US Product Approval

 

TIDMIIN 
 
 
Inion Oy 
05 March 2009 
 
? 
 
 
Inion Oy 
("Inion or the "Company") 
 
 
Inion strengthens US product portfolio in spine and specialty orthopaedics 
New biodegradable bone graft substitutes receive 510(k) marketing clearance 
Tampere, Finland and Guildford, UK. 5 March 2009, Inion (LSE: IIN.L), a company 
focused on the development and commercialisation of novel biodegradable medical 
implants, has received 510(k) regulatory clearance from the US Food and Drug 
Administration (FDA) for its new Inion BioRestore(TM) Sahara bone 
filling implants for use in spinal and orthopaedic surgical procedures. 
 
 
Inion BioRestore(TM) Sahara is a synthetic bioactive and biodegradable bone 
grafting substitute that can be cut or shaped precisely to fit and fill voids in 
bone that may result from surgery or from traumatic injury. It is made from 
bioactive glass fibres and provides a highly porous scaffold onto which the 
patient's new bone will grow, while gradually degrading to allow new bone to 
fill the void, allowing complete repair of the defect. Inion BioRestore(TM) 
Sahara can be used alone or in conjunction with Inion's other biodegradable 
implants across a range of indications. 
 
 
Inion BioRestore(TM) initially received both 510(k) clearance in the USA and CE 
Mark in Europe in October 2007. The new Inion BioRestore(TM) Sahara products now 
offer surgeons greater flexibility and precision for filling voids where better 
contact to the bone is required, as its wider porosity range allows the implant 
to better retain its three-dimensional space-filling structure during shaping 
and/or demanding implantation. 
 
 
Inion BioRestore(TM) has demonstrated in preclinical studies that it has 
bioactive properties that stimulate and accelerate new bone formation. It is 
designed to replace current bone grafting techniques in certain surgical 
procedures, where it also 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. 
 
 
Chris Lee, Inion's CEO, said: "We are pleased to receive this clearance for our 
latest biomaterial as it complements and reinforces our focused product offering 
in the orthopaedic trauma and spine areas in the US." 
 
 
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     | Tel: +44 | 
| Oy        | (0)1483  | 
| Chris     | 685390   | 
| Lee,      |          | 
| Chief     |          | 
| Executive |          | 
| Officer   |          | 
| Julien    |          | 
| Cotta,    |          | 
| Chief     |          | 
| Financial |          | 
| Officer   |          | 
|           |          | 
+-----------+----------+ 
| Citigate  | Tel: +44 | 
| Dewe      | (0)207   | 
| Rogerson  | 638 9571 | 
| Mark      |          | 
| Swallow   |          | 
| / David   |          | 
| Dible /   |          | 
| Helena    |          | 
| Galilee   |          | 
+-----------+----------+ 
 
 
About Inion (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 (ticker: IIN). 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. 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
 NRAGGGGFVDRGLZM