Investor Brief – Pediatric Pulmonary Valve
Series A Opportunity • Exit $250M Midpoint Back to DashboardExecutive Summary
The pediatric pulmonary valve market is a niche but high-impact opportunity: U.S. TAM of $125–140M in 2025 trending toward $180–200M by 2030, with global expansion from $300M in 2024 to $677M in 2035. Autus Valve’s growth-accommodating design addresses a $2.2M lifetime patient cost burden and is positioned for trade sale at $150–400M, midpoint $250M.
Investment Thesis
- Current prosthetic valves cannot grow; average patient incurs 2–3 re-ops before adulthood and $2.2M lifetime cost burden.
- Autus Valve: one-time surgical implant + serial cath expansions; FDA Breakthrough designation; pivotal study active.
- Premium ASP justified by avoided surgeries and payer HEOR dossier.
Valuation Anchors
- Series A: $30M pre / $45M post, $15M raise.
- Ownership: 33.3%, with 15% ESOP.
- Exit target: $250M midpoint (range $150–400M).
Multiples by Stage
| Stage | Valuation Range | Median |
|---|---|---|
| Pre‑rev (Breakthrough) | $12–80M | ~$20M |
| Clinical (positive data) | $5–75M | ~$14M |
| Commercial specialty | $3–63M | ~$16M |
Use of Proceeds (18–24 months)
- Clinical: pivotal study execution (sites, monitoring, core lab).
- Regulatory: IDE maintenance, PMA planning, interactions.
- Manufacturing: process validation, sterilization, supply chain scale-up.
- HEOR/Market: dossier, KOL engagement, reference centers.
- BD: strategic partnership discussions ahead of PMA.
Competitive Positioning
Autus is uniquely positioned vs. Medtronic (fixed-size Melody/Harmony) and emerging players (Renata, PECA, PolyVascular, Xeltis). Only Autus directly addresses growth accommodation with synthetic durability.
Competitive Landscape
- Autus Valve: growth-accommodating synthetic valve; pivotal trial active.
- Medtronic Melody/Harmony: FDA-approved TPVs; fixed-size tissue valves.
- Renata Medical: Minima stent; FDA-approved growth-accommodating stent.
- Xeltis: restorative bioabsorbable conduit; EU pivotal.
- PECA Labs: MASA surgical conduit; early feasibility IDE.
- PolyVascular: polymeric TPV for young children; early clinical.
- Annoviant: TxGuard regenerative conduit; NIH-backed, early clinical.
Recent M&A Comps
| Acquirer | Target | Year | Value |
|---|---|---|---|
| Edwards Lifesciences | CardiAQ Valve Technologies | 2015 | $320M |
| Boston Scientific | Apama Medical | 2017 | $300M |
| Abbott | Cardiovascular Systems Inc. | 2023 | $851M |
| Johnson & Johnson | V-Wave | 2024 | $600M upfront (+ milestones) |
Risks
- Durability risk: multi-expansion fatigue/calcification must be validated.
- Regulatory: PMA timeline is long; pivotal follow-up up to 10 years.
- Niche pediatrics: small patient pool.
Mitigants
- Bench/animal + pivotal trial designed to stress-test expansions.
- Breakthrough Device designation expedites FDA engagement.
- Premium pricing; crossover to adult congenital and global markets.
Cap Table Snapshot (Series A)
| Holder | Pre-A % | Post-A % |
|---|---|---|
| Founders & Early Holders | 77.5% | 51.7% |
| ESOP | 22.5% | 15.0% |
| Series A Investors | — | 33.3% |
Exit IRR Math
- Exit: $250M midpoint.
- Ownership: 33.3% at close → 30% at exit (10% dilution).
- 5× MOIC → ~31% IRR over 6 years.
Fund Benchmark Context (Q4 2024)
Global medtech and healthcare-focused venture funds delivered median net TVPI of ~1.4× and IRRs in the 12–15% range in Q4 2024, per industry reports. Top-quartile healthcare/medtech funds posted 2.0–2.5× net TVPI with IRRs above 20%. These benchmarks contextualize Autus Valve’s Series A opportunity, where a 5× MOIC and 30%+ IRR on a $250M exit midpoint materially outperforms recent sector norms, aligning with Broadview’s mandate to back high-impact, high-return pediatric innovations.