NeoVista, Inc.
King’s College Hospital, London, Performs First Pioneering Surgical Procedure
Fremont, CA and London, UK- November 16, 2009- NeoVista, Inc. announced today that the company’s revolutionary new surgical device is now available in the UK and offers fresh hope to 250,000 patients with wet age-related macular degeneration (AMD) – a debilitating and aggressive eye condition that can lead to blindness within 3 months if left untreated. Every year 26,000 new cases of wet AMD are diagnosed in the UK.
The VIDION® Anti NeoVascular (ANV®) Therapy System, developed by NeoVista Inc and distributed by Carleton Ltd in the UK, has recently received a CE mark certifying that it has met the EU’s Medical Device Directive.
The new device is initially being introduced in 15 hospitals across the UK as part of a large clinical trial called MERLOT, where it will be used in patients whose current standard of care treatment involves regular injections of a drug into the eye to control their condition (up to one injection every month, indefinitely). Although the treatment is initially only available at select hospitals, it is anticipated that the number of sites using the device will increase quickly, to provide nationwide availability.
The MERLOT trial has been recently awarded portfolio status by The National Institute for Health Research (NIHR) Comprehensive Clinical Research Network (CCRN). The CCRN was created as part of the government’s research and development strategy, “Best Research for Best Health” to provide a world-class infrastructure for clinical trials in all areas of disease and clinical need within the NHS in UK.
Mr Tim Jackson, a Consultant Eye Surgeon at King’s College Hospital, who is the lead investigator for MERLOT said: “This is a relatively straightforward operation and the published results are very impressive. My experience in our own trials of this device has also been encouraging and it is a big step forward to be able to offer patients this new treatment throughout the UK, within a large randomized controlled clinical trial.”
Unlike previous radiation therapies for wet AMD, NeoVista’s innovative epimacular brachytherapy delivers the peak dose of strontium-90 beta ionizing radiation directly to the lesion, minimizing exposure to the surrounding tissue. The device includes a delivery tip similar in size to a needle, and delivers a highly targeted dose of radiation directly to the area of the retina affected by wet AMD. Importantly for patients, the systemic radiation exposure is minimal, as the effective dose to the entire body from NeoVista’s device is less then a routine chest x-ray.
“This is a big step forward for NeoVista and for those suffering from Wet AMD in the UK,” stated John N. Hendrick, President and CEO of NeoVista. “To date over 400 patients have been treated safely with epimacular brachytherapy in our comprehensive clinical program. Today, with the launch of our proprietary VIDION® ANV® Therapy System, we offer hope to thousands of patients in the UK who require ongoing and frequent injections to treat their Wet AMD. We are looking forward to bringing VIDION® to millions of European patients with wet AMD who are seeking a more cost-efficient option that we expect will be as effective, if not better, than the current standard of care.”
About Wet AMD
Wet AMD occurs when abnormal blood vessels behind the retina start to grow under the macula, where they leak blood and fluid, causing scar tissue to form and vision to become impaired. With wet AMD, vision loss may occur faster and be more noticeable than with dry AMD. The longer the abnormal vessels leak or grow, the more vision will be lost. The earlier wet AMD is diagnosed, the better the patients’ chance of preserving some or much of their central vision.
About MERLOT Study
The MERLOT Trial is a multi-centre, randomized, controlled clinical study of the VIDION® ANV Therapy System. It is designed to test the hypothesis that epimacular brachytherapy will reduce the frequency of injections needed by patients to control their disease. A total of 363 patients will be enrolled into the trial.
MERLOT tests the VIDION® ANV® Therapy System in patients who continue to require ongoing and frequent injections to control their disease in the UK. These patients may have a poor quality of life due to repeated frequent visits to hospital. They have the most to gain from a device that may reduce their life long burden of treatment. The study compares the VIDION® ANV® Therapy System to the ongoing standard treatment with intravitreal injection therapy.
About NeoVista, Inc.
NeoVista, Inc. is a privately held medical device company based in Fremont, California. NeoVista’s epimacular brachytherapy procedure is currently being studied in a definitive Phase III clinical study to support eventual filing for regulatory approval to market the product in the United States. For more information about the company, the clinical trial or this novel wet AMD therapy, please visit the company’s Website at www.neovistainc.com.
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