Neola Medical

What Neola Medical does

Neola Medical AB (publ) is a Swedish MedTech company headquartered in Lund that develops Neola®, a Class II medical device for continuous, non-invasive lung monitoring of preterm born babies in neonatal intensive care units (NICUs). The product is built on patented GASMAS (Gas in Scattering Media Absorption Spectroscopy) technology originating from Professors Sune and Katarina Svanberg's research group at Lund University, using safe near-infrared light to detect lung collapse and oxygen gas concentration through the skin, with real-time alerts for life-threatening complications. The company holds multiple patent families across the U.S., Europe and China covering disposable probes, optical noise reduction and background signal compensation, and has obtained ISO 13485 certification (2022) and an IECEE CB certificate (2024).

Neola Medical operates a razor-and-blade business model combining one-time device sales (the Neola hardware) with recurring revenue from single-use disposable probe sets, targeting NICUs globally where 15 million preterm births annually drive unmet need for continuous lung monitoring. The go-to-market is sales-led with direct engagement of neonatology key opinion leaders and hospital procurement; initial sales were to research institutions including University College Cork's INFANT Centre (2021), and the company is preparing for U.S. FDA approval followed by European market entry, with a U.S. clinical study planned by mid-2027. Listed on Nasdaq First North Growth Market Stockholm (ticker: NEOLA) since October 2020 and led by CEO Hanna Sjöström, the firm had 1-10 employees and was pre-revenue as of the most recent reporting period, with funding sourced primarily from successive rights issues and a 2024 institutional round led by Cicero Funds and Adrigo Funds.

Name

Neola Medical

Legal name

Neola Medical AB (publ)

Website

https://neolamedical.com

Company type

Public

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

Neola Medical AB (publ) is a Swedish MedTech company developing Neola®, a Class II medical device that uses patented GASMAS near-infrared spectroscopy to provide continuous, non-invasive lung monitoring for preterm infants in neonatal intensive care units, combining hardware sales with recurring disposable probe revenue.

Ownership category

akta.pro rank

Product category

Neonatal Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Maternal, Fetal & Neonatal Monitoring (CTG, Infant Wearables) (HLAHACAF)

akta.pro secondary industry

Maternal & Neonatal Remote Monitoring Platforms (HLACAFAC)

Keywords

• Neonatal lung monitoring
• Medical device manufacturing
• Preterm infant care
• Non-invasive monitoring
• Optical spectroscopy devices

Headquarters

HQ city

Lund

HQ country

Sweden

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Neola Device Sales: One-time sales of the Neola medical device (Neonatal Lung Analyzer), a Class II medical device for continuous lung monitoring
2. Disposable Probe Sets: Recurring revenue from single-use disposable probe sets used with the Neola device. Scalable business model with recurring revenue opportunities from disposables ensuring predictable revenue streams

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

Neola Medical develops and manufactures the Neola® (Neonatal Lung Analyzer), a Class II medical device that uses patented GASMAS near-infrared spectroscopy technology to provide continuous, non-invasive lung monitoring of preterm born babies in neonatal intensive care units, enabling instant detection of lung collapse. The company also supplies the single-use disposable probe sets used with the Neola® device, generating a scalable combination of one-time device sales and recurring consumable revenue targeted at hospital NICUs.

Product overview

Neola Medical offers a single unified product portfolio centered on Neola® (Neonatal Lung Analyzer), a class II medical device for continuous, non-invasive lung monitoring of preterm born babies. The system includes reusable monitoring hardware and single-use disposable probes. The technology is based on patented GASMAS spectroscopy developed at Lund University, using near-infrared light to measure lung volume changes and oxygen gas concentration. The company operates a combination of one-time device sales and recurring revenue from disposable probe sets, with the device targeting neonatal intensive care units globally.

Differentiator

Problem solved

Functional benefit

Brands

• Neola®: Neonatal Lung Analyzer - Class II medical device for continuous, non-invasive lung monitoring of preterm born babies with real-time alerts for potentially life-threatening lung collapse.

Products and services

• Neola® (Neonatal Lung Analyzer) A Class II medical device designed for non-invasive, continuous lung monitoring of preterm born babies in neonatal intensive care. Uses patented GASMAS technology based on near-infrared light spectroscopy to detect lung collapse and provide real-time alerts for life-threatening complications. Targeted at hospital NICUs treating preterm born babies with respiratory complications.
• Disposable Probes for Neola® Single-use disposable probe sets used with the Neola® Neonatal Lung Analyzer for continuous lung monitoring, generating recurring revenue and ensuring predictable revenue streams as part of a scalable razor-and-blade business model. Targeted at hospital NICUs operating the Neola® device.

Quantifiable outcome

• Clinical pilot study confirmed favorable safety profile across studied patient population including very low birth weight preterm born babies

Named customers1 record

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Nine partnerships are on record, tiered core, minor and major.

