BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S. The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division. “We are honored to be working with the leading […]
Bayer, Versant close $225m Series A to launch stem cell company
Bayer (ETR:BAYN) and Versant Ventures said today that the 2 groups closed a $225 million Series A financing round to launch BlueRock Therapeutics, a regenerative medicine company focused on developing induced pluripotent stem cell therapies. The funds are estimated to support the company for 4 years as it advances cell therapy clinical programs for cardiovascular and degenerative diseases. “Accessing […]
AngioSoma taps new CEO
AngioSoma (OTCQB:SOAN) said today that it named Ken Stephenson to the Montgomery, Texas-based company’s corner office. Alexanderia Blankenship will now serve as chief operating officer and executive VP. Stephenson has worked with hospitals, health insurance organizations and physician’s offices throughout Texas, according to the company. He previously helped set up practices for interventional radiologists and […]
Micell begins MiStent clinical trial in Japan
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, […]
OrbusNeich launches Combo Plus stent
OrbusNeich said today that it launched the latest version of its dual-therapy stent, the Combo Plus, featuring an antibody biological coating designed to promote vessel healing in patients with complex coronary artery disease. After the stent is implanted, the biological coating captures endothelial progenitor cells and kicks off formation of an endothelial layer. A coating of bioabsorbable polymer […]
Injectable Regeneron biologic therapy reduces triglycerides, cholesterol
Researchers from the University of Pennsylvania presented preliminary data from a trial evaluating Regeneron Pharmaceutical‘s (NSDQ:REGN) injectable biologic drug therapy for reducing triglyceride levels. The team, led by Dr. Richard Dunbar, presented their work at the annual meeting of the American Heart Assn. The Phase I, placebo-controlled, double-blind study tested the safety and efficacy of Evinacumab, an […]
Mast Therapeutics touts interim data from pulmonary hypertension study
Mast Therapeutics (NYSE:MSTX) touted interim data from a Phase II study of its AIR001 candidate in patients with pulmonary hypertension (PH) and PH associated with heart failure with preserved ejection fraction. Positive interim results from the ongoing trial were published in the Journal of Clinical Investigation. The San Diego-based company enrolled 50 patients to study its nebulized […]
Stellarex drug-coated balloon from Spectranetics bests PTA at 1 year
The Stellarex drug-coated balloon made by Spectranetics (NSDQ:SPNC) beat out percutaneous transluminal angioplasty in the 300-patient Illumenate pivotal study reported today at the 2016 Transcatheter Cardiovascular Therapeutics Symposium. The study followed a complex group of patients over 12 months to evaluate the low-dose balloon’s efficacy and safety. Nearly 50% of the patient population had diabetes, […]
Mast Therapeutics inks deal with Philips Respironics for iNeb aerosol delivery device
Mast Therapeutics (NYSE:MSTX) said today that its subsidiary Aires Pharmaceuticals landed a collaborative agreement with Royal Philips (NYSE:PHG) sleep and respiratory care subsidiary Philips Respironics. The agreement covers Philips’ iNeb aerosol drug delivery device and Mast’s lead product candidate, AIR001, a sodium nitrite solution for intermittent inhalation. The iNeb system is a portable, small vibrating mesh technology […]
QT Vascular wins CE Mark for Chocolate Heart DCB
QT Vascular said today that it won CE Mark approval in the European Union for its Chocolate Heart drug-coated balloon for treating coronary artery disease. The Chocolate Heart device is a paclitaxel-coated version of the Chocolate balloon that won FDA approval back in June 2014, the Singapore-based company said. “We are delighted with the CE […]
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