# Photoacoustic Tool to Improve Visualization and Success Rates in Sacral Neural Modulation Lead Placement

> **NIH NIH R43** · ACTUATED MEDICAL, INC. · 2024 · $331,416

## Abstract

In this Phase I SBIR, Actuated Medical, Inc. (AMI) will develop and demonstrate the feasibility of a
Photoacoustic Visualizer (PAV) system for greatly improving implantation accuracy of sacral neurostimulation
(SNS) leads for better outcomes with people with bladder (urinary) or bowel incontinence. The system will
enable ‘through-the-needle visualization’ and guidance control to direct SNS leads adjacent to the sacral
nerve. This phase culminates with an in vivo preclinical demonstration of visualization and placement feasibility
at the Penn State Milton S. Hershey Medical Center.
Unmet Need: Loss of bladder or bowel control, or urinary or bowel incontinence, is an embarrassing and
debilitating condition that greatly impacts the daily life of those affected. Over the continuum of severity,
incontinence is estimated to affect between 18M and 80M people and incur healthcare costs over $90B in the
U.S. alone, with many reports acknowledging low estimates because people do not want to be associated with
the social stigma. Conservative treatments are cumbersome or produce side effects, and up to two-thirds of
people stop treatment within a year. Because incontinence is ultimately caused by lack of muscle control, the
sacral nerve, which controls the bladder and other pelvic muscles, has been a focus. Direct neurostimulation of
the sacral nerve via an implant has become a viable option in otherwise intractable cases. After successful
implantation, long-term effectiveness of 50-80% has been reported, however, initial implantation success has
been reported as low as 24%. A significant factor in failure is inadequate proximity between the nerve and
electrodes in the stimulation lead, which is placed in a multi-step, minimally invasive surgical procedure that
requires high precision but has limited means of imaging to guide through the S3 foramen of the sacrum.
Muscle stimulation checks are the primary means of confirmation for alignment of the lead with the curved
nerve path. Representative cadaver studies have shown separations up to 16 mm, too far for clinical efficacy.
In this SBIR project, AMI is leveraging its experience in neuroscience, ultrasound and photoacoustics (PA),
and catheters/stems for medical devices to develop the PAV, a unique PA-based guidance system that aligns
with standard SNS lead implantation techniques. The PAV integrates optical transmit and ultrasound detection
to visualize the distance between the nerve and lead tract during the procedure to ensure millimeter-level
proximity for all SNS electrodes. The planned PAV system is a combination disposable kit with the PA-based
tools, used in conjunction with current SNS placement kits, and a reusable display/processing unit.
Specific Aims:
Aim 1. Design of PA transducers, hardware, and in vitro performance demonstration.
Aim 2. Integrate deflection, confirm performance ex vivo, and complete surgical plan.
Aim 3. PAV preclinical study demonstration and evaluation of minimal stimulatio...

## Key facts

- **NIH application ID:** 10930716
- **Project number:** 1R43DK139914-01
- **Recipient organization:** ACTUATED MEDICAL, INC.
- **Principal Investigator:** Roger Brooks Bagwell
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $331,416
- **Award type:** 1
- **Project period:** 2024-07-15 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10930716

## Citation

> US National Institutes of Health, RePORTER application 10930716, Photoacoustic Tool to Improve Visualization and Success Rates in Sacral Neural Modulation Lead Placement (1R43DK139914-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10930716. Licensed CC0.

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