GYG Gyg Plc

RNS Number:0319Q
Gyrus Group PLC
16 January 2002

Embargoed for release, Wednesday 16 January 2002 - 07.00am (GMT)



Gyrus Group PLC

Announces European introduction of Somnoplasty(R) Tonsillectomy and

UK approval to commence clinical trials on its

PlasmaKinetic(R) II Cosmetic Surgery System



Gyrus Group PLC ("Gyrus" or "the Group"), whose innovative medical devices
focus on the management of tissue using less traumatic techniques, today
announces the European introduction of its Somnoplasty system for
tonsillectomy, following CE marking of the product.



In addition, Gyrus has received UK approval to commence clinical trials on its
PlasmaKinetic II (see notes to editors) cosmetic surgery system, following
review by the UK Medical Device Agency.





Somnoplasty Tonsillectomy:



Using their temperature controlled radiofrequency (TCRF) technology currently
applied to the treatment of obstructive breathing disorders such as Sleep
Apnoea, the Somnoplasty technique shrinks the enlarged tonsils as opposed to
the conventional technique of surgically removing the tonsils.  Importantly
for patients and healthcare providers alike, the Somnoplasty treatment can be
performed on older children and adults as an out-patient, local anaesthetic
procedure.



A recently published US study demonstrated that the beneficial effects of
Somnoplasty tonsil shrinkage were maintained at follow-up 1 year later.  There
is evidence that the tonsils play an immunological role in providing a first
line of defence against organisms ingested through the mouth.  Retaining some
functional tonsil tissue as opposed to excising the whole gland has some
potential benefits.  Surgeons in Germany have so far led this preservation
approach.



As a single use instrument, it is expected that Somnoplasty Tonsillectomy
should eliminate the theoretical risk of transmission of vCJD when using
reusable instruments as identified by the Spongiform Encephalopathy Advisory
Committee in January 2001.  Furthermore, as a single-use instrument
eliminating excision of tissues and functioning solely from a dedicated
generator, the Somnoplasty technique should overcome the widely reported
bleeding complications associated with excision tonsillectomy performed using
generic disposable instruments.



Tonsillectomies are the second most common surgical procedure performed on
children in Europe, and the US National Office of Hospital Statistics
estimates that at least 400,000 tonsillectomies were performed in the US alone
in 2000.





PlasmaKinetic II Cosmetic Surgery:



Gyrus Group is also pleased to announce that it has received UK approval to
commence clinical trials on its PlasmaKinetic II cosmetic surgery system,
following review by the UK Medical Device Agency.



To date Gyrus' PlasmaKinetic Tissue Management Systems have utilised plasma
energy to provide superior performance and versatility across a wide range of
surgical procedures.  Cosmetic surgery is a new application of this technology
targeted at skin rejuvenation, wrinkle removal and other related procedures.



Pre-clinical trials on the system conducted at a leading independent medical
research organisation demonstrated:



*         A more controlled and predictable effect compared to laser
treatments.

*         At low to moderate settings, a rapid healing profile with
remodelling of the skin surface suitable for treating minor skin blemishes
including sun damaged skin and wrinkles.

*         An aggressive treatment option with generation of new skin collagen
in combination with remodelling of the skin surface suitable for treating
moderate skin blemishes and tumours of the skin surface.



Approval to pursue clinical studies in the UK has now been received from the
Medical Device Agency. Now that this has been received, approvals to commence
similar studies in the US will be sought.



Once preliminary results from the UK study are available, plans to
commercialise the system will be accelerated.  This is a significant market
with the American Society of Plastic Surgeons estimating that nearly 3.6
million skin rejuvenation procedures were undertaken in 2000 in the US alone
with a total value in excess of US$1.6 billion.





Commenting on the announcement, Mark Goble, Group Chief Executive, today said:



"Both these developments demonstrate our ability to leverage our core
technologies in order to bring innovative, non-invasive and less traumatic
procedures to large and growing markets."



