Medical devices & diagnostics · Dry eye
AesculaTech
A Los Angeles materials company whose cold liquid sets into a custom plug inside the tear duct. The pilot readout was strong, the FDA file is still empty, and the company has quietly repositioned around partnering.
Reverse chocolate
Chocolate is solid until you warm it, and then it runs. AesculaTech built a material that does the opposite. Cold, it pours. Warm it toward body temperature and it thickens into a gel, then sets into a soft solid shaped by whatever it set inside.
Niki Bayat called it reverse chocolate in 2018, and the phrase stuck to the company.
The place AesculaTech wants to put it is the punctum, the drain at the inner corner of the eyelid. A clinician presses one button on a sterile, disposable, prefilled micro volume autoinjector. A few microliters of cold liquid go into the canaliculus, body heat does the rest, and the plug forms against that patient’s own anatomy. Tears stay on the eye instead of draining away. Two plugs go in under three minutes, the company says, and the injector cap doubles as a dilator.
To remove it, a clinician flushes the punctum with room temperature saline. The plug softens, releases, and leaves through the nasolacrimal system.
The problem it is aimed at
Punctal occlusion is old, and the complaints are consistent. The company’s own NIH grant abstract puts them bluntly: punctal plugs “offer rapid symptom relief but are prone to sizing issues, patient discomfort, and in some cases the need for surgical removal.” They come in sizes, so someone has to guess. They migrate. They fall out. Patients feel them. The alternatives are not much better: prescription drops take weeks to work and can sting, lubricants last minutes.
How many people this affects depends on which AesculaTech document you read. The NIH abstract says more than 16 million diagnosed Americans, the website says 23 million, the Y Combinator profile says more than 25 million, a 2019 trade interview said over 64 million, and a 2018 university interview said 150 million have symptoms. The direction is clear. The numbers are not.
Two chemical engineers
Bayat and Andrew Bartynski met in 2012 as graduate students in chemical engineering at the University of Southern California. AesculaTech was spun out of the labs of Mark Thompson, Bayat’s doctoral adviser and a co-inventor of the phosphorescent OLEDs now in most phone screens, and Mark Humayun, who developed the Argus II artificial retina.
The reason was personal. “One day I was talking to my dad and I heard from him that he’d been diagnosed with glaucoma, but because he’d had heart surgery, he couldn’t have another one,” Bayat told TechCrunch in 2018. She had watched him miss doses of the drops meant to hold the disease off.
The company was filed in California on August 5, 2016. Bartynski was the founding chief executive, and a 2021 SEC exhibit filed by a later employer still describes him that way. Bayat was chief science officer then and is chief executive now. AesculaTech went through the Texas Medical Center accelerator and then Y Combinator’s Winter 2018 batch, and that June MIT Technology Review named Bayat to its 35 Innovators Under 35 list.
The pilot, and the clock
In June 2021 the team met the FDA’s device center. “The FDA confirmed that Humidifeye is a 510(k) device and a predicate was established.” That is the cheaper of the two device routes.
The first human study ran outside the United States, at one cornea clinic in Guadalajara, Mexico. It was registered as NCT05748951 and started March 7, 2023.
On August 30, 2023 the company posted that the pilot was done: 22 patients, three months, results it called concrete and statistically significant. “Data will be made public over the coming months, but a quick summary is provided below,” the post said. Three weeks later the National Eye Institute awarded a Fast Track SBIR. In November, Bayat took second place in the Winning Pitch Challenge at Eyecelerator during the American Academy of Ophthalmology meeting, and the company presented at the Ophthalmology Innovation Summit, saying it was moving toward clearance in 2024.
Then the news stopped. The last post on the company news page is dated November 20, 2023.
What happened next was a rewrite
In March 2025 AesculaTech rewrote its About page. Humidifeye is still there, still labeled investigational, but the emphasis moved to the material itself and to sealants, skincare, coatings and composites. “AesculaTech actively partners with industry leaders,” the page now says. The product page reads like a licensor’s sheet rather than a device launch: patented, tested, ready for partners.
