Konan Medical USA

What Konan Medical USA does

Konan Medical USA, Inc. is a privately held, Irvine, California-based medical device company that manufactures and distributes specialized ophthalmic diagnostic instruments for eye care providers, eye banks, and clinical trial sponsors. The company's product portfolio comprises six core diagnostic platforms: objectiveFIELD (the first and only FDA 510(k)-cleared truly objective perimeter using multifocal pupillographic objective perimetry), EyeKinetix (an objective binocular pupillometer for relative afferent pupillary defect assessment, reimbursable under CPT 95919), ColorDx CCT HD (a cone-isolation contrast sensitivity test developed under CRADA with the US Air Force School of Aerospace Medicine), and three specular microscope lines (CellChek 20/20 PLUS for clinical use, CellChek XL/SL for practice-based endothelial analysis, and CellChek D/D+ for eye bank donor corneal evaluation). The underlying technology stack rests on patented methods including the Clustered Volley stimulus presentation, the Center Method and Flex-Center Method for specular microscopy (cited as the gold standard in FDA panel minutes, with established accuracy of +/-2.5%), and the RAPDx Score methodology for pupillometry, with a joint patent portfolio held with the Australian National University.

Konan's business model is anchored in high-value capital equipment sales to ophthalmologists, optometrists, eye banks, and hospitals, augmented by a Clinical Trials Rental and Maintenance Program that serves virtually all major ophthalmic pharmaceutical and medical device companies (including Staar Surgical, Abbott Medical Optics, and Alcon) for multi-site FDA safety data collection. Recurring revenue mechanics include KonanCare service agreements, online training subscriptions via learn.konanmedical.com, and device-specific CPT reimbursement codes (92083, 95919, 92286, 92283) that enable provider-side reimbursement economics. A secondary market for gently-used CellChek devices serves cost-sensitive US customers, while an International Distributor Portal extends reach across CE Mark, TGA, Health Canada, and PMDA (Japan) jurisdictions. The company maintains a lean management team led by Co-CEO Dale Sadlik and CFO Gina Schumann, operates under ISO-13485 quality certification, and is privately held with no disclosed institutional investors or funding rounds.

Name

Konan Medical USA

Legal name

Konan Medical USA, Inc.

Website

https://konanmedical.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

Konan Medical USA manufactures and distributes FDA-cleared ophthalmic diagnostic devices, including objective perimeters, pupillometers, color vision analyzers, and specular microscopes, serving ophthalmologists, optometrists, eye banks, and clinical trial sponsors globally.

Ownership category

akta.pro rank

Product category

Ophthalmic Diagnostic Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Ophthalmic Goods Manufacturing (339115)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Refractive Diagnostics & Biometry (Autorefractors, Keratometers, Topography/Tomography, A-Scan/Optical Biometry) (HLAHAJAA)

akta.pro secondary industry

Retinal Imaging & OCT Systems (OCT/OCTA, Fundus Cameras, Fluorescein/ICG Angiography) (HLAHAJAB)

Keywords

• Ophthalmic diagnostic devices
• Specular microscopy
• Objective perimetry
• Binocular pupillometry
• Color vision testing

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

Personnel, Technology or R&D, Marketing or Sales, Operations, Supply Chain, Infrastructure

Revenue model

1. Diagnostic Medical Devices - Capital Equipment Sales: Konan Medical manufactures and sells ophthalmic diagnostic devices including specular microscopes (CellChek series), objective perimeters (objectiveFIELD), pupillometers (EyeKinetix), and color vision analyzers (ColorDx CCT HD). Devices are sold as capital equipment to eye care practices, hospitals, eye banks, and clinical trial sponsors. Revenue is primarily one-time capital expenditure with optional service agreements.
2. Clinical Trials Rental & Maintenance Program: Konan offers rental programs for specular microscopes and other devices for clinical trials. Includes equipment standardization, pre-study device calibration, trial-specific technician training, full documentation, and priority service support throughout the study term. Service agreements (KonanCare) provide ongoing extended support and maintenance. Virtually all major ophthalmic pharmaceutical and medical device companies utilize this program.
3. Device Reimbursement - CPT Codes: Several Konan products carry specific CPT codes enabling reimbursement: objectiveFIELD (92083 - Visual field examination), EyeKinetix (95919 - Quantitative pupillometry), ColorDx CCT HD (92283 - Extended color vision testing), CellChek 20 (92286 - Specular microscopy). This creates a recurring reimbursement stream for eye care providers using the devices, incentivizing adoption.
4. Gently-Used / Refurbished Device Sales: Konan offers gently-used CellChek SL and XL specular microscopes (demo units, clinical trial returns, trade-ins) with same-as-new warranty. Limited availability in the USA only. This secondary market creates incremental revenue from returned or traded-in equipment.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels5 records

Core offering

Konan Medical USA manufactures and distributes FDA 510(k)-cleared ophthalmic diagnostic devices used by eye care professionals for the screening, diagnosis, and management of glaucoma, corneal disease, retinal pathology, and neuro-ophthalmic conditions. The portfolio includes the objectiveFIELD Analyzer (objective perimeter), EyeKinetix pupillometer, ColorDx CCT HD color vision analyzer, and three CellChek specular microscope lines (20/20 PLUS, XL/SL, and D/D+), each built around proprietary patented analysis methods.

