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AI that unlocks leadless LBBAP today—and enables a septal “central hub” pacemaker tomorrow

A neutral, multi‑OEM platform that turns multi‑modal signals and imaging into real‑time guidance for leadless left bundle branch area pacing (LBBAP), and paves the way for an AI‑assisted leadless pacemaker at the interatrial, interventricular, and atrioventricular septa convergence (the central fibrous body).

Problem Solution Why now Phases Regulatory Business model Traction Team Ask

Quick facts

  • OEM‑neutral SaMD platform for leadless CSP
  • Real‑time targeting & capture‑verification
  • Guardrails: depth, perforation, conduction injury
  • Post‑implant closed‑loop optimization
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Problem

Conduction‑system pacing (CSP) is rising, but reliably achieving leadless LBBAP is non‑trivial. OEMs duplicate AI/analytics efforts while clinicians face high‑dimensional signals (intracardiac EGMs) and imaging (ICE/TEE/fluoro/CT). Safety—septal thickness, penetration depth, perforation, and conduction injury—adds complexity. To reach a future septal “central hub” leadless pacemaker at the central fibrous body, industry needs validated AI for navigation, capture, and optimization.

Solution

  • AI Mapping & Targeting – Fuses imaging + EGMs to produce a dynamic septal heat‑map, predicting optimal insertion vectors and depth for LBBAP.
  • Real‑time Capture Verification – Detects selective/non‑selective capture via morphology (e.g., V6 surrogates, stimulus‑to‑LVAT patterns, QRS changes).
  • Safety Guardrails – Risk scoring for perforation, conduction injury, thromboembolic events; proximity and thickness awareness.
  • Closed‑loop Optimization – Post‑implant adaptive output/rate‑response using patient‑specific electro‑mechanical signatures.

Why now

CSP adoption and leadless growth are converging. A shared, OEM‑neutral AI layer compresses time‑to‑market, reduces duplicated cost, and standardizes safety and validation.

Phases

Phase I (SaMD): Leadless LBBAP enablement—targeting & capture‑verification for EP labs (co‑dev + licensing).

Phase II (Device): AI‑assisted septal leadless pacemaker near the central fibrous body—physiologic coordination “hub.”

Regulatory & clinical

  • SaMD pre‑sub with FDA (CDRH); multi‑center prospective validation.
  • IDE/EFS path for Phase II device; endpoints: implant success, capture durability, hemodynamic response, safety.

Business model

  • Annual platform license + per‑procedure software fee.
  • Milestone‑based co‑development with royalties for integrations.
  • Clinical‑data services; Conduction‑System AI Consortium memberships.

Traction & milestones

  • LOIs from high‑volume EP centers for data/validation.
  • Prototype AUC & safety metrics on retrospective datasets; benchtop/phantom studies.
  • Targets: 2+ OEM MoUs; pre‑sub outcome letter; first‑in‑human SaMD guidance study start.

Team

Clinical EP advisors (CSP/LBBAP), imaging specialists; med‑device engineers (leadless fixation, energy delivery, telemetry); ML/AI experts in multi‑modal fusion and real‑time safety‑critical systems.

Raise & use of funds

Raising: $[X]M seed.

  • Data partnerships & curation – 35%
  • SaMD v1 & validation – 35%
  • Regulatory & quality systems – 15%
  • OEM BD & IP – 15%

KPIs to next round: SaMD clinical validation complete; ≥2 OEM codevelopment agreements; FDA pre‑sub feedback incorporated; pilot EP‑lab deployments.

Contact

Jesus Devesa • info@abcfarma.net • www.abcfarma.net

Last updated: September 10, 2025 • This one‑pager is an informational overview and not medical advice.