AOI Medical, Inc. Treats Fifty-Four (54) Patients


 

TIDMAOI 
 
RNS Number : 5948W 
AOI Medical, Inc. 
30 July 2009 
 
Press Information 
 
AOI Medical, Inc. Treats Fifty-Four (54) Patients in Ascendx(TM) VCF 
Reduction System Clinical Trial 
 London, UK, 30 July 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 surgical 
procedures on fifty-four (54) patients in a clinical trial with Ascendx(TM) 
Vertebral Compression Fracture ("VCF") Reduction System ("Ascendx(TM)") at eight 
sites across the United States. AOI has treated ten (10) patients since the last 
Company announcement on 24 June 2009. The board is pleased with the progress of 
the clinical trial and results to date; evaluation of clinical outcomes is 
ongoing. 
William J. Christy, CEO of AOI, said: "This is an exciting time in AOI's history 
as we near the completion of our sixty (60) patient Ascendx(TM) clinical trial 
and we are very pleased with the progress we have made to date. The Ascendx(TM) 
system is designed to provide notable improvements in the way physicians 
traditionally treat VCFs. While all currently existing VCF procedures offer 
immediate pain relief to the patient, the Ascendx(TM) technology is specifically 
designed to provide a mechanical, repeatable cutting of cancellous bone and to 
deliver an even distribution of the bone cement. Over time, these features may 
potentially provide benefits with respect to clinical outcomes, subject to 
ongoing clinical evaluation." 
The single arm trial of Ascendx(TM) will ultimately involve sixty (60) subjects, 
with the primary end point being 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). The clinical trial is expected to complete 
its final patient enrollment and make its 510(k) submission to the FDA later 
this year. The Company believes that it remains on target for a market launch of 
Ascendx(TM) in the United States in Q1 2010. 
For more news and information on AOI Medical, Inc., please visit 
www.IRGnews.com/coi/AOI where you can find the CEO's video, 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) will 
comprise 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). 
Enquiries: 
 
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| AOI Medical, Inc.                              | Tel: +1 407 770 1800                   | 
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| William J. Christy, CEO                        |                                        | 
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| Numis Securities Limited                       | Tel: +44 (0) 20 7260 1000              | 
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| Nominated Adviser: Michael Meade / Brent Nabbs |                                        | 
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| Corporate Broking: David Poutney               |                                        | 
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|                                                |                                        | 
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| The Investor Relations Group                   |                                        | 
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| Erika Moran/Tom Caden                          | Tel: +1 212 825 3210                   | 
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| Public Relations: Susan Morgenbesser           |                                        | 
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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.n 
t 
 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
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