Our Timeline

Why We Must Act Now

Congenital Birth Defect

Most common birth defect: 2.4M in US

Infant Mortality

#1 Cause of birth defect related infant mortality

More Fatal than Cancer

Twice as many children die from CHD than all childhood cancers combined

Hearts to Mend

3,000
per year in US

$90M US Market

Using existing reimbursement codes and payment levels

102,000
per year in ROW​

$3.1B ROW Market

Traction We’ve Made

$3.3M Grants and Philanthropic funding

 

50,000+ development hours to date

2014

PolyVascular Founded
$675k in Donations & Awards

2020

NIH SBIR Phase II Grant: $2.4M
3-year Animal Study Complete

2022

Commercial Valve Development
Patent Issued on Design

2016

NIH STTR Phase I Grant: $225k
Prototype Valve Development

2021

Manufacturing Readiness
Full Time Team & Manufacturing

2023

6mo Animal Study
Gather Data for FDA Submission

Our Accelerated Path to Market

Seed: $6M
Clinical Readiness

  • Design Validation- 6mo Animal Study
  • Delivery System Development
  • FDA: Quarterly Pre- Subs and Clinical
Trial (IDE) Approval

  • FDA: Humanitarian Designation

Series A: $12M
Clinical Study

  • Conduct Clinical Study
  • FDA: Breakthrough Designation

Series B: $6M
Go-to-Market

  • Build Sales & Marketing Team
  • FDA: HDE Submission
  • Commercial Launch

Our Accelerated

Humanitarian Path to Patients

Pursuing FDA’s Humanitarian Device Exemption (HDE) pathway that enables accelerated regulatory approval

For smaller markets where no treatments are available
Path to market is 5 years from commercial design instead of typical 10-15 years with Premarket Approval (PMA)

Our Technology

is an easy to use transcatheter pulmonary valve for young children