What Centerline Biomedical does

Centerline Biomedical is a Cleveland Clinic spin-out founded in 2014 that develops the Intra-Operative Positioning System (IOPS), an FDA 510(k)-cleared electromagnetic tracking-based 3D surgical navigation platform for endovascular procedures. The system builds a patient-specific 3D vascular model from pre-operative CT scans and tracks sensor-equipped catheters and guidewires in real time to provide GPS-like visualization of tip position, shape, and orientation, enabling navigation without continuous fluoroscopy or iodinated contrast. IOPS integrates with CBCT imaging systems from GE, Siemens, and Philips and includes proprietary Spintegration technology for intraoperative CBCT overlay. The company serves hospital vascular surgery departments performing complex aortic and peripheral endovascular procedures, with deployments at Cleveland Clinic, Massachusetts General Hospital, Vanderbilt, University of Virginia, Allegheny Health Network, Memorial Hermann, and other academic medical centers across the United States, and over 200 cumulative procedures documented as of May 2024.

The business model combines capital equipment sales of the IOPS platform (cart, tracking pad, field generator, software) with recurring revenue from single-use disposables including 6Fr Viewpoint Catheters and the IOPS Guidewire Handle. Distribution is direct enterprise sales to hospital vascular surgery and interventional radiology departments, supported by key opinion leader engagement, peer-reviewed clinical publications, and presence at major vascular conferences. Additional revenue and strategic optionality comes from military R&D collaborations with the USAF 59th Wing and US Army Institute of Surgical Research. The company has raised over $57 million across multiple funding rounds and holds three FDA clearances in the 2024-2025 period, indicating an active transition from R&D to commercial scaling, though no revenue is publicly disclosed.

Name

Centerline Biomedical

Legal name

Centerline Biomedical, Inc.

Website

https://centerlinebiomedical.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Centerline Biomedical is a Cleveland Clinic spin-out that markets IOPS, an FDA-cleared 3D electromagnetic navigation system for endovascular surgery that reduces radiation exposure. It sells capital equipment plus disposable catheters to U.S. hospital vascular surgery departments.

Ownership category

akta.pro rank

Product category

Surgical Navigation Systems

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical and Medical Instrument Manufacturing (339112), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

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

akta.pro primary industry

Surgical Navigation, Tracking & Intraoperative Guidance (Ortho/Neuro/ENT) (HLAHADAG)

akta.pro secondary industries

Surgical Navigation, Robotics & Patient-Matched Instrumentation (Ortho/Spine) (HLAHAEAL), Vascular Access & Closure Devices (Sheaths, Guidewires, Closure Systems) (HLAHAFAK)

Keywords

• Endovascular navigation
• Surgical navigation systems
• Medical imaging devices
• Vascular surgery equipment
• Electromagnetic tracking

Headquarters

HQ city

Cleveland

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, Personnel, Supply Chain, Marketing or Sales, Operations, Others

Revenue model

1. IOPS Navigation System Sales: Sale of the IOPS hardware platform including the IOPS Cart, Tracking Pad, field generator, and sensor control unit. The system is marketed to hospital vascular surgery and endovascular procedure departments as capital equipment.
2. IOPS Disposables (Catheters, Guidewires, Handles): Recurring revenue from single-use disposables including the 6Fr Viewpoint Catheters (Simple Curve and Double Curve variants), IOPS Guidewire Handle, and IOPS Fiducial Tracking Pad. These are consumable products used in each procedure.
3. IOPS Software Licensing and Updates: The IOPS software platform (V1.0 through V1.5) is provided as part of the system. Software updates and new versions (e.g., V1.4, V1.5) are released with new features. The software enables 3D model building, real-time navigation, Spintegration CBCT overlay, and multi-view display.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels10 records

Core offering

Centerline Biomedical develops and commercializes the IOPS (Intra-Operative Positioning System), an FDA 510(k) cleared 3D surgical navigation platform for endovascular procedures. The system uses electromagnetic tracking combined with patient-specific 3D vascular models to provide real-time catheter and guidewire positioning without continuous fluoroscopy, reducing radiation exposure for both patients and surgical teams. Revenue is generated through capital equipment sales of the IOPS hardware platform and recurring sales of single-use disposable catheters and guidewire accessories.

