SOLESTA receives approval in Europe for treatment of fecal incontinence
Q-Med’s product SOLESTA has received a CE certification for the indication fecal incontinence.
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.
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