The company announced today that it has expanded the Celution System CE Mark approval in Europe to include several new indications including cryptoglandular fistula. This is the most common cause of perianal infection, abnormal fecal contamination and incontinence. This new indication will facilitate the use of the Celution System for clinical cases potentially as part of independently sponsored and funded studies. In addition to this indication, Cytori has expanded its European approval for Celution to three other indications: tissue ischemia; deficiency or injury of skin, fat, muscle and fascia; and soft tissue wounds or fistulae associated with trauma, diabetes, and ischemia or radiation injury.
In a related development, Cytori reported that an investigator-sponsored clinical study in Japan using the Celution System for treatment of cryptoglandular fistulae was approved under the new Ministry of Health, Labor and Welfare Guidelines on Clinical Research Using Human Stem Cells and patient enrollment in the study is underway. Cytori’s Celution System will be able to provide these researchers easy access to adipose-derived stem and regenerative cells at the point-of-care.
The initial impact to the company from the new indications is expected to come from additional translational system and consumable sales to meet demand by international hospitals to perform cell therapy clinical studies. For further information about Cytori Therapeutics, its Celution System and other products, please visit the company’s website at www.cytori.com
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