AOI Aoi (Regs)

 

TIDMAOI 
 
RNS Number : 5242Y 
AOI Medical, Inc. 
03 September 2009 
 

 
 
AOI Medical, Inc. Completes Enrollment for Its Sixty (60) Patient 
Ascendx(TM)VCF Reduction System Clinical Trial 
 
 
FDA Approval And Market Launch Anticipated For First Quarter 2010 
 
 
London, UK, 7 September 2009 - AOI Medical, Inc. (the "Company" or "AOI") (AIM: 
AOI), a medical device company focusing on innovative orthopaedic medical 
devices for the spine and trauma markets, has successfully completed enrollment 
for the sixty (60) patient clinical trial of its Ascendx(TM) Vertebral 
Compression Fracture ("VCF") Reduction System ("Ascendx(TM)"). The trial was 
initiated in June 2008 in eight sites across the United States. 
 
 
The primary end point of the trial was acute procedural success defined as 
successful device deployment, cement delivery, and device withdrawal. The data 
from the trial will be used as clinical support for the Company's 510(k) 
submission to the FDA in relation to Ascendx(TM). With the completion of the 
clinical trial, the Company believes it remains on track for FDA approval and 
market launch in the United States in the first quarter of 2010. 
 
 
"While results are still in the process of being evaluated, we are pleased with 
the data and patient outcomes we have seen from the clinical trial thus far," 
said Dr. Achecar, Chairman of the Company's clinical advisory board. 
William J. Christy, CEO of AOI, said: "We are delighted to have reached this 
very important milestone in our Company history. The Ascendx(TM) system was 
designed to provide notable improvements in the way physicians have 
traditionally treated VCFs and we look forward to updating our shareholders as 
we move toward approval and the introduction of the Ascendx(TM) product into the 
marketplace." 
 
 
For more news and information on AOI Medical, Inc., please visit 
www.IRGnews.com/coi/AOI where you can find a fact sheet on the company, investor 
presentations, and more. 
 
 
About Ascendx(TM) 
 
 
Ascendx(TM) is an investigational device which comprises a set of tools 
specifically designed for use in the treatment of painful pathological fractures 
of the vertebral body that may result from osteoporosis, benign lesions and/or 
malignant lesions such as metastatic cancers and myeloma. Ascendx(TM) comprises 
two main instruments: a cutting device that creates a cavity in cancellous bone, 
and a reduction device that is used to restore the height of the fractured 
vertebra and which can deliver and contain the bio-material (bonding agent) in 
the cavity. The set of tools is designed to offer a potential enhancement over 
current techniques. Ascendx(TM) is an investigational device limited to 
investigational use in the ongoing IDE study in the United States. 
 
 
Ascendx(TM) presents an attractive market opportunity. The size of the market is 
estimated to be in the region of USD700 million annually, rising to over USD900 
million by 2012 (source: CRT Capital, LLC 2008). 
 
 
Background to AOI Medical, Inc. 
 
 
AOI is a medical device company focusing on the development and 
commercialisation of innovative orthopaedic medical devices for the spine and 
trauma markets. It is progressing the development of three separate technology 
platforms: Ascendx(TM) VCF Reduction System, BAMF Trauma and Cervical Plate. 
Further information can be found at www.aoimedical.net 
 
 
Enquiries: 
 
 
+------------------------------------------------+--------------------------+ 
| AOI Medical, Inc.                              | Tel: +1 407 770 1800     | 
+------------------------------------------------+--------------------------+ 
| William J. Christy, CEO                        |                          | 
+------------------------------------------------+--------------------------+ 
|                                                |                          | 
+------------------------------------------------+--------------------------+ 
|                                                |                          | 
+------------------------------------------------+--------------------------+ 
| Numis Securities Limited                       | Tel: +44 (0) 20 7260     | 
|                                                | 1000                     | 
+------------------------------------------------+--------------------------+ 
| Nominated Adviser: Michael Meade / Brent Nabbs |                          | 
+------------------------------------------------+--------------------------+ 
| Corporate Broking: David Poutney               |                          | 
+------------------------------------------------+--------------------------+ 
|                                                |                          | 
+------------------------------------------------+--------------------------+ 
| The Investor Relations Group                   |                          | 
+------------------------------------------------+--------------------------+ 
| Erika Moran/Tom Caden                          | Tel: +1 212 825 3210     | 
+------------------------------------------------+--------------------------+ 
| Public Relations: Susan Morgenbesser           |                          | 
+------------------------------------------------+--------------------------+ 
 
 
 
 
Background to AOI Medical, Inc. 
 
 
AOI is a medical device company focusing on the development and 
commercialisation of innovative orthopaedic medical devices for the spine and 
trauma markets. It is progressing the development of three separate technology 
platforms: Ascendx(TM) VCF Reduction System, BAMF Trauma and Cervical Plate. 
Further information can be found at www.aoimedical.net 
 
 
 
 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
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