UPPSALA, Sweden, April 16, 2002 (PRIMEZONE) -- The IMPLACER(TM) injection device, which Q-Med has developed to facilitate treatment of stress urinary incontinence, has been approved by the authorities in Europe.
IMPLACER has been approved within the European Union. The Swedish company Q-Med has developed this device, which a patent has been applied for, in order to enable injection without having to use a keyhole instrument together with the product ZUIDEX(TM). ZUIDEX is Q-Med's product for the treatment of stress urinary incontinence in women. The product has been approved in Europe for treatment of this condition since 1999, but so far has only been able to be used via so-called endoscopic treatment (keyhole surgery). Endoscopic treatment is usually performed by specialists in the operating theater. Using IMPLACER the treatment with ZUIDEX can also be performed in outpatient care. In this way the treatment should become more generally available than it is today and thereby a much larger number of patients can be treated.
Stress urinary incontinence is a great health problem, which primarily affects women. It is a condition, which means that increased abdominal pressure leads to urine involuntarily leaking out. Stress urinary incontinence occurs in many cases after childbirth. ZUIDEX can be injected using IMPLACER into the wall of the urethra.
ZUIDEX consists of a combination of Q-Med's NASHA technology (Non-Animal Stabilized Hyaluronic Acid) and a sugar-like substance called dextranomer. This combination is also used in one of Q-Med's other products, DEFLUX(R), for the treatment of children who suffer from reflux, the reverse flow of urine to the kidneys. Recently published results around this product suggest that the effect last at least five years.
The expectations are that ZUIDEX will show similar results.
The approval of IMPLACER in Europe means that Q-Med can start the planned European study, which will show the effect of ZUIDEX together with IMPLACER. The study will be carried out in 5 countries on 150 patients and be ongoing for 12 months with subsequent long-term follow-up.
Initial sales of ZUIDEX IMPLACER are estimated to start up as from the middle of the year through Q-Med's own subsidiaries.
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 four areas of Esthetics, Orthopedics, Uro- Gynecology, and Cell Therapy and Encapsulation. The products PERLANE, RESTYLANE and RESTYLANE Fine Lines are used for the filling out of lips and facial wrinkles and today account for the majority of sales. Development of MACROLANE for body contouring, for example breast augmentation, is ongoing. DUROLANE, Q-Med's product for the treatment of osteoarthritis of the knee joint, has been approved in Europe since May 2001. DEFLUX is a product which has been approved in Europe and the U.S.A. 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 in the middle of 2002. Since July 2000 Q-Med has owned a majority interest in the American biotechnology company Ixion Biotechnology, Inc., with research within cell therapy for diabetes. Q-Med today has approximately 300 employees, with 210 at the company's production facility and head office in Uppsala, 20 at Ixion and the remainder in wholly owned foreign sales companies. The Q-Med share was first listed on the O-list of the Stockholm Stock Exchange in December 1999.
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