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SOLESTA receives approval in Europe for treatment of fecal incontinence |
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01 Dec 2006 |
Q-Med's product SOLESTA has received a CE certification for the indication fecal incontinence
UPPSALA, Sweden | Nov 30, 2006 | The approval is an important step in the development of the product and SOLESTA will be further documented together with leading colorectal surgeons in the field. This will be done through a product up-take and experience trial across Europe that will start this autumn.
In parallel, Q-Med will continue its efforts to develop clinical data to support a US approval. Recently, the first patient was enrolled in the US/EU controlled study that is a corner stone for the US documentation.
"There is a big treatment gap facing women that suffers from fecal incontinence. If conservative treatment or Biofeedback don't work the healthcare system has not much to offer than quite invasive surgery. SOLESTA will assist physicians to close this treatment gap. In addition the SOLESTA injection technique is much easier to manage than for other injectable treatments and the gel is easy to inject by finger pressure" says Bengt Ågerup, CEO.
SOLESTA is a treatment for fecal incontinence and is based on Q-Med's patented NASHA technology. Fecal incontinence affects about 2 percent of the general population and predominantly women. The most common cause is trauma to the rectal structures during child birth.
In the study that served as the basis for EU approval 27 patients were followed for 12 months. At the 12 months follow-up 67 percent of the subjects experienced at least a 50 percent reduction of their fecal incontinence symptoms. Despite the fact that perceived value of treatment benefits tend to decrease over time, still 55 percent of the patients described their global situation as excellent or good compared to before being treated with SOLESTA. Of the patients that have been evaluated 24 month post treatment, 90 percent report persistent efficacy and benefit of SOLESTA. No serious adverse events were reported in the study.
Queries should be addressed to:
Per Langö, Senior Director Corporate Development and Strategy
Tel: +46 (0) 733- 87 15 21
Erika Kjellberg Eriksson, Vice President and CFO
Tel: +46 (0)70-974 90 20.
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, www.q-med.com, Org.nr. 556258-6882
Q-Med AB is a rapidly growing and profitable biotechnology/medical device company. The company develops, produces, markets and sells implants for esthetic and medical use. All products are based on the company's patented technology for the production of stabilized non-animal hyaluronic acid, NASHA™. The product portfolio today contains: RESTYLANE for the filling out of lips and facial wrinkles and for facial contouring, DUROLANE, for the treatment of osteoarthritis of the hip and knee joints, DEFLUX for the treatment of vesicoureteral reflux (a malformation of the urinary bladder) in children and ZUIDEX, for the treatment of stress urinary incontinence in women. Sales are made through the company's own subsidiaries or distributors in over 70 countries. Q-Med today has approximately 580 co-workers, with approximately 390 at the company's head office and production facility in Uppsala, Sweden. The Q-Med share is listed on the Stockholm Stock Exchange, Mid Cap.
NASHA, DUROLANE, ZUIDEX, IMPLACER, DEFLUX, MACROLANE and all product names within the RESTYLANE family are trademarks that belong to Q-Med.
SOURCE: Q-Med |
