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Inion Receives 510(k) Marketing Clearance to Sell its Biodegradable Graft Containment Systems in the USA for Spinal Fusion Procedures



7/21/2008 10:19:05 AM

TAMPERE, Finland and GUILDFORD, England, July 21 /PRNewswire-FirstCall/ -- Inion , the company focused on the development and commercialisation of novel biodegradable medical implants, today announces it has received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for its biodegradable graft containment systems for spinal fusion procedures.

The US marketing clearance has been received for the Inion S-1(TM) Anterior Cervical Fusion System, the Inion S-1(TM) double-level plate and the Inion S-2(TM) Anterior Thoraco-Lumbar Fusion System. These systems consist of biodegradable plates and screws, which are designed for bone graft containment in spinal fusion procedures. Such procedures are carried out as a treatment for a range of spinal conditions including ruptures and displacement of inter-vertebral discs. Inion's S-1(TM) and Inion S-2(TM) graft containment systems include implants intended for use along the entire length of the spine in conjunction with traditional rigid fixation.

These new graft containment systems also incorporate a radiographic marker to the edges of the plates and to the tips of screws. These markers enable 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.

More than 183,000 cervical plating procedures (Ref. 1) and more than 10,000 anterior thoraco-lumbar plating procedures (Ref. 2) were performed in 2006 in the USA. The US market for these procedures was worth approximately EUR318 million and EUR32 million, respectively. The number of spinal plating procedures has since grown at an annual rate of approximately 30%.

Inion's biodegradable implants offer significant clinical benefits over traditional metal materials, primarily in that they slowly and completely degrade over time into carbon dioxide and water, which are absorbed into the body.

The Inion S-1(TM) and Inion S-2(TM) graft containment systems received CE Mark marketing clearance in Europe in August 2007 and September 2007, respectively.

Chris Lee, Inion's CEO, said: "The US marketing clearance for our biodegradable spine products is great news. We are already seeing increased uptake of this important product line in Europe where awareness and acceptance of the clinical benefits of biodegradable medical implants is rapidly growing among surgeons, who are adopting this technology into their practice. Our aim now is to push these new biodegradable products aggressively into the US spine market where we believe it will make an attractive alternative to traditional metal plates and a strong driver of value for the Company."

References

1. Spinemarket, Inc: US spinal implant market: Cervical plate analysis. 2007

2. Spinemarket, Inc: US spinal implant market: Anterior lumbar plating analysis. 2007

About Inion (http://www.inion.com)

Inion Oy is a medical devices company focused on the development and successful commercialisation of innovative and unique biodegradable and bioactive surgical implants in selected high value orthopaedic market segments.

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 offices in the UK and USA, and its head office, R&D and production facilities are 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.

CONTACT: 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, Tel:
+44(0)207-638-9571


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