TNI medical

What TNI medical does

TNI medical AG is a German medical-device company that develops, manufactures, and markets nasal high-flow (NHF) therapy equipment for patients with respiratory insufficiency. Founded in 2007 as a spin-off of Seleon and headquartered in Würzburg, the company operates as a wholly-owned subsidiary of Masimo Corporation (NASDAQ: MASI) following the March 2020 acquisition. Its commercial flagship, the Masimo softFlow (formerly TNI softFlow), delivers warm, humidified airflow through a nasal cannula with optional oxygen admixture, and is offered in two device variants: an adult/adolescent version with a 10-60 L/min flow range and a pediatric (softFlow Junior) version with a 2-15 L/min flow range for premature infants through toddlers.

The underlying platform is built around precision flow regulation, dew-point humidity control adjustable in 1°C increments from 30°C to 37°C, automatic recognition of nasal, tracheal, and pediatric applicators, an integrated flow generator that eliminates the need for external compressed air, and a bacterial/viral filter for cross-contamination reduction. Recurring-revenue consumables include nasal applicators in six adult sizes, tracheal applicators, junior nasal applicators in four sizes, heated InnoTube tubing, and replacement filters. Recent extensions comprise the Transport Battery 60 (60 minutes of operation at full 60 L/min load) and the "softFlow on the Move" mobile transport solution. The technology is protected by a multi-jurisdictional patent portfolio spanning the US, EU, Japan, and China, and the company holds ISO 13485 and MDSAP certifications.

TNI medical generates revenue through one-time device sales to hospitals, clinics, and homecare providers, complemented by hardware sales of consumables and accessories. Its go-to-market is a direct, Germany-focused enterprise sales motion supplemented by trade-fair presence at major European respiratory and intensive-care congresses and a website-based demo/trial ordering workflow. A dedicated toll-free line serves homecare CPAP patients, who can also order replacement accessories directly. Pricing is not publicly disclosed; general terms require a €15.00 minimum-order surcharge for orders under €50.00 net, with prices quoted ex-works. The company operates from a single Würzburg office following a 2024 relocation, maintains an 11-50 employee range, and serves clinical and reference accounts including Universitätsklinikum Würzburg.

Name

TNI medical

Legal name

TNI medical AG

Website

https://tni-medical.de

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

TNI medical AG develops, produces, and markets the Masimo softFlow nasal high-flow therapy system, serving hospitals, clinics, and homecare providers treating respiratory insufficiency in patients ranging from premature infants to adults, primarily in Germany and via its Masimo parent internationally.

Ownership category

akta.pro rank

Product category

Respiratory Therapy Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113)

SIC

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

akta.pro primary industry

Nasal Drug Delivery Devices (Sprays/Powder Devices) (HLAHAIAK)

akta.pro secondary industry

Pulmonology & Allergy Specialty Pharmaceuticals (HLAIACAF)

Keywords

• Nasal high flow therapy
• Respiratory care equipment
• Medical device manufacturing
• Ventilation therapy devices
• Respiratory insufficiency treatment

Headquarters

HQ city

Freiburg

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Sales: Sale of Masimo softFlow high-flow therapy devices to hospitals, clinics, and homecare settings. Devices sold directly through sales team with trial/demo options available.
2. Accessories and Consumables: Sales of applicators (nasal, tracheal, junior sizes), heated tubes (InnoTube), bacterial filters, and other accessories. CPAP accessories catalog available for self-payer products.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels3 records

Core offering

TNI medical AG develops, produces, and markets the Masimo softFlow nasal high-flow therapy system, a medical device that delivers constant warm, moist airflow through a nasal cannula to support patients with respiratory insufficiency. The product line includes the Masimo softFlow for adolescents and adults (10-60 L/min) and the Masimo softFlow Junior for premature babies and children (2-15 L/min), supported by a range of accessories including nasal and tracheal applicators, heated tubes, bacterial filters, and a portable transport battery solution.

Product overview

TNI medical AG (now part of Masimo Group) offers the Masimo softFlow, a nasal high-flow therapy system for respiratory insufficiency. The product line includes two main device versions: Masimo softFlow for adolescents and adults (10-60 L/min flow range) and Masimo softFlow Junior for premature babies and children (2-15 L/min). Both are supported by a range of accessories including nasal and tracheal applicators in multiple sizes, a transport battery (60 minutes at full load), and a mobile transport solution. The therapy delivers constant warm, moist air through a nasal cannula to improve ventilation and eliminate CO2, serving patients from premature infants to adults in both clinical and homecare settings.

