Consolidated Deep Dive Dashboard

Updated: Sep 8, 2025 ← Back to Index

Total Addressable Market (U.S.)

$125–140M
2025 TAM; trending to ~$180–200M by 2030

Global Market Outlook

$677M
Projected global 2035 PPV/conduits

Core Unmet Need

Repeat Surgeries
Growth → multiple re-ops; durability & expansion are key

What’s in this Summary

This single-page dashboard consolidates insights from 11+ reports into the exact areas Broadview requested: care standards & gaps, new approaches, regulatory requirements (FDA PMA/HDE/Breakthrough/IDE), market & exits, and the thought-leader/pub landscape. Use the left rail to open full appendices.

Tip: press Ctrl/⌘ + F to search, or use the quick filter above.

Quick Links

FDA Requirements → VC & Exits → Competitive Matrix → KOLs & Key Pubs →

Standard of Care & Unmet Needs

Treatment Paradigm Today

  • Surgical RV-PA conduits and transcatheter pulmonary valves (TPVs) for select anatomies.
  • Biologic (homograft/xenograft) vs. synthetic (ePTFE, polymer) options.
  • Constraint: fixed-size devices in growing children → reinterventions.

Top Unmet Needs

  • Growth accommodation (repeat balloon expansion without valve failure).
  • Durability under multiple expansions & pediatric hemodynamics.
  • Compatibility across native/repaired RVOT anatomies and sizes.
  • Minimize re-ops; enable transcatheter management over time.

New Approaches & Competitive Landscape

Landscape Matrix (selected)

Company Approach Growth Capability Stage Notes
Autus Valve Size-adjustable synthetic valve (surgical; balloon-expandable) ✔ Growth-accommodating U.S. pivotal (IDE); Breakthrough First-in-human 2021; pediatric-focused design
Medtronic Melody / Harmony Transcatheter pulmonary valves Fixed-size Approved (PMA) Established TPV options for suitable anatomies
Renata Medical Minima™ growth-accommodating pediatric stent ✔ Expandable FDA approved Useful adjunct for staged RVOT/PA interventions
PECA Labs MASA surgical RV-PA conduit ✔ Growth-accommodating concept Early feasibility (IDE) Synthetic conduit; U.S. EFS ongoing
Xeltis Restorative bioabsorbable valved conduit Tissue restoration EU pivotal Regenerative approach; long EU follow-up
PolyVascular Polymeric transcatheter PV (younger kids) Potential staged expansion Pre/early clinical Pediatric-first TPV concept
Annoviant TxGuard™ regenerative valved conduit Host remodeling Pre/early clinical NIH-backed; regenerative platform

Regulatory Environment – Requirements for FDA Approval

PMA (Class III Valves)

  • Demonstrate safety & effectiveness (durability, gradients, regurgitation, freedom from re-op).
  • Robust bench + animal data; clinical pivotal with long-term follow-up (often ≤10 yrs).
  • Examples: Medtronic Melody & Harmony TPVs.

HDE / HUD (Rare Pediatric)

  • <8,000 U.S. patients/year; show safety & probable benefit.
  • Pediatric devices can be sold for profit under HDE.
  • Useful when RCT-scale evidence impractical.

Breakthrough Device

  • For devices addressing life‑threatening/irreversible diseases with major advantages.
  • Expedited interactions/review; non‑substantive review benefits across IDE/PMA.

IDE, Timelines & Costs

  • IDE enables U.S. clinical studies (EFS → Pivotal).
  • Illustrative pace: ~26 months FIH → pivotal start; primary endpoints ~2–8 yrs by program.
  • Capital: pivotal programs typically $10M+; long‑term follow-up commitments common.

Market Dynamics, Investors & Exits

Market Snapshot

  • U.S. TAM: ~$125–140M (2025); projected ~$180–200M (2030).
  • Global: ~$300M (2024) → ~$677M (2035 projected).
  • Strategics: Medtronic, Edwards, Abbott, Boston Scientific.

Exit & Valuation Anchors

StageTypical RangeNotes
Pre‑rev (Breakthrough)$12–80M PMVMedian ≈ $20M
Clinical (positive data)≈ 2–7× last roundDe‑risked by IDE/pivotal data
Commercial specialty≈ 3–10× last roundNear‑term revenue
Revenue‑stage M&A≈ 4–8× revenueStructural heart comps
Selected comps: Edwards–CardiAQ ($320M), Boston Sci–Apama ($300M), Abbott–CSI ($851M), J&J–V‑Wave ($600M upfront).

Investor Landscape (selected)

Grants & Consortia

  • NIH/NHLBI SBIR/STTR; FDA grants
  • UCSF‑Stanford PDC; CTIP; APDI; SW PDC

Venture/Angels

  • Broadview Ventures; RA, Versant, Deerfield
  • BlueTree Angels; Life Science Angels

Strategics

  • Medtronic; Edwards; Abbott; Boston Sci

Thought Leaders & Key Publications

Key Opinion Leaders (selected)

  • Dr. Sophie‑Charlotte Hofferberth (Autus; PI)
  • Dr. Pedro del Nido (Boston Children’s)
  • Dr. Elazer R. Edelman (MIT/Harvard)
  • Dr. Jonathan Chen (CHOP)
  • Dr. Joseph Rossano (CHOP)
  • Dr. David Brown (Boston Children’s)
  • Drs. Toshiharu Shinoka & Christopher Breuer (Nationwide TEVG)

Key Publications & Registries

  • Science Translational Medicine (2020): growth‑accommodating valve prototype.
  • Mai et al. 2019; Hoffman & Kaplan 2002; van der Linde 2011; Liu 2019 (CHD epidemiology).
  • AHA/ACC 2018 Adult CHD Guideline.
  • Renata GROWTH pivotal (Minima stent) – FDA approved.
  • ClinicalTrials.gov: NCT05006404 (Autus pivotal).
Prepared for Broadview Ventures (Daniel Gottlieb) – Consolidated from project HTMLs & notebooks. This dashboard is designed to be the single entry point; use links in the left rail to open detailed appendices.