InfraReDx

What InfraReDx does

Infraredx, Inc. (commercial brand InfraReDx) designs, develops, and manufactures intelligent catheter-based intravascular imaging systems used by interventional cardiologists in hospital catheterization laboratories for coronary artery disease diagnosis and percutaneous coronary intervention (PCI) guidance. The company's core technology combines Intravascular Ultrasound (IVUS), which provides high-resolution structural imaging of vessel walls, with Near Infrared Spectroscopy (NIRS), which detects the chemical signature of lipid-core plaques that are prone to rupture and cause major adverse cardiac events (MACE). The flagship product platform is the Makoto Intravascular Imaging System, which supports two proprietary single-use imaging catheters — the Dualpro IVUS+NIRS catheter (the only catheter on the market combining both modalities) and the Clarispro HD-IVUS catheter for high-definition structural imaging — along with the SmartImaging AI software layer for automated lumen and vessel border detection.

The company operates a razor-and-blades commercial model: Makoto capital systems are sold through direct enterprise sales to hospital cath labs (with physician key opinion leader relationships and clinical evidence driving adoption), followed by recurring revenue from disposable catheters required for each imaging procedure. A 12-month support and maintenance contract is included with each capital placement. The company was founded circa 1995, acquired by Nipro Corporation (a Japanese medical device company) in 2015, and is currently a wholly-owned US subsidiary headquartered in Bedford, Massachusetts, with global distribution through Nipro's network. Clinical validation is anchored by the landmark Lipid-Rich Plaque (LRP) Study published in The Lancet in September 2019, which demonstrated that NIRS-identified lipid core plaques predict future cardiac events with quantified risk thresholds.

Going to market is anchored on enterprise field sales targeting hospital catheterization labs, supported by active presence at major cardiology conferences (TCT, VIVA, EuroPCR, SCAI, RSNA), a clinical education program including the IVUSAID mobile app co-developed with Mount Sinai Heart, and a digital resource center. The company maintains FDA-cleared products, EU MDR compliance, and a patent portfolio of 40+ US and foreign patents. As of April 1, 2026, Nipro Corporation plans to merge Infraredx with Avantec Vascular Corporation into a new consolidated US entity called NIPRO Vascular Innovations Americas, Inc. to strengthen its global vascular product portfolio.

Name

InfraReDx

Legal name

Infraredx, Inc.

Website

https://infraredx.com

Company type

Private

Founded year

1995

Operating status

Operating

Headcount range

51–100 employees

Short description

Infraredx designs and manufactures catheter-based intravascular imaging systems combining IVUS and NIRS for interventional cardiologists, enabling high-resolution vessel visualization and lipid-core plaque detection during coronary procedures.

Ownership category

akta.pro rank

Product category

Intravascular Imaging Systems

NAICS

Surgical and Medical Instrument Manufacturing (339112), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)

SIC

Surgical & Medical Instruments & Apparatus (3841), Optical Instruments & Lenses (3827)

akta.pro primary industry

Hemodynamic Monitoring & Cardiac Diagnostics (Cath Lab, FFR/IVUS/OCT) (HLAHAFAI)

akta.pro secondary industries

Medical Imaging AI (HDAAAEAH), AI Orchestration & Imaging Analytics Platforms (Model Management/Triage) (HLACALAG)

Keywords

• Intravascular imaging systems
• Cardiac catheterization products
• Coronary diagnostic devices
• Interventional cardiology equipment
• Vulnerable plaque detection

Headquarters

HQ city

Burlington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Capital Equipment Sales: Sale of Makoto Intravascular Imaging System capital equipment to hospital catheterization labs. Equipment includes hardware, software, systems, content and documentation. Seller installs equipment and provides initial training. Followed by 12 months of included support and maintenance.
2. Consumable Catheter Sales: Recurring revenue from sale of disposable imaging catheters including Dualpro IVUS+NIRS and Clarispro HD-IVUS. Razor-and-blades commercial model tying capital equipment placement to disposable catheter revenue. Catheters are single-use devices required for each imaging procedure.
3. Support and Maintenance Services: Included support for 12 months post-installation covers software updates, one service visit, and telephone support during business hours. Additional out-of-scope services available for purchase including extended maintenance agreements.
4. Razor-and-Blades Model: Strategic commercial model where capital equipment placement (Makoto Imaging System) drives recurring disposable catheter revenue. Once system is placed in catheterization lab, ongoing revenue generated from single-use catheters required for each procedure.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels8 records

