Q-Med submits application for approval of DEFLUX in USA

Q-MED SUBMITS APPLICATION FOR APPROVAL OF DEFLUX IN USA Application submitted in USA for registration of DEFLUX for the treatment of children with vesicoureteral reflux On July 11, 2000 Q-Med submitted a PMA (pre-market approval) application for DEFLUX for the indication VUR to the FDA, the American regulatory authority. In Q-Med's discussions with the authority, the FDA were very positive to the application, and Q-Med is therefore hopeful of approval during 2001. "The treatment of children with vesicoureteral reflux is a small but prestigious market. Today there is no approved implant for endoscopic treatment of VUR in USA and in the discussions that we have had with the FDA they have been very positive to our application. Our belief that the American authorities see this as an important product leads us to hope that we will be able to receive approval for sales as early as next year. Furthermore, we intend to document DEFLUX in order to also receive approval for the product in USA for the treatment of stress urinary incontinence in women," says Anna Eriksrud, Vice President, Q-Med Uro- Gynecology Business Unit. DEFLUX DEFLUX has already received approval for sales in Europe for two indications, the treatment of vesicoureteral reflux (VUR) in children and stress urinary incontinence in women. The product is a copolymer between NASHA and dextranomer. NASHA (Non-Animal Stabilized Hyaluronic Acid) is the technology which is the base for all of Q-Med's products. Dextranomer is a crosslinked polysaccharide that promotes the natural formation of connective tissue, which is necessary in order to prolong the volume- creating effect of DEFLUX. VUR Vesicoureteral reflux, VUR, is a condition primarily in small children which leads to urine leaking from the urinary bladder back into the kidneys via the ureter, which in the long term can lead to irreversible kidney damage. DEFLUX is injected using the keyhole technique into the wall of the urinary bladder in order to improve the valve mechanism at the opening of the ureter. This method can spare many children a major operation or the cost and trouble of years of treatment with anitbiotics. In clinical trials which have comprised around 500 patients this new implant has proved to be highly competitive when compared with existing injectable materials which are used for endoscopic treatment of VUR. Long- term follow-up suggests that over 80% of the children do not need further treatment for their VUR. VUR occurs in approximately 1% of all children and about half of these need treatment of some kind. An estimate of the current world market for endoscopic treatment of VUR is more than SEK 100 million (approximately USD 11 million) per year. Q-Med's product for VUR is today sold in more than 10 markets, primarily in Europe. The FDA, the American regulatory authority Deflux for the indication VUR is the first product for which Q-Med is applying for approval in USA. Products which are sold in USA must be produced in accordance with the American GMP-QSR standard (Good Manufacturing Practices - Quality System Regulations). During the year Q- Med has carried out intensive work to bring the company into line with this standard. Before the FDA (Food and Drug Administration), the American regulatory authority, has approved a so-called pre-market approval (PMA) application for a product, it may not be marketed or distributed. The FDA's scrutinization process normally takes up to a year but can take longer or even be postponed indefinitely. It is usually required that the application contains comprehensive clinical studies carried out in USA. In the case of DEFLUX for the indication VUR, Q-Med has made the assessment that the studies which have been performed outside USA will be approved as a sufficient basis in order to obtain PMA approval. July 12, 2000 Uppsala, Sweden Q-Med AB (publ) Per Olof Wallström President and CEO Queries should be addressed either to Per Olof Wallström, President and CEO, on +46(0)18-474 90 00 or +46(0)70-974 90 70 or to Anna Eriksrud, Vice President, Q-Med Uro-Gynecology Business Unit, on 018-474 90 00 or 070-974 90 92. 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 Q-Med is a rapidly growing and profitable biotechnology and medical device company that develops, produces and markets non-animal hyaluronic acid based 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 and Uro-Gynecology. Esthetics contains the products RESTYLANE, RESTYLANE FINE LINES and PERLANE for facial esthetics. RESTYLANE, for the filling out of lips and facial wrinkles, today accounts for the majority of sales. The development of MACROLANE for the filling out of breasts is ongoing. Orthopedics is responsible for DUROLANE, the product for the treatment of osteoarthritis in the knee-joint which is under development. Uro- Gynecology contains DEFLUX for vesicoureteral reflux (malformation of the urinary bladder) in children and stress urinary incontinence in women. Q- Med today has 145 employees, with 110 at Q-Med's production facility and head office in Uppsala 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 since December 6, 1999. ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/07/12/20000712BIT00190/bit0001.doc http://www.bit.se/bitonline/2000/07/12/20000712BIT00190/bit0002.pdf