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2007-02-21 12:44:00 CET 2008-01-17 12:46:20 CET REGULATED INFORMATION Inion Oyj - Company AnnouncementInion CPS/OTPS FreedomPlate™ Receives 510(k) Regulatory Clearance for Treating Wide Range of Orthopaedic Trauma Indications, including Ankle FracturesInion CPS/OTPS FreedomPlate™ Receives 510(k) Regulatory Clearance for Treating Wide Range of Orthopaedic Trauma Indications, including Ankle Fractures Tampere, Finland and Takeley, UK. 21 February 2007…Inion [LSE: IIN.L], a company focused on the development of novel biodegradable medical implants, has received 510(k) regulatory clearance from the US Food and Drug Administration (FDA) 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. 510(k) clearance is required of medical device manufacturers prior to commercial distribution in the US. 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. Importantly, this 510(k) clearance now allows Inion to sell its biodegradable implant offering for all orthopaedic trauma indications, making it the first complete biodegradable plating system. This also removes the previous limitation of the Inion OTPS™ product line to target the high-value ankle fracture segment of the trauma market in the USA, for which a biodegradable plating system is currently undergoing a clinical trial to demonstrate its efficacy compared to a metal construct. Dr Auvo Kaikkonen, CEO of Inion, commented, “This is a very important new product launch for Inion as it means we can market the Inion OTPS™ line for all orthopaedic trauma indications in the USA, including for ankle fractures. We will naturally continue with ongoing prospective randomised clinical multicentre study of our Inion OTPS™ ankle system and expect results, i.e. clinical efficacy data, by early 2008. We are sure that this clearance strengthens our product offering and therefore our position in the orthopaedic surgery market.” 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 during 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 | | Dr Auvo Kaikkonen, Chief Executive | Tel: +44 1223 394 206 | | Officer | | | Dr Kirk Andriano, VP of R&D | | -------------------------------------------------------------------------------- | Citigate Dewe Rogerson | Tel: +44 207 638 9571 | | Mark Swallow / David Dible / Helena | | | Galilee | | -------------------------------------------------------------------------------- About Inion (www.inion.com) Inion Oy is a Finnish company that specializes in the development of biodegradable medical implants. The Inion core expertise and technology lies in the design and manufacture of innovative biodegradable plates, screws, pins and membranes that are used to enhance the healing of skeletal injuries (bone and soft tissue), 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 has developed and launched products in five strategic business areas - cranio-maxillofacial surgery, orthopaedic trauma, sports medicine, dental surgery and most recently in the spinal implant area - in nearly 50 countries worldwide. Inion was incorporated in early 2000 by an international team of experts in biodegradable materials and their clinical applications, and listed on the Official List of the UK Listing Authority in December 2004. The Company's has operations in the UK, R&D and production facilities in Tampere, Finland, and a US office in Oklahoma City, OK. 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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