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Development and clinical assessment of a robust, 3D printed titanium, myoelectric powered prosthetic digit system

Award Number: R44NS122687
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2021
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Development and clinical assessment of a robust, 3D printed titanium, myoelectric powered prosthetic digit system - ABSTRACT Approximately 600,000 people live with partial hand amputations in the United States, with an estimated 14,500 new cases occurring each year. Despite the advances in miniaturized electronics and motors, there has been very little advancement in mechatronic prosthetic digits for this underserved patient population. In fact, to date, there is only one myoelectric prosthetic option for patients with partial hand loss in the US. This option is fragile, often limited to light-duty tasks, and is too large to use on most partial hand loss cases. Considering this, it is no surprise that less than half of the individuals with partial hand absence are able to return to their previous employment, and those who do must often make considerable changes to their work-related tasks. Thus, there is a substantial need to deliver a robust, low-profile myoelectric prosthetic digit system. To address this need, we have formed a collaborative development team that has successfully launched six devices, which have been fit on over 3,300 patients with upper limb loss and has significant regulatory experience, having received two 510(k) approvals and five CE marks for upper limb prosthetic devices. With this background, through this Fast-Track SBIR application, our collaborative team will develop and launch the Point Powered system: an advanced mechatronic prosthesis system for individuals with partial hand loss which includes 1) robust Point Powered digits; 2) low profile EMG electrodes; 3) a multi-input controller; 4) an iPad-based user interface and 5) a flexible battery-based power system. The Point Powered system will 1) have industry leading strength and speed, 2) offer anatomical rotation and flexion around the patient’s metacarpophalangeal (MCP) joint, 3) have three anatomically accurate joints and sizes small enough to accommodate over 90% of men and women, and 4) be compatible with future sophisticated control strategies. In Phase I, we will perform three main tasks: 1) complete working prototypes of the electromechanical Point Powered digit, controller, electrodes, and user interface 2) perform iterative testing with a focus group of 5 patients and prosthetists and verify component-level functionality and 3) complete internal verification on the Point Powered system. Successful completion of these tasks will gate the progress of the project to Phase II. In Phase II, the Point Powered system will be evaluated in two aims. In the first aim, we will complete third-party verification to ensure compliance with medical device standards and we will perform clinical validations in preparation for our long-term clinical study. Once the verification and validation steps are complete, a clinical trial will be conducted to evaluate the system in 10 participants with partial hand loss against their standard-of- care treatment. At the conclusion of these studies, we will have established safety and efficacy of the devices and will submit a 510(k) application for premarket clearance. It is our long-term goal that the Point Powered system will achieve a high degree of clinical impact through empowerment of partial hand amputees.


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: 2026 ( Subtotal = $0 )
2026	2025	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	5	6/2/2026	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2026	2025	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	5	12/5/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2026	2024	POINT DESIGNS, INC.	2100 W 6TH AVE STE A	BROOMFIELD	CO	80020	BROOMFIELD	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	3/16/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $1,547,205 )
2025	2025	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	004	5	9/26/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2025	2025	INFINITE BIOMEDICAL TECHNOLOGIES, LLC	8 MARKET PL STE 500	BALTIMORE	MD	21202	BALTIMORE CITY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	5	9/20/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,497,205
2025	2025	POINT DESIGNS, INC.	1216 COMMERCE CT STE 3	LAFAYETTE	CO	80026	BOULDER	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	3/27/2025	SUPPLEMENT FOR EXPANSION	$50,000
2025	2024	POINT DESIGNS, INC.	1216 COMMERCE CT STE 3	LAFAYETTE	CO	80026	BOULDER	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	4	9/20/2025	NON-COMPETING CONTINUATION	$0
2025	2022	POINT DESIGNS, INC.	2100 W 6TH AVE STE A	BROOMFIELD	CO	80020	BROOMFIELD	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	2/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,547,205

Issue Date FY: 2024 ( Subtotal = $1,498,585 )
2024	2024	POINT DESIGNS, LLC	1216 COMMERCE CT	LAFAYETTE	CO	80026	BOULDER	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	8/23/2024	NON-COMPETING CONTINUATION	$1,498,585
														Subtotal = $1,498,585

Issue Date FY: 2023 ( Subtotal = $1,499,932 )
2023	2023	POINT DESIGNS LLC	1216 COMMERCE CT	LAFAYETTE	CO	80026	BOULDER	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	9/18/2023	EXTENSION WITH OR WITHOUT FUNDS	$1,499,932
														Subtotal = $1,499,932

Issue Date FY: 2022 ( Subtotal = $1,003,850 )
2022	2022	POINT DESIGNS, LLC	1216 COMMERCE CT STE 3	LAFAYETTE	CO	80026	BOULDER	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/15/2022	NON-COMPETING CONTINUATION	$1,003,850
														Subtotal = $1,003,850

Issue Date FY: 2021 ( Subtotal = $1,024,164 )
2021	2021	POINT DESIGNS, LLC	1216 COMMERCE CT STE 3	LAFAYETTE	CO	80026	BOULDER	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	8/31/2021	NEW	$1,024,164
														Subtotal = $1,024,164

Grand Total All Awards = $6,573,736

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Development and clinical assessment of a robust, 3D printed titanium, myoelectric powered prosthetic digit system

Award Number: R44NS122687

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2021

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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