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2007-09-06 12:57:00 CEST 2008-01-17 12:58:21 CET REGULATED INFORMATION Inion Oyj - Company AnnouncementInion Receives First Regulatory Clearance for Inion BioRestore™ – A New Synthetic Bioactive and Biodegradable Material for Filling Bone DefectsInion Receives First Regulatory Clearance for Inion BioRestore™ - A New Synthetic Bioactive and Biodegradable Material for Filling Bone Defects 510(k) Clearance Received in the USA for Dental and Cranio-Maxillofacial Applications Tampere, Finland and Guildford, UK. 6 September 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 its newest implant material, Inion BioRestore™. This new product is a synthetic bioactive and biodegradable bone grafting substitute material made from bioactive glass fibres and is designed to fill bony voids or gaps in the skeleton that may result from surgery or from traumatic injury, a market worth an estimated $158 million in the US in 2007 (see below). Inion BioRestore™ can be cut or shaped precisely to fit the defect and provides a highly porous scaffold onto which the patient's new bone will grow, allowing complete repair of the defect. A key property of Inion BioRestore™ material is its bioactivity; in preclinical studies, it demonstrated osteoconductive and osteostimulative properties, accelerating new bone formation while gradually degrading over approximately six months to allow bone to fill the void. Inion BioRestore™ is designed to replace current bone grafting techniques in certain surgical procedures, where it offers other important advantages, primarily in that its synthetic origin excludes risks of disease transmission and overcomes the limitations in quantity and quality of available bone graft. Initially Inion BioRestore™ is approved for use in dental and cranio-maxillofacial (CMF) applications, e.g. alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy), dental extraction sites (ridge maintenance, implant preparation/placement), sinus lifts and craniofacial augmentation. It is also being reviewed currently by FDA for use in orthopaedic trauma indications, which represent key areas of focus for the Company. Inion BioRestore™ is also under review in Europe for use in orthopaedic, CMF and dental applications and Inion expects to receive decisions on these filings during the second half of 2007. The Company plans to launch Inion BioRestore™ in these markets as soon as possible thereafter. Chris Lee, Inion's CEO, said: “Inion BioRestore™ is an exciting new biomaterial with significant and increasing commercial appeal as it can be used in many applications where bone grafting or filling is necessary to repair bone injuries or defects. This new state-of-the-art biomaterial developed by Inion can be used alone or in conjunction with Inion's other biodegradable products across a range of indications, offering many clinical advantages to surgeons and patients, and will complement our focused product offering in the orthopaedic trauma and spine areas.” According to Millennium Research Group and Knowledge Enterprises, the US market for bone graft substitutes is estimated at $1.5 billion between 2007 and 2011. The market for synthetic bone graft substitutes is approximately $158 million and is growing at a compound annual rate of 10%. Bone graft substitutes are used in the following application areas: spine (approximately 63% of market value), orthopaedic trauma (17%), dental (17%), reconstructive surgery (i.e. hips, knees, 2%), cranio-maxillofacial (CMF, 1%) (NB: numbers do not add to 100% due to rounding). The market outside the US is estimated to be worth 36% of the US market. -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 | Mob: +44 (0)7903 737703 | | 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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