Research Update
December 19 2007 - 2:03AM
UK Regulatory
RNS Number:2416K
AOI Medical, Inc.
19 December 2007
AOI Medical, Inc.
("AOI Medical" or "the Company")
AscendX(TM)Product Update
AscendX(TM)Cleared to Commence Clinical Trials
London, UK, 19 December 2007 - AOI Medical Inc. (the "Company" or "AOI") (AIM:
AOI), the medical device company focusing on innovative orthopaedic medical
devices for the spine and trauma markets, today provides an update on progress
with its AscendX(TM) Fracture Reduction System ("AscendX"), formerly known as
BAMF Spine.
AOI announced in October 2007 that the US Food and Drug Administration ("FDA")
had asked AOI to conduct a clinical study of AscendX(TM). The Company is
pleased to announce that the FDA has granted conditional approval for AOI to
begin a sixty subject, single arm study of the Company's AscendX(TM) Fracture
Reduction System.
End points of the trial will include acute procedural success and other clinical
parameters, which has met management expectations and is within the Company's
budget. The trial is expected to commence in Q1 2008. AOI continues to expect
commercial launch of AscendX(TM) in the US in H2 2008.
In 2004, the worldwide market for devices targeted towards spinal conditions had
a value of around $3.5 billion and more recent estimates indicate that the
spinal products market will approach $10 billion by 2010. The growth is being
driven by increasing incidences of osteoporosis in an ageing population and a
growing number of sports related injuries as people become more active. In
2009, the AscendX(TM) global market size is estimated to be over $500 million.
Bill Christy, CEO of AOI, said:
"We are pleased to be able to commence the clinical study for AscendX(TM), which
we believe will provide AOI with the clinical data required to both obtain
approval and assist marketing this important product.
AscendX(TM) addresses a global market worth over $500 million per annum and we
are confident that the product's profile will enable it to enjoy strong market
penetration."
For further details please contact:
AOI Medical Inc. Tel: +1 407 770 1800
William J. Christy, CEO
Angela Johnston, CFO
Financial Dynamics Tel: +44 (0) 20 783 3113
Ben Atwell
Susan Quigley
Numis Securities Tel: +44 (0) 20 7260 1000
Bruce Garrow
David Poutney
Background to AOI Medical Inc.
AOI is a medical device company focussing 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) Fracture Reduction System, BAMF Trauma and Cervical Plate.
Further information can be found at www.aoimedical.net
AscendX(TM)
AscendX(TM) is an investigational product which provides a set of tools intended
to be used to address compression fractures of the spine caused by osteoporosis,
cancer or trauma. AscendX(TM) will comprise two main instruments: a cutting
device that creates a cavity in cancellous bone, and a balloon-like device which
is used to restore the height of the fractured vertebra and to deliver and
contain the cement in the cavity. The set of tools is designed to offer a
potential enhancement over current techniques.
Current techniques used to treat progressive vertebral compression fractures
include vertebroplasty and kyphoplasty (so named by Kyphon, the company that
developed the technology). In July 2007, it was announced that Medtronic (NYSE:
MDT) had acquired Kyphon for $3.9 billion. This acquisition fully underpins the
market opportunity that lies within this area as patients and doctors continue
to seek modern, minimally invasive spinal treatments that enhance patient
life-styles and are simpler, faster and less-invasive than the traditional
surgical treatments. The Directors of AOI believe that the Company has a product
that can significantly challenge the current products on the market.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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