DEFLUX LONG-TERM DATA PUBLISHED
A study has been carried out at the University Hospital of Uppsala on 220 patients in order to measure the long-term effect and the safety of the product DEFLUX for treatment of vesicoureteral reflux (VUR, reflux) in children. Data show that DEFLUX cures the patient in almost 70% of the cases and that a further 10% are greatly improved. These study results have now been published in volume 166 in the November issue of the American "Journal of Urology".
Please note that in the USA Q-Med operates under the name of Q-Med Scandinavia, Inc.
Vesicoureteral reflux
Vesicoureteral reflux occurs in approximately one percent of
all children. In these children the valve function that prevents
urine from running back from the urinary bladder up towards the
kidneys does not work. Reflux is usually discovered upon
examination of children who have had serious urinary tract
infections, and reflux occurs in approximately 50% of these
children. The combination of a urinary tract infection and reflux
can result in scarring of the kidneys and in a few isolated cases
can even lead to irreversible kidney damage. Reflux is classified
from level I to level V, from mild to serious, and the less
serious levels of reflux usually disappear as the children grow
older but during the years where there is still a problem some
form of treatment is necessary. The alternatives available today
are long-term treatment with antibiotics (often for several
years), endoscopic injection treatment using
tissue-strengthening material (e.g. DEFLUX), or surgery.
DEFLUX
DEFLUX consists of Q-Med's so-called NASHA (Non-Animal
Stabilized Hyaluronic Acid) mixed together with "sugar
beads", dextranomer. The latter gives the product a
long-term effect for a period of several years. The combination
of dextranomer and hyaluronic acid has many advantages. Both
substances are natural, have no immunogenic properties and are
not associated with migration to other organs.
DEFLUX is injected into the wall of the urinary bladder using "keyhole surgery" or endoscopic treatment, in order to create a slightly raised area at the opening of the ureter. This prevents the urine from running back from the urinary bladder. The treatment is fast and effective. The child is given a general anesthetic and the treatment is over within a few minutes.
DEFLUX is approved for treatment of VUR in Europe and in the US. In the US, DEFLUX is indicated for treatment of VUR grade II to grade IV.
The study
Two pediatric urologists at the University Hospital of
Uppsala, Göran Läckgren and Arne Stenberg, have performed a
study using DEFLUX over a period of up to 7.5 years in total (5
years of follow-up on average). Over 220 children between the
ages of 1 and 15 (mean age 4.7 years) were treated with DEFLUX
1.3 times on average and were followed up for 2 - 7.5 years. At
the most recent 1-year follow-up 68% were cured and a further 13%
had improved greatly, that is a total of 81% of the children
needed no further treatment. The cure rate of 49 children was
determined through complete clinical testing and the cure rate of
the remaining patients was determined through accepted clinical
practice methods. The children have been followed up until the
present day, that is 7.5 years after treatment, and there has
been a lasting effect. "For a product which is based on a
biological, natural substance these long-term results are quite
unique. Previously there has been uncertainty about the long-term
effect of biological preparations but now we have shown that
DEFLUX has a lasting effect," says Göran Läckgren.
Läckgren goes on to say "The children in the study suffered from level III-V reflux, which means that several patients had more serious reflux than the levels II-IV for which DEFLUX is normally used. In spite of this there were only 27 children (12%) who needed to undergo major surgery due to persisting high level reflux."
The doctors participating in the study at the University Hospital have worked together with Q-Med for a long time to develop DEFLUX and to adapt it according to existing needs regarding results and safety. The collaboration started when the doctors contacted Q-Med and expressed the need for a substance with a high safety profile and a long-term effect. The form of treatment had been in existence for a long time, but the doctors were not happy with the available materials, which were based on Teflon and silicone, for example. The collaboration resulted in DEFLUX - a safe substance with a lasting effect. "During 7.5 years of using DEFLUX and treatment of more than 500 children we have not seen any serious side-effects. We are very happy with the safety of the product," says Göran Läckgren.
Pediatric urologists have the "Journal of Urology" as their official journal. This important journal is distributed to all American urologists and pediatric urologists and it also has an international circulation.
DEFLUX is injected into the wall of the urinary bladder in order to prevent urine running back into the kidneys.
The market
VUR occurs in approximately one percent of all children and
about half of these need treatment of some kind. Based on birth
statistics this indicates that approximately 40,000 new cases
arise each year in Europe and almost as many in USA. DEFLUX is
today sold in over 10 markets, principally in Europe. At the end
of September this year DEFLUX was also approved by the FDA (Food
and Drug Administration), the American regulatory authority. The
long-term study which has now been published will be a very
important tool in the launch of DEFLUX which has started in the
USA.
The publication is to be released at the same time as the annual meeting for all American pediatricians is held, this year in San Francisco on October 20-25, where approximately 10 000 pediatricians will gather.
October 19, 2001
Uppsala
Q-Med AB (publ)
Bengt Ågerup
President and CEO
Queries should be addressed to Bengt Ågerup, President and CEO, on 018 474 90 00 or 070-974 90 25 or to the Director of the Business Unit, Anna Eriksrud, on 018-474 90 00 or 070-974 90 92. For access to the pictures in this release, please contact the Director of Investor Relations, Sofia Wahlberg, at s.wahlberg@q-med.com or on 018-474 90 15.
Q-Med is a rapidly growing and profitable biotechnology/medical device company that develops, produces and markets medical implants. All products are based on the company's patented technology for the production of NASHA - Non-Animal Stabilized Hyaluronic Acid. Q-Med's operations focus on the areas of Esthetics, Orthopedics, Uro-Gynecology, and Cell Therapy and Encapsulation. The products RESTYLANE, RESTYLANE Fine Lines and PERLANE are used for the filling out of lips and facial wrinkles. DUROLANE, for the treatment of osteoarthritis in the knee-joint, has been approved in Europe since May 2001. DEFLUX is a product which has been approved in Europe and the USA for the treatment of vesicoureteral reflux (malformation of the urinary bladder) in children. ZUIDEX for the treatment of stress urinary incontinence in women is estimated to be available in Europe at the beginning of 2002. Within Ixion Biotechnology, Inc., Q-Med carries out research within cell therapy for diabetes. Q-Med today has over 230 employees, with 170 at the company's head office in Uppsala, 20 at Ixion and the remainder in wholly owned foreign subsidiaries. The Q-Med share has been listed on the O-list of the OM Stockholm Stock Exchange.
Q-Med AB (publ), Seminariegatan 21, SE-752 28 Uppsala, Sweden. Corporate identity number 556258-6882. Tel: +46(0)18-474 90 00. Fax: +46(0)18-474 90 01. E-mail: info@q-med.com. Home page: www.q-med.com
This information was brought to you by Waymaker http://www.waymaker.net
The following files are available for download:
 |
 |