SAN DIEGO--(EON: Enhanced Online News)--Cytori Therapeutics (NASDAQ:CYTX) has received approval from the Health Sciences Authority (HSA) in Singapore for the Celution® System for autologous re-implantation or re-infusion of a patient’s own adipose-derived regenerative cells (ADRCs). The Celution® System enables access to a patient’s own ADRCs at the point-of-care for a range of injuries and conditions.
“We will continue to pursue new regulatory approvals in large markets and strategic countries in Asia as well as continue to expand existing claims for the Celution® System in the more than 40 countries where we already have approval.”
“Celution® System approval and claims in Singapore complements our existing Asia-Pacific approvals by strengthening market access in the region and reinforcing our global regulatory strategy. We anticipate seeing a relevant impact on sales in 2014 as a result of the approval in Singapore, combined with recent approvals and registrations in Australia, New Zealand and in Japan,” said Seijiro Shirahama, President of Asia-Pacific for Cytori. “We will continue to pursue new regulatory approvals in large markets and strategic countries in Asia as well as continue to expand existing claims for the Celution® System in the more than 40 countries where we already have approval.”
Asia-Pacific has been and continues to be a key region for Cytori, supported by a growing number of regulatory approvals and patents issued. In 2007 and 2008, Cytori received patents in Singapore covering the Celution® System and for vascular conditions relating to the use of ADRCs to restore blood flow.
Singapore represents a major medical market and is a leader in medical innovation and research, being ranked fourth in global healthcare infrastructure in the IMD World Competitiveness Yearbook in 2010. Singapore has committed more than $12 billion in continued support of research, innovation and enterprise activities between 2011 and 2015, $2.9 billion of which is dedicated to the biomedical space.
About Adipose Tissue & ADRCs
Adipose tissue is considered the richest source of regenerative cells in the body. These cells are comprised of a heterogeneous population of cells which are collectively referred to as ADRCs. The heterogeneous nature of ADRCs are believed to contribute to the healing process via multiple mechanisms, which include cell-to-cell signaling, supporting improved blood flow and regulation of the inflammatory response.
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, a sales impact in 2014 from recent regulatory approvals and obtaining and expanding current Celution® approvals 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 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.