GYG Gyg Plc

RNS Number:9658U
Gyrus Group PLC
24 April 2002


Embargoed for release Wednesday 24 April 2002 - 07.00am (BST)


GYRUS RECEIVES FDA CLEARANCE AND COMMENCES SHIPMENTS OF ITS NEW G1
RADIOFREQUENCY GENERATOR FOR TREATMENT OF UPPER AIRWAY OBSTRUCTIONS


Reading, UK - Gyrus Group plc (GYG.L "Gyrus" or "the Group"), a world leader in
the management of tissue using less traumatic techniques, has received 510(k)
clearance from the U.S. Food and Drug Administration for its new "G1
Temperature-Controlled Radio Frequency Generator" ("G1 System"). The device
which powers the associated single-patient-use surgical instruments also
manufactured by Gyrus can be used by head and neck surgeons for the correction
of upper airway obstructions, including sleep apnoea, nasal obstructions and
habitual snoring, conditions that adversely affect many millions of sufferers
world wide. The unit addresses a market opportunity valued in excess of $1
billion in the United States alone according to the Group.

The new device, from the Group's U.S. based Gyrus ENT division, replaces the
first generation Somnoplasty system that was incorporated into the group's
broadening product portfolio following the acquisition of Somnus Medical
Technologies, Inc. in June 2001.

Performed under local anaesthesia the G1 System shrinks soft tissue in the upper
airway including the base of the tongue.  The system is designed to minimize
bleeding, preserve the mucosal lining and thereby reduce the pain often
associated with other invasive surgical techniques. These surgical procedures
are generally performed on an "outpatient" or day case basis.

The system features an advanced modular energy platform that can be upgraded and
expanded as new developments based on the Group's core PlasmaKinetic technology
are incorporated into the product line.

"Not only does the unit have more physician friendly features but it represents
the first phase of our technology integration programme targeted at reducing the
cost of generator placement," said Mark Goble, Group Managing Director. "This
introduction reduces our working capital needs and significantly takes us into a
neutral cash flow position."

"The G1 System will be manufactured at our Gyrus Medical Ltd. facility in
Cardiff and completes the final integration step associated with the acquisition
of Somnus.  A key strategy is to utilize the world-class technology available in
Cardiff in the design and development of generators for the entire Group.  This
will help leverage our infrastructure costs and create a very significant
reduction in the basic cost of the G1 System compared to the original Somnus
unit," said Mark Goble.



                                    - Ends -





Notes to editors



About Gyrus

Gyrus Group plc is a growing 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.  Gyrus ENT is the largest division
in the Group and is a leader in the field of ENT and head and neck surgery.





Enquiries:


Gyrus Group PLC
Christian Williams, Director of Corporate Communications      Tel: 01189 219720

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





BACKGROUND AND MARKET UPDATE



Head and neck applications for G1 System



Temperature Controlled Radio Frequency (TCRF)



The G1 System is part of the Group's broad range of products designed
specifically to provide the physician with less traumatic tissue management for
patients suffering from obstructive sleep apnoea (OSA), habitual snoring, nasal
obstruction and enlarged tonsils.  The procedures address in excess of 10
million potential patients representing a potential market size of $1billion.
It is an underserved market with only 10% of all patients diagnosed.  The market
represents a significant opportunity for Gyrus.



Additionally the Company received CE marking in January 2002 for use of the
device for the treatment of tonsillitis by way of shrinking the gland as opposed
to excision.  This application can also be driven off the same new platform.



The Company is currently pursuing broader utilisation of the energy platform in
the areas of obstructive breathing disorders, head and neck oncology, thyroid
surgery and oesophageal surgery through the second phase integration of its
PlasmaKinetic technology.



                         Additional background material



The G1 System is a radiofrequency tissue reduction system designed to treat
upper airway obstructions such as sleep apnoea, nasal obstructions and habitual
snoring.  The system works by helping shrink redundant tissue in the upper
airway and nasal passages. The Gyrus procedure is generally performed in a "day
surgery" or "outpatient" setting in a physician's office.  The system uses
radiofrequency (RF) energy produced by an advanced control unit.  That energy is
then transmitted through various single-patient-use hand pieces directly to the
targeted tissue area.  The procedure generates heat at approximately 85 degrees
C (185 F) to create finely controlled coagulative lesions at precise locations
within the upper airway or nasal passages.  The lesions created by the procedure
are naturally resorbed reducing excess tissue volume and opening the airway.
The patented TCRF Technology controls the temperature allowing for more
predictable, consistent, predictable lesion size and improved outcomes.
Typically the procedure takes 15 minutes.  More than one treatment may be
necessary to achieve optimal results.



Other treatment modalities such as behaviour modification and medication may be
palliative at best.  The Gyrus system represents an effective cure for
obstructive sleep apnoea.  Unlike standard electrosurgical treatment or laser
approaches, the RF system has continuous monitoring for temperature, power and
impedance.  The minimally invasive nature of this procedure over traditional
surgery means the patient will experience less pain and faster return to normal
activities.



Clinical studies have shown the Gyrus procedure to be highly effective.  One
study conducted by Stanford University has shown that the radiofrequency
procedure effectively treated obstructive sleep apnoea (OSA) in moderately and
severely affected patients.  Test results showed that 72% of the patients had a
favourable response with an average of 17% percent reduction in tongue tissue
volume and a reduction of 77% in the apnoea index. To date more than 100,000
procedures utilizing the first generation Somnus technology have been performed
on patients suffering from OSA.





                      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