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OASIS Diagnostics S.A.

Getting ONIRY from certified device to commercial reach

Industry
Medical Devices (Women's Health / Perinatal Diagnostics)
Headquarters
Warsaw, Poland
Public information as of
January 2026

A4BEE prepared this analysis from publicly available sources. It reflects our own reading of OASIS Diagnostics S.A.'s published strategy and is not endorsed by, or produced in cooperation with, OASIS Diagnostics S.A.. Company website

Strategic priorities

OASIS Diagnostics S.A. holds MDR Class IIa certification for the ONIRY system — an electrical impedance spectroscopy device that detects the Obstetric Anal Sphincter condition with 90.6% sensitivity and 84.6% specificity, compared to sub-45% sensitivity for the conventional digital rectal exam. The company entered stand-by mode in early 2025 when a financing round did not close, reducing the team to a core of three while it seeks strategic partnership, technology transfer, or Series A capital to fund commercial scale-up.

The company commissioned Future Processing, a Polish strategic consultancy, to assess the operational gap between the prototype stage and what commercial operations require. The consultancy identified the absence of integrated ERP and CRM as the primary operational friction point, and recommended a modular approach adding logistics, distributor management, and client relationship functions to the existing accounting system rather than a full ERP replacement.

Thirty-five manufacturing sites and 43 R&D sites at Abbott were cited as a reason for continuous emissions measurement; at OASIS the equivalent problem is the regulatory and quality documentation that scales with each new market, distributor, and hospital system the company attaches to. MDR certification is held; FDA 510(k), UKCA, and Asian regulatory filings are planned but have not started.

Challenges we see

  • Operations Financial

    Confirming financing and commercial capability before stand-by becomes terminal

    The company achieved MDR Class IIa certification and clinical validation with published sensitivity and specificity data, but entered stand-by mode in early 2025 when long-term financing for market scale-up was not secured.

    A three-person team in stand-by mode can maintain the certified product but cannot simultaneously run a commercial expansion, which means the window for capital-free partnership negotiations is time-limited.

  • Digital Operations

    Building ERP and CRM capability for a distributed commercial network

    A strategic consultancy engagement with Future Processing identified the absence of integrated systems for managing logistics, distributor networks, and client relationships as the primary operational friction as the company moves from R&D to production and distribution.

    Where order management, inventory, and client records are held in separate manual systems, scaling the commercial network multiplies the error surface without adding equivalent capacity.

  • Operations Manufacturing

    Reaching hospital procurement across fragmented European healthcare systems

    OASIS must establish purchasing relationships with hospital procurement systems, medical distributors, and maternity ward decision-makers across multiple European healthcare markets as a precondition for revenue.

    Without a distributor network in place at launch, the certified product competes for shelf space against established device companies with existing procurement relationships.

  • Compliance Regulatory

    Extending MDR Class IIa into FDA, UKCA, and Asian regulatory filings

    MDR Class IIa certification covers EU markets. Accessing the United States, United Kingdom, and Asian markets requires separate regulatory submissions with clinical evidence packages compiled to each jurisdiction's requirements.

    Resources split across parallel submissions extend the timeline for each market; resources focused sequentially extend the total period of EU-market dependence.

  • Operations Manufacturing

    Moving from prototype to operationally-ready supply chain for single-use probes

    The ONIRY probe is a single-use medical device requiring consistent quality in tetrapolar electrode production and sterile packaging. Contract manufacturing, supplier qualification, and quality assurance processes are not yet operationally ready for commercial volumes.

    Commercial launch against purchase orders requires a validated supply chain; a probe that cannot be manufactured to specification at scale is a launch risk even with certification in place.

Opportunities, by urgency and business impact

Each bubble is one opportunity, numbered to match the list below. Further right means it bites sooner; higher means a bigger effect on the business. A bigger bubble means a bigger implementation effort.

Source: A4BEE analysis of public sources

  1. Connecting ONIRY diagnostic output to hospital IT systems

    The ONIRY system generates impedance spectroscopy data analyzed by machine learning and delivers a pass/fail result, but has no standardized interface to hospital LIMS, EMR, or PACS systems, requiring manual transcription of results into clinical records.

    HL7 FHIR and DICOM middleware connectors enable automated diagnostic result delivery into existing hospital workflows, eliminating transcription and enabling automated care-pathway triggers directly from the ONIRY output.

