March 15 (Reuters) - Shares of Cytori Therapeutics Inc fell as much as 17 percent Monday on concerns over a delay in the U.S. approval for the company's key product, the Celution system.
'The Food and Drug Administration has requested a pre-market approval (PMA) path for Cytori's Celution system, pushing out our U.S. approval assumption to 2013,' Piper Jaffray analyst Edward Tenthoff wrote in a research note to clients on Friday.
The analyst said the company continues to face financing challenges, particularly as it undertakes a new PMA study.
'Even assuming the Cytori stock price holds above $6 through mid-year, we project Cytori will run out of cash by mid-2011,' Tenthoff, who also cut the price target on the stock to $3.00 from $4.00, said.
On Friday, in a filing with regulatory authorities, Cytori said it will be required to seek U.S. FDA approval for the Celution system for use in aesthetic body contouring and filling of soft tissue defect voids through the PMA application process.
The company also posted a wider-than-expected quarterly loss Friday.
Cytori's Celution system processes fat tissue into several types of cells that can be potentially be used for various therapeutic purposes.
Cytori shares are down 33 percent over the last two days, from Thursday's close of $7.50. They fell 13 percent to $5.22 in late morning trade.
Earlier in the session, they touched a low of $5.01, making the stock one of the top percentage losers on Nasdaq.
(Reporting by Shailesh Kuber in Bangalore; Editing by Bijoy Koyitty) Keywords: CYTORI/SHARES (shailesh.kuber@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: shailesh.kuber.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
'The Food and Drug Administration has requested a pre-market approval (PMA) path for Cytori's Celution system, pushing out our U.S. approval assumption to 2013,' Piper Jaffray analyst Edward Tenthoff wrote in a research note to clients on Friday.
The analyst said the company continues to face financing challenges, particularly as it undertakes a new PMA study.
'Even assuming the Cytori stock price holds above $6 through mid-year, we project Cytori will run out of cash by mid-2011,' Tenthoff, who also cut the price target on the stock to $3.00 from $4.00, said.
On Friday, in a filing with regulatory authorities, Cytori said it will be required to seek U.S. FDA approval for the Celution system for use in aesthetic body contouring and filling of soft tissue defect voids through the PMA application process.
The company also posted a wider-than-expected quarterly loss Friday.
Cytori's Celution system processes fat tissue into several types of cells that can be potentially be used for various therapeutic purposes.
Cytori shares are down 33 percent over the last two days, from Thursday's close of $7.50. They fell 13 percent to $5.22 in late morning trade.
Earlier in the session, they touched a low of $5.01, making the stock one of the top percentage losers on Nasdaq.
(Reporting by Shailesh Kuber in Bangalore; Editing by Bijoy Koyitty) Keywords: CYTORI/SHARES (shailesh.kuber@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: shailesh.kuber.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.