KeraMed

What KeraMed does

KeraMed, Inc. is a privately-held medical device company founded in 2005 by Yichieh Shiuey, MD (former Associate Chief of Ophthalmology at Harvard Medical School), headquartered in Placentia, California, with 1-10 employees and ISO13485:2016 and CE Mark certifications. The company develops and commercializes surgical devices for minimally invasive corneal surgery, anchored by the KeraKlear Artificial Cornea, the first commercially available foldable, non-penetrating keratoprosthesis designed for synthetic lamellar keratoplasty through small 3.5 mm incisions into a femtosecond-laser-created corneal pocket. The portfolio includes the KeraKlear XT variable-depth variant (200-700 microns in 100-micron steps), the EndoInjector (for DSAEK graft delivery using patented double coil no-touch technology under U.S. Patent No. 8,029,515), and the Shiuey Spatula surgical instrument; peer-reviewed evidence reports over 90% vision improvement and over 90% retention at 43 months mean follow-up in non-inflammatory corneal blindness indications.

The company monetizes through two distinct revenue streams: (i) hardware sales of the KeraKlear and related instruments to hospitals, eye clinics, and corneal surgeons across an exclusive international distributor network spanning Japan (SightLife), the DACH region (Ziemer Ophthalmic Systems AG, with bundled KeraKlear Software on the Z6 femtosecond laser), Turkey, Saudi Arabia, Canada, Czech Republic, Iran, Italy, Spain, South Africa, and additional markets, and (ii) technology licensing royalties from multiple OEMs (Network Medical Products, Coronet Medical Technologies, Angiotech Pharmaceuticals, Surgical Specialties) for the double coil no-touch endothelial graft insertion IP embedded in the Tan EndoGlide. KeraKlear is investigational in the United States (available only via compassionate use for high-risk failed transplants and aniridia), commercially available in CE Mark jurisdictions, and approved in Saudi Arabia; commercial activity is therefore entirely ex-U.S. today, supported by SBIR/STTR, NIH, and National Eye Institute development funding and a 2017 SBA Tibbetts Award recognizing the program's economic and social impact.

Name

KeraMed

Legal name

KeraMed, Inc.

Website

https://keramed.com

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

1–10 employees

Short description

KeraMed, Inc. is a privately-held medical device company developing the KeraKlear, a foldable non-penetrating artificial cornea for minimally invasive treatment of corneal blindness, sold through an exclusive international distributor network in Europe, the Middle East, Asia, and Africa while investigational in the United States.

Ownership category

akta.pro rank

Product category

Ophthalmic Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Ophthalmic Goods (3851)

akta.pro primary industry

Cornea & External Disease Surgical Devices (Keratoplasty Tools, Cross-Linking Systems, Amniotic Membrane Delivery) (HLAHAJAK)

akta.pro secondary industry

Injection Molded Optical & Transparent Parts (Lenses, Light Guides) (IMANAFAL)

Keywords

• Artificial cornea
• Keratoprosthesis devices
• Corneal surgery implants
• Lamellar keratoplasty
• Ophthalmic medical devices

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D

Revenue model

1. KeraKlear Artificial Cornea Sales: Sale of the KeraKlear foldable artificial cornea and related surgical devices (EndoInjector) to hospitals, eye clinics, and corneal surgeons through a global distributor network.
2. Technology Licensing: Licensing of proprietary double coil no touch technology for endothelial graft insertion under U.S. Patent No. 8,029,515 to Network Medical Products Ltd., Coronet Medical Technologies Ltd., Angiotech Pharmaceuticals, Inc., and Surgical Specialties Corp. for use in the Tan EndoGlide device.

Go-to-market motion1 record

Distribution channels10 records

Marketing channels4 records

Core offering

KeraMed develops and manufactures the KeraKlear foldable non-penetrating artificial cornea for synthetic lamellar keratoplasty, along with the KeraKlear XT variable-depth variant, the EndoInjector endothelial graft delivery device, and the Shiuey Spatula surgical instrument. The company's products are designed for minimally invasive corneal surgery using small 3.5mm incisions and femtosecond laser-created corneal pockets to treat corneal blindness. KeraMed also licenses proprietary double coil no-touch technology (U.S. Patent No. 8,029,515) for use in third-party endothelial graft insertion devices.

Product overview

KeraMed is a medical device company specializing exclusively in surgical devices and implants for the cornea. The core product is the KeraKlear Artificial Cornea, the world's first commercially available non-penetrating artificial cornea for synthetic lamellar keratoplasty. The product portfolio includes the standard KeraKlear (implanted at depths from 300-700 microns) and the KeraKlear XT variant (variable depth 200-700 microns). An EndoInjector device is also offered for endothelial keratoplasty procedures. The company also developed the Shiuey Spatula for use during implantation. All devices are designed for minimally invasive corneal surgery using smaller incisions than traditional procedures.

Differentiator

Problem solved

Functional benefit

Products and services

• KeraKlear Artificial Cornea A foldable, non-penetrating artificial cornea implanted into a femtosecond-laser-created partial-thickness corneal pocket for synthetic lamellar keratoplasty through 3.5mm incisions, indicated for non-inflammatory corneal blindness in adult patients treated by corneal surgeons at ophthalmic hospitals and clinics.
• KeraKlear XT Variable-depth variant of the KeraKlear artificial cornea offering implantation depths from 200 to 700 microns in 100-micron increments for customized treatment of keratoconus, stromal corneal opacities, and corneal edema, supplied to ophthalmic hospitals and corneal surgeons.
• EndoInjector An endothelial graft insertion device using KeraMed's proprietary double coil no-touch technology to deliver DSAEK endothelial grafts through incisions as small as 3.5mm, used by corneal surgeons performing endothelial keratoplasty.
• Shiuey Spatula A surgical instrument designed to open the corneal pocket during KeraKlear Artificial Cornea implantation, supplied to corneal surgeons as part of the KeraKlear surgical instrument set.

