# Regulatory clearance of a rehabilitation system for individuals with upper limb loss

> **NIH NIH U44** · INFINITE BIOMEDICAL TECHNOLOGIES, LLC · 2024 · $1,110,259

## Abstract

ABSTRACT
Our work to date has resulted in the development of several technologies focused on improving the lives of
individuals with upper-limb loss (ULL). First, our Sense pattern recognition control system (and associated
Element low-profile surface EMG electrodes and FlexCell flexible lithium-polymer batteries) can interface with
most myoelectric hands, wrists, and elbows on the market. Second, our MyoTrain virtual-limb pre-prosthetic
training system has been demonstrated to help individuals with ULL learn to use pattern recognition. This system
is valuable in the “golden window” time period after amputation but before it is feasible to fit the patient with a
definitive prosthesis.
Based on our clinical experience, we identified three ways in which we could deepen our clinical impact,
particularly as related to the MyoTrain system. First, we noted that EMG classification accuracy could be
improved by decreasing intra-class scatter (improving repeatability) and/or increasing inter-class separation
(improving separability). How individuals incorporate these methods is user specific and they could benefit from
the incorporation of visual feedback – something that we call “Active Coaching”. Second, our business model
allows us to provide MyoTrain to the patient before reimbursement is available, which offers significant clinical
advantage. However, this currently still requires the prosthetist to fabricate a check socket for use with
each individual. We now propose to integrate a reusable wireless armband which would eliminate this issue.
Third, we plan to evaluate the efficacy of MyoTrain with a prospective trial of our technology suite and
associated clinical methodology. Specifically, we will test three hypotheses: 1) use of MyoTrain results in
skills transference to control of the final prosthesis; 2) the virtual outcome measures in MyoTrain are
correlated with real-world functional outcome measures; and 3) use of MyoTrain results in improved clinical
outcomes as measured by functional, subjective and usage metrics. The capstone of this project is the
submission of a 510(k) premarket notification application for the MyoTrain system.

## Key facts

- **NIH application ID:** 10892989
- **Project number:** 5U44NS119842-04
- **Recipient organization:** INFINITE BIOMEDICAL TECHNOLOGIES, LLC
- **Principal Investigator:** Rahul Reddy Kaliki
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,110,259
- **Award type:** 5
- **Project period:** 2021-01-15 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10892989

## Citation

> US National Institutes of Health, RePORTER application 10892989, Regulatory clearance of a rehabilitation system for individuals with upper limb loss (5U44NS119842-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10892989. Licensed CC0.

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