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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44NS122687-03
Agency Tracking Number: R44NS122687
Amount: $1,499,932.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 106
Solicitation Number: PAR18-618
Solicitation Year: 2018
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-01
Award End Date (Contract End Date): 2026-08-31
Small Business Information
1216 Commerce Ct Ste 3
Lafayette, CO 80026
United States
DUNS: 080319380
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (720) 600-4753
Business Contact
Phone: (720) 600-4753
Research Institution

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.

* Information listed above is at the time of submission. *

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