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Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced that the European Medicines Agency’s (EMA) Micro, Small and Medium-sized Enterprise (SME) office has granted SME status to Cytori Therapeutics. The newly granted SME status allows Cytori to participate in significant financial incentives, fee reductions, and fee waivers for selective EMA regulatory filings.
Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced that the European Medicines Agency’s (EMA) Micro, Small and Medium-sized Enterprise (SME) office has granted SME status to Cytori Therapeutics. The newly granted SME status allows Cytori to participate in significant financial incentives, fee reductions, and fee waivers for selective EMA regulatory filings.
According to the news:
The primary aim of the SME initiative is to promote innovation and the development of new medicinal products by smaller companies. To achieve this, incentives are provided to help SMEs overcome the main financial and administrative hurdles associated with pre-marketing procedures, particularly scientific advice, marketing authorization application and inspection procedures.
Tiago Girao, CFO of Cytori Therapeutic commented:
Our SME status could not have come at a more opportune time as we prepare to engage with the EMA for discussions regarding our lead development program for impaired hand function from scleroderma. Incentives provided, including reductions in regulatory fees will result in significant savings, which will help to bolster our cash management activities. More importantly, Cytori is dedicated to commercializing a treatment for scleroderma patients. This SME designation will help us drive towards that objective.