What Lung Bioengineering does

Lung Bioengineering Inc. is a wholly-owned subsidiary of United Therapeutics Corporation (NASDAQ: UTHR) that operates the first and only full-service centralized Ex Vivo Lung Perfusion (EVLP) service centers in the United States. Founded in 2014, the company uses the Toronto EVLP protocol to evaluate and reassess deceased-donor lungs outside the body, enabling transplant centers to utilize marginal donor lungs that might otherwise be discarded. Since its founding, the company has performed over 1,100 EVLP procedures and facilitated 500+ lung transplants through its two dedicated EVLP centers in Silver Spring, Maryland (28,000 ft², six procedure rooms) and Jacksonville, Florida (25,000 ft², three procedure rooms).

The company's core technology platform is the Centralized Lung Evaluation System (CLES), supported by the Case Management Exchange (CMX) cloud-based clinical decision support system and OrganVue software, which together provide transplant physicians with real-time access to EVLP data including high-definition video, bronchoscopy footage, radiographs, and live perfusion monitoring for remote organ viability assessment. In June 2026, the FDA granted premarket approval for the LungFX device, which Lung Bioengineering plans to integrate into its commercial EVLP service in 2027.

Lung Bioengineering operates on an outcome-based revenue model, charging only for cases resulting in lungs accepted for transplant, which minimizes financial risk for transplant center partners. The company targets hospital-based lung transplant programs and organ procurement organizations (OPOs) through a direct enterprise sales relationship model, with 24/7/365 availability via a dedicated referral line. Named customers include Vanderbilt University Medical Center, INOVA Fairfax, and Duke University, among 16 transplant center sites that participated in the pivotal clinical trial. The service addresses the significant gap of approximately 75% of donor lungs currently not utilized due to concerns about viability, logistical constraints, or complexities in the transplant process.

Name

Lung Bioengineering

Legal name

Lung Bioengineering Inc.

Website

https://lungbioengineering.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

11–50 employees

Short description

Lung Bioengineering operates the first and only full-service centralized EVLP centers in the United States, providing ex vivo lung perfusion services to lung transplant programs to evaluate and recover marginal donor lungs, as a subsidiary of United Therapeutics Corporation.

Ownership category

akta.pro rank

Product category

Ex Vivo Lung Perfusion Services

NAICS

Blood and Organ Banks (621991), Medical and Diagnostic Laboratories (6215)

SIC

Services-Offices & Clinics Of Doctors Of Medicine (8011), Services-Medical Laboratories (8071)

akta.pro primary industry

Home Ventilation, Oxygen Therapy & Respiratory DME Clinical Management (HLAKANAM)

Keywords

• Ex vivo lung perfusion
• Lung transplant services
• Centralized EVLP centers
• Organ procurement support
• Donor lung assessment

GTM type

B2B

Offering type

Services

Cost components

Personnel, Infrastructure, Operations, Technology or R&D

Revenue model

1. Outcome-Based EVLP Services: Lung Bioengineering charges only for cases resulting in lungs accepted for transplant. This payment model carries minimal financial risk for transplant centers and aligns incentives toward successful organ utilization. The centralized service model allows transplant centers to outsource otherwise cost and resource-intensive in-house EVLP processes.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Lung Bioengineering provides centralized ex vivo lung perfusion (EVLP) services that evaluate deceased-donor lungs outside the body to determine transplant suitability and increase donor lung utilization. Services include donor lung procurement coordination, transport logistics, EVLP procedures performed at dedicated centers in Silver Spring, MD and Jacksonville, FL, real-time clinical data sharing via proprietary cloud-based platforms (CMX and OrganVue), and 24/7/365 clinical specialist support. The outcome-based pricing model charges only for cases resulting in lungs accepted for transplant, removing financial risk for transplant centers.

