VisionAir Solutions

What VisionAir Solutions does

VisionAir Solutions (legal entity New COS, Inc.) is a Cleveland, Ohio-based medical device company that develops FDA-cleared, patient-specific 3D-printed silicone airway stents for the treatment of symptomatic central airway obstruction (CAO) in patients 22 years and older. Its core offering pairs the VisionAir 3D Stent Architect, a cloud-based, browser-accessible design application, with a proprietary manufacturing process that combines 3D-printed molds and medical-grade silicone injection. The product originated as a 2018 spinout of Custom Orthopaedic Solutions (COS) following the 2017 sale of COS's orthopedic assets to Arthrex, and was developed in collaboration with Cleveland Clinic interventional pulmonologist Dr. Thomas Gildea. VisionAir 3D Stent Architect received initial FDA 510(k) clearance in 2019 with alpha launches at Cleveland Clinic, University Hospitals of Cleveland, and Mayo Clinic, and a v2.0 clearance in 2022 added advanced positioning controls, a DICOM viewer with real-time overlay, airway diameter visualization, and Jailed Airway Indicators for fenestration guidance.

The workflow is a five-step, human-in-the-loop process: the physician uploads a CT DICOM scan through the Architect software, VisionAir engineers produce a 3D airway model within approximately 24 hours using semi-automatic segmentation, the physician designs and tailors the stent in-browser with automated design suggestions, approves it as a 3D prescription, and orders the finished device, which is manufactured in Cleveland and shipped to the medical center in 4–6 business days. The company cites cumulative milestones of 600+ (2024) to 900+ patient-specific stents created, and reports double-digit sales growth and an expanding provider network as of May 2025.

VisionAir operates a direct enterprise sales motion: physicians are onboarded through account registration and one-on-one virtual training with company engineers, medical centers must formally approve VisionAir as a vendor, and orders flow through quote-based purchase orders. Pricing is not publicly disclosed. The customer base spans 50+ U.S. hospitals and academic medical centers — including Cleveland Clinic, Mayo Clinic, Mount Sinai, Stanford, UCLA, UCSF, Memorial Sloan Kettering, Cedars-Sinai, Brigham and Women's, and Massachusetts General — and 80+ interventional pulmonologists across 30+ states. Ownership passed from Cleveland Clinic to Theken Companies in 2023, and then to NextStep in the same year; founder Randy Theken and inventor Dr. Gildea (as Head of the Clinical Advisory Team) remain with the company.

Name

VisionAir Solutions

Legal name

New COS, Inc.

Website

https://visionairsolutions.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

VisionAir Solutions develops FDA-cleared, patient-specific 3D-printed silicone airway stents via its cloud-based VisionAir 3D Stent Architect software. It serves interventional pulmonologists at 50+ U.S. hospitals and academic medical centers treating central airway obstruction.

Ownership category

akta.pro rank

Product category

Patient-Specific Airway Stents

NAICS

Surgical and Medical Instrument Manufacturing (339112), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

3D-Printed & Patient-Specific Implants (Custom Ortho/Spine/Cranial) (HLAHAEAJ)

akta.pro secondary industry

Medical & Dental 3D Printing Services (patient-specific devices, dental labs) (IMAAADAG)

Keywords

• Patient-specific airway stents
• 3D-printed medical devices
• Cloud-based stent design
• Interventional pulmonology devices
• Custom silicone implants

Headquarters

HQ city

Cleveland

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Patient-Specific Airway Stents: VisionAir generates revenue from the sale of custom 3D-printed silicone airway stents to hospitals and medical centers. Stents are manufactured per physician order and shipped nonsterile with instructions for sterilization prior to use. Pricing is quote-based through purchase orders from medical centers.
2. VisionAir 3D Stent Architect Software: Cloud-based software platform used by physicians to design patient-specific stents. The software is provided as part of the stent ordering workflow, with physicians requiring account registration and training to access the platform.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

VisionAir Solutions designs, manufactures, and sells patient-specific 3D-printed silicone airway stents for the treatment of symptomatic central airway obstruction (CAO) in adults. The company operates a cloud-based design platform, the VisionAir 3D Stent Architect, in which physicians upload CT scans, work with VisionAir engineers to create a 3D airway model within 24 hours, and design a custom stent in the browser before placing a purchase order. Custom stents are then manufactured in Cleveland, OH using proprietary 3D-printing and medical-grade silicone injection, and shipped nonsterile to ordering medical centers in 4-6 business days.

