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Ultrasound treatment device gains CE

EyeTechCare focused ultrasound treatment device gains CE mark extension to treat surgery-naive glaucoma - Use of the EyeOP1R device is now open to less advanced glaucoma 

EyeTechCare SA, which develops and sells non-invasive therapeutic medical devices for ophthalmology, today announces that it has received CE mark extension to new indications for its focused ultrasound glaucoma treatment. The medical procedure will now address all patients living with uncontrolled glaucoma irrespective of their prior treatment history. This innovative and non-invasive therapy reduces intraocular pressure by utilizing proprietary focused ultrasound technology. It benefits from a very good safety profile and offers a predictable, trouble-free patient follow-up.

Clinical trials for the EyeOP1 device commenced in 2010 (Pilot Study, EyeMUST 1 & 2 studies) and have resulted in excellent outcomes in terms of both tolerance and efficacy. These results compelled the investigators to push for a broader application for this treatment. The aim was to include patients with moderate-stage glaucoma who have not yet undergone surgery. As a result, the company launched the EyeMUST 3 clinical investigation. After 12 months of follow-up, the results of this new trial involving 30 patients proved successful in individuals with uncontrolled glaucoma under hypotensive medical treatment.

"We are very pleased to expand the indications of our device," said Dietrich Wolf, CEO of EyeTechCare. "This marks an important milestone in the development of our company, especially from a clinical standpoint. From now on, the treatment can be offered to a far greater number of patients. We are convinced that this new therapeutic procedure will soon play a key role in the management of glaucoma patients who are often apprehensive about having surgery."

About EyeTechCare

EyeTechCare SA develops and markets non-invasive therapeutic medical devices for ophthalmology utilizing focused ultrasound technology. EyeOP1, the company's first product, was designed to treat glaucoma, a degenerative disease of the optic nerve associated with an elevation in intraocular pressure (IOP). Glaucoma affects about 70 million people worldwide and can result in blindness if the pressure is not kept under control throughout the lifetime of the patient. Currently available treatments for glaucoma include drops, lasers and surgery.

With its non-invasive approach, EyeTechCare aims to respond to the market need for a treatment offering a sound balance between efficacy and safety. The EyeOP1 makes use of pioneering technology that neutralizes part of the minute ciliary glands that produce aqueous humor. The precision of this targeted treatment enables the practitioner, in less than five minutes, to reduce IOP while preserving adjacent tissue. The EyeOP1 underwent clinical trials across Europe. Since the initial CE marking was issued in June 2011 more than 1,500 patients have benefited from the treatment. Based near Lyon, France, EyeTechCare was founded in 2008 and today employs around 20 people.

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