    • OASIS Diagnostics S.A. | Future Processing case study, 2024
    • ONIRY: Impedance Spectrometry For Postpartum Diagnosis, consonance.tech

  2. Establishing validated contract manufacturing for commercial probe volumes

    The transition from prototype to commercial production requires ISO 13485 compliant processes, validated assembly procedures, and qualified suppliers for silver electrodes, probe housings, and sterile packaging — none yet operationally ready.

    A structured ISO 13485 programme covering QMS documentation, supplier audits, and IQ/OQ/PQ protocols for the assembly line enables production to begin against purchase orders without the delay of building capability from scratch.

    • OASIS Diagnostics S.A. | Future Processing case study, 2024

  3. Building a clinical decision support module on top of the ONIRY output

    ONIRY delivers an automated OASI detection result, but maternity ward staff must separately determine repair protocols, post-operative care pathways, and follow-up scheduling based on severity grade — a workflow gap between diagnosis and treatment.

    A decision support layer mapping OASI severity grades to evidence-based repair and care pathways turns the diagnostic output into a care management trigger, increasing the value proposition to hospital customers beyond detection alone.

    • ONIRY: Impedance Spectrometry For Postpartum Diagnosis, consonance.tech

  4. Connecting ONIRY to a cloud platform for remote specialist review

    Postpartum OASI screening is available only at facilities with ONIRY hardware and trained staff, limiting coverage to hospitals that already have the device and the expertise to interpret results.

    A secure cloud gateway transmitting impedance spectrograms from the ONIRY device to a centralized specialist review portal extends expert diagnostic confirmation to any maternity ward with basic trained operators and internet access.

    • OASIS Diagnostics S.A. | Future Processing case study, 2024

  5. Developing VR probe-rotation training before clinical deployment

    The 360-degree probe rotation technique requires trained positioning to produce accurate impedance maps; digital hesitancy among clinicians accustomed to manual examination limits adoption speed at new hospital sites.

    A VR training module simulating the full probe rotation procedure with haptic feedback and anatomical guidance lets clinical staff develop competency before patient contact, reducing on-site training burden and deployment timelines.

    • OASIS Diagnostics S.A. | Future Processing case study, 2024

What we'd propose

  • Digital Lab

    Medical device IT/OT integration for ONIRY and hospital systems

    We deploy HL7 FHIR and DICOM middleware connecting the ONIRY spectrometer and its ML analysis module to the hospital's EMR, LIMS, and PACS systems, so the pass/fail diagnostic result reaches the clinical record automatically.

    • HL7 FHIR and DICOM gateway

      Automated result delivery into EMR

      Implement standardized healthcare interoperability protocols enabling ONIRY diagnostic output to reach the electronic medical record automatically, replacing manual transcription with a structured, auditable data flow.

    • Data contracts and interface specifications

      Stable integration with hospital IT

      Define the FHIR resource structures and DICOM object mappings specific to each hospital's IT environment, so the integration is specified before development begins and the interface is tested against real system versions.

    • Clinical workflow dashboards

      Impedance maps and trend views for clinical staff

      Build role-appropriate dashboards displaying impedance maps, OASI severity classifications, and historical trends, with access controls and audit logging that meet the documentation requirements of MDR post-market surveillance.

    • Diagnostic results reach the clinical record automatically, eliminating transcription errors and delays.
    • Automated care-pathway triggers from the ONIRY output reduce the time between diagnosis and treatment decision.
    • A documented data flow supports MDR post-market surveillance and adverse event reporting.

    We've done this before

    See how we do Digital Lab
  • Digital CDMO

    ISO 13485 quality system for contract manufacturing readiness

    We design the ISO 13485 quality management system documentation — design controls, risk management to ISO 14971, and production validation protocols — and establish the supplier qualification programme needed to move ONIRY probe production from prototype to a validated contract manufacturing operation.

    • QMS documentation framework

      Design controls and risk management to ISO 14971

      Develop the quality management system documentation structure covering design controls, risk management files, and production validation protocols required for MDR compliance and FDA 510(k) submission.

    • Supplier qualification programme

      Audited vendors for electrodes, housings, and sterile packaging

      Define the supplier audit criteria, qualification protocols, and on-going monitoring requirements for the silver electrode supply, probe housing production, and sterile packaging operations.

    • IQ/OQ/PQ production validation

      Installation, operational, and performance qualification for the assembly line

      Create the IQ/OQ/PQ documentation suite for the probe assembly line, establishing the acceptance criteria and test protocols that prove each production batch meets specification before release.

    • Production can begin against purchase orders once the contract manufacturer is qualified and the validation documentation is in place.
    • A complete QMS documentation package supports both MDR post-market surveillance and the FDA 510(k) technical file.
    • Supplier audits and incoming inspection protocols are established before the first commercial order, not after.

