Market Sizing (Top‑Down & Bottom‑Up)

Global Cardiovascular Devices – Public anchor (Grand View Research; IMARC; Fortune Business Insights; TowardsHealthcare)
Public range for context: $60–75B (2024 base); ~6–8% CAGR to 2032–2034.
Sourced from public summaries; used as a deck‑safe anchor range. Our internal Statista‑licensed anchor ($74.7B / 7.5%) sits at the top of this band.
Statista (2024) – Global Cardiovascular Devices Internal
Key figures used internally: $74.7B 2024 baseline; ~7.5% CAGR to 2035.
Use for internal modeling only; in external materials cite the public range above.
BCC Research (HLC/MDS series) – Pediatric subset Internal
Working assumption (internal): Pediatric cardiac devices ≈ ~4% of CV devices (~$3.0B in 2024); CAGR ~8.5%; pediatric PPV share ≈ ~10%.
No public breakout available from BCC pages; treat as Osprey assumption derived from licensed content and epi mapping.
Transcatheter Pulmonic Valves (TPV) – Category guardrails Public anchor (Grand View Research; Expert Market Research; MetaTech Insights)
Directional band: ~$70–100M (2023–2024) with ~6–8% CAGR toward early–mid 2030s; scope varies by source.
Use as public guardrails for the category; does not equal pediatric PPV subset.
Pediatric PPV devices – Internal model Internal
Model anchor: ≈ $300M (2024) → $677M (2035); CAGR ~8.6%.
No exact public match; show build‑up (volumes × ASP × mix) in appendix; cross‑check against TPV guardrails.
U.S. Pediatric Pulmonary Valve – Top‑Down Sizing Internal
U.S. TAM $125–140M (2025); ≈ 3,800 annual interventions; 5–8% CAGR → $180–200M by 2030.
Label “Osprey model (internal)”; grounded in CHD/RVOT epidemiology and center‑level volumes.
Pediatric PPV Canvas (Top‑Down vs Bottom‑Up) Internal
2025 realized revenue ≈ $65–70M; strategic TAM ≈ $133M (3,800 × $35k ASP).
Maintain in appendix with ASP ±20% sensitivity and surgical/TPV mix toggles.

Epidemiology & Burden

Hoffman JIE, Kaplan S. JACC (2002).
Key figures used: CHD incidence baseline widely cited for modeling prevalence.
Secondary: Osprey Intel research and analysis – epidemiology worksheet.
van der Linde D, et al. JACC (2011).
Key figures used: Global birth prevalence long‑run trend.
Secondary: Osprey Intel research and analysis – global→U.S. scaling.
Liu Y, et al. Int J Epidemiol (2019).
Key figures used: Global birth prevalence 1970–2017 meta‑analysis; defect‑level prevalence.
Secondary: “CHD vs Pulmonary Valve Disease” data explanation.
Mai CT, et al. Birth Defects Res (2019).
Key figures used: U.S. defect‑specific prevalence; used to allocate RVOT cohort (~16% of CHD).
Secondary: Pediatric CHD Sources Packet – cohort mapping.
Gilboa SM, et al. Circulation (2010).
Key figures used: U.S. CHD mortality trend; informs lifetime cohort curve.
Secondary: Osprey Intel research and analysis.
Additional Ventures (HEOR, 2024).
Key figures used: Lifetime cCHD cost ≈ $2.2M per patient; ≈ $650k in first 5 years.
Secondary: IC memo – burden of illness slide.

Standard of Care & Technologies

Medtronic Melody / Harmony – FDA PMA Summaries & Labeling.
Key details used: Fixed‑size tissue TPVs; indication constraints by anatomy; durability outcomes across follow‑up.
Secondary: Competitive Landscape – Autus vs. Medtronic.
Science Translational Medicine (2020) – Growth‑Accommodating Valve Prototype.
Key details used: Serial expansion concept; maintaining leaflet performance across sizes.
Secondary: Autus engineering notes.
Renata Minima™ Stent – FDA Approval & GROWTH Pivotal.
Key details used: First FDA‑approved pediatric growth‑accommodating stent; expansion profile and early outcomes.
Secondary: Osprey Intel research and analysis.
Xeltis Restorative Valved Conduit – EU Clinical Disclosures.
Key details used: Endogenous tissue restoration; EU pivotal pathway.
Secondary: Market landscape notes.