Product overview

Lung Bioengineering is a subsidiary of United Therapeutics Corporation (founded 1996, public benefit corporation since 2021), established in 2014 as the first and only full-service EVLP provider in the United States. The company operates a centralized EVLP service model built on its proprietary Centralized Lung Evaluation System (CLES) platform, using the Toronto EVLP protocol. Its core product is the ex vivo lung perfusion (EVLP) service, which evaluates deceased-donor lungs outside the body to determine transplant suitability and increase organ utilization. The service integrates two key software components: the Case Management Exchange (CMX), a cloud-based clinical decision support system providing real-time EVLP data including high-definition video and bronchoscopy to transplant physicians for remote assessment, and the OrganVue software for data management. Lung Bioengineering maintains two dedicated EVLP centers (Silver Spring, MD and Jacksonville, FL) with combined nine procedure rooms, staffed by LBE Clinical Specialists available 24/7/365. The company recently added the FDA-approved LungFX device (premarket approval June 2026) to its service portfolio, expected to be commercially available via its EVLP service in 2027.

Differentiator

Problem solved

Functional benefit

Products and services

• Ex Vivo Lung Perfusion (EVLP) Services
• Case Management Exchange (CMX)
• OrganVue
• Centralized Lung Evaluation System (CLES)
• LungFX

Quantifiable outcome

• 20% increase in transplant volume observed by partner program
• +2 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

One partnership is on record.

• United Therapeutics CorporationcoreStrategic or Co-development Partner · 1 January 2014United Therapeutics founded Lung Bioengineering as a subsidiary in 2014 to be a leading provider of EVLP services. United Therapeutics is a public benefit corporation (since 2021) focused on developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. Lung Bioengineering operates as part of United Therapeutics' mission to transform transplantation.

Scale indicators5 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• TransMedics Group: Publicly traded (NASDAQ: TMDX) organ preservation company offering the Organ Care System for heart, lung, and liver. Directly comparable as a commercial organ perfusion platform with overlapping customer base of transplant centers and OPOs.
• XVIVO Perfusion: Swedish-based developer of the XPS™ with STEEN Solution™ Perfusate, the most widely adopted EVLP technology referenced in Lung Bioengineering's own materials. Directly comparable as the primary competing EVLP platform, with FDA-approved indications for donor lung assessment.

Emerging players

• OrganOx: Developer of the metra normothermic liver perfusion system. Comparable as an organ preservation technology company targeting transplant centers with similar clinical and economic value propositions around increasing transplantable organ utilization.
• Paragonix Technologies: Developer of hypothermic organ preservation and transport devices for heart, lung, liver, and kidney. Comparable as an organ preservation company addressing similar transplant center and OPO customers with complementary (not identical) technology.
• Tevosol: Emerging developer of normothermic organ perfusion devices targeting ex vivo organ repair and assessment. Comparable as an emerging EVLP-style platform company addressing transplant center demand for marginal organ evaluation.

Broad incumbents

• United Therapeutics Corporation: Parent company of Lung Bioengineering (NASDAQ: UTHR), developer of the LungFX device and broader portfolio of transplant and pulmonary pharmaceuticals. Comparable as the strategic parent and technology licensor with overlapping mission in lung transplantation.
• Organ Recovery Systems: Established provider of LifePort hypothermic organ preservation systems used by transplant centers and OPOs. Comparable as a long-standing organ preservation vendor operating in similar procurement workflows.

Regional players

• Bridge to Life: Provider of organ preservation solutions and devices, with strong international and European presence. Comparable as an organ preservation supplier serving similar end customers across transplant programs.

Others

• InspireMD: Medical device company with adjacent focus on vascular and structural heart technologies. Thematically adjacent as a small-cap medical device company addressing similar hospital and procedural specialist customers.
• Institut Georges Lopez (IGL): Manufacturer of preservation solutions and devices used in organ transplantation. Comparable as a supplier of complementary inputs to the same transplant programs and OPOs served by Lung Bioengineering.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 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 Lung Bioengineering