NEOLANasdaq StockholmMedical DevicesIFRS · SEK

Neola Medical

Neola Medical is a Swedish medical technology company focused on developing Neola®, a noninvasive device for continuous lung monitoring in neonatal intensive care units. The company is organized around product development, clinical validation, and future commercialization, with operations centered in Lund, Sweden and a U.S. presence in Palo Alto.

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Revenue0.0m SEK
−86.2 %y/y
Operating profit (EBIT)-2.5m SEK
EBIT margin-5,600.0%
−5,600.0 ppy/y
Net income-2.7m SEK
+70.5 %y/y

Fiscal year 2025 · change from previous year

Development 2021–2025

-12.5-10.0-7.5-5.0-2.50.02.5m SEK20212022: EBIT -10 m SEK20222023: EBIT -9.6 m SEK20232024: 0.33 m SEK2024: EBIT 0.00 m SEK20242025: 0.05 m SEK2025: EBIT -2.5 m SEK20250.05-2.5
RevenueOperating profit (EBIT)
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Business

Share of revenue
Medical monitoring device70 %

Neola® hardware used for continuous lung monitoring in neonatal intensive care.

Disposable probes20 %

Single-use probes replaced daily for ongoing patient monitoring.

Clinical development and validation10 %

Clinical studies and regulatory work supporting market approval and launch.

Customers

Neola Medical sells to neonatal intensive care units, with a particular focus on hospitals that treat premature infants and need continuous respiratory monitoring. The initial commercial target is teaching hospitals and children’s hospitals in the U.S., where adoption depends on clinical validation, reimbursement, and integration into NICU workflows.

U.S. teaching hospitals with NICUs

Buy Neola® to pilot continuous lung monitoring and establish early clinical reference cases.

Children’s hospitals

Purchase the system for high-acuity neonatal care and institutional research/education use.

General hospitals with neonatal intensive care units

Adopt the device for NICU monitoring where clinical and reimbursement fit is proven.

International NICUs

Potential future buyers after U.S. validation and European CE marking.

Strategy

Neola Medical’s strategy is to complete U.S. clinical studies, secure FDA market authorization, and then establish pilot installations in a small number of large NICUs. The company also plans to build a reimbursement and pricing model suited to the U.S. healthcare system before expanding to Europe with CE marking.

U.S. clinical validation and FDA approvalShort term

Regulatory clearance is required before commercialization and market entry.

Pilot installations in reference NICUsShort term

Early hospital references support adoption, reimbursement discussions, and distribution.

Reimbursement and pricing modelMedium term

NICU adoption depends on payer acceptance and hospital economics.

European expansion after CE markingMedium term

Broadens the addressable market once the product is validated and approved.

Geography

The company is headquartered in Lund, Sweden and also maintains a U.S. office in Palo Alto, California. Commercial focus is on the United States first, followed by Europe after FDA approval and CE marking, so geography is closely tied to regulatory milestones and market access.

Risks

The business depends on successful clinical trials, regulatory approvals, and protection of intellectual property, all of which are common failure points for medical device developers. As a capital-intensive pre-commercial company, Neola Medical also faces financing risk and dependence on specialist personnel, while hospital adoption will depend on reimbursement and clinical evidence.

Sorted by severity
LowMediumHighLowMediumHighImpact →Likelihood →Clinical trial and regulatory approval risk1Financing risk2Intellectual property risk3Key personnel dependence5
Impact is the risk’s severity and likelihood how probable it is over the next few years, both assessed from the company’s reports. Numbers match the list.
  1. Clinical trial and regulatory approval riskImpact: CriticalLikelihood: Medium

    Neola® must satisfy market-specific medical device requirements before launch.

    Exposure: U.S. FDA and later European CE processes

  2. Financing riskImpact: HighLikelihood: Medium

    Development and clinical work consume cash before commercial revenue scales.

    Exposure: Equity funding and shareholder support

  3. Intellectual property riskImpact: HighLikelihood: Low

    The company relies on patents and trade secrets to protect a novel medical device.

    ExposurePatent grantScopeEnforcement
  4. Reimbursement and adoption riskImpact: High

    Hospitals may delay purchase if payer coverage or economic value is unclear.

    Exposure: U.S. NICU commercialization

  5. Key personnel dependenceImpact: MediumLikelihood: Medium

    Specialist engineering, clinical, and regulatory expertise is concentrated in a small team.

    Exposure: Product development continuity

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Accounting

Judgemental items
Fixed asset valuation

Management notes that market conditions can affect the value of fixed assets and future adjustments.

Impact: Could change reported asset values and impairment charges

Consolidation assessment

The Delaware subsidiary is considered insignificant, so no consolidated financial statements are prepared.

Impact: Affects group reporting scope and comparability

Warrants and dilution

Ongoing warrant programs can increase share count and dilute per-share measures.

Impact: Impacts EPS and ownership dilution

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Last updated: 24/09/2026