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2007-10-10 13:07:00 CEST 2008-01-17 13:08:30 CET REGLERAD INFORMATION Inion Oyj - Company AnnouncementInion announces interim results of its clinical study evaluating bone quality following the use of Inion OptimaPLUS™ bioactive materialInion announces interim results of its clinical study evaluating bone quality following the use of Inion OptimaPLUS™ bioactive material Tampere, Finland and Guildford, UK. 10 October 2007…Inion [LSE: IIN.L], a company focused on the development of novel biodegradable medical implants, announces interim results of its second clinical proof of principle study with Inion OptimaPLUS™ bioactive material from the first 13 patients to have completed the six-month clinical follow-up. This study, which is designed to evaluate the quality of new bone generated following a dental implant surgical procedure, has shown a positive trend towards improved bone quality from the Inion OptimaPLUS™ bioactive material when compared to new bone resulting from the use of a market-leading non-biodegradable competitor product. These results have led Inion to support the continuation of the trial. The current trial, which began in December 2006, is aiming to recruit 40 patients across four centres in Zurich, Switzerland. The study is designed to evaluate a number of measures of bone quality in newly generated bone (such as density and mineralization) following the use of Inion OptimaPLUS™ in conjunction with a dental implant and standard bone filler. The results to date are not statistically significant as they are based on data from the first 13 patients to have completed the six-month follow-up. However the results from these initial 13 patients favour the Inion OptimaPLUS™ test group over the control group in each of the study's performance criteria. A total of 31 patients are expected to have completed the six-month follow up by Q1 2008 and further interim data will be released at that time. The recruitment of the nine remaining patients needed to complete the study is on-going. Chris Lee, Inion's CEO said: “We are pleased that the first set of results from this trial has shown a positive trend towards improved bone quality in patients using Inion OptimaPLUS™. This gives us the confidence to continue with this trial to its completion and using the information generated from both this and the trial evaluating accelerated bone growth will enable us to determine our strategy for the future development and commercialisation of OptimaPLUSTM.” - 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 | | -------------------------------------------------------------------------------- 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[TM] 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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