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2007-09-11 13:01:00 CEST 2008-01-17 13:02:55 CET REGULATED INFORMATION Inion Oyj - Company AnnouncementInion Receives CE Mark Regulatory Clearance for Extended Indications for Inion Hexalon™ ImplantInion Receives CE Mark Regulatory Clearance for Extended Indications for Inion Hexalon™ Implant Tampere, Finland and Guildford, UK. 11 September 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 its Inion Hexalon™ biodegradable screw for an extended range of clinical procedures including soft tissue fixation to bone in surgeries for foot, ankle, hand and wrist. This product received equivalent 510(k) regulatory clearance for marketing in the USA in August 2007. The Inion HexalonTM biodegradable screw is the world's first coloured biodegradable screw for the surgical fixation of soft tissue (including ligament and tendon) to bone. It was originally developed and launched for the repair of injuries to the anterior and posterior cruciate ligament in the knee where it allows clear visibility during arthroscopic insertion (keyhole surgery). In addition to knee surgeries, Inion Hexalon™ has now received both CE Mark and 510(k) clearance for use in surgeries of the shoulder, elbow, ankle, foot, hand and wrist, thereby greatly extending the range of trauma injuries it can be used to treat. Chris Lee, Inion's CEO, said: “Receiving US and European regulatory clearance for the extended use of Inion Hexalon™ means that we are now able to offer a full range of screw sizes appropriate to the particular surgery in these applications, and custom instruments for conducting the procedure, across two of our focus segments - foot and ankle and upper extremity. The extended range means that more patients and surgeons will be able to benefit from the product's key benefits: its unique enhanced visibility during surgical insertion, its strength and its biodegradable properties.” *CE Mark is issued by a number of accredited bodies to medical device manufacturers prior to commercial distribution in the European Union. -Ends- For further information, please contact: -------------------------------------------------------------------------------- | Inion Oy | Tel: +44 (0)1483 685390 | | Chris Lee, Chief Executive | | | Officer | | | Julien Cotta, Chief Financial Officer | | -------------------------------------------------------------------------------- | Citigate Dewe Rogerson | Tel: +44 (0)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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