GYG Gyg Plc

RNS Number:3412Y
Gyrus Group PLC
9 July 2002



Embargoed for release 9 July 2002 - 07.00am (BST)


MULTICENTRE STUDY RESULTS ON TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
PRESENTED AT THE BRITISH ASSOCIATION OF UROLOGICAL SURGEONS MEETING


Reading, UK - Gyrus Group PLC (GYG.L "Gyrus" or "the Group"), a world leader in
the management of tissue using less traumatic techniques, has announced the
findings of a major multicentre comparative study of the Gyrus PlasmaKinetic(TM)
System and conventional monopolar surgery for the treatment of benign prostatic
hyperplasia (BPH).  The findings were presented recently at the annual meeting
of the British Association of Urological Surgeons held in Glasgow, Scotland.

The 3 month follow-up data derived from the eight departments of urological
surgery involved in the study was based on 176 men with a mean age of 69
randomised to either conventional monopolar transurethral resection of the
prostate (TURP) or treatment with the PlasmaKinetic System (PKVP).

Analysis of the results against the primary end-points of the study showed:

  • The outcomes in terms of restoring urinary flow and reducing symptoms
    associated with an enlarged prostate were equivalent in both Groups.

  • The time to first removal of the urinary catheter was significantly less
    in the PlasmaKinetic treatment group.

The presentation concluded with the question, "will PKVP replace TURP?" to which
the answer was, "in the opinion of the investigators, yes."

"Given the incremental improvements we have made to the system since this study
commenced, these results are very encouraging.  Unlike many other alternatives
to TURP that have been tried over recent years, we have demonstrated that PKVP
is potentially better than what is accepted as the "gold standard"," said Mark
Goble, Group Managing Director.  "PKVP also offers men an alternative to
traditional surgery because it has been shown that it can be done on a day-case
(outpatient) basis."

The PKVP procedure also offers men the advantage of reducing or eliminating the
risk of TUR syndrome. This occurs when too much of the irrigant fluid used
during traditional TURP is absorbed, leading to a dilution of salts (principally
sodium) in the blood, a potentially life-threatening complication.  The study
demonstrated a significantly higher fall in blood sodium in the TURP group as
the PKVP system operates in a safe saline environment thereby eliminating the
root cause of this complication.

The Gyrus PlasmaKinetic System for PKVP works by providing high levels of radio
frequency (RF) energy.  That energy forms a plasma corona, which rapidly and
consistently vaporizes excess tissue that is pressing against the urethra.  This
type of surgery relieves the obstruction and incomplete bladder emptying caused
by BPH.

The PlasmaKinetic System, developed and manufactured at the Group's Cardiff
centre and distributed in the U.K by Gyrus International, and in the U.S. by
Gyrus Medical Inc. is part of the Group's complete system for urology.



                                    - Ends -


Notes to editors:

About Gyrus

Gyrus Group PLC is a fast growth medical technology company based in Reading,
UK. The Group comprises four operational units: Gyrus Medical Inc. Gyrus Medical
Ltd., Gyrus International Ltd. and Gyrus ENT.  For more information see:
www.gyrusgroup.com.


Enquiries:


Gyrus Group PLC                                             Tel: 01189 219720
Mark Goble, Group Managing Director
Tom Murphy, Group Finance Director
Christian Williams, Director of Corporate Communications

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

Fleishman-Hillard UK                                        Tel: 0207 395 7079
Jennifer Ryan


BACKGROUND AND MARKET UPDATE

Additional information on the "Multicentre Comparative Study of the Gyrus
PlasmaKinetic(TM) Bipolar Electrosurgical System (PKVP) & Conventional Monopolar
Loop TURP in BPH

The primary objectives of the study were a) to prove safety and effectiveness of
PKVP compared to TURP, and b) timing of trial without catheter and successful
voiding. The secondary objectives compared operative times, irrigating fluid
volumes, electrolyte and haemoglobin changes, transfusion rates, and IPSS and
QoL scores.

The study was randomised on a 2:1 basis (PKVP/TURP) on the basis that a wealth
of data exists for the "Gold Standard" TURP. 176 patients were enrolled in the
study (119/57), with a mean age of 69 years and mean estimated prostate volumes
of 35cc for both groups. This included a subgroup of patients with acute and
chronic urinary retention.

Operation time was found to be around 30 minutes for both arms, with no
statistical significance in the variance. The median irrigating fluid volumes
recorded were 10.5 litres in the PKVP arm and 12.3 litres in the TURP arm. This
was not statistically significant.

A statistically significant change was noted in the Serum Sodium levels, (p =
0.019), with a greater fall in the TURP group. The fall in haemoglobin
post-operatively was not found to be statistically significant between the two
groups.

With regard to the primary endpoint of time to 1st Trial Without Catheter
(TWOC), a statistically significant change was noted (p = 0.02) in favour of the
PKVP arm, with a mean difference of 8 hours recorded. This excluded 5 patients
(both arms) who had catheter times > 120 hours due to co-morbidities. The time
from catheter insertion to final TWOC was not found to be statistically
significant, although it is interesting to note that the median value for those
patients suffering from Acute Urinary Retention was 8.5 hours less in the PKVP
arm.

The number of patients discharged with a catheter was 12 in the PKVP arm and 2
in the TURP arm. It should be noted, however, that 6 of the PKVP patients were
electively treated as day case patients, where discharge with an indwelling
catheter was part of their care plan. In terms of voiding success, 85% of the
PKVP patients were discharged voiding satisfactorily, compared to 89.7% in the
TURP arm.

Changes in IPSS and QoL scores correlated closely between the two arms, with
both PKVP and TURP recording scores of 5 (IPSS) and 1 (QoL) at 3 months. Peak
Urinary Flow was also closely correlated in both arms and no statistically
significant difference was found between the groups.

Another pertinent finding was that 8 patients in the PKVP arm were
anticoagulated at the time of surgery, with no increased bleeding observed. This
was deemed significant, and worthy of further study.  Although it was also noted
that there was a short learning curve involved in maximising the haemostatic
performance of the system with two patients in the PKVP arm receiving
transfusions (1.7%) compared to three patients in the TURP arm (5.4%).

Urologic applications for the PlasmaKinetic Tissue Management System

The PlasmaKinetic family of products offers urologists an entire line of
instruments to vaporize, vapour seal, resect, enucleate or incise prostate
tissue.

Half of all men have BPH identifiable histologically by age 60 and 90% by age
85, representing a potential market size for surgical treatment in the range of
$150-300 million.  The procedure may also address a subset of typically older
men who may have failed other forms of palliative treatment and have a larger
prostate gland by the time of surgical intervention, a niche focus for the use
of the system which the Company estimates is valued at $50 million.

Because the PKVP procedure can be performed on a day-case (outpatient) basis the
Gyrus system can help decrease the cost of care for men in the UK suffering from
BPH.



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