• Södra Älvsborgs Sjukhus, BoråscoreStrategic or Co-development Partner · 1 January 2025Clinical pilot study conducted at neonatal intensive care unit. 10 babies included with gestational age from 28 weeks and weight between 1000-3000 grams. Study confirmed favorable safety profile and provided valuable insights into signal behavior in clinical environment.
• Nordic Innovation House, Palo AltominorOthers · 10 June 2024Innovation hub in Palo Alto, California providing office space and ecosystem support for Neola Medical's U.S. subsidiary as part of upcoming market launch preparations in the American market.
• FORCE TechnologymajorImplementation/ SI/ Consulting Partner · 4 June 2024Accredited and independent IECEE testing house that conducted rigorous testing and evaluation of Neola against IEC 60601-1 and IEC 60601-1-2 standards for CB certificate, confirming safety and essential performance for neonatal intensive care use.
• Lucile Packard Children's Hospital StanfordcoreStrategic or Co-development Partner · 1 January 2024Top-ranked neonatal intensive care clinic visited by Neola Medical to strengthen clinical network. Strong connection to Stanford University benefits hospital with world-leading research, expertise and interest in latest medical technology products for neonatal care.
• Stanford University (Impact1 Program)coreStrategic or Co-development Partner · 1 January 2023Neola Medical selected as Stanford Impact1 company recognized by leading experts in neonatology at Stanford University. Company receives support from Stanford Impact1 program and participates in CEO Summit 2023. Recognition as promising innovation with potential to upgrade neonatal intensive care from the first day in clinic.
• BSI Group The Netherlands B.V.majorImplementation/ SI/ Consulting Partner · 21 November 2022Leading international accredited certification body that certified Neola Medical's quality management system according to ISO 13485. Certification is prerequisite for CE-marking and FDA market approval in USA.
• University College Cork (INFANT Centre)coreStrategic or Co-development Partner · 1 January 2021First sale of Neola device to INFANT Centre at University College Cork, Ireland. Device used in independent clinical research study (NIOMI) involving 100 newborns - largest clinical study ever conducted with Neola technology.
• Lund UniversitycoreStrategic or Co-development Partner · 1 January 2005Founding technology partner. GASMAS (Gas in Scattering Media Absorption Spectroscopy) technology originally developed by professors Sune and Katarina Svanberg's research group at Lund University. Technology shows medical potential and forms basis for Neola Medical's continuous lung monitoring product.
• FNCA Sweden ABmajorOthersCertified Adviser for Neola Medical on Nasdaq First North Growth Market, providing advisory services for continued listing requirements.

Scale indicators7 records

Recent moves10 records

Expansion highlights6 records

Direct peers

• Vyaire Medical: Respiratory care company with neonatal ventilation and airway products. Comparable in serving the same NICU respiratory workflow and competing for similar hospital budgets and formulary slots.
• Fisher & Paykel Healthcare: Specialist in respiratory care and humidification for neonates (incl. NIV interfaces). Highly comparable given the overlapping focus on neonatal respiratory outcomes and recurring consumable revenue model.
• Natus Medical: Focused on neonatal and neurology care products (e.g., NICU monitoring, hearing screening). Direct competitor in neonatal clinical workflow tools and a natural reference point for Neola's go-to-market.
• Inspiration Healthcare: UK-listed specialist in neonatal intensive care equipment (warming, ventilation, monitoring). Direct peer in NICU device category with overlapping customer base of neonatal clinicians.
• Sentec: Specializes in non-invasive transcutaneous blood gas monitoring for neonates (TcPCO2/TcPO2). Closely comparable technology category (non-invasive neonatal gas/physiological monitoring) and competing for the same NICU workflow.

Emerging players

• Bambi Medical: Early-stage developer of neonatal monitoring solutions (e.g., wireless vital-sign monitoring for NICU babies). Comparable emerging peer with a similar focus on non-invasive, continuous monitoring in preterm infants.

Broad incumbents

• GE HealthCare: Large incumbent across NICU monitoring, imaging and anesthesia. Sets the integration standard hospital procurement teams expect, creating both a competitive threat and a potential channel partner.
• Dräger: Major MedTech incumbent with a full neonatal/ICU portfolio including incubators, ventilators and patient monitoring. Represents a bundled, integrated competitor that Neola would need to complement or displace at the NICU level.
• Masimo: Global leader in non-invasive patient monitoring (notably SET® pulse oximetry), deeply embedded in NICUs worldwide. Provides the dominant physiological monitoring platform against which Neola's lung-specific monitor would need to differentiate.
• Philips (Patient Monitoring): Broad incumbent in hospital patient monitoring with strong NICU presence. Comparable as an integrated monitoring competitor and as a potential partner for distribution of Neola's lung-specific data.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/neolamedical

Compliance3 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 Neola Medical