AOI Aoi (Regs)

RNS Number:5553Z
AOI Medical, Inc.
04 July 2007


4 July 2007

                               AOI Medical, Inc.
                        ("AOI Medical" or "the Company")


            AOI Medical announces 510 (k) submission for BAMF Spine


          Remains on track to achieve commercial launch by end of 2007


AOI Medical, the medical device company focussing on the development and
commercialisation of innovative orthopaedic medical devices for the spine and
trauma markets, today announces that it has successfully processed its 510 (k)
submission for BAMF Spine (Balloon Assisted Management of Spine Fractures), in
line with the Company's commercial strategy and timeline.

The submission was made following the development earlier this year of devices
for biomechanical tests.  Due to the existence of predicate materials and
devices having successfully attained FDA approval, the submission was made
without supporting clinical data, consistent with standard market practise.
Subject to the FDA approving the 510 (k) submission by the fourth quarter of
2007, the BAMF Spine procedure is expected be launched by the end of 2007.

BAMF Spine is a set of tools designed to address compression fractures of the
spine caused by osteoporosis or trauma. The Company anticipates that BAMF Spine
will represent an enhancement over current techniques as the process:

     -    will be accomplished through one pedicle incision rather than two;
     -    will require fewer steps and less time than incumbent procedures;
     -    will prove less susceptible to cement leakage; and
     -    will return the fractured vertebra to true anatomic position.
          
In 2004, the worldwide market for devices targeted towards spinal conditions had
a value of around $3.5 billion and most 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 BAMF Spine global market size is estimated to be over $500 million.

The Company floated on the Alternative Investment Market (AIM) of the London
Stock Exchange on 22 June 2007.

William Christy, Chief Executive Officer of AOI Medical, said:

"It is pleasing to be able to deliver on one of our milestones so soon after
coming to AIM. We are hopeful that the FDA will not require clinical data and
that we will therefore be able to launch BAMF Spine before the end of this year.
  However, if clinical data is required we have budgeted for that.

"BAMF Spine represents a significant enhancement over current methods of
treating spine fractures, which are becoming a growing problem."


Enquiries:

 AOI Medical, Inc.                                             +1 407 770 1800
 William Christy, CEO

 Numis Securities                                          +44 (0)20 7260 1000
 David Poutney / Bruce Garrow

 Financial Dynamics                                        +44 (0)20 7831 3113
 Ben Atwell / Ben Brewerton


Background to AOI Medical

AOI Medical 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: BAMF Spine, BAMF Trauma and Cervical Plate.


The Products

BAMF Spine (Balloon Assisted Management of Spine Fractures): a set of tools
intended to be used to address compression fractures of the spine caused by
osteoporosis or trauma.  BAMF Spine 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.  Current techniques used to treat
progressive vertebral compression fractures include vertebroplasty and
kyphoplasty.  The Directors believe that BAMF Spine represents an enhancement
over the current techniques as they expect the process: to be accomplished
through one pedicle access port (incision) rather than two; to require fewer
steps and less time; to be less susceptible to cement leakage; and to return the
fractured vertebra to true anatomic position.

BAMF Trauma (Balloon Assisted Management of Trauma Fractures): is a removable,
inflatable nail for the stabilisation of fractures of the long bones of the arms
and legs.  AOI's BAMF Trauma differs from the nails currently on the market in
that it is a combination of a stainless steel nail inside a balloon.  The device
is inserted into the intramedullar canal of the fractured bone with the balloon
deflated.  The balloon is then inflated to fill the remaining space.  The
Directors believe that BAMF Trauma will have a technological advantage over
existing products in the market because it will potentially: require a smaller
gauge at the point of insertion; provide a firm structure, adapted to the bone
cavity while in place; and be easily removed by deflating the balloon, thus
narrowing the diameter of the device again.  The Directors believe that this
last feature should make the device particularly interesting for treating
children, in whom growth in the affected limb is impaired if a stabilisation
device is left in place.

Cervical Plate (Motion Preserving Cervical Dynamic Stabilisation Plate): an
anterior, semi-constrained artificial ligament designed to provide some
translational and rotational motion when used subsequent to a cervical spine
disc replacement surgery.  Current practice for severe intractable disc disease
is spinal fusion.  Spinal fusion is a medical procedure by which two or more
vertebrae are linked together.  Fusion may be carried out to treat a number of
spinal conditions; however, it causes stiffness of the spine in patients and
increases stress to the adjacent levels of the spine which may lead to
additional morbidity. The failure rate after lumbar fusion has been reported to
be as high as 37 per cent.  Anterior plates provide stability following
decompression and fusion of the cervical spine.  The Directors believe that the
following technical attributes of the Cervical Plate provide it with a
technological advantage over existing spinal fusion techniques: it offers a
motion preservation fusion approach that aims to promote a return to normal
range of motion when used in combination with alternatives to fusion;  the
sculpted design and thickened rails of the Cervical Plate should allow the
support needed to allow multi-directional movement while ensuring disc
compression, reducing pressures across adjacent parts of the spine; and  it is a
smaller device than competitive devices and should therefore be less disruptive.



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