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
$675k in Donations & Awards
2020
NIH SBIR Phase II Grant: $2.4M
3-year Animal Study Complete
3-year Animal Study Complete
2022
Commercial Valve Development
Patent Issued on Design
Patent Issued on Design
2016
NIH STTR Phase I Grant: $225k
Prototype Valve Development
Prototype Valve Development
2021
Manufacturing Readiness
Full Time Team & Manufacturing
2023
6mo Animal Study
Gather Data for FDA Submission
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
