VascoMap - Whole-Body 3D Clot Visualization Platform

The Problem Being Solved

• Venous duplex ultrasound - operator-dependent, only images one segment at a time, misses ~20% of calf DVTs
• CT angiography (CTA) - ionizing radiation, iodinated contrast (nephrotoxic), expensive (~$1,500-3,000/scan), no bedside use
• MRI venography - expensive, slow, not portable
• D-dimer - blood test, non-specific, generates massive false-positives

The Technology Stack (Multi-Modal Fusion)

1. Ultrasound Tomography (UST)

• Uses a ring-array transducer that wraps around a limb or torso segment
• Transmits and receives acoustic waves from 360 degrees simultaneously
• Generates true 3D cross-sectional maps of vessel lumen, wall, and intraluminal mass (clot)
• Thrombus has distinct acoustic impedance from flowing blood - detectable via speed-of-sound and attenuation maps
• Key advantage: No operator-dependency. Full volumetric reconstruction, not a 2D B-mode slice
• Current UST companies (Delphinus Medical, QT Ultrasound) focus on breast - no vascular UST product exists

2. Near-Infrared Spectroscopy (NIRS) / Diffuse Optical Spectroscopy (DOS)

• Wavelengths 700-1000 nm penetrate 2-6 cm into tissue
• Hemoglobin oxygenation and total blood volume are chromophores - clot changes local [HbO2] and [Hb]
• Deoxyhemoglobin signature in a clotted segment differs from flowing blood
• DOS (broadband 650-1000 nm) adds lipid and water spectral features - fibrin-rich thrombus has a distinct optical signature vs. flowing blood
• Key advantage: Real-time, completely non-ionizing, no contrast agent, wearable form factor possible
• Current NIRS is used in cerebral oximetry (CASMED, Medtronic INVOS) - NOT for peripheral vascular thrombosis

3. Photoacoustic Imaging (PAI) - the fusion layer

• Pulsed laser (NIR wavelength) heats tissue selectively; thermal expansion generates ultrasound waves detected by the UST ring array
• The SAME ring array used for UST also detects photoacoustic signals
• This co-registration means optical (spectral clot chemistry) and acoustic (structural anatomy) data are inherently spatially aligned
• Achieves resolution of ~200 microns at depths of 3-5 cm - sufficient to resolve thrombus vs. vessel wall vs. lumen

Product Architecture

Sensor Ring (per body segment)
    ├── 256-element piezo UST array (360° acoustic)
    ├── 4x fiber-optic laser delivery bundles (670, 750, 850, 940 nm)
    └── Broadband photodetector array (DOS channel)

Body Coverage System
    ├── 6 sliding ring apertures (wrist → ankle, neck → pelvis)
    ├── motorized gantry (like a lightweight CT table, ~30 min whole-body scan)
    └── Wireless data to edge compute unit

Reconstruction Engine (GPU/FPGA)
    ├── Acoustic CT reconstruction (speed-of-sound, attenuation)
    ├── Photoacoustic 3D beamforming
    ├── DOS spectral unmixing (oxy/deoxy-Hb, lipid, water, fibrin index)
    └── Multi-modal fusion → single voxel volume

AI Diagnostic Layer
    ├── Clot segmentation (3D U-Net trained on CT angiography ground truth)
    ├── Age-of-thrombus estimation (acute vs. chronic - different fibrin/RBC composition)
    ├── Clot burden score (total volume, location mapping)
    └── Risk stratification output (PE risk, propagation likelihood)

Clinical Output
    └── Interactive 3D vascular atlas (web/tablet) with highlighted clot zones

Why This is Scientifically Feasible

Clinical Use Cases

1. Emergency triage - rapid DVT/PE screening in ED without CT radiation
2. ICU monitoring - continuous clot surveillance in sedated patients (stroke, post-surgical)
3. Oncology - cancer patients have 4-7x DVT risk; replace serial Doppler surveillance
4. Post-thrombectomy monitoring - confirm clot clearance without repeat CTA
5. Anticoagulation therapy monitoring - track thrombus resolution over days/weeks non-invasively
6. Aortic/peripheral arterial disease - arterial thrombus in PAD, aortic dissection flap visualization

Competitive Landscape & White Space

IP Strategy

1. Ring-aperture UST + fiber PAI co-registered system for vascular lumen imaging
2. Spectral DOS unmixing method for fibrin index quantification
3. Multi-modal fusion algorithm (acoustic CT + photoacoustic + diffuse optical)
4. Thrombus age classification AI model
5. Wearable continuous NIRS patch for post-surgical DVT monitoring (line extension)

Regulatory Pathway

• FDA Class II (510(k)) - predicate: vascular ultrasound systems (most likely path, 12-18 months)
• Alternatively De Novo if no clear predicate for the multi-modal combination (~24 months)
• CE Mark (EU MDR Class IIb) in parallel
• Clinical validation study: 200-patient prospective trial vs. CTA/duplex as gold standard
• IRB sites: academic vascular surgery programs (Johns Hopkins, Mayo, Cleveland Clinic)

Go-to-Market

• Partner with 3-5 academic medical centers
• Focus on DVT/PE screening (largest immediate market)
• Revenue model: capital equipment ($250-400K per unit) + SaaS AI reads ($50/scan)

• Target: ICU, ED, vascular surgery suites
• Portable version for procedural labs

• NIRS-only wearable patch for continuous outpatient DVT monitoring post-surgery (orthopedic, cancer)
• Subscription model ($200/month per patient)

Market Size

• Global DVT/PE diagnostics market: ~$4.2B (2025), growing ~8% CAGR
• CTA contrast market alone: ~$1.8B (addressable replacement)
• Post-surgical DVT monitoring wearable TAM: ~$900M
• Total addressable market: $5-7B

Funding Roadmap

Team Needed

• CTO: PhD in acoustic imaging or photoacoustics (ex-iThera, Verasonics, or academic UST lab)
• CMO/Clinical Lead: Vascular surgeon or interventional radiologist with clinical trial experience
• Signal Processing Engineer: UST reconstruction + PAI beamforming
• AI Engineer: Medical image segmentation (3D U-Net, nnU-Net architecture)
• Regulatory Affairs Lead: FDA 510(k) experience in imaging devices
• Business Lead: MedTech commercialization (ex-Siemens Healthineers, Hologic)

Key Technical Risks & Mitigations

Bottom Line