SAN DIEGO--(BUSINESS WIRE)--
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
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
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
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
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
2. Furst, Daniel et al. “Epidemiology of systemic sclerosis in a large
US managed care population.” J Rheum 2012; 38:784-6.
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Source: Cytori Therapeutics, Inc.