The EyeOp1 device is now available in ten centers across France, with this figure expected to double in 2014
Rillieux-la-Pape, France, December 10, 2013 – EyeTechCare SA, which develops non-invasive therapeutic medical devices for the ophthalmology market based on the use of ultrasound, today announces that six more health care facilities in France now have the new EyeOP1 device.
With the four centers of excellence set up in June 2013, the number of devices installed across the country now stands at ten, bringing this new therapeutic alternative for glaucoma to a larger number of patients. During 2013 an estimated 300 patients in France have benefited from the technique. The number should exceed 1,000 patients in 2014.
Lille and Grenoble university hospitals and the Saint Joseph and XV-XX hospitals in Paris were the first centers to have the device installed last June. EyeOP1 technology is also now available at the Val de Grace hospital in Paris, the Croix Rousse hospital in Lyon, the Sourdille clinic in Nantes, the Pasteur and Saint Nicolas clinics in Toulouse and the Aguilera clinic in Biarritz.
A further ten centers in France are currently trialling the device. Between now and the end of 2014, a total of 20 glaucoma treatment referral centers should be able to offer this new, non-invasive therapy based on high-intensity focused ultrasound (HIFU).
Known as UC3, the treatment is a promising therapeutic innovation. The groundbreaking idea behind it is a world first resulting from a collaborative effort by EyeTechCare, INSERM (the French national institute for health and medical research) and internationally-renowned clinicians. For the moment, UC3 therapy is restricted to particular types of patient whose current treatment is failing. The technique is entirely non-invasive, quick and accurate. It has been proven as an effective means of reducing internal eye pressure in some patients and is very well tolerated.
Each health care facility's decision to acquire this technology is based on the benefit to patients: when UC3 can be offered as an alternative to surgery, it is better for the patients. Following three years of international clinical research involving 160 patients, ophthalmologists who use this method now know when it should be offered. It gives patients whose current treatment is failing another chance to preserve their sight without the usual risks associated with traditional techniques. Further work involving several hundred patients is underway to refine the scope of application for UC3 therapy.
French hospitals are in charge of the treatment for eligible patients and use of this innovative technology in health care facilities is now funded under an existing reimbursement.
Fabrice Romano, CEO of EyeTechCare, welcomes the development: "Facilities which already have UC3 technology have shown genuine willingness to offer their patients the latest therapeutic innovations, without being deterred by the cost of the device. Nonetheless, 2014 will see EyeTechCare commence the regulatory proceedings required for the health authorities to classify the EyeOP1 device appropriately and, potentially, to re-evaluate it."
EyeTechCare is poised to pursue the extension of its network of EyeOP1 users to the rest of Europe. One system is already set up in Lausanne, Switzerland and another is newly installed in Barcelona, Spain. Furthermore, special premium reimbursement was recently granted in the Andalusia region of Spain in recognition of the innovative and potentially cost-saving nature of the UC3 procedure. A significant number of carefully selected glaucoma reference centres are currently trialing the product in eight Western European countries from Scandinavia to Portugal. Further to strong interest earlier this year the company plans to install another ten systems across Spain and Italy during 2014.
About Glaucoma
Glaucoma is a degenerative disease of the nervous cells of the retina which develops slowly and silently, affecting more than a million people in France. If not treated sufficiently early in its development, it can lead to blindness. The vast majority of patients respond well to treatment with eye drops, but around 20,000 operations are carried out in France each year in cases where drug therapy is no longer sufficient.
About EyeTechCare
EyeTechCare SA is developing non-invasive therapeutic medical devices for the ophthalmology market based on High-Intensity Focused Ultrasound (HIFU). HIFU technology allows ambulatory and rapid treatment to be performed, thereby limiting the cost and the risk to the patient.
The company's first device, EyeOP1(R), is for the treatment of glaucoma, a disease that affects about two per cent of the world population and can lead to blindness. None of the therapies currently on the market provide a satisfactory cure for glaucoma. The treatments offered up to now have been constructed around eye drops, lasers and surgery, but they have limitations (low compliance, dependence on the operator, patient relapse, technical difficulties and so on).
EyeOP1(R) has been undergoing clinical trials in France and Europe and was launched onto the market at the end of 2012. The device utilizes the UC3 (ultrasound circular cyclo-coagulation) procedure, which makes it possible to reduce intraocular pressure by partially and accurately destroying the ciliary bodies that produce aqueous humor. The device obtained the CE mark in May 2011.
Based in Rillieux-la-Pape, near Lyon, France, EyeTechCare was founded in 2008 by three experienced managers with complementary expertise in the medical, industrial and regulatory fields. Today it employs close to 25 employees. The company has submitted eight patent applications in conjunction with the Lyon-based laboratory (Unit 1032) of Inserm, the French National Institute of Health and Medical Research. Since 2008, the company has secured nearly EUR 1.2 million in aid and subsidies from OSEO (the French innovation promotion agency), as well as official recognition from a number of state technology authorities. The company has raised a total of EUR 18.7 million since inception.
For more information, go to http://www.eyetechcare.com
Mark Tidmarsh
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