Core offering

Infraredx designs, manufactures, and commercializes catheter-based intravascular imaging systems for coronary artery disease diagnosis and PCI guidance. Its Makoto Imaging System platform uniquely combines intravascular ultrasound (IVUS) with near-infrared spectroscopy (NIRS) in single-use catheters (Dualpro IVUS+NIRS and Clarispro HD-IVUS) to detect lipid-core plaques and visualize vessel structure. The company sells the capital equipment, disposable catheters, accessories, and SmartImaging AI software to hospital catheterization labs globally via direct sales and through parent Nipro Corporation's distribution network.

Product overview

InfraReDx, a Nipro Company, offers a comprehensive portfolio of intravascular imaging products for coronary artery disease diagnosis and PCI guidance. The core offering centers on the Makoto® Imaging System platform, which supports two catheter-based imaging modalities: Clarispro® HD-IVUS for high-definition structural ultrasound imaging and Dualpro® IVUS+NIRS for combined ultrasound and near-infrared spectroscopy analysis that detects vulnerable lipid-core plaques. The SmartImaging™ AI software layer automates lumen and vessel border detection in IVUS images. Essential accessories including the GM-30 Inflation Device and OKAY II® Y-Connector complete the product ecosystem.

Differentiator

Problem solved

Functional benefit

Brands

• Makoto: Intravascular imaging platform that combines high-resolution structural views with plaque compositional analysis
• Dualpro
• Clarispro
• IVUSAID

Products and services

• Makoto Imaging System Intravascular imaging platform that combines high-resolution structural IVUS views with NIRS-based plaque compositional analysis to deliver treatment insights for coronary artery disease. Available as standalone and Integrated Makoto System for catheter lab integration. Sold to hospital catheterization labs.
• Integrated Makoto Imaging System Unified component of the catheterization lab designed as an always-on, always-connected imaging platform with ergonomic design and minimal setup for efficient clinical workflow.
• Dualpro IVUS+NIRS Imaging Catheter Single-use intravascular catheter combining IVUS and NIRS technologies. Near-infrared light delivered through microscopic mirrors at the catheter tip propagates through blood, tissue, and interstitial spaces to interrogate plaque for chemical fingerprint (lipid core detection) while simultaneously providing structural vessel imaging.
• Clarispro HD-IVUS Catheter High-definition intravascular ultrasound catheter delivering best-in-class vessel structure visualization for coronary imaging procedures.
• SmartImaging AI Software AI-powered application that automates lumen and vessel border detection in IVUS images using proprietary algorithms, providing assisted analysis that must be reviewed and verified by qualified healthcare providers. HIPAA and GDPR compliant.
• GM-30 Inflation Device Inflation device used during percutaneous coronary interventions for balloon catheter inflation.
• OKAY II Y-Connector Y-Connector device used in catheter procedures for connecting and managing multiple fluid lines.

Quantifiable outcome

• Patients with maxLCBI4mm >400 face 89% higher risk of NC-MACE within 24 months (vs <400)
• +5 more outcomes

Named customers5 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature6 records

Partnerships

Four partnerships are on record, tiered core - parent company, core - primary us distribution, key strategic partnership and product development partnership.

