Light + sound therapy device for diabetic foot ulcers 

Improving patient outcomes with an automated photo-biomodulation & extracorporeal shockwave therapy device for faster and better healing

Raising: Pre-Seed Round of €50K to enable €1.5M grant-funding

The problem: DFU is common, costly, and deadly

People affected annually

18.6M

Worldwide

Annual U.S. patients

1.6M

New DFU cases/year

People affected annually

18.6M

Worldwide

Economic burden (U.S.)

$9-13B

incremental annual payer cost above diabetes care

The opportunity scalable, repeatable clinic workflows that speed healing and reduce downstream complications

Clinic care today is time- and labor-intensive

Why DFUs remain hard to treat at scale

Standard care is effective but labor-heavy and advanced adjunct therapy options often don't fit routine workflows

Clinic reality

  • Debridement, offloading, dressings, infection control, vascular workups

  • High visit cadence; variable clinician technique

  • Slow closure → recurrence risk and frequent complications

  • Typical 24-week treatment duration

Common gaps with adjunct therapies

  • Bulky systems and setup time not aligned to outpatient workflows

  • Hard to target repeatably across clinicians and visits

  • High cost and complex supply chains can limit adoption

We need a more effective and automated adjunct DFU therapy that fits seamlessly into existing clinical workflows

Our solution

A point-of-care platform that brings repeatable and automated “sound + light” therapy into routine DFU visits, with high clinical efficacy

  • Dual, complementary modality

    Photobiomodulation (PBM) and focused shockwave therapy (ESWT) delivered in one streamlined procedure

  • Standardized targeting

    Foot-shaped cradle positions the wound consistently visit-to-visit, independent of operator technique

  • Automated therapy administration with AI

    Image-based AI-targeting of treatment zones enables seamless automation of therapy

Designed to integrate into existing DFU clinical pathways in ≤20 minutes per visit

Our product: Lumipulse

AI-automated Light- and Sound Therapy device for DFUs

  • First-of-its-kind combination of photo-biomodulation therapy (PBM) and extracorporeal shockwave therapy (ESWT)

  • Automated therapy administration to reduce workflow burden

  • Fits seamlessly into existing outpatient DFU workflows as an adjunct therapy

Current state of product: Concept design, patent filed, existing miniaturized ESWT-technology licensed

Workflow: built for routine DFU clinic visits

Fast setup, standardized positioning, and automated therapy administration.

  • 1. Position

    Place foot into cradle (targets plantar ulcers)

  • 2. Couple

    Apply disposable coupling pad (acoustic consistency)

  • 3. Treat (ESWT)

    Focused ultrasound therapy pulses (~10 min)

  • 4. Treat (PBM)

    Red + NIR light dose (~10 min)

  • 5. Document

    Auto log: presets, dose, operator, timestamp

Designed for throughput

  • ≤20 minutes add-on to a routine DFU visit

  • Automated therapy; only setup time required from clinic

Clinical rationale

Both ESWT and PBM have been clinically shown to improve DFU care – Lumisonix is combining & automating the two therapies in one device

Photobiomodulation (PBM)

  • Red + near-infrared light can modulate inflammation and support cellular energy processes (adjunct).

  • Controlled randomized DFU trials reports a tendency toward faster ulcer area reduction vs control with an odds ratio of 6.72

Focused ESWT (shockwave)

  • Mechanical stimulus that can promote tissue repair signaling, angiogenesis, and remodeling (adjunct to standard care).

  • Systematic review/meta-analysis reports across 10 RCTs show 1.57x higher complete healing rates vs standard of care

What Lumisonix adds vs. incumbent ESWT devices

Automated therapy → consistent energy delivery visit-to-visit.

Core thesis: Combining ESWT + PBM in a single clinic workflow will improve treatment effect due to complementary mechanisms of action and automated therapy will improve adoption rates

Appendix

Go-to-market
Total Addressable Market
Beachhead market size
Pricing
Summary of clinical literature on efficacy of PBM and ESWT
Competitive landscape
Intellectual Property