Provisional Patent Filed — USPTO Oct 2025

Seeing the Heart.
Beyond the Surface.

First-in-class multimodal intracardiac catheter unifying three sensing technologies with AI-powered real-time tissue classification.

0K+ Heart failure diagnoses/year (US)
$56B Global cardiac device market
~3 Yrs Avg diagnostic delay for amyloidosis
≤100ms AI tissue classification latency
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Silent diseases. Invisible damage.

Cardiovascular disease remains the leading cause of mortality worldwide. Conditions like cardiac amyloidosis and myocardial fibrosis progress silently — often undetected until irreversible damage has occurred.

No existing intracardiac tool simultaneously characterizes the biochemical, electrical, and mechanical state of heart muscle in real time at the point of contact during a live procedure.

Three modalities. One catheter.

An 8 Fr deflectable catheter integrating hyperspectral optics, bio-impedance mapping, and piezoelectric micro-elastography — fused by CardioSpectra-AI™ for real-time 3D tissue classification.

01

Hyperspectral Optics

450 – 1000 nm · VIS–NIR

Chromophore content, autofluorescence & scattering coefficients. Detects amyloid deposits, collagen density, and ischemia markers at molecular level.

2× 150 μm Silica Fibers 300 μm Collection GRIN Lens 0.25p AR-Coated Sapphire
02

Bio-Impedance Mapping

Pt-Ir Electrodes · 4-Ring Array

Tissue conductivity & cellular integrity profiling. Maps electrical substrate, distinguishes scar from border zone with contact-quality feedback.

Platinum-Iridium 4× Circumferential 150 μm Ring Width LSTM Encoder
03

Piezoelectric Elastography

0.5 – 5 MHz · PZT + PVDF

Myocardial stiffness (kPa), shear wave velocity & viscoelasticity. Quantifies fibrosis (25–60 kPa) and amyloid infiltration (60–100+ kPa).

200 μm PZT Disc PVDF / PMN-PT 0.5–5 MHz Range Dense Layer
CardioSpectra-AI™ · Late-Fusion Deep Network
Optical CNN Encoder
+
Impedance LSTM
+
Stiffness Dense Layer
Cross-Attention Fusion
Tissue Classification
≤100 ms ≥90% Classification Target

Spectral Tissue Signatures

Pathology Spectral Signature Stiffness
Normal Myocardium Baseline reflectance 10–20 kPa
Cardiac Amyloidosis Elevated scatter 600–750 nm 60–100+ kPa
Myocardial Fibrosis Increased NIR 700–900 nm 25–60 kPa
Ischemia / Hypoxia Drop in oxy/deoxy-Hb 540/580 nm 8–15 kPa

Four platforms. One ecosystem.

Flagship · EP Lab

CardioSpectra™ Catheter

8 Fr deflectable catheter with real-time 3D tissue classification. Compatible with existing EP infrastructure — no new capital equipment required.

  • Real-time classification: Normal / Fibrotic / Amyloid / Ischemic
  • Micro-channel for biopsy, ablation, or drug delivery
  • FDA pathway: 510(k) / De Novo
Smart Implant

CardioSpectra-Lite™

Miniaturized sensing in pacemaker leads. Continuous myocardial monitoring with <1% duty cycle.

  • Multispectral indices for amyloid/fibrosis surrogates
  • Micro-elastography stiffness tracking
  • OEM pathway: Medtronic, Abbott, BSC
SaMD Platform

FusionSuite™

Real-time Electro-Structural Digital Twin with graph-neural-network tissue classification and confidence-weighted mapping.

  • Lesion depth & transmurality prediction
  • Signal reliability scoring
  • Advisory-mode: augments clinician judgment
AI Analytics

Nexus™

Population-level analytics platform. Multi-center learning for model improvement and drift detection.

  • Catheter performance analytics
  • HIPAA / GDPR compliant cloud
  • SaMD subscription platform

96-month pathway. Concept to commercialization.

Phase 01
0 – 6 mo

Feasibility & Concept

System architecture, phantom testing, provisional patent filed, SBIR Phase I proposal.

Phase 02
6 – 18 mo

Prototype Development

Optical subsystem, sensor integration, bench-test cardiac phantoms, early AI classifier.

Phase 03
18 – 30 mo

Preclinical Validation

Porcine/bovine studies, histology correlation, AI fusion model V2, ISO 13485 prep.

Phase 04
30 – 48 mo

Clinical Feasibility

First-in-Human (n≈20), FDA Pre-Submission, QMS implementation, Series A.

Phase 05
48 – 72 mo

Pivotal Trials & FDA

Multicenter trial (n≈100–150), 510(k)/De Novo, FusionSuite beta at 5 sites.

Phase 06
72 – 96 mo

Commercial Launch

FDA clearance, CE Mark EU, Lite OEM launch, global SaaS rollout.

USPTO Patent Filed
NIH SBIR In Progress
FDA 510(k) / De Novo
ISO 13485
CE Mark (EU)
HIPAA / GDPR

Physician-led innovation.

KS

Krtin Singhal, MD

Inventor · Principal Investigator

Physician-innovator and cardiovascular medicine specialist at Brookdale University Hospital Medical Center, Brooklyn, NY. Combines deep clinical insight in cardiology with a rigorous engineering approach to medical device innovation.

USPTO Patent Inventor NIH SBIR PI Brookdale UH
VP

Vikaskumar Patel, MD

Co-Investigator · Brookdale University Hospital

AB

Adarsh Balaji, MD

Co-Investigator · Brookdale University Hospital

Affiliation Brookdale University Hospital Medical Center
Patent USPTO Provisional — Oct 2025
Grant NIH SBIR Phase I In Progress

Scientific foundation.

Draft Manuscript

CardioSpectra: A Multimodal Intracardiac Platform for Real-Time Optical, Electrical, and Mechanical Myocardial Tissue Characterization

Singhal K, Patel V, Balaji A

Target: JACC Clinical Electrophysiology

Conference

NYACC Shark Tank 2025 — Selected Presentation

New York Area Cardiology Conference

Presented to panelists · 2025

NIH Abstract

NIH SBIR Phase I — Innovation & Significance Submission

Singhal K (PI)

Demonstrating clinical and scientific merit

Conference Target

TCT 2026 — Abstract Submitted

Transcatheter Cardiovascular Therapeutics

Cardiovascular interventional conference

Referenced Literature

Platform grounded in 15+ peer-reviewed studies including TOCCASTAR, DECAAF, Fire-and-Ice, SMART-SF, and foundational cardiac spectroscopy research.

Partner with CardioSpectra.

We welcome inquiries from clinical collaborators, research partners, and industry leaders interested in advancing intracardiac diagnostics.

Brooklyn, NY
Brookdale University Hospital Medical Center