    We've done this before

    See how we do Digital CDMO
  • Digital Lab

    Clinical decision support module for ONIRY

    We build a treatment protocol engine that takes the OASI severity grade from the ONIRY ML output and maps it to evidence-based repair protocols, post-operative care pathways, and follow-up scheduling — turning a diagnostic result into a care management trigger.

    • Treatment protocol rules engine

      OASI grade to repair protocol mapping

      Implement a rules engine mapping OASI severity grades to standardized surgical repair protocols, post-operative care pathways, and scheduling recommendations based on current clinical guidelines.

    • Risk stratification dashboard

      Patient outcome prediction from impedance patterns

      Deploy ML models that combine impedance pattern data with patient history to predict fecal incontinence risk and flag patients requiring urgent specialist referral.

    • Automated theatre scheduling integration

      Surgical team notification from diagnostic result

      Configure automated notifications to surgical teams, theatre booking systems, and patient communication channels when the ONIRY output indicates a grade requiring operative repair.

    • The diagnostic result becomes a care pathway trigger, increasing ONIRY's value to hospital procurement committees beyond the initial detection capability.
    • Automated theatre scheduling reduces the delay between diagnosis and primary repair, which has a materially higher success rate when performed within 12 to 24 hours.
    • A complete audit trail from diagnostic result to treatment decision supports both clinical governance and regulatory compliance.

    We've done this before

    See how we do Digital Lab
  • Digital Lab

    Cloud-connected remote diagnostics platform for ONIRY

    We develop a secure cloud infrastructure connecting distributed ONIRY devices to a centralized specialist review portal and a continuously updated ML model — enabling remote expert interpretation of impedance spectrograms from any maternity ward with basic trained operators.

    • HIPAA and GDPR compliant data gateway

      Encrypted edge-to-cloud data transmission

      Implement encrypted data pipelines from the ONIRY device with patient data anonymization, access controls, and audit logging meeting healthcare privacy regulations across EU, US, and UK jurisdictions.

    • Centralized ML model deployment

      Consistent diagnostic quality across all connected devices

      Deploy ONIRY machine learning models on scalable cloud infrastructure with continuous performance monitoring and automated model updates, ensuring all connected devices run the current algorithm version.

    • Expert review telemedicine portal

      Specialist confirmation of impedance spectrograms remotely

      Build a web application where specialist clinicians can review complex impedance spectrograms, confirm or revise the automated OASI classification, and communicate findings back to the bedside operator.

    • Specialist diagnostic capability reaches maternity wards without ONIRY experts on staff, extending market coverage beyond leading hospitals.
    • Centralized ML model updates arrive on every connected device simultaneously, ensuring diagnostic consistency without physical device access.
    • A subscription-based SaaS layer creates a recurring revenue model independent of device placement volume.

    We've done this before

    See how we do Digital Lab

Digital maturity: today and target

Scored out of 100 across six dimensions. The target is what OASIS Diagnostics S.A.'s own published ambition implies — not a perfect score.

Source: A4BEE analysis of public sources
Data Integration 35 → 80
ONIRY produces ML-analyzed impedance spectroscopy data with a pass/fail output, but has no HL7 FHIR or DICOM interface to hospital EMR, LIMS, or PACS systems, leaving results isolated from the clinical record.
Cloud Readiness 25 → 75
The device operates in standalone mode without cloud connectivity for remote analysis, model updates, or multi-site data aggregation — limiting use to facilities with both the hardware and trained staff.
Manufacturing Digitization 30 → 85
Probe production is at prototype stage with no MES integration, no automated quality control, and no digital batch record capability required for commercial-scale operation.
IT/OT Convergence 40 → 85
Strong ML and AI diagnostic algorithm capability sits alongside a three-person team managing stand-by operations with no ERP, CRM, or distributor management system.
Regulatory Data Systems 45 → 80
MDR Class IIa certification is held, but post-market surveillance, adverse event reporting, and international regulatory submission systems are not yet built — the FDA 510(k) filing requires a new technical file structure.
Training & Change Management 30 → 75
Clinical training for the 360-degree probe rotation technique has not been digitized; on-site training for each new hospital deployment adds time and cost to the commercial rollout.

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This is an independent analysis prepared by A4BEE from publicly available information as of January 2026. It reflects A4BEE's own interpretation and opinion, is not affiliated with, endorsed by, or verified with OASIS Diagnostics S.A., and may be incomplete or inaccurate. All company names and trademarks are the property of their respective owners. To request a correction or removal, contact [email protected].