The company has not gone quiet where it is harder to fake. A patent application naming Bayat as inventor was filed on September 29, 2025 and published on January 29, 2026, covering a device for controlled injection across a variety of material properties. Two more published in December 2025. California’s registry showed the corporation active and in good standing when last extracted on March 25, 2026.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA status | No 510(k), premarket approval, device registration, listing or UDI record in FDA databases as of Sep 22, 2026. | Public record |
| Regulatory pathway | Company reported in June 2021 that CDRH confirmed a 510(k) route and a predicate. No submission has appeared since. | Company-stated |
| Registered trial | NCT05748951. Single group, open label, no phase. 33 participants at one site in Guadalajara, Mar 7, 2023 to Feb 22, 2024. Primary outcome: change in Schirmer I at week 12. | Public record |
| Enrollment as announced | The Aug 30, 2023 post calls the study complete and says it “treated 22 patients in a 3-month OUS first in Human study.” The registry records 33 participants and completion six months later. | Differs from registry |
| Pilot results as marketed | Two releases three weeks apart describe the same 44 eye study differently. Nov 2, 2023: 82% OSDI reduction, 73% staining reduction, 197% rise in basal tears. Nov 20, 2023: 86%, 72%, 153%. | Releases disagree |
| Study results in the record | No results posted to ClinicalTrials.gov. No PubMed indexed publication found for the company or device. | Not found |
| Federal funding | NEI SBIR Fast Track R44EY034758: $250,487 in FY2023 and $1,220,683 in FY2025, $1,471,170 total, PI Niki Bayat, through Feb 28, 2026. Announced as over $1.5 million. | Public record |
| Patents | US 11,400,044 granted Aug 2, 2022. Five further applications published from 2022 to Jan 29, 2026. | Public record |
| Corporate status | Filed in California Aug 5, 2016, incorporated in Delaware, active and in good standing, CEO Niki Bayat, as of Mar 25, 2026. | Public record |
| Timeline slippage | TechCrunch, 2018: available by 2019. Company news page: FDA review in 2021. Late 2023 releases: clearance in 2024. | Claims versus record |
Read plainly: the chemistry is real, protected, and still being extended, and a small first in human study produced numbers the company was glad to quote. What is missing is everything that would let an outsider check them. No registry result, no paper, no FDA submission, no press since November 2023, and two 2023 releases that disagree about the pilot.
What to watch
- A 510(k) submission. The pathway and predicate have been settled since 2021, so a filing is the single event that changes the picture.
- Results posted to NCT05748951, or a paper on the pilot. Either would settle which set of 2023 numbers is right.
- What followed the NEI SBIR, whose project period ended February 28, 2026.
- A named licensing or development partner. The March 2025 rewrite points at that model and none has been announced.
- Whether Humidifeye stays the lead product or becomes a proof point for the platform.
In their words
“One day I was talking to my dad and I heard from him that he’d been diagnosed with glaucoma, but because he’d had heart surgery, he couldn’t have another one”
Niki Bayat, co-founder, TechCrunch, 2018 · Independent
“To allow people to get the treatment they need without having to interact with medication on a daily basis is hugely valuable because you deliver the treatment to them continuously so they don’t have to interrupt their daily life or be bound to an eye drop or pill pack”
Andrew Bartynski, co-founder and then chief executive, TechCrunch, 2018 · Independent
“We are thinking of a platform for drug delivery technology.”
Niki Bayat, TechCrunch, 2018 · Independent
“through working together we both developed an appreciation for the way chemistry can have a significant impact on the quality of life and healthcare outcomes for patients.”
Andrew Bartynski, MedTech Strategist interview, 2019 · Interview
“The purpose of engineering is to make the world a better place,”
Andrew Bartynski, USC Viterbi, 2016 · Independent
“The FDA confirmed that Humidifeye is a 510(k) device and a predicate was established.”
AesculaTech news post, June 10, 2021 · Company
“Data will be made public over the coming months, but a quick summary is provided below”
AesculaTech post on the completed pilot, August 30, 2023 · Company
“AesculaTech actively partners with industry leaders.”
AesculaTech About page, rewritten March 2025 · Company
Related companies
Sources
- Public recordClinicalTrials.gov NCT05748951
- Public recordNIH RePORTER R44EY034758, Humidifeye Plug for Dry Eye Disease
- Public recordopenFDA 510(k), registration and listing, and UDI queries
- Public recordSEC EDGAR company and full text search for AesculaTech
- Public recordNeuroBo Pharmaceuticals Form 8-K, exhibit 99.1
- Public recordUS 11,400,044 B2 and five AesculaTech applications
- Public recordCalifornia business registry, Aesculatech, Inc., document 3932999
- IndependentBiomedical startup AesculaTech is creating a new drug delivery system
- IndependentPersonalized occlusion medical device targets DED treatment
- InterviewAesculaTech: Reverse Chocolate for Dry Eye
- IndependentA Better Way
- IndependentEyecelerator at AAO 2023 finalists and placings
- CompanyAesculaTech to Showcase HUMIDIFEYE at OIS XIII
- CompanyAesculaTech news posts, June 10, 2021 to Sep 30, 2023
- CompanyAesculaTech website pages
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
