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Market Positioning

Problem

HF patients prioritize quality of life (breathing, swelling, mobility). Regulators increasingly accept QoL improvements as endpoints in approvals. The incumbent KCCQ is episodic (2‑week recall), subject to bias, and shows ceiling/floor effects — limiting trial sensitivity and clinical utility.

Solution

A continuous, AI‑powered QoL platform that augments KCCQ with ambient signals from speech, behavior, wearables, and context. Converts unstructured interactions into digital biomarkers and interpretable QoL scores suitable for trials and care.

Differentiation

  • Beyond ePRO: not just digitized surveys; extracts insights from natural interactions.
  • Beyond wearables: captures subjective experience (dyspnea, fatigue, mood, social).
  • Regulator‑aligned: produces versioned, auditable endpoints, exportable as FHIR MeasureReport / EDC‑ready.
  • Clinician‑first: interpretable domains; conservative alerting.

Market

  • Customers: Pharma, CROs, health systems running cardiology trials.
  • Why now: Regulatory shift toward QoL endpoints; pharma pressure for faster, cheaper trials; lack of strong incumbents in continuous, AI‑driven QoL.
  • Model: B2B SaaS or per‑patient licensing; KCCQ‑adjunct path lowers adoption friction.

Next Steps

  1. Pilot with academic site; demonstrate correlation to KCCQ and earlier decompensation detection.
  2. Publish; pursue CRO partnerships.
  3. Expand to oncology/COPD where QoL endpoints matter.