and research collaboration.

Scale indicators5 records

Recent moves7 records

Expansion highlights7 records

Emerging players

• Elidah: Elidah makes Elitone, an at-home pelvic floor stimulation device for female urinary incontinence. Comparable to OASIS as a small FemTech company focused on women's pelvic floor disorders using a clinically validated, consumer-/clinic-friendly device and pursuing FDA clearance.
• Renovia: Renovia developed the Leva pelvic floor disorder diagnostic and therapeutic system for women with urinary incontinence. Comparable to OASIS as a venture-backed women's pelvic floor device company targeting postpartum and urogynecology specialists with an objective diagnostic/therapeutic workflow.
• Sera Prognostics: Sera Prognostics (NASDAQ: SERA) commercializes the PreTRM blood test for preterm birth risk prediction. Comparable as a clinical-stage diagnostics company targeting the maternal care pathway with a peer-reviewed, biomarker-based test pursued for reimbursement in public payer systems.
• Joylux: Joylux is a women's health technology company developing connected devices (vFit, vSculpt) for pelvic floor and intimate wellness. Comparable as an emerging FemTech device company targeting postpartum and menopausal pelvic floor health with a hybrid direct-to-consumer and clinician channel.
• Bloomlife: Bloomlife builds connected maternal health sensors and analytics for prenatal monitoring and contraction tracking. Comparable as an emerging FemTech company combining connected hardware with AI/ML to deliver objective, point-of-care diagnostics in the maternal care workflow.
• InControl Medical: InControl Medical develops FDA-cleared, prescription intravaginal devices (e.g., Apex) for at-home treatment of female urinary and fecal incontinence. Comparable as a women's pelvic floor device company selling through clinicians with both device and recurring accessory revenue.

Broad incumbents

• Hologic: Hologic (NASDAQ: HOLX) is a large incumbent women's health medical device and diagnostics company across diagnostics, surgical, and skeletal health. Comparable as a broad incumbent that hospital OB/GYN departments already purchase from and that OASIS would either partner with or compete against for budget share.
• CooperSurgical: CooperSurgical is a global incumbent in women's health and obstetrics medical devices (acquired by The Cooper Companies). Comparable as the dominant established vendor of obstetric consumables and devices into maternity wards — the same customer OASIS targets with ONIRY.

Direct peers

• Maltron International: Maltron International manufactures bioelectrical impedance analyzers for clinical and research body-composition measurement. Comparable as a direct technology peer using impedance-based measurements in medical device workflows and serving specialty clinical end markets.
• ImpediMed: ImpediMed commercializes bioimpedance spectroscopy devices (L-Dex, SOZO) for clinical diagnostics, primarily lymphedema and body composition. It is the closest direct peer because it uses the same underlying impedance spectroscopy technology in regulated medical-device workflows, has navigated FDA and EU MDR pathways, and serves hospital specialty departments.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/oasis-diagnostics-sa-poland
• Xx.com/oasisdiagsa
• Facebookfacebook.com/OASISDiagnosticsSA

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds1 record

Investors1 record

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 OASIS Diagnostics