SBIR Phase I: Actively-Controlled Transtympanic (ACT) Drug Delivery System

Award Information
Agency:
National Science Foundation
Branch
n/a
Amount:
$150,000.00
Award Year:
2013
Program:
SBIR
Phase:
Phase I
Contract:
1315779
Award Id:
n/a
Agency Tracking Number:
1315779
Solicitation Year:
2012
Solicitation Topic Code:
BC
Solicitation Number:
n/a
Small Business Information
1614 NE Glisan, Portland, OR, 97232-2841
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
Y
Duns:
963409797
Principal Investigator:
RezaShekarriz
(503) 784-9804
reza@yainaxmed.com
Business Contact:
RezaShekarriz
(503) 784-9804
reza@yainaxmed.com
Research Institute:
Stub




Abstract
This Small Business Innovation Research Phase I project proposes to demonstrate and develop a prototype of a minimally-invasive drug delivery technology to address the need for a more practical and effective transtympanic drug delivery system. The technology combines a proprietary trocar catheter with a MEMS-based microfluidic system for controlled, sustained delivery of vestibulo-active or cochleo-active drugs into the middle ear for absorption to the inner ear, for common hearing and vestibular disorders for applications in the otolaryngology, office-based setting. This Phase I project will utilize preliminary research, including prior catheter studies with human temporal bones, as well as research around dosing and micropumping to design and develop a breadboard prototype for controlled, transtympanic delivery that includes: (a) insertion technology and circulating system for improved drug perfusion, and (b) a microfluidics technology to deliver drugs with the optimal protocol. The feasibility with physician testers using both plastic ears and temporal bone cores will be evaluated. The broader impact/commercial potential of this project is anticipated to be in more effective treatment of common inner ear diseases such as Meniere?s disease, chronic labyrinthitis, sudden sensorineural hearing loss and intractable tinnitus that impact millions of people worldwide. Meniere?s disease affects approximately 12 in 1000 individuals worldwide, and it is estimated that 7.9 million individuals in the U.S. suffer from tinnitus. Although the advantages of transtympanic delivery are generally understood, control remains a major challenge to realizing optimal and consistent outcomes. Wide inter-subject, and even intra-subject, variability in outcomes has presented a major problem with current practice, introducing the potential of serious side effects, such as oto-toxicity, that can lead to permanent hearing loss and vestibular hypofunction, or dysfunction. Recent studies indicate these shortcomings can be largely overcome with precise, controlled, sustained, low concentration delivery to the round window membrane. While research is underway to develop products for surgically-implanted controlled or passive time-release delivery, there is significant value for advancing a non-surgical, less invasive and more actively-controlled delivery. It is expected that this technology will overcome both efficacy and practical shortcomings of the technologies on the market and in development.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government