PolyVascular
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.
- Company typePrivate
- Founded2014
- HeadquartersHouston, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
PolyVascular firmographics
Firmographics- 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
PolyVascular industry classification
Industry- Product category
- Pediatric Heart Valves
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts) (HLAHAFAH)
Keywords
Where PolyVascular is headquartered
LocationHeadquarters
- HQ city
- Houston
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
PolyVascular business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Infrastructure
Revenue model
- 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
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Medical device pricing — not publicly disclosed |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
PolyVascular product offering
Product offeringCore 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
Companies that use PolyVascular
Customer profileSegments1 record
Ideal customer profiles1 record
PolyVascular technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
PolyVascular partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and minor.
- CobiCurecoreCobiCure, 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)minorPediatric 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 PDCminorListed as a partner and champion supporting PolyVascular's pediatric device innovation efforts.
- Alliance for Pediatric Device Innovation (APDI)minorAPDI listed as a partner and champion supporting PolyVascular's pediatric device development and innovation mission.
Scale indicators10 records
Recent moves6 records
Expansion highlights5 records
PolyVascular competitors and assessment
Company assessmentDirect 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
PolyVascular social profiles
Digital presencePolyVascular compliance and trust
Trust signalCompliance1 record
PolyVascular financial estimates
Financial estimateRevenue estimate
Valuation estimate
PolyVascular leadership team
Management profileNumber of profiles
Profiles10 records
PolyVascular funding detail
Funding detailFunding overview
Funding rounds5 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
PolyVascular M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about PolyVascular
What does PolyVascular do?
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.
Is PolyVascular a public or private company?
PolyVascular is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was PolyVascular founded?
PolyVascular was founded in 2014. It employs 1 to 10 people.
Where is PolyVascular based?
PolyVascular is headquartered in Houston, United States, in the North America region.
How does PolyVascular make money?
One revenue line is on record: transcatheter Heart Valve Device Sales.
Who are PolyVascular's main competitors?
Medtronic is listed as a direct peer. Broad incumbents are Edwards Lifesciences, Abbott and Boston Scientific. Emerging players are JenaValve Technology, Venus Medtech, 4C Medical Technologies, CroíValve, Anteris Technologies and HighLife Medical.
Does PolyVascular have an API?
No public API is recorded for PolyVascular.
What industry is PolyVascular in?
PolyVascular's product category is Pediatric Heart Valves. Its primary akta.pro industry code is HLAHAFAH, Cardiac Surgery Devices (Cannulas, Clamps, Closure, Grafts). Its SIC code is 3841.