# Acoustic-anatomic modeling and development of a patient-specific wearable therapeutic ultrasound device for peripheral arterial disease

> **NIH NIH R43** · VIBRATO MEDICAL, INC. · 2023 · $300,000

## Abstract

PROJECT SUMMARY
Peripheral arterial disease (PAD) is a highly prevalent condition that is growing rapidly due to shifting
demographics, affecting 202M people worldwide and 18M in the USA, with an annual growth rate of 6.8%.
Early stages of PAD result in claudication, while the advanced stage of PAD results in resting pain, skin ulcers,
gangrene and amputation, all of which reduce mobility, function and independence of seniors. Advances in
catheter-based therapies including angioplasty, stenting, and drug-coated balloons, as well as surgical bypass
treatments, are often ineffective in PAD and associated with complications and up to 40% rate of long-term
restenosis.
Acoustic energy modalities such as therapeutic ultrasound (TUS) have been shown to promote collateral
vessel growth, angiogenesis, and to improve perfusion in animal models of coronary artery disease and PAD,
with promising early human data in both disease processes. Vibrato Medical has developed a novel treatment
with the first wearable therapeutic ultrasound (TUS) device for the non-invasive, outpatient treatment of PAD
that will promote collateral vessel growth and angiogenesis, restore perfusion and reduce amputation rates.
We have already demonstrated VibratoSleeve’s efficacy in markedly improving lower extremity perfusion in
healthy volunteers using multiple perfusion measures with as little as 30 minutes of therapy over the posterior
calf. However, this was done with a device of a single size/frequency regardless of patient size, and patients at
the extremes of size may not have optimal safety and efficacy.
The goal of this Phase 1 SBIR proposal is to systematically measure depths of subcutaneous fat,
gastrocnemius/soleus muscle, posterior tibial artery and bone from the VibratoSleeve’s posterior calf approach,
and over a wide range of patient sizes. These anatomic measurements will be used to inform acoustic
simulations, that will then predict the size and frequency of transducers needed to provide safe and effective
therapy to the posterior tibial angiosome. Candidate transducers will be assembled based on simulation data,
and incorporated into 16-transducer VibratoSleeve arrays in a commercially viable manner.

## Key facts

- **NIH application ID:** 10603253
- **Project number:** 1R43HL167492-01
- **Recipient organization:** VIBRATO MEDICAL, INC.
- **Principal Investigator:** Juliana Elstad
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $300,000
- **Award type:** 1
- **Project period:** 2023-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10603253

## Citation

> US National Institutes of Health, RePORTER application 10603253, Acoustic-anatomic modeling and development of a patient-specific wearable therapeutic ultrasound device for peripheral arterial disease (1R43HL167492-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10603253. Licensed CC0.

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