Cytori Therapeutics Inc (NASDAQ:CYTX) announced that it received SME status from EMA’s Small and Medium Sized Enterprises office. EMA or European Medicines Agency is the regulatory authority responsible for granting SME status to all those businesses that fulfill the minimum requirements.
As a result of this SME status, Cytori will be able to take part in a number of financial incentives, fee waivers and fee reductions for SME filings.
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When asked about this decision, one of the spokespersons of EMA said that the primary driving force behind granting SME status to Cytori and other such companies is to promote development and innovation of new medical products & services by smaller companies. As soon as new businesses enter the market, they face a handful of financial and administrative challenges regardless of their product quality. To help them overcome these challenges and take care of procedures like marketing authorization application, scientific advice, and inspection, EMA provides them financial incentives.
As per the reports, these financial incentives comprise of 90% fees reduction for quality inspection and scientific advice of facilities along with other fee deferrals. Apart from ordinary financial incentives, all those companies that get SME status are eligible to receive certification of manufacturing data and quality even before the clinical trial takes place.
EMA also provide transactional service of all the regulatory and other important documents that are needed for market authorization. Details of these documents can easily be found on the official website of European Medical Agency.
The senior management team of the company is delighted to announce this news and hopes that it will make the best use of this opportunity. There couldn’t have been a better time for SME approval than this. Cytori is engaged in discussions with EMA for its program related to impaired hand function from scleroderma. The financial incentives granted by EMA will help the company save a significant amount in the coming months. More details about this development program will be announced shortly.