GYG Gyg Plc

RNS Number:3777X
Gyrus Group PLC
18 June 2002

Embargoed for Release, Tuesday 18 June 2002 - 7.00am (BST)


"SOMNOPLASTY" FROM GYRUS GROUP PLC RECEIVES FDA CLEARANCE FOR USE IN TEEN AND
ADULT TONSIL REDUCTION

READING, UK - Gyrus Group PLC, (GYG.L "Gyrus" or "the Group") a world leader in
the surgical management of tissue using less traumatic techniques has received
510(k) clearance from the United States Food and Drug Administration for use of
its Gyrus ENT Somnoplasty(R) System for tonsil reduction.

This advanced, minimally invasive technology utilizes temperature controlled
radio frequency energy (TCRF) to reduce obstructive symptoms of tonsillar
hypertrophy (tonsil enlargement), a condition affecting millions worldwide. The
approval provides for treatment of tonsil enlargement, a common cause of upper
airway obstructions in adolescents and adults. This condition can lead to a
variety of problems such as sleep apnoea, daytime sleepiness, snoring, loss of
voice clarity, difficulty in swallowing and throat irritation.

The Somnoplasty procedure takes about 30-45 minutes and is performed under local
anaesthesia, usually in a day case (outpatient) setting. The device consists of
a single-patient-use probe, which delivers specific amounts of radio frequency
energy to the target tissue at relatively low temperatures (up to 85 C) creating
finely controlled lesions beneath the surface of the tissue. As the tissue heals
it shrinks, reducing the size of the tonsil, whilst leaving the surface intact
and reducing postoperative discomfort.

"Shrinking the tonsils is less painful than removing them and this treatment
clears the way for teen and adult patients who associated tonsil surgery with
significant pain and time away from school and work," said Lionel Nelson, MD, a
world leader in the surgical treatment of upper airway obstructive disorders.  "
TCRF tonsil reduction using the Somnoplasty system provides an effective
alternative treatment option in selected groups of patients, eliminating the
need for general anaesthesia and decreasing the potential risks associated with
traditional surgery."

To date the U.S. FDA has cleared Somnoplasty for use in the treatment of
obstructive sleep apnoea, chronic nasal obstruction (enlarged inferior
turbinates) and habitual snoring (soft palate and uvula).  This latest clearance
provides another step in broadening the opportunity for Gyrus Group PLC in the
$1 billion head and neck surgery market.  The procedure specific market for
tonsil reduction surgery represents an opportunity of $150M, according to Mark
Goble, Gyrus Group Managing Director.

"This regulatory clearance continues our strategic mission of developing new
minimally invasive procedures for our existing line of energy-based platforms,"
said Mark Goble, Gyrus Group Managing Director. "More importantly it gives
surgeons a cost-effective, less painful alternative than conventional surgery to
offer to their patients."

Notes to editors

About Gyrus

Gyrus Group PLC is a growing medical technology company with principal UK
operations based in Cardiff and Reading. The Group comprises four operational
units: Gyrus Medical Inc. Gyrus Medical Ltd., Gyrus International Ltd. and Gyrus
ENT.

"Meet the Management" day

On Wednesday June 26th Gyrus Group PLC will hold its first "Meet the Management"
day for financial analysts and members of the media at 9:30 a.m.  It will be
held at The City Media Centre of The London Stock Exchange, London EC2N 1HP.

Enquiries:

Gyrus Group PLC                                             Tel: 01189 219 720
Mark Goble, Managing Director
Christian Williams, Director of Corporate Communications

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

Fleishman Hillard Public Relations                          Tel: 0207 306 9000
Jennifer Ryan


                      This information is provided by RNS
            The company news service from the London Stock Exchange

Gyg (LSE:GYG)
Historical Stock Chart
Von Jun 2024 bis Jul 2024

Gyg (LSE:GYG)
Historical Stock Chart
Von Jul 2023 bis Jul 2024