Transcript CLINICAL TEST in the hospital “CASA DI CURA VALDESE”

GYNEDIL
Hydraulic Dilation System
Audiotel doo, 11A, Miljakovacke staze street, Belgrade, Republic of Serbia
Tel/fax: + 381 11 7589 387
E-mail: [email protected]
Website: www.gynedil.com
Cervical canal dilation - problem and its traditional solution
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The classical and most widely used procedure of cervical canal dilation is mechanical dilation
using the metal dilators by Hegar, shaped to fit the anatomy of the cervical canal. They have a
tapered and slightly bent tip. They are inserted into the canal and taken out one by one,
successively, the next dilator having a larger diameter than the previous one thus widening the
cervical canal gradually.
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Each dilation performed in such a way, and particularly careless and abrupt one, causes damage
to the muscular and collagenous fibers of the cervix, which often precedes its functional
incompetence, the most often complication of this intervention later. The direct complication of
the procedure (laceration of the cervix complicated by lesion of descendent branch of uterine
artery; perforation of uterus) can be life-threatening for patient.
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The risk associated with this, most widely used procedure in gynecology, made us to try to offer
a different solution. As a result of ten-years work we successfully developed a different dilation
concept, tested also in the clinical practice.
Set of Hegar dilators
New solution for dilation
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Gynedil is a hand-operated pistol shaped pump, made entirely of medical plastic,
intended and allowed for medical use, and it can be sterilized under the same
conditions of sterilization valid for other surgical instruments.
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This hand-operated piston pump makes it easy to achieve the pressure for dilation
of single-use balloon, which is the most important element of this system. The
instrument injects pressurized fluid into the balloon, which causes widening of the
elastic membrane of the single-use balloon dilator to the size allowed by the fabric
thus widening the cervical canal.
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The final dimension during dilation is absolutely defined by the geometry of the high
resistance polyethylene fabric, otherwise used for bulletproof jackets.
Gynedil – design of the instrument
Advantages of the new method
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This method offers major advantages over the existing ones in practice
for the following reasons:
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The doctor can control the speed and rhythm of dilation and adjust
them according to the resistance given by the cervical canal,
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There is almost no risk of direct complications,
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The dilator is intended for single use, so the risk of intrauterine
infection is a very low one,
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The instrument is small-sized, light, mobile, easy to handle, shaped as a
modern surgical instrument and already sterilized
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Development of the device
1999.
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The first prototype of the device was the result of joint efforts of experts from the
Faculty of Medicine and Faculty of Engineering in Kragujevac, Serbia.
2001.
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The inventors signed the License contract with the company Audiotel, Belgrade
2002- 2006.
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Audiotel develops device made of steel with changeable dilation tip. Presents the device in
the form of prototype at various international congresses and fairs to the well known
manufacturers and distributors of medical equipment
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Audiotel obtains the following patents for the device: Europatent, China patent and Hong
Kong patent
2006-2008.
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Audiotel initiates the development of a new device, made entirely of plastic and intended
for single use.
2011.
Start of industrial production is planned for 2011
International fairs and congresses where the device was presented
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IV INTERNATIONAL SYMPOSIUM “Informatics, Telematics i
Cybernetics in Surgery”, Naples, 23-26 March 2002
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The Audiotel Company was invited and took part in this International Symposium
presenting the Hydraulic Dilation System within the Gynecological Section. The
device aroused great interest of gynecologists, especially of the president in chief of
the session Prof. Dr. C. Nappi who wanted to take it right away and try it in his
hospital.
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The FAIR “Eurosalute 2002” Milan, 6-9 November, 2002
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On behalf of the Lombardia Region, the Audiotel was invited to visit the Exhibition
and Convention on equipment, products, services, technologies and meetings for
health. Mr. Antonio Pernice who was in charge of coordination of innovative
projects within the General Direction of the Lombardia Region, fixed us a meeting
with dr. Giuseppe Amuso, Director of Gynecology Department in the Hospital
Ospedale Alzano Lombardo in Bergamo/Italy.
International fairs and congresses where the device was presented
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MEDICA 2004, Dusseldorf, 24-27 November 2004
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Along with our Italian distributor BMP&T Group who had a stand in this medical
fair, we took the opportunity to exhibit our Device. Since this is the world’s largest
medical fair with a significant share of international visitors, it was very useful being
there because the Gynedil arouse a high interest among specialist trade visitors
from various countries.
