Israel-based Dune Medical Devices received a $12.5-million investment, of which $11.5 million comes from Apax Partners, the medical device startup said Thursday. The funding will be used to complete clinical studies of Dune’s BP probe and console systems, get clearance from the FDA for BP systems in the United States, and begin development of its second product.
Also, Dune said it’s received the European Union’s CE Marking distinction, which permits it to market its device in the EU.
“This has the potential to drastically reduce the disturbingly high rate of re-excisions, and there is a particularly noteworthy need for this especially in breast cancer,” Apax Partners’s Amos Goren, director of Dune’s board, said in a statement.
Biogen, Elan Get MS Approval
Biogen and Elan received approval from the European Commission to market Tysabri as a treatment for relapsing remitting multiple sclerosis, the companies announced on Thursday.
Tysabri will be used as a treatment to delay the progression of disability from MS and reduce the relapse frequency. Approval was based on, among other things, data from a two-year phase III clinical trial. Shares of Biogen increased $0.95 to $45.93, while shares of Elan lost $.08 to $16.25.
Biogen is based in Cambridge, Massachusetts. Elan is based in Dublin, Ireland.
Bristol-Myers Squibb: FDA Nod
Bristol-Myers Squibb on Wednesday announced that the U.S. Food and Drug Administration has given accelerated approval to Sprycel, a treatment used for chronic myeloid leukemia in adults.
New York-based Bristol-Myers Squibb expects Sprycel to be available in the U.S. within days.
Bristol-Myers Squibb shares increased $0.40 to $25.65 in recent trading.
Contact the writer:SMartin@RedHerring.com