M Dialysis

What M Dialysis does

M Dialysis AB is a privately held Swedish medical device company founded in 2011 and headquartered in Stockholm, with a wholly-owned US subsidiary in North Chelmsford, Massachusetts. The company develops, manufactures, and markets clinical microdialysis solutions used by hospitals, intensive care units, universities, and pharmaceutical companies for minimally invasive continuous monitoring of tissue chemistry in living patients. The technology platform consists of a fully integrated system comprising specialized microdialysis catheters (brain, bolt, peripheral tissue, and intravenous variants), portable syringe pumps (106 Microdialysis Pump), point-of-care analyzers (ISCUSflex with 30 measurements/hour throughput and 16-sample batch capacity, and the newer MD System LOKE for real-time continuous ICU monitoring), proprietary consumables (perfusion fluids, microvials, syringes), and supporting software (ICUpilot, LABpilot, IscusCollect). Catheters incorporate proprietary features including gold-tip CT visibility, 100kD high cut-off membranes for cytokine sampling, and a patented linear design for multi-day implantation.

The business operates a razor-and-blade model: capital equipment (analyzers and pumps) is placed at clinical sites, generating recurring consumables revenue from single-use catheters, perfusion fluids, microvials, and reagents. Go-to-market combines direct sales in primary markets (Sweden and the USA) with a global distributor network of 25+ named partners covering Europe, the Americas, Asia-Pacific, the Middle East, and Africa. M Dialysis holds ISO 13485 certification, FDA clearance for the US market, and achieved full EU MDR certification in 2024. The company traces its technology lineage to CMA Microdialysis AB (founded 1984) and the 1974 pioneering work of Professor Urban Ungerstedt at the Karolinska Institute. The product is supported by more than 16,400 peer-reviewed scientific publications on microdialysis methodology, anchoring the technology's clinical credibility in neurocritical care, general intensive care, reconstructive surgery, and pharmaceutical research applications.

Name

M Dialysis

Legal name

M Dialysis AB

Website

https://mdialysis.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

M Dialysis AB is a Swedish medical device company that develops integrated clinical microdialysis systems (catheters, pumps, analyzers, and software) for continuous tissue chemistry monitoring, serving hospitals, ICUs, universities, and pharmaceutical companies globally through direct sales and a 25+ country distributor network.

Ownership category

akta.pro rank

Headquarters

HQ city

Stockholm

HQ country

Sweden

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Device Hardware Sales: Sale of capital equipment including ISCUSflex analyzers, 106 and 107 Microdialysis Pumps, and catheter accessories. These are one-time equipment purchases with ongoing consumables revenue.
2. Consumables and Supplies: Recurring revenue from consumables including catheters (multiple models for different applications), perfusion fluids (T1, CNS, CNS Dextran), microvials, syringes, and reagents for the ISCUSflex analyzer.
3. Software Licenses and Updates: Software products including ISCUSflex software, ICUpilot, IscusCollect, LABpilot, and QC Charts. Software updates and licenses provided as part of product ecosystem.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

M Dialysis AB develops, manufactures and markets a complete clinical microdialysis platform consisting of specialized catheters (brain, bolt, peripheral, IV), the 106 syringe pump, the ISCUSflex point-of-care analyzer and the LOKE real-time monitoring system, plus perfusion fluids, microvials and supporting software. The offering is sold to hospitals, intensive care units, universities and pharmaceutical companies worldwide for continuous monitoring of tissue chemistry in neurocritical care, reconstructive surgery, general intensive care, and clinical/drug development research.

Product overview

M Dialysis develops and markets clinical microdialysis solutions consisting of a modular system of instruments, catheters, consumables, and software. The core platform includes the ISCUSflex Microdialysis Analyzer (third-generation point-of-care analyzer using enzymatic reagents and colorimetric measurements) and the MD System LOKE (real-time continuous monitoring system). The catheter portfolio includes specialized devices for brain monitoring (70 Brain MD, 70 MD Bolt, 71 High Cut-Off variants), peripheral tissue monitoring (63, 66 Linear, 67 IV), supporting pumps (106 Microdialysis Pump) and consumables (perfusion fluids, microvials, syringes). The system is completed by software solutions (ICUpilot, LABpilot) for data transfer and analysis. The complete microdialysis workflow involves inserting catheters into tissue, using pumps to perfuse fluids through semipermeable membranes, collecting dialysate in microvials, and analyzing samples with the ISCUSflex or LOKE system.

