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3D microprinting-enabled microinjection needle arrays for enhanced therapeutics delivery into the brain

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41MH135827-01
Agency Tracking Number: R41MH135827
Amount: $403,847.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 101
Solicitation Number: PA22-178
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-10
Award End Date (Contract End Date): 2024-09-09
Small Business Information
Rockville, MD 20852-4222
United States
DUNS: 080939245
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (301) 807-0889
Business Contact
Phone: (301) 807-0889
Research Institution
Room 3112 Lee Building 7809 Regents Drive
COLLEGE PARK, MD 20742-0001
United States

 Nonprofit College or University

Microinjection technologies underlie many research and clinical applications that require gene and cell delivery,
including studies and emerging treatments of neurological conditions (e.g., neurodegenerative diseases,
traumatic brain injury, and cancer). Unfortunately, challenges associated with the microinjection tools by which
the viral vectors and cells inherent in these applications are delivered into brain tissues remain major barriers in
these rapidly growing fields. Although widely used, the currently used industry standard needles (ISNs) comprise
one needle with a single output port at the tip and are associated with a variety of validated customer pain points.
In particular, (1) the physical size of therapeutics such as lentiviral particles (80–100 nm) and stem cells (rt10
μm) restricts ISN-mediated delivery into a single injection site inherently restricts the effective coverage range;
(2) the single injection site for ISNs can also result in inhomogeneous distributions of delivered therapeutics,
which can be detrimental to efficacy; and (3) the shape and size of ISNs can lead to brain tissue injury.
Consequently, alternative, novel microinjection tools for both gene and cell delivery are in critical demand.
The objective of this proposal is to develop an entirely new class of microneedle arrays (MNAs) that can be
realized to simultaneously address all three aforementioned pain points of ISNs. The working hypothesis is that
the minimal viable product (MVP) will transform microinjection outcomes via unparalleled versatility in realizing
geometrically sophisticated MNAs innovations, improve the efficacy of delivering therapeutics to the brain and
reducing microinjection-associated tissue damage. Preliminary studies demonstrated the ability of 3D
microprinting-enabled microneedle arrays (MNAs) delivery strategy to penetrate and deliver microfluidic
payloads into mouse brains. In addition, 3D-printed multi-side-port microneedles showed reduced penetration
and retrieval-associated damage to zebrafish embryos during microinjection protocols. This proposal will
examine the efficacy of this innovation to enhance fundamental performance metrics underlying both gene and
cell delivery into brain tissue. To effectively accomplish this goal, we will: 1) establish and characterize MNA
additive manufacturing protocols for novel 3D microneedle designs, 2) assess microfluidic and cell delivery
efficacy of our innovative delivery strategy versus ISNs in vitro, and 3) evaluate gene and stem cell delivery into
mouse brains mediated by our MNA innovation versus ISNs in vivo. This proposal to prototype MNA MVPs that
improve penetration, injection, and retrieval efficacy versus ISNs bridges an important need in the biomedical
industry, which will positively impact foundational human health-related research and medical applications.

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

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