Product overview

Konan Medical USA manufactures and distributes best-in-class ophthalmic diagnostic devices for eye care providers. The product portfolio consists of six core diagnostic product lines: objectiveFIELD® (objective perimeter using pupillographic perimetry), EyeKinetix® (objective pupillometer for RAPD assessment), ColorDx® CCT HD® (cone-isolation color vision testing), and three specular microscope lines (CellChek® 20 for clinical use, CellChek® XL/SL for practice-based endothelial analysis, and CellChek® D/D+ for eye bank applications). These devices address visual field testing, pupillary assessment, color vision diagnostics, and corneal endothelial evaluation—providing diagnostic precision for glaucoma, diabetic retinopathy, AMD, corneal diseases, and surgical planning. All products carry FDA 510(k) clearance with CE Mark and Health Canada licensing, and the company operates under ISO-13485 quality management.

Differentiator

Problem solved

Functional benefit

Brands

• objectiveFIELD: First and only truly objective perimeter FDA 510(k) cleared to assess visual field abnormalities using multifocal pupillographic objective perimetry (mfPOP).
• EyeKinetix
• ColorDx CCT HD
• CellChek 20 | 20 PLUS
• CellChek XL | SL
• CellChek D | D+

Products and services

• objectiveFIELD Analyzer (OFA) First and only truly objective perimeter FDA 510(k) cleared to assess visual field abnormalities. Uses multifocal pupillographic objective perimetry (mfPOP) to measure sensitivity and pupil response delay at visual field locations in both eyes simultaneously without requiring patient button presses. Records cortically mediated pupillary responses via infrared video cameras and pupil tracking. Produces four visual fields per exam (OD sensitivity, OS sensitivity, OD delay, OS delay). Reimbursable with CPT Code 92083.
• EyeKinetix Objective Binocular Pupillometer Objective binocular pupillometer that accurately analyzes pupils for relative afferent pupillary defects (RAPD/APD). Uses high-definition infrared video cameras to simultaneously record direct and consensual pupillary light reflexes, producing quantified RAPDx scores for glaucoma suspects and patients. An order of magnitude more granular APD quantification than neutral density filter methods. Reimbursable under CPT Code 95919.
• ColorDx CCT HD High-precision diagnostic color vision testing system using cone-isolation contrast sensitivity methodology. Developed with the US Air Force School of Aerospace Medicine under CRADA. Features custom-calibrated IPS matte display, Bayesian Psi-Marginal Adaptive thresholding, and testing for L, M, and S cone populations down to ~0.25% contrast. Ships with US Air Force and US Navy cut-off criteria. CE Marked, FDA Listed, TGA Approved, and available in Canada. Reimbursable under CPT Code 92283.
• CellChek 20 | 20 PLUS Specular Microscope Fully-automated non-contact specular microscope for corneal endothelial imaging. One-touch bilateral exams in approximately 40 seconds. CellChek 20 PLUS adds near-limbal imaging extending capture to 4.5mm from center with 13 total fixation points. Features Auto Center Method with automatic cell center marking and guttae exclusion, 25% higher resolution, 30% larger image area (0.25mm x 0.55mm), and EMR/EHR-ready DICOM connectivity. FDA 510(k) cleared, CPT Code 92286.
• CellChek XL | SL Specular Microscope Gold standard specular microscopes for clinical specular microscopy featuring robust analysis methods including the patented Center Method and Flex-Center Method (accuracy +/-2.5% per FDA clinical studies). Includes multi-point pachymetry, trends analysis, and FDA-cleared database functions for endothelial cell density assessment. Used by virtually every professional reading center. Gently-used SL and XL units available in the USA only with same-as-new warranty.
• CellChek D | D+ Eye Bank Specular Microscope Eye bank specular microscopes for donor corneal analysis. CellChek D+ features the first multi-imaging system for donor cornea analysis with patent-applied-for Donor Enhanced imaging providing views of endothelium, intra-stromal structure, and epithelium, including detection of blood cells, fungus, keratome cuts, dead cells, and epithelial anomalies. Multi-point pachymetry and full graft imaging with digital measurement tools. FDA 510(k) cleared, CE Marked.

Quantifiable outcome

• 45,000+ donor corneas processed over 24 years using Konan devices at Lions Eye Institute
• +4 more outcomes

Named customers12 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability3 records

Feature7 records

Partnerships

Six partnerships are on record, tiered core and minor.

