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2007-05-24 12:38:00 CEST 2008-01-17 12:40:02 CET REGULATED INFORMATION Inion Oyj - Company AnnouncementInion CPS/OTPS FreedomPlate™ Biodegradable Orthopaedic Implant Receives CE MarkInion CPS/OTPS FreedomPlate™ Biodegradable Orthopaedic Implant Receives CE Mark for Sale in Europe Tampere, Finland and Takeley, UK. 24 May 2007…Inion [LSE: IIN.L], a company focused on the development of novel biodegradable medical implants, has received CE Mark from the British Standards Institution (BSI) for the Inion CPS/OTPS FreedomPlate™ biodegradable device for surgical application in fixation of fractures and osteotomies in the entire skeleton, but excluding the spine. CE Mark is required by a number of accredited bodies to medical device manufacturers prior to commercial distribution in the European Union. This product received equivalent 510(k) regulatory clearance for marketing in the USA in February 2007. The Inion CPS/OTPS FreedomPlate™ biodegradable implant system has been cleared for the fixation of a wide range of bones, including those in the arm, leg, skull and ankle, in the presence of appropriate additional immobilization or fixation, such as plaster cast. Chris Lee, CEO of Inion, commented, “This is an important new product launch for Inion as it means we can now market the Inion OTPS™ line for all orthopaedic trauma indications, including for ankle fractures, in the USA and in Europe.” The Inion CPS/OTPS FreedomPlate™ implants are made of Inion Optima™ biodegradable polymer blend, which have a long history of safe medical use and that degrade in the body into carbon dioxide and water. The implants gradually lose their strength after 18-36 weeks and bioresorption takes place within two to four years. A picture of the Inion CPS/OTPS FreedomPlate™ is available on request. -Ends- -------------------------------------------------------------------------------- | Inion Oy | Tel: +44 1279 874 222 | | Mr Chris Lee, Chief Executive Officer | | | Mr Julien Cotta, Chief Financial Officer | | | | | -------------------------------------------------------------------------------- | Citigate Dewe Rogerson | Tel: +44 207 638 9571 | | Mark Swallow / David Dible / Helena | | | Galilee | | -------------------------------------------------------------------------------- About Inion (www.inion.com) Inion Oy is a medical devices company focused on the development and successful commercialisation of innovative biodegradable and bioactive implants in key target markets. The Company's target segments are Spine and Specialty Orthopaedics. Inion's core expertise and technology lies in the design and manufacture of innovative biodegradable plates, screws, pins and membranes, which are used to enhance the healing of bone or soft tissue injuries to the skeleton, such as those caused by trauma or by reconstructive surgery. Inion implants are made from its proprietary Inion Optima™ family of biomaterials, with properties tailored for specific surgical applications, in terms of strength, flexibility and rate of degradation. Inion is also focused on developing proprietary new bioactive and biodegradable biomaterials that promote bone healing and accelerate patient rehabilitation. Inion was incorporated in early 2000 and listed on the Official List of the UK Listing Authority in December 2004. The Company has an office and an R&D facility in the UK and head office, R&D and production facilities in Tampere, Finland. This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Inion's funding requirements, regulatory approvals, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statement. |
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