Optos Plc Medical P200MA Device Cleared for Market by US Food & Drug Administration
3/23/2006
LONDON, 23 March 2006 – Optos plc (LSE: OPTS), a leading medical technology company for the design, development, manufacturing and marketing of retinal imaging devices, today announced that it has received clearance from the US Food & Drug Administration (FDA) under Section 510(k) of the Federal Food, Drug and Cosmetic Act (Act) to market its P200MA medical device in the United States of America, subject to the usual general controls provisions of the Act. European CE marking under Medical Devices Directive (MDD) 93/42/EEC was received in December 2005.
“Aimed at the secondary as opposed to the primary care market, we have designed the P200MA to produce an angiographic retinal image product called optomap® fa which we believe will offer eye-care practitioners advanced diagnostic, monitoring and treatment capabilities for particular eye disorders, including diabetic retinopathy and age-related macular degeneration,” said Alastair Atkinson, Global Product Director, Optos plc.
Optos’ platform technology is the P200 Scanning Laser Ophthalmoscope (P200), which produces a high resolution retinal image – optomap®. In a quarter of a second the P200 device produces a high resolution image of up to 200 degrees or approximately 80 percent of the retina in a single capture. It is the Company’s core retinal image product and is used in the primary level eye-care market to assist practitioners in screening for eye and non-eye diseases and disorders.
“Receiving FDA clearance to market in the USA, combined with the European approval that was granted late last year, provides access to all of our main existing markets for this exciting new product platform,” said Stephane Sallmard, Chief Executive Officer, Optos plc. “We already have evaluation agreements in place to install the P200MA device in a select number of sites, after which we will proceed on a targeted basis reflecting the specialist characteristics and needs of practitioners and patients in the secondary care market. We are pleased to be able to demonstrate early progress on the plan we set out at our recent IPO.”
Notes to Editors
About Optos plc
Optos is incorporated in Scotland under the Companies Act 1985 with registered number SC139953 and with its subsidiaries collectively is known as Optos plc. Founded in 1992 Optos plc is a leading medical technology company for the design, development, manufacturing and marketing of devices able to image the retina, the light-sensitive area at the back of the eye. Optos’ platform technology is the Panoramic200 Scanning Laser Ophthalmoscope device – known as the P200. In a quarter of a second the P200 device produces a high resolution image of up to 200 degrees or approximately 80 percent of the retina in a single capture. The image – branded the optomap® – provides eye care practitioners with clinically useful information that facilitates the early detection of disorders and diseases evidenced in the retina. Optos believes that its technology provides an unequalled combination of wide-field retinal imaging, speed and convenience for both practitioner and patient. Optos plc is headquartered in Dunfermline, Scotland and currently has approximately 200 employees serving more than 2,000 customers in four country markets – USA, Canada, UK and Germany. Optos plc trades on the Main Market of the London Stock Exchange under the symbol OPTS.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates and projections about its industry, its beliefs and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors, some of which are beyond the Company's control, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.