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Mainpage / News Archive / News 2007 / Inion Receives CE Mark for Enhanced Inion S-1™ Biodegradable System for Spinal Fusion Procedures

Inion Receives CE Mark for Enhanced Inion S-1™ Biodegradable System for Spinal Fusion Procedures

Technological advance makes implants visible to x-rays thereby facilitating post-operative assessment

Tampere, Finland and Guildford, UK. 31 August 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 S-1™ Anterior Cervical Fusion System enhanced with a radiographic marker. This advance is designed to facilitate the post-operative evaluation of the site of surgery using x-rays, by allowing the surgeon both to confirm the accurate positioning of implants and to visualise and assess the healing progress.

Launched in late 2005, the Inion S-1™ Biodegradable Anterior Cervical Fusion System, consists of biodegradable plates and screws, that, in conjunction with adjunctive immobilization (i.e. collar) can be used to stabilise the vertebrae during cervical spinal fusion procedures. These procedures are carried out as a treatment for a range of spinal conditions including ruptures and displacement of inter-vertebral discs.

This advance builds on a key benefit of Inion's biodegradable implants, which, in comparison to conventional metal implants, are invisible to x-rays. This allows proper post-operative evaluation of healing at the operated sites. To further enhance the functionality of its Inion S-1™ implants, Inion incorporates a radiographic marker to the edges of the plates and to the tips of screws in the form of dot-like markers, enabling surgeons to view the position of the implants in post-operative x-ray without interfering with their assessment of the site of surgery and its healing progress.

As well as covering this technological advance, the CE Mark received also covers an extended indication of the Inion S-1™ Anterior Cervical Fusion System to include double-level fusions, where three vertebrae are fused together. The product was previously cleared only for single-level fusions where two vertebrae are fused together. As a result, the Inion S-1™ product range has been enlarged to include biodegradable plates of various lengths for this purpose. This CE Mark therefore makes Inion S-1™ products suitable for a wider range of procedures and provides surgeons using Inion products with a greater choice of implant to use.

Chris Lee, Inion's CEO, said: "The S-1™ Anterior Cervical Fusion System is the only biodegradable product of its type that is cleared for sale in both the USA and Europe. The spinal market is a key focus for Inion due to the size of the market, the need for an enhanced clinical solution and the clear benefits that our biodegradable products can offer. The extension of our spinal implant product range in Europe through the addition of a radiographic marker and new indications for the S-1™ System further increase Inion's potential to make a significant impact in the key world markets in this rapidly growing sector."

-Ends-

*CE Mark is required by a number of accredited bodies to medical device manufacturers prior to commercial distribution in the European Union.

For further information, please contact:

Inion Oy 
Chris Lee, Chief Executive Officer
Julien Cotta, Chief Financial Officer

Tel: +44 (0)1483 685390

Citigate Dewe Rogerson
Mark Swallow / David Dible / Helena Galilee

Tel: +44 (0)207 638 9571

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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