Q-Med receives FDA approval to initiate the ZUIDEX clinical trial in the USA

UPPSALA, Sweden, Sept. 8, 2003 (PRIMEZONE) -- Q-Med in Sweden has been informed by the FDA (Food and Drug Administration), the American regulatory authority, that the company's application to initiate clinical trials with ZUIDEX has been approved. Q- Med developed and markets ZUIDEX for the treatment of female stress urinary incontinence. The product has been marketed in Europe since September 2002. The main substance used in the ZUIDEX treatment is already approved by the FDA for use in children suffering from vesico- ureteral reflux (back-flow of urine).

"Approximately 5 percent of all women over the age of 35 suffer from stress urinary incontinence and today only very few of those suffering are treated. There is a great potential for a safe and simple method, requiring no hospital stay or long recovery. The potential for the ZUIDEX treatment in the US is one of the most significant opportunities for Q-Med," said Bengt Agerup, Q-Med's President and CEO.

18 leading centres in the US and Canada will treat about 360 patients. The study entails a double blind comparison (the patient and evaluating investigator are unaware of which product has been used) of the ZUIDEX treatment with Contigen, a collagen based substance. The study results will be compiled after a 12 month efficacy follow-up assessment, and included in support of the registration (PMA) application for ZUIDEX treatment in the USA.

"Today, women with stress urinary incontinence in the US often undergo a surgical intervention or an endoscopic treatment, if behavioral modification and pelvic floor exercises fail to adequately treat their symptoms. ZUIDEX promises to be a simple and effective alternative to these current treatment options," said Dr. Eric Rovner, Urologist at the University of Pennsylvania School of Medicine in Philadelphia, coordinating investigator of the US ZUIDEX clinical study.

"We are eager to start the study. This novel product may help the millions of American women who today restrict their daily life because of this condition," concluded Urologist Dr. Eric Rovner.


The ZUIDEX treatment is the latest advance in the treatment of women with stress urinary incontinence. ZUIDEX consists of two natural sugars, dextranomer and hyaluronic acid (NASHA- Non-Animal Stabilized Hyaluronic Acid) and an implacement device, IMPLACER, that significantly simplifies the procedure by guiding the substance to the appropriate area. Both Dextranomer and Hyaluronic Acid have been extensively used in other medical applications for decades. Dextranomer is widely used, among other, in the treatment of wounds; and Hyaluronic Acid is present in all the body tissues and is used in both eye surgery and cosmetic applications. Both substances are non-allergenic, and are produced using a biotechnological (non-animal) process. After the treatment, the hyaluronic acid in ZUIDEX is gradually broken down by the body's natural processes, and is replaced by the body's own tissues, which along with the remaining Dextranomer has the effect of maintaining the size of the bulge and the effectiveness of the treatment.

The substance in the ZUIDEX treatment is injected using the IMPLACER, a Q-Med proprietary device, which simplifies the treatment and makes it possible to make the injection without the need for complicated surgical equipment. The ZUIDEX treatment is a short, the whole procedure only takes about 15 minutes, and simple outpatient procedure that requires no operating theatre, no hospital stay or long recovery time, the patient is free to go home within a couple of hours. A local anaesthetic is applied prior to treatment to avoid discomfort during the procedure. European studies show that 70% to 80% of the women that have undergone the ZUIDEX treatment were either cured or showed marked improvement.

The combination of Dextranomer and Hyaluronic Acid, marketed under the name DEFLUX, has been approved for use in Europe since 1998, in the USA since 2001 and was recently approved in Canada as an injectable agent for the treatment of vesico-ureteral reflux in children. So far, more that 15 000 children have been successfully treated worldwide with this product and most recent clinical studies indicate that the substance stays in the body for as long as five years.

The US Market According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 13 million Americans suffer from urinary incontinence and about $28 billion was spent on incontinence on those 65 years of age and older in the US in 1995. Even so, studies show that more than half of the people suffering from urinary incontinence are reluctant to seek medical help or even mention the problem to friends and family.

Stress Urinary Incontinence The sudden leakage of urine (urinary incontinence) is a major clinical problem and a significant cause of disability and diminished quality of life for the individual. The most common type of incontinence is stress urinary incontinence (SUI), accounting for 50% of all cases. Among the primary contributing factors to SUI are childbirth and loss of pelvic muscle support. The word "stress" in the term stress urinary incontinence refers to increased pressure on the bladder from ordinary physical activities, which leads to involuntary leakage of urine. These activities may range from lifting a bag of groceries to sneezing, coughing, laughing or rising from sitting to a standing position.

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. The products RESTYLANE, RESTYLANE Fine Lines and PERLANE are used for the filling out of lips and facial wrinkles and today account for the majority of sales. 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 USA for the treatment of vesicoureteral reflux (malformation of the urinary bladder) in children. ZUIDEX for the treatment of stress urinary incontinence in women has been sold in Europe since July 2002. Since July Q-Med today has 430 employees, with approximately 290 at the company's production facility and head office in Uppsala. The Q-Med share was first listed on the O-list of the Stockholm Stock Exchange in December 1999.

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