Product overview

Centerline Biomedical offers the IOPS (Intra-Operative Positioning System) platform, an FDA 510(k) cleared surgical navigation technology. The platform consists of the IOPS Software (current version V1.5), IOPS Fiducial Tracking Pad hardware, and compatible sensor-equipped disposable catheters including the Viewpoint Simple Curve and Double Curve catheters (6Fr), as well as the IOPS Guidewire Handle. These components work together to provide real-time 3D navigation, reduce radiation exposure, and improve visualization during endovascular procedures in peripheral, aortic, and aortic side branch vasculature.

Differentiator

Problem solved

Functional benefit

Brands

• IOPS: Intra-Operative Positioning System - FDA 510(k) cleared 3D endovascular navigation technology that reduces radiation exposure and improves accuracy during vascular procedures.

Products and services

• IOPS (Intra-Operative Positioning System) FDA 510(k) cleared 3D GPS-like surgical navigation and visualization technology for endovascular procedures. Provides real-time catheter and guidewire tip positioning within a patient-specific 3D vascular model generated from pre-operative CT scans, enabling navigation without continuous radiation exposure. Includes the IOPS Cart, Tracking Pad, field generator, and sensor control unit sold to hospital vascular surgery departments as capital equipment.
• IOPS Software Surgical navigation software platform (current version V1.5) that builds 3D models from CT scans, displays multi-view anatomy via up to four concurrent 3D views, captures CBCT overlays through the Spintegration feature, and tracks IOPS catheter and guidewire positions in real time. Sold as part of the IOPS system with ongoing software version updates.
• 6Fr Viewpoint Simple Curve Catheter Single-use sensor-equipped navigation catheter with 75cm or 125cm working length, 0.035 inch guidewire compatibility, and a 75 degree curve designed for standard endovascular procedures. Provides reliable pushability and 1:1 torque control. Recurring disposable consumable used with the IOPS platform.
• 6Fr Viewpoint Double Curve Catheter Single-use sensor-equipped navigation catheter with 75cm or 125cm working length and a 133 degree curve to distal tip, designed for navigating tortuous anatomy. Recurring disposable consumable used with the IOPS platform.
• IOPS Guidewire Handle FDA 510(k) cleared guidewire handle accessory for the IOPS platform that enables sensor-equipped guidewire navigation with enhanced control during endovascular procedures.
• IOPS Fiducial Tracking Pad Hardware component of the IOPS platform that enables electromagnetic tracking of catheter and guidewire positions during procedures by serving as the field generator reference.

Quantifiable outcome

• 46.6% reduction in vessel cannulation time using IOPS 3D navigation vs. traditional 2D fluoroscopy (in vitro study)
• +6 more outcomes

Named customers8 records

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

AI capability5 records

Feature13 records

Partnerships

Six partnerships are on record, tiered minor, core and flagship.

