# Actigraphy Enhanced Clinical Chronic Lower Back Pain Management: Sleep Algorithm Assessment

> **NIH NIH U44** · ARBOR MEDICAL INNOVATIONS, LLC · 2024 · $139,506

## Abstract

Project Summary
The successful completion of our final Phase I SBIR milestone for our Fast-Track SBIR award requires us to obtain
FDA 510(k) clearance for our VERABANDTM medical device. Our 510(k) application is currently about half-way
though the FDA’s Substantive Review process. However, recently we received an unanticipated Additional
Information request from the FDA that required us to increase the scope of the project beyond what was originally
proposed by including a sleep-related assessment measure in the report we provide to physicians. Incorporating
this measure while ensuring our quality system and Device History File remains compliant with the FDA’s Quality
System Regulation, requires us to re-validate the software that generates the reports. The inability to complete
these tasks in a timely manner may result in rejection from the FDA review process. This application requests
additional support to complete the work required by the increased scope of the project so that we can successfully
complete the FDA review and obtain 510(k) clearance for the VERABANDTM technology. This will allow us to
advance to Phase II and onward toward commercialization.

## Key facts

- **NIH application ID:** 11030459
- **Project number:** 3U44NS122002-02S1
- **Recipient organization:** ARBOR MEDICAL INNOVATIONS, LLC
- **Principal Investigator:** Grant H Kruger
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $139,506
- **Award type:** 3
- **Project period:** 2024-02-15 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11030459

## Citation

> US National Institutes of Health, RePORTER application 11030459, Actigraphy Enhanced Clinical Chronic Lower Back Pain Management: Sleep Algorithm Assessment (3U44NS122002-02S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11030459. Licensed CC0.

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