PolyVascular

What PolyVascular does

PolyVascular is a privately held, preclinical medical device company founded in 2014 and headquartered in Houston, Texas. The company is developing the first polymer-based transcatheter pulmonary valve (PTV) designed specifically for pediatric patients with congenital heart disease (CHD), including children as young as 2 years old for whom no non-surgical valve replacement option currently exists. The device features a patented biocompatible tri-leaflet polymer valve mounted within a polymer-covered, balloon-expandable metal stent, delivered via a minimally invasive catheter-based procedure. The balloon-expandable design allows redilation as the child grows, reducing the need for repeat open-heart surgeries, and the polymer composition eliminates the endocarditis and immune-sensitization complications associated with animal tissue and human donor valves.

The company operates an ISO 13485-compliant Quality Management System with an ISO Class 7 clean room and in-house durability testing capability. It has secured over $5 million in non-dilutive funding through successive NIH/NHLBI SBIR Phase I, II, and IIb grants, plus a $2 million strategic collaboration with nonprofit CobiCure, and supplements this with a small equity offering to accredited investors. Strategic and accelerator partnerships include CTIP, APDI, Southwest National PDC, Midwest Pediatric Device Consortium, Impact 1, and the Graeme McDaniel Foundation. Leadership includes co-founders Henri Justino (CEO/CMO, interventional cardiologist) and Daniel Harrington (CSO), COO Will Clifton, MD, VP R&D Cindy Clague, PhD, and Board member Steven Girouard, PhD (ex-J&J, Guidant, Cleveland Clinic, Securus Medical acquired by Boston Scientific).

Commercially, PolyVascular is pre-revenue with no product sales. Pricing is not publicly disclosed; revenue is intended to come from hardware sales of the transcatheter pulmonary valve and its delivery system to US hospitals and pediatric interventional cardiology centers through a planned enterprise direct-sales motion. First-in-human clinical trials are planned for early 2026, and the underlying stented polymer valve platform is described as scalable to larger pediatric, adolescent, and adult sizes, with potential extension into the aortic, mitral, and tricuspid valve markets representing over $11 billion globally.

Name

PolyVascular

Legal name

PolyVascular, Inc.

Website

https://polyvascular.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

PolyVascular is a Houston-based preclinical medical device company developing the first polymer-based transcatheter pulmonary valve for pediatric patients as young as 2 years old with congenital heart disease. The company plans first-in-human trials in early 2026 and intends to sell its device to hospitals and pediatric cardiology centers.

Ownership category

akta.pro rank

Product category

Pediatric Heart Valves

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts) (HLAHAFAH)

Keywords

• Transcatheter heart valves
• Pediatric cardiac devices
• Congenital heart disease
• Polymer medical devices
• Minimally invasive valves

Headquarters

HQ city

Houston

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, Operations, Infrastructure

Revenue model

1. Transcatheter Heart Valve Device Sales: PolyVascular generates revenue through the sale of its polymer-based transcatheter pulmonary valve devices and associated delivery systems to hospitals and pediatric cardiology centers. The company is currently in preclinical development stage with first-in-human clinical trials planned for early 2026.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

PolyVascular develops and manufactures a polymer-based transcatheter pulmonary valve system designed specifically for children as young as 2 years old with congenital heart disease. The product consists of a patented biocompatible polymer tri-leaflet valve mounted within a balloon-expandable metal stent, delivered via a minimally invasive catheter-based procedure using a pediatric-specific delivery system. The technology platform is scalable to larger sizes for teens and adults and can be extended to additional valve positions.

Product overview

PolyVascular offers a single unified product portfolio centered on its polymer-based transcatheter pulmonary valve system. The core offering consists of the PolyVascular Transcatheter Pulmonary Valve — a patented tri-leaflet polymer valve mounted within a metal stent — paired with an accompanying delivery system designed for pediatric use. The valve is the only non-surgical pulmonary valve suitable for children as young as 2 years old. The company's stented polymer valve platform serves as the underlying technology that can be scaled to additional valve positions (aortic, mitral, tricuspid) for teens and adults, expanding beyond the pediatric congenital heart disease market.

