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Personalized occlusion medical device targets DED treatment

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AesculaTech, Inc. 's Co-Founder and CEO Niki Bayat, PhD, featured the company’s novel dry eye treatment as a finalist in The Winning Pitch Challenge at Eyecelerator during the American Academy of Ophthalmology (AAO) annual meeting.

Edited to add on Dec.12, 2023:
Glance President Jaclyn Garlich, OD, FAAO, spoke with Dr. Bayat regarding the winning product, including a demonstration on how the device works.

Let’s start with some background on this challenge.

The Winning Pitch Challenge is an independent organization that provides ophthalmology innovators free access to:

  • Key educational resources
  • Networking opportunities
  • Potential financial resource exposure
  • Mentors with relevant business knowledge to turn their ideas of how to solve a significant ophthalmic problem into a reality.

Give me more on this competition.

  1. Participants submit innovation concepts (in the early stages, generating no or little revenue) and are paired with industry experts in a “Shark Tank”-style competition.
  2. Three finalists are selected to present their ideas to a panel of venture capital and industry veterans.
  3. Prize money totaling $45,000 is awarded to the top three participants.

Learn more here.

Gotcha. And this year’s three finalists?

  • Niki Bayat, PhD – AesculaTech HumidifeyeMentor: Leonard Borrmann, PharmD
  • Oussama Boundaoui, MD – Regenoptics Tamponading HydrogelMentor: Shravanthi Reddy, PhD 
  • David Kleinman, MD – Calm Water Therapeutic, LLCMentor: Robert Dempsey

Who are the moderators / judges?

  • Moderators:
    • Vance Thompson, MD
    • Robert Warner​
  • Judges:
    • Adrienne Graves, PhD
    • Richard Lindstrom, MD
    • Jim Mazzo
    • Angela Macfarlane

Now talk about AesculaTech.

Founded in 2016 by the University of Southern California researchers, the private company’s platform technology incorporates a proprietary smart material to develop biomedical and consumer products designed for adaptability and responsiveness.

Per the company, AesculaTech has used its technology to develop novel products such as adaptable medical sealants and personalized skin care.

And this novel dry eye treatment?

The Humidifeye device is designed to provide personalized occlusion for tear retention via delivering a proprietary temperature-sensitive gel.

The device consists of a sterile, disposable, one-size-fits-all micro-volume autoinjector that is administered as a liquid and delivered to the tear duct.

Dr. Bayat demonstrates how the device works below.

What does it do, exactly?

By pressing one button on the injector delivers the plug, potentially providing both immediate and sustained symptom relief, according to the company. It’s also reported that two plugs can be placed in less than 3 minutes. When administered, the hydrogel “adapts to patient anatomy and turns into a soft, flexible solid” when exposed to bodily heat.

To note, the injector’s green cap can also act as an optional dilator.

Below, Dr. Bayat explains how the device can be removed.

Give me more details.

The estimated 3-minute treatment is intended to provide a reduced need for drops as well as a rapid and sustained improvement in dry eye symptoms, per AesculaTech, and offers:

  • No sizing required
  • No foreign body sensations
  • No plug loss

How do you remove the plug?

The plug can be flushed from the punctum by room-temperature saline irrigation. According to the company, it will soften, release from the anatomy, and exit through the nasolacrimal system.

Patients can then receive a replacement plug, if needed.

Any clinical data on it?

Per AesculaTech, a 44-eye pilot study assessing dry eye patients found that Humidifeyecould improve signs and symptoms—including ocular, vision, and environment-related—and quality-of-life (QoL) over the course of 3 months.

Following insertion of the punctal plug via Humidifeye, the Ocular Surface Disease Index (OSDI) scores by percentage of symptom reduction were as follows:

  • 2 weeks
    • 71%
  • 6 weeks
    • 76%
  • 3 months
    • 86%

Dr. Bayat discusses the trial results further, below.

And when might this be available?

Hear what Dr. Bayat has to say:

The Winning Pitch Challenge at the Eyecelerator is being held Thursday, Nov. 2, 2023, at the San Francisco Marriott Marquis ahead of the American Academy of Ophthalmology (AAO) annual meeting (Nov. 3-6, 2023) in San Francisco, California.

*Featured image property of AesculaTech.

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