• Nipro Corporationcore - parent companyOthers · 1 April 2026Nipro Corporation acquired Infraredx in 2015 and remains the parent company. Effective April 1, 2026, organizational changes will merge Infraredx and Avantec Vascular Corporation into NIPRO Vascular Innovations Americas, Inc. to strengthen global vascular product portfolio expansion under Global Vascular Headquarters within the Vascular Division.
• Nipro Medical Corporation (NMC)core - primary us distributionChannel Partner/ Reseller/ Distributor · 1 January 2021Strategic collaboration to deliver cutting-edge technologies to the US market. NMC established a Vascular Division in the US to build a world-class vascular product portfolio addressing unmet needs in the vascular space. This aligns with Nipro Corporation's long-term goals to enhance patient care and expand vascular footprint in the United States.
• B. Braun Interventional Systems Inc.key strategic partnershipStrategic or Co-development Partner · 1 January 2021Collaboration to execute FDA IDE clinical trial for SeQuent Please ReX Drug Coated PTCA Balloon Catheter, which received FDA Breakthrough Device Designation. Market-leading global organizations strengthening cooperation to navigate US regulatory pathway for coronary artery disease management. Extends long-term global cooperation between B. Braun Group and Japan-based Nipro Corporation.
• Mount Sinai Heartproduct development partnershipTechnology or IntegrationCollaboration to develop IVUSAID App, a free educational mobile application helping medical professionals hone IVUS skills for PCI guidance. Leverages Infraredx's intravascular imaging technology expertise and Mount Sinai Heart's leadership in interventional cardiology education.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Emerging players

• HeartFlow: HeartFlow provides non-invasive FFR-CT analysis for coronary artery disease assessment, addressing similar vulnerable plaque and lesion significance questions as InfraReDx's NIRS-based lipid detection but via CT imaging rather than catheter-based imaging.
• B. Braun Interventional Systems: B. Braun Interventional Systems is both an InfraReDx collaboration partner (SeQuent Please ReX Drug Coated PTCA Balloon, FDA Breakthrough Device Designation) and an adjacent vendor in PCI and vascular intervention. The B. Braun-Nipro strategic relationship creates a dual-partner/competitor dynamic.

Broad incumbents

• Terumo Corporation: Terumo is a global medical device company with substantial cardiovascular interventional offerings including guidewires, catheters, and access devices. It competes with InfraReDx-adjacent cath-lab product categories and serves similar interventional cardiology customers globally.
• Boston Scientific Corporation: Boston Scientific is a dominant intravascular imaging vendor with OptiCross IVUS catheters and the AVVIGO+ multi-modality system. It is the most direct competitor to InfraReDx in cath-lab imaging, with substantially larger installed base and integrated cath-lab ecosystem.
• GE HealthCare: GE HealthCare is a major cardiovascular imaging and interventional cardiology solutions provider, historically a venture investor in InfraReDx (GE Capital, 2011). It competes broadly in cath-lab imaging ecosystems and hybrid OR environments.
• Philips (IntraSight / KODEX-EPD): Philips offers the IntraSight platform integrating IVUS, FFR, and angiography for PCI guidance. As a broad incumbent in interventional cardiology imaging with global distribution, it competes directly with Makoto for cath-lab capital equipment placements.
• Siemens Healthineers: Siemens Healthineers offers cardiovascular imaging systems and cath-lab integration solutions. As a broad incumbent with global distribution and large R&D budget, it represents an adjacent competitive force in interventional cardiology imaging infrastructure.

Direct peers

• ACIST Medical Systems: ACIST Medical Systems provides intravascular imaging and contrast injection systems used in cath labs. Its HDi HD-IVUS system competes directly with InfraReDx's Clarispro HD-IVUS catheter in high-definition vessel visualization for PCI.
• Abbott (OPTIS / OCT systems): Abbott's OPTIS Imaging System uses Optical Coherence Tomography (OCT) for high-resolution intracoronary imaging, the primary alternative modality to IVUS in PCI guidance. Abbott also acquired Cardiovascular Systems, expanding its vascular interventional portfolio.

Others

• Nipro Corporation: Nipro Corporation is InfraReDx's parent company (acquired 2015) and provides global distribution infrastructure, manufacturing scale, and capital backing. As InfraReDx's owner and primary channel partner, Nipro is the key strategic enabler for international expansion rather than a direct competitor.

Market position

Strengths5 records

Weaknesses3 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/infraredx
• YouTubeyoutube.com/user/InfraredxMedia
• LinkedInlinkedin.com/company/infraredx

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

Funding overview

Funding rounds11 records

Investors4 records

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 InfraReDx