Cytori's Celution(R) One Receives European CE Mark Approval
The Celution® One is intended for hospital-based use with key improvements including greater cell yield, greater range of processing volumes and faster processing times, increasing the versatility and efficiencies of potential treatments. Additionally, it contains new features for improved operator ease-of-use.
"Approval of Celution® One in Europe is an important achievement that lays the foundation for further growth in the European hospital market," said Christopher J. Calhoun, Chief Executive Officer of Cytori. "In addition to offering the device to hospitals in Europe, we are using the Celution® One in our pivotal heart attack trial, ADVANCE, with the goal of seeking expanded market access through broader indications-for-use and subsequent reimbursement applications."
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position, such as the potential for uses of the Celution® One device in the hospital setting, for our ADVANCE clinical trial, and for market expansion and reimbursement. 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, such as those associated with the ADVANCE clinical trial, including risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
Source: Cytori Therapeutics, Inc.
Cytori Therapeutics, Inc.
Cytori is a leader in providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. The Celution® System family of medical devices and instruments is being sold into the European and Asian cosmetic and reconstructive surgery markets but is not yet available in the United States. Our StemSource® product line is sold globally for cell banking and research applications. Our PureGraft® products are available in North America and Europe for fat grafting procedures. www.cytori.com