What Colibri Heart Valve does

Colibri Heart Valve LLC is a privately held medical device company founded in 2010 and headquartered in Broomfield, Colorado, with research and development operations in Houston, Texas. The company develops transcatheter aortic valve implantation (TAVI) systems intended to treat patients with aortic valve disease. Its core product, the Colibri TAVI System, is built on proprietary dry-tissue technology that enables the valve to be pre-mounted, pre-crimped, and pre-loaded for immediate clinical use, eliminating the rinsing and preparation steps required by conventional tissue-preserved valves. The platform spans four sizes (21mm, 24mm, 27mm, 30mm) and a delivery profile that has migrated from 14Fr in the first generation to 9Fr in the second generation.

Name

Colibri Heart Valve

Legal name

Colibri Heart Valve LLC

Website

https://colibrihv.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

Colibri Heart Valve is a pre-commercial medical device company developing transcatheter aortic valve implantation (TAVI) systems based on proprietary dry-tissue technology, serving patients with aortic valve disease and the interventional cardiology centers that treat them.

Ownership category

akta.pro rank

Product category

Transcatheter Heart Valves

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Structural Heart Valves (TAVR/SAVR) & Valve Repair (HLAHAFAB)

Keywords

• Transcatheter heart valves
• Structural heart devices
• Cardiovascular medical devices
• Balloon-expandable TAVI system
• Aortic valve replacement

Headquarters

HQ city

Broomfield

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel

Revenue model

1. TAVI System Commercialization (Future): Colibri Heart Valve is a pre-revenue company with products in clinical development. The company plans to generate revenue through commercialization of its TAVI system following regulatory approval (CE Mark). The company has completed first-in-human feasibility studies and was preparing for a larger CE Mark clinical study as of 2018.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

Colibri Heart Valve is a pre-commercial medical device company developing the Colibri TAVI System, a transcatheter aortic valve implantation system that uses proprietary dry tissue processing to deliver a pre-mounted, pre-crimped, and pre-loaded valve that is sterilized and ready for use directly from the package. The current clinical product is a balloon-expandable system offered in 21mm, 24mm, 27mm, and 30mm sizes delivered through a low-profile (9Fr second-generation) custom balloon catheter, with additional self-expanding, mitral, pulmonary, and pericardial patch devices in the pipeline.

Product overview

Colibri Heart Valve is a medical device company developing disruptive structural heart technologies. The core product is the Colibri TAVI System, the only true low profile ready-for-use transcatheter aortic heart valve that uses dry tissue technology for pre-mounted, pre-crimped, and pre-loaded delivery. The portfolio includes a balloon-expandable TAVI system currently in clinical development (available in 21mm, 24mm, 27mm, and 30mm sizes) and a self-expanding aortic valve in the pipeline. Additional pipeline products include pericardial patches, mitral valve, and pulmonary valve devices all leveraging the proprietary dry tissue platform. A spin-off entity, Colorado Therapeutics LLC, commercializes the tissue processing technology in non-structural heart applications.

Differentiator

Problem solved

Functional benefit

Products and services

• Colibri TAVI System Pre-mounted, pre-crimped, and pre-loaded balloon-expandable transcatheter aortic valve implantation system sterilized and ready-for-use directly from the package, using proprietary dry tissue technology that eliminates valve preparation at the point of use. Currently in clinical development (second-generation 9Fr delivery) with 21mm, 24mm, 27mm, and 30mm valve sizes intended for treating severe symptomatic aortic stenosis in TAVI candidates at cardiac surgery centers and hospitals.

Quantifiable outcome

• Effective orifice area (EOA) >2.0 cm2 maintained up to 5 years post-implantation in first-in-human study patients
• +4 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered minor.

• Colorado Therapeutics LLCminorStrategic or Co-development PartnerSpin-off company formed by Colibri Heart Valve in February 2016. Colibri granted Colorado Therapeutics a license to develop and market xenogenic biologic tissue matrix products for soft tissue reinforcement, regenerative, and vascular applications outside of structural heart. Allows Colibri to monetize tissue processing technology in non-cardiac applications.
• Venibri MedtechminorStrategic or Co-development PartnerChinese joint venture partnership referenced in context of Colibri's plans to pursue emerging markets globally through this joint venture arrangement.

Scale indicators6 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Edwards Lifesciences: Edwards Lifesciences is the dominant global TAVI/TAVR company with its Sapien platform, holding the largest share of the structural heart market that Colibri targets. Edwards sets the clinical-evidence and commercial bar Colibri must clear, with deep physician relationships and decades of outcome data.
• Medtronic: Medtronic's CoreValve/Evolut platform is the second major TAVI franchise and was the defendant in Colibri's $106M+ 2023 patent infringement case. As a diversified medical device giant with full structural heart commercial infrastructure, Medtronic is the most direct incumbent competitive threat.
• Boston Scientific: Boston Scientific markets the ACURATE neo2 TAVI platform primarily in Europe and is a direct structural heart competitor to Colibri's TAVI system. As a broad incumbent, Boston Scientific offers overlapping transcatheter valve capabilities as part of a larger cardiology portfolio.
• Abbott: Abbott's Portico and Navitor TAVI systems compete in the same transcatheter aortic valve space as Colibri. Abbott is a diversified medtech incumbent with global structural heart sales coverage that small entrants like Colibri lack.
• CryoLife (now Artivion): Artivion (formerly CryoLife) is a structural heart and cardiac surgery company with tissue-based valve products including cryopreserved and biologic implants. It is comparable to Colibri as a tissue-focused structural heart peer with overlapping bioprosthetic valve technology.

Emerging players

• Venus Medtech: Venus Medtech is a Chinese structural heart company developing transcatheter aortic, mitral, and tricuspid valve replacement systems. It is the closest geographic and stage peer to Colibri's planned Chinese market entry via the Venibri Medtech JV, and a relevant emerging-market benchmark.
• Peijia Medical: Peijia Medical is a Chinese structural heart company developing TAVI and TTVR devices. It represents another emerging competitor in transcatheter aortic valve technology, particularly relevant given Colibri's Venibri Medtech Chinese joint venture.
• JenaValve Technology: JenaValve is a clinical-stage developer of transcatheter aortic and mitral valve repair/replacement systems focused on aortic regurgitation and TAVR. It is comparable to Colibri as a similarly-sized, clinical-stage structural heart peer with overlapping indications.
• 4C Medical Technologies: 4C Medical is a clinical-stage structural heart company developing transcatheter mitral valve replacement technology. Comparable to Colibri as a similarly small, clinical-stage peer extending transcatheter valve technology beyond the aortic position.
• Cardiovalve: Cardiovalve (acquired by Venus Medtech) developed a transcatheter mitral and tricuspid valve replacement system. As a small clinical-stage transcatheter valve company targeting mitral indications that overlap with Colibri's pipeline, it is a relevant emerging peer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds3 records

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 Colibri Heart Valve