Konan Mission and History
We are passionate about providing innovation and excellence in our products and serviceswe treat our customers the way we want be treated ourselves
The Beginning of Konan Medical
Konan Medical Inc. in Japan (“KMI”), was established in 1947 in Hyogo Japan after WWII by a group of camera enthusiasts.
KMI has been in the specular microscope business since 1979 and holds over 1,600 patents including many remarkable new products such as the balloon camera (meteorology) 1955, radar camera 1956, electrofax copy machine 1960, the first disposable camera 1963, and the specular microscope 1979.
As the market leader in specular microscopy, Konan has a significant majority share of the healthy and growing market for devices used to image and assess the corneal endothelium for clinical and donor corneas.
people | vision | inspiration | innovation | dedication
Konan Medical USA Inc.: Founding to Present
2007 – 2008
Konan Medical USA, Inc. (“Konan Medical”) established as California C Corporation to manage sales, marketing, and customer service / support in North America for KMI products.
2009 – 2010
Charles Wm. Stewart as CEO and Dale Sadlik as COO join the Konan team and begin developing Konan Medical’s quality system for ISO certification. Konan Medical acquires ONTest Corporation including its key Kandel patents and in process intellectual properties on pupil assessed neuro-diagnostics. Konan’s RAPDx product is a result of more than a decade of research and development. Konan Medical’s role expands all of the Americas for Konan (Japan) products. Konan Medical relocates to Irvine, California, arguably the epicenter of ophthalmic device / pharma industry globally.
Konan Medical’s role expands to include Western Europe for KMI products. Konan Clinical Services launched to provide specialized products and services to ophthalmic manufacturers of implantable devices and pharmaceutical agents. Konan Medical achieves ISO-13485 certification.
RAPDx® commercial sales are initiated in the Americas, Europe and Asia. ColorDx® brand established for color vision diagnostic products. RAPDx becomes CE-marked.
Licensing of pseudo-isochromatic color vision test products, print and digital, are added to the Konan Medical family of diagnostic products.
Konan Medical licenses Neucodia product to be marketed as EvokeDx® visual electrophysiology products from Professor Vance Zemon, and Dr. George Hu.
EvokeDx commercial sales initiated in USA. CellChek® SL is launched as the all-in-one replacement for the very successful CellChek XL specular microscope series. CellChek D+ launched at AAO for donor cornea analytics. US Navy adds ColorDx application as one of only three electronic tests permitted for color vision assessment of Naval personnel along with CCT(Cone Contrast test) and CAD. Konan enters into a global licensing agreement with Vulintus / University Texas / University of Iowa for NeuroTriage products (pupil – ocular motor function and consumer wearable for detection of head / acceleration injuries).
Konan Medical enters into CRADA (Creative Research and Development Agreement) with US Air Force, Operational Based Vision Assessment team at Wright Patterson AFB for the development of a commercial high-fidelity, cone-isolation contrast sensitivity test for assessment of genetic and acquired color vision deficiencies.
EvokeDx is CE-marked with an indication for the diagnosis of glaucoma in countries that require the CE mark. Konan Medical relocates and triples the size of its Irvine, California headquarters to continue to expand in-house sales team, manufacturing, warehousing, and customer services. Konan Medical’s CRADA developed product with the US Air Force, CCT-HD®, is previewed at global specialty meetings Aerospace Medical Association (Denver, USA), European Society of Aerospace Medicine (Rome, Italy), and International Colour Vision Society (Erlangen, Germany), each featuring presentations / papers from the US Air Force OBVA team. CCT-HD commercial deliveries commence as the world’s first cone-isolation contrast test FDA listed and CE-marked. Konan Medical initiates USA distribution of LKC’s hand-held ERG device RETeval®, and novel electrodes to complement it’s EvokeDx visual electrophysiology device. Recognized, creative, ophthalmic devices engineer, David Liu PhD, joins Konan Medical as VP of Research and Development.
2018 and beyond
Konan successfully completes ISO MDSAP certification audit of the Medical Device Single Audit Program, with current participation from Australia (TGA), Brazil (ANVISA), Canada (Health Canada), USA (FDA), and Japan ((PMDA).
Konan Medical’s pipeline is full … watch this space for breaking news of more innovation.
a corporate culture that is creative, respectful, and hard-working in pursuit of excellence
With a focus in specialized diagnostic devices, Konan Medical’s flagship specular microscopes are recognized eye care practitioners, regulatory groups, professional reading centers, and clinical trial experts as the gold standard for endothelial cell density analysis. Konan Medical’s product portfolio extends into color vision diagnostics, objective assessment of vision and retinal function using VEP and ERG, high definition pupillography and ocular-motor function.
Konan Medical USA, Inc. has a global sales and distribution channel comprised of direct sales, selected sales representatives, and distributors with extensive eye care experience. Today there are over 20,000 Konan-branded systems and products (KMI and Konan Medical) in use in 60 countries worldwide and all 50 states in the USA using Konan specialized diagnostic products. Konan Medical’s clinical trials services program counts virtually every FDA registered manufacturer of ophthalmic implantable and pharmaceuticals as customers.
Konan Medical continues to earn its solid position in the marketplace with core strengths in clinical evidence, web-enabled customer support, expert service, and leading technologies. Konan additionally is the market-leader in the donor cornea tissue / eye bank specular microscopy segment.
Konan Medical owns or represents well recognized ophthalmic brands including:
Konan Medical USA, Inc. has intellectual property issued, licensed and applied for in pupillometry, ocular motor function, concussion-related technology, visual evoked potentials, electro-diagnostic electrodes, as well as color and other vision assessment diagnostics.
Business Development & Investment
Konan Medical core activities include actively seeking promising new technologies and products to complement its existing product line and leveraging its medical device infrastructure including global regulatory, R&D, marketing, customer service, and clinical trials support services.
Explore opportunities for cooperation by contacting Charles Wm. Stewart, OD or Dale Sadlik.
Constant, brilliant product innovation. Paul Karpecki, OD