Differentiator

Problem solved

Functional benefit

Products and services

• ISCUSflex Microdialysis Analyzer Third-generation point-of-care microdialysis analyzer that uses enzymatic reagents and colorimetric measurements to analyze glucose, lactate, pyruvate, glycerol, glutamate and urea, with batch capacity of 16 samples and throughput up to 30 measurements per hour for early detection of metabolic crisis and ischemia in clinical settings.
• MD System LOKE Continuous real-time microdialysis monitoring system for glucose and lactate (pyruvate under development), designed for routine bedside monitoring of Critical Care patients in the Intensive Care Unit.
• 70 Brain MD Catheter Highly flexible microdialysis catheter designed for implantation in brain tissue, with a gold thread tip visible on CT scan for precise positioning and early detection of brain ischemia and vasospasm via stereotaxic or manual implantation.
• 71 High Cut-Off MD Bolt Catheter Bolt-implantable microdialysis catheter with a 100,000 Dalton high cut-off membrane that allows diffusion of large molecules such as cytokines, with a gold tip visible on CT for placement verification.
• 71 High Cut-Off Brain Microdialysis Catheter Brain microdialysis catheter with a 100,000 Dalton cut-off membrane for sampling of large molecules such as cytokines, available in 10mm, 20mm and 30mm membrane lengths for different target areas.
• 70 MD Bolt Catheter

Quantifiable outcome

• Throughput of up to 30 measurements per hour on ISCUSflex analyzer
• +3 more outcomes

Named customers4 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Two partnerships are on record, tiered core.

• M Dialysis Inc. (US Subsidiary)coreOthersWholly-owned US subsidiary handling US, Canada and South American markets. Located at 73 Princeton Street, North Chelmsford, MA 01863.
• Global Distributor NetworkcoreChannel Partner/ Reseller/ DistributorOver 25 named distributors globally including Aurora Borealis Control (Netherlands/Belgium/Luxembourg), 4Med France, Linton Instrumentation (UK/Ireland), Saffronica (Australia), Anatech (China/Taiwan/Hong Kong), DiaSense Korea, and many others managing local sales, service and support.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Harvard Bioscience: Harvard Bioscience is the parent of CMA Microdialysis, the original microdialysis commercial entity from which M Dialysis was spun off in 2011. Harvard now focuses on pre-clinical microdialysis instruments and consumables, making it the closest lineage-based competitor to M Dialysis's clinical microdialysis products.
• Eicom USA: Eicom (Japan-based with US operations) manufactures HPLC- and electrochemical-based microdialysis systems, including automated in vivo analyzers. It is the primary direct competitor in microdialysis instrumentation for both research and clinical applications worldwide.
• Pinnacle Technology: Pinnacle Technology produces microdialysis instrumentation and probes primarily for pre-clinical and animal research, including sleeping and freely moving animal systems. It competes with M Dialysis in the research segment and overlaps on probe and sampling technology.

Emerging players

• Oxford Optronix: Oxford Optronix makes tissue oxygen (pO2), pH, and laser Doppler tissue perfusion sensors, and offers microdialysis-capable instruments for research and clinical use. It overlaps with M Dialysis around tissue chemistry monitoring for neurocritical and surgical applications, though its primary focus is oxygen sensing rather than general metabolite monitoring.

Broad incumbents

• Integra LifeSciences: Integra LifeSciences is a large neurosurgery and neurosurgical implant company, offering cranial bolt kits (e.g., Camino / Licox bolt systems) and neuromonitoring devices that are used alongside microdialysis for intracranial pressure and brain tissue monitoring. Indirectly competes with M Dialysis on the patient access and monitoring workflow in neurocritical care.
• Natus Medical: Natus Medical produces neurodiagnostic and neurocritical care equipment including EEG, intracranial pressure monitors, and cerebral blood flow devices. Their neuro monitoring portfolio overlaps with the broader ICU clinical workflow in which M Dialysis's brain catheters and analyzer are deployed.
• Nova Biomedical: Nova Biomedical manufactures point-of-care clinical analyzers (blood gas, chemistry, glucose/lactate analyzers) used in ICUs. Its StatStrip and other POC platforms are adjacent to M Dialysis's ISCUSflex analyzer for blood-based metabolic monitoring, though Nova focuses on whole-blood analytes while ISCUSflex analyzes dialysate.

Others

• Raumedic AG: Raumedic supplies the PTO 2L cranial bolt kits compatible with M Dialysis 70 and 71 Bolt Catheters. It is a partner and component supplier in M Dialysis's neurosurgical workflow rather than a direct competitor, though Raumedic's own pressure and ICP sensors sit in adjacent neurocritical care device space.
• ICU Medical: ICU Medical is a large critical care medical device company best known for IV therapy, infusion pumps, and closed-system transfer devices. It does not directly compete in microdialysis or tissue metabolic monitoring but is present in the same ICU customer environment as M Dialysis's LOKE-based ICU installations.
• Transonic Systems: Transonic Systems manufactures perivascular and transit-time flow probes used in vascular, reconstructive, and transplant surgery. Its flow measurement technology is adjacent to M Dialysis's free-flap/peripheral tissue viability monitoring use case but does not directly compete on microdialysis catheters or analyzers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

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 M Dialysis