• US Air Force School of Aerospace Medicine - OBVA (Operational Based Vision Assessment)coreStrategic or Co-development Partner · 1 January 2014Konan Medical collaborated with USAF School of Aerospace Medicine OBVA team under a CRADA (Cooperative Research and Development Agreement) to develop ColorDx CCT HD - a next-generation cone-isolation contrast sensitivity test with expanded low-contrast range, higher granularity, and robust Bayesian threshold method. The result was commercialized in late 2017. The USAF OBVA team and global allied partners (Singapore, Australia, Canada, Israel, NAMI, USAARL, University of Melbourne, University of Waterloo, York University) contributed to evaluation and clinical validation.
• Major Ophthalmic Pharmaceutical & Medical Device CompaniescoreStrategic or Co-development PartnerVirtually all major ophthalmic medical device and pharmaceutical companies, and many startups in the ophthalmic space, utilize Konan's Clinical Trials Rental and Maintenance Program. Major ICL (implantable contact lens) manufacturers including Staar Surgical (Visian ICL), Abbott Medical Optics (Verisyse), and Alcon (AcrySof Cachet) require endothelial cell density measurements per FDA labeling requirements and use Konan specular microscopes for collection of FDA safety data. These partnerships represent the company's primary clinical trial revenue stream.
• US NavyminorStrategic or Co-development PartnerCCT HD ships with US Navy cut-off criteria for color vision testing, in addition to US Air Force criteria. Indicates a multi-branch military partnership for operational vision assessment.
• Global International DistributorsminorChannel Partner/ Reseller/ DistributorKonan maintains an International Distributor Portal (https://konanmedical.com/distributors) for managing distribution partners outside the USA, supporting global reach in markets where direct sales are not present.
• Australian National University (ANU)coreTechnology or IntegrationKonan Medical holds a joint patent portfolio with ANU (Australian National University), as shown on the Konan Patent Index page. Ted Maddess, PhD, a key figure in the mfPOP (multifocal pupillographic objective perimetry) technology underlying objectiveFIELD, is associated with ANU. This partnership is foundational to Konan's core mfPOP technology.
• Professional Reading CenterscoreStrategic or Co-development PartnerKonan's Center Method is used by virtually every professional reading center for independent assessment of corneal endothelial analytics. The company works with several reading centers to develop detailed site instructions and standardize technical training for clinical trial site networks.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Carl Zeiss Meditec: Carl Zeiss Meditec is the global leader in ophthalmic devices, including the Humphrey Field Analyzer (the dominant subjective perimeter competing with objectiveFIELD) and other diagnostic imaging systems. Direct overlap on visual field diagnostics and broader portfolio reach across cataract, refractive, and retinal workflows.
• Heidelberg Engineering: Heidelberg Engineering is a leading ophthalmic diagnostic imaging company specializing in confocal microscopy and OCT. Its HRT and SPECTRALIS platforms compete with Konan's imaging-based diagnostic portfolio in glaucoma and corneal assessment workflows.
• Topcon Healthcare: Topcon Healthcare manufactures a broad portfolio of ophthalmic diagnostic devices including OCT, fundus imaging, and perimetry systems. Multi-modality product overlap with Konan across several diagnostic categories and a much larger global sales footprint.
• Haag-Streit Group: Haag-Streit manufactures ophthalmic diagnostic and imaging equipment including slit lamps and perimetry systems. Their products compete with various Konan diagnostic offerings in clinical ophthalmology practices.

Direct peers

• Nidek: Nidek manufactures specular microscopes (e.g., CEM-530) and other ophthalmic diagnostic devices that directly compete with Konan's CellChek product line. Both companies serve ophthalmologists, optometrists, and eye banks with comparable corneal endothelial imaging solutions.
• Tomey Corporation: Tomey is a Japanese ophthalmic diagnostic manufacturer with a specular microscopy product line (EM-4000) that competes head-to-head with Konan's CellChek series. Direct overlap in corneal endothelial imaging, OCT, and perimetry markets.

Emerging players

• iCare Finland (Icare Finland Oy): iCare manufactures ophthalmic diagnostic devices including rebound tonometers and imaging systems, and following the Centervue acquisition, has retinal imaging and perimetry offerings that partially overlap with Konan's diagnostic portfolio.
• Visionix (Optovue): Visionix (acquired Optovue) produces OCT and corneal diagnostic systems that overlap with parts of Konan's imaging portfolio. Specializes in anterior/posterior segment imaging for optometry and ophthalmology.
• Medmont International: Medmont manufactures ophthalmic diagnostic devices including corneal topographers and perimeters that compete with several Konan product lines in the optometry and ophthalmology segments.
• CenterVue (acquired by Revenio / iCare): CenterVue (now part of iCare/Revenio) developed fundus imaging and visual field systems that overlap with Konan's diagnostics. Historical presence in screening and early-disease detection in ophthalmology.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCgAdHfPIthpvVlhq8jpJtOw
• LinkedInlinkedin.com/company/konan-medical-usa
• Xx.com/konanmedicalusa
• Facebookfacebook.com/konan-medical-362022383929667

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 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 Konan Medical USA