"We expect Somnoplasty to become an important treatment for diseased tonsils
and once integrated with our other PlasmaKinetic technologies later this year,
it will provide surgeons with a unique and comprehensive range of less
traumatic treatment options in head and neck surgery."



"The PlasmaKinetic II cosmetic surgery system further compliments this
strategy and I am delighted that we can now commence clinical trials and move
forward with our plans to commercialise our technology in this high growth
opportunity."



                                     Ends



Enquiries:


Gyrus Group PLC
Dr Mark Goble, Group Managing Director               Tel: 01189 219720

Financial Dynamics                                   Tel: 0207 831 3113
Edward Bridges/Sarah Manners





Notes to editors:



PlasmaKinetic II



The Group's PlasmaKinetic technology is comprised of two platforms:
PlasmaKinetic I (PKI), capable of producing tissue vaporisation in operative
sites distended with conductive fluid, and PlasmaKinetic II (PKII), capable of
producing tissue vaporisation in operative sites distended with gas or air or
on the surface of the body.  PlasmaKinetic techniques have been shown to
reduce trauma and recovery times, in certain markets providing a compelling
alternative to other forms of treatment.  With the continued pressure to
reduce healthcare costs, less traumatic surgical management of a variety of
diseases becomes an attractive option.  Gyrus believes that this trend will be
accelerated as advances in surgical techniques enable more and more surgery to
be performed in clinics and day centres.



PKII systems are based on Gyrus' second technology platform designed for use
in minimal access surgical procedures performed in air or under gaseous
distension.  PKII products comprise an RF generator and a range of single use,
disposable instruments specifically designed for the surgical speciality.



The Somnoplasty tonsillectomy procedure



The Somnoplasty technology utilises temperature controlled radiofrequency
(TCRF) energy to shrink tissues responsible for causing obstruction of the
upper airway (breathing passage).  This obstruction often manifests itself as
a condition known as sleep apnoea; disordered sleeping with breath holding,
snoring and drowsiness during the day.  The condition is also associated with
an increased risk of heart attacks, high blood pressure and abnormal heart
beat.  The tissues responsible for the obstruction may be one or a combination
of those in the nose (turbinates), the palate (at the back of the throat), the
back of the tongue or the tonsils.  Introduced using a needle puncture, TCRF
causes a reduction in the volume of these tissues whilst leaving the surface
intact.  It has already been used extensively to treat the tissues of the
palate, turbinates and tongue, successfully reducing obstructive symptoms,
improving sleep apnoea scores and increasing the size of the airway.  Results
on its use to treat enlarged tonsils are now also showing encouraging results
where, once again, the tissue is shrunk whilst preserving the surface intact.
The Somnoplasty tonsil instrument and generator are shown in the picture.  The
two needles at the tip of the instrument are inserted into the tonsils which,
subject to patient tolerance, can be done under local anaesthetic.  The energy
delivery and temperature of the tissue is then controlled, adjusted and
monitored by the generator.  Depending on the size, between 1-4 insertions are
made into each tonsil resulting in a total treatment time of under 5 minutes
per tonsil.  Following an initial swelling lasting about 24 hours, the tonsil
then progressively shrinks over the next few days.  There is commonly a
resumption of normal eating and drinking earlier than in patients treated by
conventional excision.





The PKII cosmetic surgery procedure



The PKII cosmetic surgery system was designed to treat tissues on and just
below the surface of the skin in order to produce a range of effects from a
light tightening of the skin with minimal surface trauma, through to
full-thickness rejuvenation with removal of the epidermis and superficial
dermal layers.  This range of effects from a single technology, we believe, to
be unique in the market.  It provides the ability to customise the treatment
to the particular needs of a patient depending on the severity of skin
blemishes and the amount of "down-time" or healing time acceptable to the
patient.  These effects are created using short bursts of high energy plasma
delivered through the nozzle of the instrument shown held in the hand in the
picture.  The generator controls precisely the duration and amount of energy
in the pulse.  In the trials conducted to date, the effect has been shown to
be more uniform than that created by lasers so that the healing is faster and
more even, both of which are very desirable features in the cosmetic market.

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