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VISIT to Minsk, Republic of Belarus, November 2004
As a part of the Chamber of Commerce of Serbia Delegation, the Audiotel visited
and presented the Device in Minsk and Gomel to some distributors of medical
instruments. In that occasion we had the opportunity to meet Mr. Chapelnikau,
Head of Department of Medical Equipment within the Belarus Ministry of Health.
He was informed about Gynedil and its functioning principles.
Clinical tests
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CLINICAL TEST in the hospital “CASA DI CURA VALDESE” in Turin,
November 2002
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In the presence of Tyco’s representative Dr. Grasso and the Audiotel staff, dr. Marco
Cammani used the Gynedil in the operating theatre on the patients. He was very
satisfied with the Device, because, unlike the Hegar dilators, it did not cause any
damage of the cervix tissue. He, along with the Supplies Director of the Hospital,
wanted to know when it would be possible to have the Device ordered for the
Hospital.
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CLINICAL TEST at the Clinical Hospital Center of Podgorica 2009
The Gynedil – hydraulic dilation system was tested at the Clinical Hospital Center
of Podgorica from September 2009 to January 2010. Next two pages show the
microscopic findings.
Histhological finding of cervix after dilation by Gynedil:
Covering and glandular epithelium is preserved
Basal membrane is continuous
There is no bleeding in the sample
Histhological finding of cervix after dilation by Hegar:
Covering and glandular epithelium is damaged
Basal membrane is disrupted
Intraepithelial and stromal bleeding occurs
Visits to multinational companies
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MEETING with the TYCO representative in Milan, May 2002
Further to our participation in the Naples’ IV International Symposium, we had a meeting
with dr. Davide Grasso, Tyco’s Marketing Manager in Milan, and explained him the basic
principles of Hydraulic Dilation System. Since he evaluated our Device as a very innovative
one, interesting also in the terms of business, he informed us that he would organize a
clinical test to verify its validity.
VISIT to GYNECARE Programs for ETHICON R&D in Europe,
Johnson&Johnson Company in Norderstedt Germany, June 2005
Mr. Axel Hentrich, Ph.D. in Biomedical Engineering within the Ethicon GmbH, has
contacted us and a meeting was settled, along with the presentation of our product THE
HYDRAULIC DILATION SYSTEM.
The presentation took place in the premises of the Ethicon GmbH, in the presence of Mr.
A. Hentrich, Dr. Peter Meier, Manager Europe, and Ms. Susanne Landgrebe, Biomedical
Engineer. Our Project Manager showed the instrument and explained its functioning, as
well as answered the questions of the experts mentioned above.
The Device was evaluated straightaway as a very interesting one and it was suggested
developing a prototype for single use.
Audiotel – Letter of intent
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Audiotel is the exclusive owner of the trade mark and the license for the patented
gynecological device Hydraulic Dilation System – GYNEDIL®, for the previous
prototype, as well as for the new device which is the subject of this presentation
(patent application), without time or territorial limit.
The hydraulic dilator is intended for single use and it is estimated that the annual
demand in the world would be between 200.000.000 i 300.000.000 pieces.
This device completely eliminates risk for patient’s health as well as pain and tissue
damage during intervention.
This medical instrument is medically tested in some gynecology clinics in Serbia and
in PR of China upon invitation of the Ministry for Science and Technology of PR of
China and several faculties in China – as a part of international cooperation, as well
as in Turin in the hospital Casa di Cura Valdese.
The production of this device is completely organized and initial, small-quantity
production series has been made.
Audiotel – Letter of intent
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As the owners of the patent we are able to carry out a public presentation at a
clinic in Serbia and to demonstrate the results obtained during many years of
practice.There is a possibility of video presentation.
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We are interested in finding a serious partner able to organize the production and
sale of the dilator worldwide, and to control it successfully, but we would retain
production and distribution rights for the Balkan countries.
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We are able to organize the production of the 10.000 pieces of the dilator in one
month time starting from the contract signing date, and 300.000 pieces in the first
year.
Audiotel – Letter of intent
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In relation to our partner, we are willing to:
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Renounce our license rights for a compensation which would be fixed in one part
and the other part would be a royalty,
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Renounce our license rights as well as complete technological project for device
production – KNOW HOW,
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Renounce our license rights and deliver ALL THE ELEMENTS of the device in which
case the partner would organize the assembly of the device under our supervision
and instructions,
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or to consider other forms of cooperation which would be subject of a direct
agreement.