ORLANDO, FL--(Marketwire - March 31, 2009) -
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AOI Medical, Inc. Treats Thirty (30) Patients in AscendxTM VCF
Reduction System Clinical Trial
Procedure Designed to Provide a Mechanical, Repeatable Cutting of
Cancellous Bone and to Provide Even Distribution of Bone Cement
London, UK, 31 March 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 thirty (30) patients
in a clinical trial with AscendxTM Vertebral Compression Fracture
("VCF") Reduction System ("AscendxTM") at six sites across the United
States. 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 Medical, said: "The clinical program has
gained momentum and we are pleased with our progress to date. The
AscendxTM 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 AscendxTM
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.
On 12 March 2008, AOI received final approval from the FDA to commence
a clinical trial for its AscendxTM technology. The single arm trial of
AscendxTM will ultimately involve sixty (60) subjects in eight centers,
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 AscendxTM.
The clinical trial is expected to complete its last patient enrollment
and make its 510(k) submission to the FDA in mid-2009. The company
believes that it remains on target for a market launch of AscendxTM in
the United States towards the end of 2009.
About AscendxTM
AscendxTM 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. AscendxTM 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. AscendxTM is an investigational device limited to
investigational use in the ongoing IDE study in the United States.
AscendxTM 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).
About 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 innovative product platforms: AscendxTM VCF Reduction
System, BAMF Trauma and Cervical Plate. Further information can be
found at www.aoimedical.net
Enquiries:
AOI Medical, Inc.
William J. Christy, CEO Tel: +1 407 770 1800
Angela Johnston, CFO
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
This information is provided by RNS
The company news service from the London Stock Exchange
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