Differentiator

Problem solved

Functional benefit

Products and services

• PolyVascular Transcatheter Pulmonary Valve The company's flagship product is the first polymer-based transcatheter pulmonary valve designed for children as young as 2 years old. It features a patented biocompatible tri-leaflet polymer design mounted within a polymer-covered metal stent, delivered via a minimally invasive catheter-based procedure to eliminate repeat open-heart surgeries for pediatric patients with congenital heart disease.
• Pediatric Valve Delivery System An easy-to-use transcatheter delivery system designed specifically for pediatric patients that enables clinicians to safely position and deploy the polymer pulmonary valve percutaneously through a small incision during minimally invasive procedures.

Quantifiable outcome

• Only transcatheter pulmonary valve suitable for children as young as 2 years old
• +3 more outcomes

Segments1 record

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

Four partnerships are on record, tiered core and minor.

• CobiCurecoreStrategic or Co-development Partner · 12 July 2023CobiCure, a nonprofit pediatric initiative with a mission to solve unmet needs in pediatric medicine, awarded PolyVascular a $2 million grant as part of a strategic collaboration. The partnership includes advisory and strategic expertise alongside funding. The collaboration aims to eliminate repeat surgeries in children with congenital heart disease and improve quality of life. CobiCure's mission aligns with PolyVascular's goal to accelerate advancement of life-changing medical technologies for children with rare and underserved conditions.
• Consortium for Technology & Innovation in Pediatrics (CTIP)minorStrategic or Co-development PartnerPediatric technology innovation consortium listed as a partner and champion supporting PolyVascular's mission and contributing to the advancement of pediatric heart valve technology.
• Southwest National PDCminorStrategic or Co-development PartnerListed as a partner and champion supporting PolyVascular's pediatric device innovation efforts.
• Alliance for Pediatric Device Innovation (APDI)minorStrategic or Co-development PartnerAPDI listed as a partner and champion supporting PolyVascular's pediatric device development and innovation mission.

Scale indicators10 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Medtronic: Medtronic's Harmony transcatheter pulmonary valve and Melody valve are the closest direct competitors to PolyVascular's pediatric transcatheter pulmonary valve. Both target pulmonary valve dysfunction, though Medtronic's products are approved for older children and adults, leaving a gap PolyVascular aims to fill.

Broad incumbents

• Edwards Lifesciences: Edwards Lifesciences is the dominant incumbent in transcatheter heart valves with the Sapien platform across multiple valve positions. As the structural heart market leader, Edwards represents both the long-term platform opportunity for PolyVascular and the most formidable competitive threat.
• Abbott: Abbott's structural heart portfolio includes transcatheter valve technologies (Portico, Navitor) and MitraClip. Its broad cardiovascular device presence and hospital relationships make it a key incumbent peer as PolyVascular targets the transcatheter valve market.
• Boston Scientific: Boston Scientific has expanded into structural heart through acquisitions and internal development. Its ACURATE neo2 and Watchman FLX platforms demonstrate active competition in transcatheter cardiovascular devices, and the company previously acquired PolyVascular board member Girouard's prior firm.

Emerging players

• JenaValve Technology: JenaValve is developing transcatheter aortic valve replacement (TAVR) technology with a focus on aortic regurgitation. As an emerging structural heart company pursuing transcatheter valve indications, it is comparable in stage and category to PolyVascular.
• Venus Medtech: Venus Medtech is a Chinese-based emerging player in transcatheter heart valves with products approved in China and pursuing global expansion. Comparable as an emerging structural heart company developing transcatheter valve platforms.
• 4C Medical Technologies: 4C Medical is developing transcatheter mitral valve replacement technology using a unique partial annulus design. As an early-to-mid-stage structural heart company pursuing a specific valve indication, it shares a development profile with PolyVascular.
• CroíValve: CroíValve is an Irish startup developing a transcatheter tricuspid coaptation valve technology. Comparable as an early-stage European structural heart company focused on a specific valve position with limited capital and team.
• Anteris Technologies: Anteris Technologies (formerly Admedus) is developing the DurAVR transcatheter aortic valve system using a single-piece biomimetic design. Comparable as an emerging structural heart company pursuing transcatheter valve innovation.
• HighLife Medical: HighLife Medical is developing a transcatheter mitral valve replacement system with a distinctive transapical approach. Comparable as an early-stage structural heart company pursuing a specific valve indication in transcatheter delivery.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/polyvascular
• Xx.com/PolyVascular

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds5 records

Investors3 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 PolyVascular