Cytori Therapeutics (NASDAQ: CYTX) has received a CE Mark in Europe for
Intravase®, a reagent intended to be used with Cytori’s
Celution® System for preparing safe and optimized
adipose-derived stem and regenerative cells (ADRCs) for intravascular
delivery into the same patient.
“This approval expands our market access for our cell therapy platform
to include intravascular applications,” said Marc Hedrick, President of
Cytori Therapeutics. “As a result, this is expected to contribute to
revenue growth in 2013 and beyond. We will target select centers to
build patient data, which we believe can be used to further expand these
claims and increase the adoption of our technology. Furthermore, CE Mark
approval of Intravase will allow independent European investigators to
conduct their own vascular studies.”
Intravase is a sterile, GMP-grade secondary reagent used with the
Celution System to prepare the Celution cell output for safe
intravascular delivery. Intravase is currently being used in both our
U.S. ATHENA trial in patients with refractory heart failure due to
chronic myocardial ischemia and the European ADVANCE trial for acute
heart attack patients.
About Adipose Tissue and ADRCs
Adipose tissue is the richest source of stem and regenerative cells in
the body. This mixed population of cells, collectively referred to as
ADRCs, is accessible at the point-of-care through the Celution System
for use in the same patient, creating new treatment opportunities for
currently unmet medical needs. ADRCs collectively contribute to the
healing process via cell-to-cell signaling, supporting improved blood
flow and regulation of the inflammatory response.
About Cytori
Cytori Therapeutics is developing cell therapies based on autologous
adipose-derived regenerative cells (ADRCs) to treat cardiovascular
disease and other medical conditions. Our scientific data suggest ADRCs
improve blood flow, moderate the inflammatory response and keep tissue
at risk of dying alive. As a result, we believe these cells can be
applied across multiple “ischemic” conditions. These therapies are made
available to the physician and patient at the point-of-care by Cytori’s
proprietary technologies and products, including the Celution System
product family. 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 expectation that the approval will have
a significant contribution to our future revenue growth, expand our
ability to obtain European regulatory claims, and increase investigative
use of the Celution System in Europe and market adoption of our
technology, are subject to risks and uncertainties that could cause our
actual results and financial position to differ materially. Some of
these risks and uncertainties include the challenges inherent in
convincing physicians and patients to adopt the new technology,
successfully expanding our European claims as well as our history of
operating losses, regulatory uncertainties, dependence on third party
performance, and other risks and uncertainties described under the "Risk
Factors" section in Cytori's Securities and Exchange Commission Filings
on Form 10-K and Form 10-Q. 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 press
release.
