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Humidifeye Plug for Dry Eye Disease

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44EY034758-01
Agency Tracking Number: R44EY034758
Amount: $250,487.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NEI
Solicitation Number: PA21-260
Timeline
Solicitation Year: 2021
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-30
Award End Date (Contract End Date): 2024-08-31
Small Business Information
2202 S. Figueroa St. #417
Los Angeles, CA 90007
United States
DUNS: 080452520
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 NIKI BAYAT
 (213) 256-6129
 niki@aescula.tech
Business Contact
 ROBY MENEFEE
Phone: (202) 280-9748
Email: roby@aescula.tech
Research Institution
N/A
Abstract

Project SummaryMore than 16 million Americans have been diagnosed with Dry Eye Disease (DED). This
number is growing due to aggravating factors like increased screen time, and an aging population.
It already has an estimated impact of $6.58 billion on the US healthcare system and $70 billion
overall economic impact due to decrease in productivity. Two contributing factors to this burden
are the price an inadequacy of existing treatments. Common treatments include pharmaceutical
drops, lubricant drops, and punctal plugs. Collectively, these therapies are plagued by poor
compliance, poor efficacy, discomfort, and untenable costs. Pharmaceutical drops (i.e.
Cyclosporine) can also take months to achieve an effect. Punctal plugs offer rapid symptom relief
but are prone to sizing issues, patient discomfort, and in some cases the need for surgical
removal. They are made in approximately the same designs and with the same materials as at
their invention over forty years ago.Our objective is to develop a patient-adaptable punctal plug using environmentally
sensitive hydrogels which exhibit a reverse phase transition. An abundance of literature, including
prior academic research by members of our team, illustrates the desirable properties of N-
isopropylacrylamide copolymers for biomedical applications. The majority of these applications
are aimed at drug release, and to-date no one has designed a material suitable for a long-term
medical insert. Durability, reliable long-term transition behavior, and scalable manufacture and
processing are all functional barriers to development. The AesculaTech team developed an early
model of such a material and a prototype applicator which can store it for two months. When
inserted, the plug flows into the duct as a liquid, molding to patient anatomy before solidifying.
Upon a standard irrigation procedure, this material reverts back to flowable gel for removal. Short
term early data has also shown preliminary biocompatibility. As a new medical material, this plug
requires optimized and reliable behavior for commercially competitive long-term use. If this project
is successful, it will provide a wealth of information on new responsive hydrogels and produce a
plug which improves outcomes and provides a safer and easier alternative for most patients.
Phase 1 will research new smart hydrogels, using rheology and simulated use to identify a
commercially suitable material. The Applicator will also be optimized for usable shelf-life.
Phase 2-1 will rigorously test the chemical and biological safety of the device using extract-based
and direct contact methods along with generating a list of contraindicated products.
Phase 2-2 will clinically validate the performance of the product.

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

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