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ICORPs Support for Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44MH131514-01
Agency Tracking Number: R44MH131514
Amount: $555,239.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 101
Solicitation Number: PAR22-073
Timeline
Solicitation Year: 2022
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-05
Award End Date (Contract End Date): 2023-05-31
Small Business Information
320 ROLLING RIDGE DR
Bellefonte, PA 16823-8445
United States
DUNS: 791379030
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 MAUREEN MULVIHILL
 (814) 355-0003
 maureen.mulvihill@actuatedmedical.com
Business Contact
 MAUREEN MULVIHILL
Phone: (814) 355-0003
Email: maureen.mulvihill@actuatedmedical.com
Research Institution
N/A
Abstract

This ICORPs project expands market understanding and conducts extensive customer discovery for the
Acoustic Implant Protection system for use with Neural Implants.
Original Abstract: This SBIR Fast-track finalizes, tests, and commercializes the Acoustic Implant Protection
(AIP) system, which uses the application of precision acoustic fields to penetrating neural implants to prevent
electrode impedance rise and improve implant longevity. This submission is in response to: Notice of Special
Interest (NOSI): NOT-MH-21-125 Translation of BRAIN Initiative Technologies to the Marketplace.
Problem to be solved: Chronic neural implants hold great potential for illuminating features of neural function,
treating neurological disorders, and enabling the next generation of brain-machine interface-based
neuroprosthetics. Penetrating microelectrode arrays provide direct access to neural signals with high
temporospatial resolution. However, their preclinical and clinical viability are limited by their poor longevity and
variability in functionality due to the immune response or foreign body response (FBR). The FBR can cause
glial scarring and neural cell loss near the electrode sites of penetrating arrays over a period of several weeks,
which are leading causes of signal recording losses through both electrical isolation and spatial distancing
effects. The FBR begins with electrode insertion, when damage to the blood brain barrier activates astrocytes
and microglia. Although ‘soft’ electrode materials, thinner shanks, and floating arrays have been developed to
minimize the mismatch between brain and implant, none of these have demonstrated sufficient recording life
and immunity to the FBR. Exogenous chemical means have been used to directly suppress the FBR, and
have yielded positive results to varying degrees, but limitations of effectiveness, high costs, and/or undesirable
side-effects still exist. A simple approach is needed to mitigate FBR for both preclinical and clinical use.
Solution: Sub-threshold therapeutic ultrasound has recently been shown to have protective and healing effects
in models of cerebral disease and injury, through promotion of neurotrophic factors. AMI successfully
leveraged this principle in an R21 study evaluating low-intensity pulsed ultrasound (LIPUS) to mitigate the
microglia response and improve longevity of neural interfaces. Product: This Fast-track delivers an AIP
system for preclinical use with a reusable (releasable) annular transducer that delivers LIPUS to produce a
neuro-protective environment around implanted microelectrodes.
Phase I: Aim 1 – Electronics/System Adaptation for Preclinical Study. Aim 2 – Confirm ultrasound parameters
for AIP annulus that safely stimulate cortical tissues comparable to Alpha design from R21.
Phase I to Phase II Go-no-go. Portable, reusable AIP prototype produces measurable improvement in neural
signal longevity over 6 weeks in preclinical microelectrode study. Positive feedback from potential end users.
Aim 3– Integrate End User Design Feedback and Conduct Verification and Validation. Aim 4 – Optimize
stimulation intervals for neural interface performance (SNR, unit detection) and demonstrate additional neuro-
protective effects (glial cell activation, E-I balance) of LIPUS in preclinical studies.

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

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