HNSN Jumps 22%, MDCO Reaches FINISH Line, SNY's Shot At Superbug Vaccine

(RTTNews) - Shares of Hansen Medical Inc. (HNSN) rose more than 22 percent on Monday after the company announced that a pivotal trial evaluating its Artisan family of Control Catheters with its Sensei X Robotic Catheter System for treatment of Atrial Fibrillation has enrolled the first patients. Under the revised protocol, the study will be a single arm, target performance goal study enrolling as few as 125 subjects at up to 14 investigational sites.

The company is scheduled to report Q2 results on Aug.7. Hansen Medical expects to report revenue of about $3.1 million to $3.4 million in the second quarter, down 4% to 12% year-over-year.

The Medicines Co. (MDCO) announced that a phase III trial of Fibrocaps, dubbed FINISH-3, met all primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, soft tissue dissection and vascular surgery.

Fibrocaps, a dry powder topical formulation of fibrinogen and thrombin, being developed to aid in hemostasis during surgery came into Medicines Co.'s fold following its acquisition of Netherlands-based ProFibrix B.V.

Regulatory filing for Fibrocaps in Europe is anticipated in the fourth quarter of this year while U.S. filing is expected in Q1, 2014.

MDCO closed Monday's trading at $31.47. In after-hours, the stock gained 1.65% to $31.99.

Mindray Medical International Ltd. (MR) reported strong results for 2Q, 2013 - with net revenues up 14.7% year-over-year to $307.2 million. Net income for the quarter was $62.1 million or $0.51 per share compared to $52.0 million or $0.44 per share in the year-ago quarter.

The company also raised its full year revenue growth outlook to 18%, up from its prior outlook of 17% growth over its full year 2012 net revenues.

MR closed Monday's trading at $41.83, up 1.31%.

Quidel Corp. (QDEL) on Monday announced that it has received 510(k) clearance from the FDA for its Sofia hCG fluorescent immunoassay for use on Sofia Analyzer for the rapid, objective detection of elevated levels of human chorionic gonadotropin, an early indicator of pregnancy.

Sanofi Pasteur, the vaccines division of Sanofi (SNY) has initiated a phase III clinical program to evaluate its investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection.

According to the Centers for Disease Control and Prevention, C. difficile infections are linked to 14,000 deaths in the U.S. each year. It is estimated that the infections cost at least $1 billion in extra health care costs annually.

The phase III program, called Cdiffense, has just started recruiting volunteers at roughly 100 sites in the U.S. The study is a multi-center, multi-national trial that will include up to 15,000 adults across 17 countries.

SNY closed Monday's trading 0.25% down at $51.02.