Named customers6 records

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• Afkom Proje Danışmanlık ve Tic. LTD. ŞTİ.coreChannel Partner/ Reseller/ Distributor · 10 October 2016Afkom Proje Danışmanlık ve Tic. LTD. ŞTİ. became the exclusive distributor for the KeraKlear artificial cornea in Turkey, partnering to provide solutions against cornea blindness.
• Network Medical Products Ltd.coreTechnology or Integration · 12 April 2016KeraMed licensed its proprietary double coil no touch technology for endothelial graft insertion under U.S. Patent No. 8,029,515 to Network Medical Products Ltd. Network Medical is the manufacturer of the Tan EndoGlide for treatment of endothelial failure.
• SightLifecoreChannel Partner/ Reseller/ Distributor · 28 April 2015SightLife is now the exclusive distributor for the KeraKlear artificial cornea in Japan. SightLife is a nonprofit organization focused on cornea transplantation that, together with partners, provided 20,807 cornea transplants globally in 2014. CEO Monty Montoya presented at Hawaiian Eye 2015 on global cornea transplantation achievements.
• Ziemer Ophthalmic Systems AGcoreChannel Partner/ Reseller/ Distributor · 24 May 2012Ziemer Ophthalmic Systems AG obtained exclusive rights for distribution of KeraKlear artificial cornea and EndoInjector in Germany, Switzerland, and Austria. Ziemer developed KeraKlear Software for its Z6 Femtosecond Laser enabling one-step bladeless implantation of the KeraKlear.
• Basha Medical GroupcoreChannel Partner/ Reseller/ DistributorExclusive distributor for KeraKlear artificial cornea in Saudi Arabia, facilitating first KeraKlear surgeries in the Kingdom performed by Dr. Raed Alomair at Elite Hospital in Riyadh.
• Ventus Sağlık Medikal San. Tic. LTD. ŞTİ.coreChannel Partner/ Reseller/ DistributorExclusive distributor for KeraKlear artificial cornea in Turkey, located in Malkara/Tekirdağ.
• Innova MedicalminorChannel Partner/ Reseller/ DistributorDistributor for KeraKlear in Canada, available only through Special Access program. Located in North York, Ontario.
• Videris Ltd.minorChannel Partner/ Reseller/ DistributorDistributor for KeraKlear in Czech Republic, located in Prague 6.
• Tavana Abzar PartominorChannel Partner/ Reseller/ DistributorDistributor for KeraKlear in Iran, Tehran.
• New TechminorChannel Partner/ Reseller/ DistributorDistributor for KeraKlear in Italy, Vimodrone (Milano).
• National MedicalminorChannel Partner/ Reseller/ DistributorDistributor for KeraKlear in South Africa, Brooklyn Square.
• Medical Mix, S.L.minorChannel Partner/ Reseller/ DistributorDistributor for KeraKlear in Spain, Sant Cugat del Vallès, Barcelona.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Glaukos Corporation: Ophthalmic medical device company developing interventional MIGS and corneal health technologies. While focused on glaucoma, Glaukos represents the profile of a small-cap, R&D-driven ophthalmic device company navigating regulatory and commercial milestones similar to KeraMed.
• EyePoint Pharmaceuticals: Specialty ophthalmic company developing sustained-release drug delivery implants. Comparable as a small-cap, clinical-stage ophthalmic company with a focused device/drug platform targeting underserved ocular indications.
• STAAR Surgical: Specialty ophthalmic implant manufacturer (phakic IOLs for refractive correction). Comparable as a niche, technology-forward ophthalmic implant company with limited product lines and a small-cap market profile.

Direct peers

• Network Medical Products: UK-based manufacturer of the Tan EndoGlide and licensee of KeraMed's double coil no-touch technology (U.S. Patent 8,029,515). Operates in the same ophthalmic surgical device category, particularly for endothelial keratoplasty, making it a peer and a commercial partner.
• Massachusetts Eye and Ear (Boston KPro): Develops the Boston Keratoprosthesis (Boston KPro), the leading artificial cornea and KeraKlear's primary direct competitor in keratoprosthesis. Both target corneal blindness with synthetic implants and compete for surgeon adoption and FDA / international approvals.
• Ziemer Ophthalmic Systems AG: Swiss femtosecond laser manufacturer and KeraMed's exclusive DACH distributor; built dedicated KeraKlear Software for its Z6 Femtosecond Laser enabling one-step bladeless implantation. A peer in corneal surgical technology with deep integration into KeraMed's procedure.
• CorneaGen: A leading corneal tissue provider and surgical device company serving corneal surgeons with donor tissue, preparation services, and complementary surgical instruments. Competes with KeraKlear as the dominant alternative for treating corneal blindness (donor cornea transplantation).

Broad incumbents

• Alcon: Largest pure-play ophthalmic device and pharmaceutical company globally. Competes broadly across cataract, refractive, and corneal surgery and is a likely strategic acquirer or distribution partner for premium keratoplasty technologies like KeraKlear.
• Carl Zeiss Meditec: Global incumbent in ophthalmic surgical devices, lasers, and IOLs. Represents the broader competitive and partnership landscape for corneal/refractive surgical platforms and is a potential strategic acquirer or channel partner for KeraMed.
• Bausch + Lomb: Global ophthalmic device and pharmaceutical company with a deep surgical and vision-care portfolio. A broad incumbent competitor and potential strategic acquirer for differentiated corneal surgical technologies.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about KeraMed