Micell Technologies said last week that it raised a debt-and-equity round worth nearly $62 million from a syndicate of 51 unnamed investors. Paris-based Micell makes the MiStent SES sirolimus-eluting absorbable polymer coronary stent, designed to treat coronary artery disease. The company, which reported a nearly $26 million round last November, said in a regulatory filing that the […]
Micell Technologies said today that it began its Dessolve J randomized, double-blind study comparing its MiStent SES sirolimus eluting absorbable polymer coronary stent to the Xience V everolimus eluting coronary stent in patients with coronary artery disease. The Durham, N.C.-based company touts its device as a bare-metal stent coated in crystalline drug, sirolimus, and an absorbable polymer, […]
Micell Technologies raised $25.8 million in a new round of equity and debt financing, according to an SEC filing posted this week. Micell currently produces the MiStent SES sirolimus eluting absorbable polymer coronary stent, designed to treat coronary artery disease. Money in the round came from 51 anonymous sources, according to an SEC filing, with the […]
St. Jude Medical (NYSE:STJ) said today that its newly acquired HeartMate PHP heart pump met its safety and efficacy endpoints in the Shield I trial used to back its CE Mark approval last summer. The results from Shield I’s 1st 30 patients led to the CE Mark nod in July. Today St. Jude said data from 46 subjects […]
Micell Technologies said today that it won approval to partner with contract manufacturer Surgical Technologies, Inc. in Britain and will begin full-scale manufacturing of its MiStent SES for distribution to European Union countries. Micell won CE Mark approval in the European Union for the drug-eluting stent in 2013. STI will serve as the primary contract manufacturer of the […]
Micell Technologies said today it launched a Chinese trial of its MiStent SES sirolimus eluting absorbable polymer coronary stent system used to treat coronary artery disease. The prospective, single-blind, multi-center, randomized, controlled Dessolve C trial looks to enroll 428-patients in a study comparing the company’s MiStent SES and the Tivoli bioabsorbable coated stent, which Durham, […]
The U.S. medical device arena is in danger of ceding the throne to countries with friendlier regulatory environments but the system is not irreparable, Dr. Martin Leon said during a lecture at this week’s Transcatheter Cardiovascular Therapeutics symposium in San Francisco.
ImThera Medical Inc. said its tongue stimulation device for sleep apnea can improve patients’ snooze time.
The San Diego-based device maker concluded a European pilot study of its aura6000, an implanted neurostimulation device for treating obstructive sleep apnea (OSA) that delivers electrical pulses to the tongue during sleep.