Solesta(TM) improves fecal incontinence - results published in The Lancet

First Randomized-Controlled Trial of Solesta(TM) Comparing Active and Sham
Treatments to Show Efficacy and Safety

Q-Med, together with its partner Oceana Therapeutics today announced the
publication of results from a randomized-controlled clinical trial of Solesta
that involved 206 patients aged 18 to 75 from the United States and Europe with
fecal incontinence. This study, published in The Lancet, of the injection of
bulking agent, NASHA(TM) DX, a dextranomer suspended in stabilized hyaluronic
acid, into the anal sphincter in patients with fecal incontinence, met primary
and secondary endpoints and demonstrated efficacy and safety. The trial was
sponsored by Q-Med AB and Oceana Therapeutics.

Solesta, has been under development as a minimally invasive treatment for
patients with fecal incontinence who have failed conservative therapy. Fecal
incontinence is the loss of ability to control passage of feces. It is estimated
to affect about two percent of the population and seven percent of the
population over age 65 years. Current treatment options are mainly medical
treatments or surgery. Solesta can be administered in an outpatient setting
without the need for anesthesia.

In June 2009, Oceana Therapeutics obtained the exclusive worldwide marketing
rights to Solesta and has since collaborated on controlled studies of the
product's effectiveness and safety. In April 2010, the Premarketing Approval
Application (PMA) was submitted to the U.S. Food and Drug Administration (FDA)
and in December 2010, the FDA's Gastroenterology and Urology Devices Panel
recommended approval of Solesta as a treatment for fecal incontinence.

"Solesta represents an important new option for patients with fecal incontinence
and can serve as an intermediary step between conservative therapies such as
diet control, antidiarrheal medication and more aggressive intervention such as
surgery," commented Dr. Cindy Wong, Chief Medical Officer at Q-Med.

The pivotal study, representing the main body of clinical evidence in the PMA
submission, involved 206 patients (136 Solesta, 70 Sham). The study consisted of
a 6-month double-blinded phase followed by an open label phase in which patients
originally randomized to Sham treatment were offered Solesta. The primary
efficacy objective of the study required: 1) demonstrating a statistically
significant Solesta effect after 6 months of treatment; 2) meeting a pre-defined
threshold for clinical significance; and 3) showing durability of the Solesta
benefit up to 12 months after treatment. All three of these endpoints were met
and Solesta was found to be safe with few serious adverse effects.

Queries should be addressed to:
Per Langö, Senior Director Corporate Development
Telephone: +46 73 387 1521
Alexander Kotsinas, CFO
Telephone: +46 73 500 111

The information in this press release is such as that which Q-Med is required to
disclose in accordance with the Swedish Securities Market Act and/or the
Financial Instruments Trading Act. The information was submitted for disclosure
at 15.20 on March 21, 2011.


Q-Med ABis a medical device company that develops, manufactures, markets, and
sells high quality medical implants for esthetic and medical use. The majority
of the products are based on the company's patented technology, NASHA(TM), for
the production of stabilized non-animal hyaluronic acid. The product portfolio
today contains: Restylane® for filling lines and folds, contouring and creating
volume in the face, Macrolane(TM) for body contouring, Durolane(TM) for the
treatment of osteoarthritis of the hip and knee joints, Deflux® for the
treatment of vesicoureteral reflux, VUR, (a malformation of the urinary bladder)
in children, and Solesta(TM) for the treatment of fecal incontinence. Sales are
made through the company's own subsidiaries or distributors in over 70
countries. Q-Med has about 650 coworkers, with almost 400 at the company's head
office and production facility in Uppsala, Sweden. Q-Med AB is listed in the Mid
Cap segment of the NASDAQ OMX Nordic.


Q-Med AB (publ), Seminariegatan 21, SE-752 28 Uppsala, Sweden. Corporate
identity number 556258-6882.
Tel: +46 18 474 90 00. Fax: +46 18 474 90 01. E-mail:info@q-med.com. Web: www.q-
med.com


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