A Medical Device Daily
Cytori Therapeutics (San Diego) reported it has received the CE mark for its Celution system. The company said the approval is the first CE mark given for a device that can process adult stem cells from adipose tissue.
By achieving this approval, the company will receive an $11 million milestone payment, for consideration of development activities undertaken, from the Olympus-Cytori 50/50 joint venture formed in November 2005 (Medical Device Daily, Nov. 7, 2005) as part of the company's regenerative medicine collaboration with Olympus (Tokyo).
“This is a significant achievement for Cytori and supports our global development and regulatory strategy for delivering a patient's own stem and regenerative cells in real time,“ said Christopher Calhoun, CEO of Cytori. “We are now positioned to use the Celution system in clinical studies to drive market adoption and reimbursement.“
The Celution system is designed to automate the proprietary process and methods developed by Cytori scientists to isolate and concentrate a high yield of autologous stem and regenerative cells without the need for cell culture (repeated cell divisions).
The Celution system can process whole adipose tissue into isolated and concentrated stem and regenerative cells from start to finish in about one hour.
European claims include the extraction, wash and concentration of patients' own stem cells and other associated progenitor cells from their own adipose tissue for re-implantation or re-infusion during the same surgical procedure.
Cytori's preclinical investigational therapies target cardiovascular disease, spine and orthopedic conditions, gastrointestinal disorders and new approaches for aesthetic and reconstructive surgery.
Medtronic (Minneapolis) reported that it has extended its pending exchange offer relating to an aggregate of up to $1 billion of its outstanding 4.375% senior notes due 2010 and 4.750% senior notes due 2015.
The expiration date for the exchange offer has been extended from midnight, EST, on Jan. 23, to midnight, EST, on Feb. 10, unless further extended.
As of Jan. 20, about $974.5 million in aggregate principal amount of the old notes, or 97.4% of all outstanding old notes, had been tendered into the exchange offer.
Medtronic is offering to exchange $2,000 principal amount and integral amounts of $1,000 of its newly issued 4.375% senior notes, Series B due 2010 and 4.750% senior notes, Series B due 2015 for each $2,000 principal amount and integral amounts of $1,000 of its respective outstanding old notes.
Wells Fargo Bank is the exchange agent for the exchange and offer and trustee of the new notes.