• Arnaud Marie (Board Advisor)minorStrategic or Co-development Partner · 16 August 2022Arnaud Marie, General Manager for Global Interventional at GE Healthcare with more than 26 years in the healthcare industry, joined as a Board advisor bringing breadth of experiences in MedTech. Represents a strategic advisory relationship with access to GE Healthcare's industry expertise.
• Augmented Reality Technology Collaboration (for trauma resuscitation)minorStrategic or Co-development Partner · 11 May 2022Development collaboration for novel augmented reality system leveraging AR technology and novel nanoparticles for trauma resuscitation applications, in partnership with US military medical research institutions.
• USA Air Force (59th Wing)coreStrategic or Co-development Partner · 1 May 2022R&D collaboration with the USAF 59th Wing focused on surgical navigation technology. The collaboration was noted as part of the company's mission to reduce radiation exposure in surgical settings, with potential defense medical applications.
• USA Army Institute of Surgical Research (ISR)coreStrategic or Co-development Partner · 1 May 2022Collaboration with USA Army ISR for trauma resuscitation and novel augmented reality navigation system development. Part of development of novel systems leveraging AR technology for military medical applications.
• Dr. Azeem Latib and Doug Teany (Clinical Advisors)minorStrategic or Co-development Partner · 21 June 2021Dr. Azeem Latib (coronary interventions) and Doug Teany joined as expert advisors to advance new clinical applications, bringing deep subject matter expertise in coronary and structural heart interventions for IOPS platform expansion.
• Cleveland ClinicflagshipStrategic or Co-development Partner · 1 November 2014Cleveland Clinic is the originating institution and co-founder of Centerline Biomedical. Centerline is a joint venture of G2 Group Ventures and Cleveland Clinic, with Cleveland Clinic originally developing the IOPS technology. The relationship includes technology licensing, clinical research collaboration (preclinical and clinical studies), and investment/follow-on funding. Key opinion leaders from Cleveland Clinic (Dr. Matthew Eagleton, Dr. Ezequiel Parodi) serve on the Scientific Advisory Board.

Scale indicators11 records

Recent moves7 records

Expansion highlights7 records

Direct peers

• Brainlab: Brainlab offers image-guided surgery and surgical navigation platforms across multiple specialties. While it focuses heavily on neurosurgery, ENT, and orthopedics, its 3D navigation, intraoperative imaging integration, and software architecture are directly comparable to Centerline's IOPS approach in endovascular procedures.
• Corindus (Siemens Healthineers): Corindus develops robotic-assisted platforms for endovascular procedures, offering precise catheter and guidewire manipulation. As the only commercial vascular robotics platform, it represents the most direct adjacent technology competitor to IOPS navigation.

Broad incumbents

• Medtronic: Medtronic's StealthStation surgical navigation system and broader cranial/spine navigation portfolio represent the dominant incumbent in image-guided surgery. As a diversified medtech giant with a large capital equipment sales force, Medtronic could extend or compete with Centerline in vascular navigation.
• Stryker: Stryker's navigation and guidance solutions (acquired with MAKO Surgical and other assets) target orthopedic and ENT surgical navigation. As a large diversified medtech with significant R&D and commercial scale, Stryker is a potential competitor or acquirer in the surgical navigation space.
• Siemens Healthineers: Siemens is a major OEM provider of CBCT imaging systems (ARTIS) used in endovascular procedures, and one of the three CBCT vendors that IOPS integrates with. Siemens has the scale and installed base to develop or bundle competing navigation capabilities.
• GE Healthcare: GE Healthcare provides the Innova CBCT imaging systems that IOPS integrates with and is also a Series B investor in Centerline. As an OEM with a large interventional imaging business, GE represents both a critical integration partner and a potential competitive threat.
• Philips: Philips' Azurion image-guided therapy platform is a leading CBCT and endovascular imaging system and is the third major OEM that IOPS integrates with. Philips has the commercial scale and clinical relationships to either partner with or compete against Centerline in vascular navigation.

Emerging players

• Penumbra: Penumbra is a high-growth endovascular device company focused on thrombectomy, embolization, and other vascular interventions. While not a navigation platform, Penumbra serves the same hospital vascular surgery and interventional radiology customers and could expand into navigation-adjacent capabilities.
• 7D Surgical: 7D Surgical develops machine-vision-based surgical navigation systems for spine and cranial procedures. As a smaller navigation-focused competitor, it represents a similar technology and commercial approach in adjacent surgical specialties.

Others

• HeartFlow: HeartFlow provides non-invasive FFR-CT analysis for cardiovascular disease, reducing the need for invasive diagnostic catheterization. While not a direct navigation competitor, HeartFlow is thematically adjacent in the effort to reduce radiation and invasiveness in cardiovascular care.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

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Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds7 records

Investors9 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 Centerline Biomedical