Research Update
31/03/2009 5:05pm
UK Regulatory
TIDMAOI
RNS Number : 8618P
AOI Medical, Inc.
31 March 2009
Press Information
AOI Medical, Inc. Treats Thirty (30) Patients in Ascendx(TM) 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 Ascendx(TM)
Vertebral Compression Fracture ("VCF") Reduction System ("Ascendx(TM)") 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 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.
On 12 March 2008, AOI received final approval from the FDA to commence a
clinical trial for its Ascendx(TM) technology. The single arm trial of
Ascendx(TM) 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 Ascendx(TM).
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 Ascendx(TM) in the United States
towards the end of 2009.
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 $700 million annually, rising to over $900
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: Ascendx(TM) VCF Reduction System, BAMF
Trauma and Cervical Plate. Further information can be found at www.aoimedical.n
t
+------------------------------------------------+----------------------------------------+
| | |
| 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
END
RESCKDKKABKDBNN