Product overview

VisionAir Solutions offers a unified platform combining cloud-based design software and manufactured medical devices. The core offering consists of VisionAir 3D Stent Architect — a cloud-based software application (web-based, accessible via Google Chrome browser) for designing patient-specific silicone airway stents — and VisionAir 3D Patient-Specific Stents — FDA-cleared silicone stents manufactured using 3D-printing and silicone injection technology. The workflow involves: (1) physician uploads a CT scan DICOM to VisionAir 3D Stent Architect; (2) VisionAir engineers create a 3D airway model within 24 hours; (3) physician designs the stent using browser-based tools with automatic design suggestions; (4) physician approves the design and places an order; (5) VisionAir manufactures and ships the stent in 4-6 business days. Supporting offerings include webinars and video training content, clinical publications, and clinician resources documentation. The system was founded from Cleveland Clinic and acquired by Theken Companies/NextStep; it serves 50+ hospitals and 80+ interventional pulmonologists across the United States.

Differentiator

Problem solved

Functional benefit

Products and services

• VisionAir 3D Patient-Specific Stents FDA-cleared personalized silicone airway stents manufactured using 3D-printing technology and medical-grade silicone injection. Each stent is designed by the treating physician to match a patient's unique airway anatomy, indicated for treatment of symptomatic central airway obstruction (CAO) in patients 22 years or older. Cleared for implantation up to 12 months.
• VisionAir 3D Stent Architect

Quantifiable outcome

• VisionAir 3D Stents can remain implanted for up to 12 months compared to stock stents requiring more frequent replacement
• +4 more outcomes

Named customers18 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

Feature5 records

Partnerships

One partnership is on record.

• ArthrexmajorTechnology or Integration · 1 January 2017Glenoid IRIS technology (the predecessor cloud-based preoperative planning software developed by Custom Orthopaedic Solutions, Inc.) was acquired by Arthrex and launched as Virtual Implant Positioning (VIP) system. This was the first major exit from the parent company COS, which later evolved into VisionAir Solutions.

Scale indicators6 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Boston Scientific: Major manufacturer of airway stents including the Ultraflex covered and uncovered tracheobronchial stents, the dominant incumbent in the same interventional pulmonology customer base that VisionAir targets.
• Cook Medical: Sells a portfolio of silicone airway stents (e.g., Dumon, Hood) used by interventional pulmonologists — directly competing with VisionAir's patient-specific silicone stents in the same hospital procedural channel.
• Merit Medical Systems: Provides airway stent systems and related interventional pulmonary products, competing for the same procedural budgets and specialist physician relationships as VisionAir.
• Materialise: Provides 3D-printed patient-specific medical devices, planning software, and anatomical models; comparable in its combination of cloud-based planning workflow plus custom 3D-printed medical device output.

Broad incumbents

• Medtronic: Broad-line medical device incumbent with stent franchises (vascular, airway, GI). Has scale, regulatory, and sales infrastructure that could be redirected into patient-specific airway stents if the market proves attractive.
• Stryker: Operates a large patient-specific implant and 3D-printed medical device business (e.g., spine, craniomaxillofacial, orthopedics); comparable technology base and regulatory familiarity, even though it does not currently address airway stents.
• 3D Systems: Healthcare 3D-printing solutions provider (anatomical models, surgical planning, patient-specific implants) with cloud-based planning workflows similar to VisionAir 3D Stent Architect.

Emerging players

• Carlsmed: Develops patient-specific 3D-printed spine implants with a physician-driven design workflow; analogous business model to VisionAir's physician-designed, patient-specific implant approach, though in a different anatomical specialty.
• TeraRecon: Provides advanced 3D medical visualization and DICOM-based planning tools used by physicians for procedural planning; overlaps with VisionAir's cloud-based DICOM viewer and anatomical analysis features.

Regional players

• Bess Medizintechnik: European manufacturer of airway stents and related interventional pulmonology devices; competes in the same clinical use case but primarily serves EU markets where VisionAir does not currently operate.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/visionairsolutions

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

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 VisionAir Solutions