SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today 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.
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.
Financial incentives for SME companies include a 90% fee reduction for scientific advice and quality inspections of facilities along with fee deferrals. SME companies are also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other financial incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process. Details can be found on the European Medicines Agency website.
“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,” stated Tiago Girao, CFO of Cytori Therapeutics. “More importantly, Cytori is dedicated to commercializing a treatment for scleroderma patients. This SME designation will help us drive towards that objective.”
Cytori is currently working with Idis Managed Access, part of the Clinigen Group plc, to establish a Managed Access Program in select countries across Europe, the Middle East, and Africa for patients with impaired hand function from scleroderma. A MAP will allow Cytori, upon completion of the statutory legal and regulatory requirements, to offer patients and their healthcare providers access to Cytori Cell Therapy™, known as ECCS-50, in advance of the product’s full marketing authorization in their respective countries.
In Europe, the scleroderma affected population appears to be between 31/million and 277/million, which would account for a market size of 17,000 to 149,000 scleroderma patients.1 Additionally, scleroderma is estimated to have a prevalence of 184/million which equates to approximately 45,000 scleroderma affected people in the United States.2
About Cytori
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding our ability to achieve a marketing authorization for Cytori ECCS-50 are forward-looking statements. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include clinical and regulatory uncertainties, the challenges inherent in convincing physicians and patients to adopt the new technology, dependence on third party performance, performance and acceptance of our products, and other risks and uncertainties described under the “Risk Factors” in Cytori's Securities and Exchange Commission Filings, including in its most recent annual and quarterly reports. Cytori assumes no responsibility to update or revise any forward-looking statements contained in this press release to reflect events, trends or circumstances after the date of this communication.
1. Varga, John et al. “Scleroderma: From Pathogenesis to Comprehensive Management.” 2012
2. Furst, Daniel et al. “Epidemiology of systemic sclerosis in a large US managed care population.” J Rheum 2012; 38:784-6.
