AOI Medical, Inc. Completes Its Sixty (60) Patient
September 07 2009 - 2:00AM
UK Regulatory
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
RESZGGGLLFVGLZM
Aoi (Regs) (LSE:AOI)
Historical Stock Chart
From Oct 2024 to Nov 2024
Aoi (Regs) (LSE:AOI)
Historical Stock Chart
From Nov 2023 to Nov 2024