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

Award Number: U44NS119842
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/15/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	5/2/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,110,259 )
2024	2024	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	4	4/29/2024	NON-COMPETING CONTINUATION	$1,110,259
2024	2023	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	11/6/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
2024	2022	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	3/12/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,110,259

Issue Date FY: 2023 ( Subtotal = $1,237,304 )
2023	2023	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	3	7/24/2023	EXTENSION WITH OR WITHOUT FUNDS	$1,237,304
2023	2022	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	7/12/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,237,304

Issue Date FY: 2022 ( Subtotal = $999,612 )
2022	2022	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	2/25/2022	NON-COMPETING CONTINUATION	$906,187
2022	2022	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	3/25/2022	NON-COMPETING CONTINUATION	$93,425
														Subtotal = $999,612

Issue Date FY: 2021 ( Subtotal = $999,863 )
2021	2021	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	1/14/2021	NEW	$999,863
														Subtotal = $999,863

Grand Total All Awards = $4,347,038

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

Award Number: U44NS119842

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/15/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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