DIOPTEX

GLOBAL LEADER IN CORNEAL TECHNOLOGY

INNOVATION IS OUR BUSINESS

 

 

COMPANY

DATA

DIOPTEX Forschungs-, Entwicklungs- und Vertriebs GmbH (DIOPTEX GmbH) is located in Linz, Austria and focuses on research, development and marketing of new and innovative technologies for eye surgery. As a globally acting medical technology company DIOPTEX is ISO 13485 certified and masters all related fields including scientific research, product development, production at industrial scale, clinical application, training of surgeons, global patent and trademark management, quality management, international regulatory affairs, global sales and marketing, etc.

In 2005 the company was financially supported in its efforts to develop a novel technology for the treatment of refractive errors and eye disorders by the seed-financing program of the AWS (Austria Wirtschafts Service), an Austrian governmental organisation responsible for the funding of most innovative new technologies in the country. The related research activities were supported by the FFG (Austrian Research Fund).

DIOPTEX has invested more than 4 Mio Euros in the development, application and marketing of the most innovative products and procedures so far. The DIOPTEX products are approved and distributed as medical devices in Europe and more than 20 countries outside Europe on 4 continents.

COMPANY

MISSION

We are dedicated to research and development on the highest level in the field of corneal and refractive surgery in order to be able to provide outstanding solutions for patients eye-sight. Solutions that no other technology can provide.

The result of our activities are most innovative technologies and unrivaled medical products for the surgical treatment of eye disorders.

Our business model is to develop our technology to a clinical application stage at which it is ready to be applied and marketed on a global scale.

 

 

INNOVATION

PIPELINE

Our unique innovation pipeline is long and includes

PocketMaker Ultrakeratome is a core product of our technological activities. That internationally patented device allows a safe and easy creation of corneal pockets with an unrivaled quality and precision. On the basis of the corneal pocket concept (CPC) a corneal pocket is the starting point for safe and effective corneal surgery. More than 8 years of experience with many thousands of eyes treated uneventful in the hands of surgeons trained on the device demonstrate the high potential for the use in corneal implant surgery, corneal cross-linking, corneal transplantation with our without artificial cornea and eye banking for corneal transplantation.

MyoRing intra-corneal implant is a real breakthrough for the treatment of keratoconus and a certain kind of myopia. It is an unrivaled product for keratoconus treatment and the only one which can achieve both, visual rehabilitation AND stop of the progression of the disease. It can be applied to cure almost all grades of keratoconus no matter whether it is a central or non-central cone. More than 8 years of experience in more than 7000 cases treated all over the world show the outstanding safety and efficacy of that therapy. Only in Europe some 1 million eyes suffer from keratoconus and some 20 million eyes from myopia which would benefit from MyoRing implantation. This internationally patented and medically approved technology is now ready for global marketing on a large scale.

Keralux  is a revolutionary new technology for the treatment of keratoconus which allows the first time the right UV-A irradiation energy transfer to every point of the irregularly shaped keratoconus cornea, no matter which actual local curvature exists. Also the implemented microtechnology improves the treatment possibilities significantly. So far only large devices have been available for that purpose which do so far not adequately consider eye movement, centration and the local curvature variation of the cornea. Our Disposable Micro-CXL device does not require an investment by the surgeon but can treat the patients at per procedure costs. This system (patents pending) may boost the penetration of the therapy to small practices and improve the possibility to treat patients already in the very early stage of the disease where that treatment method is mostly indicated. The device is currently in the approval stage and will most probably be launched by the end of 2016.

Multi-focal.vision Presbyopia Corneal Inlay is a revolutionary new approach to treat age-related farsightedness (presbyopia). The inlay uses the proven surgical technology and concept developed for the MyoRing treatment. It is the worlds tiniest inlay with dimensions of only 0.3 mm. The mechanism of action is that a central volume of the cornea is shifted by the inlay in a way that a central multifocal zone which functions as a near-vision zone is created. That near-vision zone is surrounded by a far-vision zone. Instead of wearing progressive glasses the inlay reshapes the cornea itself reversibly to a "progressive cornea". Only in Europe some 250 million eyes suffer from presbyopia. The internationally patented device will be approved as a medical device most probably by the end of 2016.

ISD IntraStromal Diagnostic Implant is the latest developmental project started. ISD is a MyoRing corneal implant equipped with nano electronics to monitor body functions such as intra-ocular pressure (IOP) via an extra-corporal receiver system and related computer-app software. The extensively, in more than 8 years and more than 7000 cases proven implantation technology of the MyoRing is the perfect cover for an atraumatic intra-corporal detector and transmitter system to monitor complex body functions. Whether or not the MyoRing is equipped with the ISD features it is minimally invasive, reversible, atraumatic, painless, safe, quick and easy to perform in topical anesthesia only (eyedrops), with healing and rehabilitation time of a few hours only. Depending on the dimensions of the implant the ISD may even come with a refractive effect if needed. That kind of monitoring of the IOP is a huge benefit for the health system since so many patients suffer from glaucoma. Increased IOP is a high risk factor for glaucoma and related blindness. It is estimated that some 70 million people (140 million eyes) suffer from glaucoma worldwide with a high rate of undetected and unreported cases and equally distributed in industrial and developing countries. The medical approval of that internationally patented device is expected in 2018.

 

 

HISTORY

OF DIOPTEX

2003: Dioptex GmbH was founded in 2003 by Dr. Albert Daxer as a research and developmental company to improve the treatment possibilities in keratoconus and difficult cases of myopia.  The project was financially supported by the AWS (Austria Wirtschaft Service), the support bank of the Republic of Austria for new and innovative technologies.

2006: Approval of PocketMaker Ultrakeratome as medical device in the EU.

2007: Approval of MyoRing as medical device in the EU.

2008 - 2014: Treatment trials in more than 20 countries around the world were performed to prove the safety and effectivity of the MyoRing-technology under routine conditions. These trials included more than 7000 eyes and were financially supported by the Austrian Research and Science Fund (FFG). The result is a mature treatment technology which allows the trained surgeon to achieve the best possible result in any give case. There is currently no treatment option of keratoconus being as effective and safe as CISIS/MyoRing.

2014: The International Keratoconus Centre was founded by Dr. Albert Daxer.

2017: Approval of Keralux as a medical device in the EU.

2018: Launch of Keralux.