Differentiator

Problem solved

Functional benefit

Brands

• Masimo softFlow: The primary product brand for nasal high-flow therapy (nasale Insufflation), formerly known as TNI softFlow. Available for adolescents, adults, and pediatric patients from premature infants to children.

Products and services

• Masimo softFlow (Adolescents and Adults) Nasal high-flow therapy device for adolescents and adults providing respiratory support with flow rates from 10-60 L/min, oxygen admixture up to 60 L/min, bacterial filter, heated applicator, and both nasal and tracheal application options. For hospital and homecare settings.
• Masimo softFlow Junior (Premature Babies and Children) Pediatric nasal high-flow therapy device designed for premature babies and children with flow range of 2-15 L/min, adjustable humidity in 1°C steps from 30-37°C, integrated flow generator, and automatic applicator type recognition.
• Nasal Applicator Heated nasal cannula applicator available in 6 different sizes for ideal adaptation to adolescent and adult patients, providing maximum freedom when speaking, eating, drinking or during medication intake.
• Tracheal Applicator Applicator for tracheal application with automatic adjustment of dew point setting to 37°C and oxygen addition up to 20 L/min.
• Applicator Junior Nasal applicator in four different sizes for use with premature babies, infants, toddlers and in pediatrics. Used in conjunction with heated InnoTube with temperature measuring element for maximum safety and ideal air-humidity mixture.
• Transport Battery 60 Portable battery solution providing power for up to 60 minutes at full load (60 L/min flow, 37°C TP). Super light and compact (1.3kg, 22x15x5cm), 100% quiet, quickly rechargeable (under 6 hours), using Panasonic lithium ion cells.
• softFlow on the Move Mobile transport solution including oxygen supply with O2 double holders for 3L or 2-5L bottles and power supply via battery for continuous therapy in transport situations.

Quantifiable outcome

• Nasal high-flow therapy shows clinical benefits in supporting insufficient breathing and improving CO2 elimination
• +2 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• MasimocoreOthers · 1 March 2020Masimo acquired TNI medical AG in March 2020 as part of their company portfolio. TNI continues to exist as a company and operates as part of the international Masimo Group. Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces monitoring technologies. The TNI softFlow became the Masimo softFlow in 2022.

Scale indicators3 records

Recent moves10 records

Expansion highlights5 records

Broad incumbents

• GE HealthCare: Major medical technology conglomerate offering respiratory and anesthesia solutions including high-flow therapy in hospital settings. Broader portfolio player that competes with TNI in hospital respiratory care but does not specialize in NHF.
• Philips Respironics: Major respiratory and sleep therapy player offering high-flow therapy as part of a broader hospital-to-homecare portfolio. Indirectly competes with TNI through installed-base dominance and broader respiratory offerings.

Direct peers

• ResMed: Global respiratory care leader offering Lumis HFT series for high-flow therapy alongside CPAP/BiPAP devices. Direct overlap with TNI in hospital-to-homecare respiratory support, particularly for COPD and post-acute care.
• Hamilton Medical: Swiss manufacturer of intelligent ventilation solutions including high-flow oxygen therapy devices. Competes directly with TNI in the ICU and hospital respiratory support market with comparable flow ranges and clinical indications.
• Vyaire Medical: Respiratory diagnostics and ventilation company offering high-flow therapy systems (e.g., bellavista, AirLife). Directly competes with TNI in hospital NHF market with similar clinical positioning and consumable-based business model.
• Fisher & Paykel Healthcare: Global leader in nasal high-flow therapy with the Airvo/Airvo 2 devices. Directly competes with Masimo softFlow in hospital and homecare NHF markets with overlapping flow ranges, humidification technology, and target customers.
• Intersurgical: UK-based respiratory care manufacturer offering high-flow nasal cannula systems and consumables. Direct overlap with TNI in NHF therapy with competing nasal cannula products and heated tubing solutions.

Emerging players

• Inspire Medical Systems: Focused on neurostimulation for sleep apnea, addressing the same patient population that uses CPAP alternatives. Comparable to TNIs homecare positioning for CPAP-intolerant patients but with a different therapeutic modality.

Regional players

• Löwenstein Medical: German respiratory care specialist offering CPAP, ventilation, and homecare respiratory products. Comparable to TNI in German-speaking hospital and homecare markets with overlapping sleep medicine and ventilation portfolio.
• Drägerwerk: German-headquartered medical and safety technology company producing ventilation and respiratory care equipment. Strong regional overlap with TNI in German hospital market with comparable ICU/critical care products.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInde.linkedin.com/company/tni-medical-ag
• Facebookfacebook.com/127550567264897

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 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 TNI medical