Regulatory & Funding Pathways

FDA – PMA / HDE / Breakthrough Device programs.
Key details used: PMA Class III standard; HDE <8,000/year, probable benefit, pediatric profit allowance; Breakthrough interactions across IDE/PMA.
Secondary: Regulatory Overview (updated) – submission checklist.
NIH/NHLBI, Pediatric Device Consortia (UCSF‑Stanford PDC, CTIP, APDI, SWPDC).
Key details used: non‑dilutive funding & technical guidance for pediatric devices.
Secondary: Investor Brief – funding strategy.

Company & Pipeline

ClinicalTrials.gov – NCT05006404 (Autus Valve Pivotal).
Key details used: Pediatric cohort eligibility; primary endpoints; long‑term follow‑up (up to 10 years).
Secondary: Autus trial dashboard.
Autus Valve – U.S. Patents & Breakthrough Designation (2023).
Key details used: Size‑adjustable frame; leaflet performance across expansions; Breakthrough status for pediatric indication.
Secondary: Autus company overview dashboard.
PECA Labs – MASA Conduit (IDE EFS); PolyVascular, Annoviant.
Key details used: Growth‑accommodating conduit; polymer and regenerative alternatives in early clinical stages.
Secondary: Competitive landscape notes.

M&A Comps & Valuation

Edwards–CardiAQ (2015).
Key details used: $320M transaction; novel valve tech benchmark.
Secondary: IC memo – comps table.
Boston Scientific–Apama (2017).
Key details used: $300M transaction; structural heart innovation.
Secondary: IC memo – comps table.
Abbott–Cardiovascular Systems (2023).
Key details used: $851M transaction; interventional device scale.
Secondary: Investor Brief – comps section.
Johnson & Johnson–V‑Wave (2024).
Key details used: $600M upfront (+ milestones; up to $1.1B); cardiology exit precedent.
Secondary: Investor Brief – comps section.

Guidelines & Registries

2018 AHA/ACC Adult Congenital Heart Disease Guideline.
Key details used: Adult congenital follow‑up expectations and intervention triggers; informs lifetime management.
Secondary: Standard of care notes.
2020 ESC Adult Congenital Heart Disease Guideline.
Key details used: European guidance parallels; registry follow‑up expectations.
Secondary: Osprey Intel research and analysis.
STS Congenital Heart Surgery Database – Annual Reports.
Key details used: Center volumes and outcomes trend overlays for bottom‑up sizing.
Secondary: Market models – bottom‑up worksheet.

Patents & IP

US 11,969,342 B2 – Growth‑Accommodating Prosthetic Heart Valve.
Key details used: Expansion range and leaflet performance limits.
Secondary: Autus patent analysis notes.
US 10,966,826 B2 – Pediatric Heart Valve Technologies.
Key details used: Valve structure and pediatric‑specific features.
Secondary: Autus patent analysis notes.
US 12,004,948 B2 – Related Autus Valve IP.
Key details used: Additional claims supporting growth accommodation.
Secondary: Autus patent analysis notes.

Internal Osprey Materials

Osprey Intel research and analysis.
Key details used: Consolidated models (top‑down & bottom‑up), epidemiology mapping, ASP & volume assumptions, HEOR synthesis.
Investment Committee Memo – Pediatric RVOT Lesion Management.
Key details used: Exit scenarios ($150–400M), $250M midpoint, valuation framework.
Pre‑Money Valuation (VC Method) & Pro‑Forma Cap Table.
Key details used: $30M pre / $45M post; 33.3% investor stake; 15% ESOP; IRR/MOIC math.
Pediatric Pulmonary Valve Canvas & Competitive Landscape Notes.
Key details used: Autus vs. Medtronic positioning; pipeline company profiles; risk/mitigant mapping.
© 2025 Osprey Intel LLC • Expanded references with annotated primary-source figures. Use Ctrl/⌘+F or the search box (/) to find entries.