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Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses

Award Number: R44HD090811
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2023
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses - Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses ABSTRACT There is a pressing need to improve control of myoelectric prostheses for individuals with upper limb loss (ULL). To date, only two fundamental control methods have been made commercially available – Direct Control (DC, introduced in 1960) and Pattern Recognition (PR, introduced in 2016). Both have significant limitations, as outlined within the proposal. Thus, we propose a new control method called Glide. The Glide architecture does not use ‘triggers’ to switch between different grasps like DC systems, nor does it require frequent ‘recalibration’ like PR systems. Instead, it combines the simplicity of DC with the functionality of PR. It is based on effecting joystick-style motions of the residual limb to move a “Glide cursor” to specific locations within a circular region called the “Glide domain.” The Glide cursor position is determined by the resultant of the vector summation of two to eight EMG channels (depending on individual patient’s needs), where each of the electrode channels are spaced at equal angular distances apart from each other on the Glide domain. To date, we have 1) developed the controller hardware; 2) iteratively developed the control strategy and user interface with direct involvement of clinicians and individuals with ULL; and 3) evaluated a total of nine individuals with trans-radial ULL including seven who completed long-term in-home testing. Of note, our experience now includes one individual who has been using the system for two and half years and counting. We now propose to commercialize the novel Glide control strategy and enable accessibility to the widest group of patients possible. We propose two aims to accomplish these goals. The first aim is a regulatory aim, where we will complete the Verification and Validation of the system and submit a 510(k) for regulatory approval. The second aim is a scientific aim, where we will evaluate the hypothesis that use of Glide results in improved functional, satisfaction and usage metrics as compared to use of a standard DC prosthesis. An important benefit of this aim, presuming the results are favorable, is that it will provide strong support for reimbursement. If we are successful, we will have met our dual mandate – to improve usability of upper limb prostheses, while simultaneously increasing real-world access to advanced prosthetic technologies.


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 = $876,333 )
2025	2025	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	6	5/28/2025	NON-COMPETING CONTINUATION	$876,333
														Subtotal = $876,333

Issue Date FY: 2024 ( Subtotal = $833,621 )
2024	2024	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	001	5	5/1/2024	NON-COMPETING CONTINUATION	$833,621
2024	2023	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	4	4/29/2024	COMPETING CONTINUATION	$0
														Subtotal = $833,621

Issue Date FY: 2023 ( Subtotal = $873,316 )
2023	2023	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	001	4	8/3/2023	COMPETING CONTINUATION	$0
2023	2023	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	4	5/17/2023	COMPETING CONTINUATION	$873,316
														Subtotal = $873,316

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2018	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	3	3/2/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $729,624 )
2018	2018	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	1101 E 33RD ST STE E305	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	001	3	8/29/2018	NON-COMPETING CONTINUATION	$729,624
2018	2016	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	1101 E 33RD ST STE E305	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	1	6/12/2018	NEW	$0
														Subtotal = $729,624

Issue Date FY: 2017 ( Subtotal = $723,890 )
2017	2017	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	1101 E 33RD ST STE E305	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Child Health and Human Development Extramural Research	000	2	8/24/2017	EXTENSION WITH OR WITHOUT FUNDS	$723,890
														Subtotal = $723,890

Issue Date FY: 2016 ( Subtotal = $224,520 )
2016	2016	INFINITE BIOMEDICAL TECHNOLOGIES LLC	2352 Huntington Dr	Pasadena	CA	91108	LOS ANGELES	USA	Child Health and Human Development Extramural Research	000	1	9/23/2016	NEW	$224,520
														Subtotal = $224,520

Grand Total All Awards = $4,261,304

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Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses

Award Number: R44HD090811

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2023

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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