pSivida (NSDQ:PSDV) released its fiscal year earnings for 2015 yesterday and said it’s eyeing an entrance into the orthopedic knee market with a new drug-device implant. The company said it is slated to submit an investigational new drug application with the FDA and begin a study of a new implant using its Durasert technology to […]
QT Vascular wins CE Mark for drug-coated balloon
QT Vascular said Monday it won CE Mark approval in the European Union for its Chocolate Touch drug-coated balloon for treating vascular disease. The device is a paclitaxel coated balloon meant to treat occluded arteries and mechanically dilate them with a balloon catheter, the company said. Singapore-based medical company said it expects a commercial launch of […]
Intersect ENT's Propel study meets endpoint
Intersect ENT (NSDQ:XENT) said a new study of its Propel mini steroid-releasing sinus implant used after frontal sinus surgery met the primary endpoint in a clinical trial. The Propel device is already approved for use in the ethmoid sinuses, behind the bridge of the nose, in conjunction with sinus surgery to treat symptoms of chronic sinusitis, […]
SteadyMed still steady on Q2
SteadyMed Therapeutics (NASDAQ:STDY) yesterday released quarterly earnings that missed expectations and reported growing losses, but shares stayed steady. SteadyMed is a developer of hypertension and pain treatments given with a discrete, patented drug-delivery device called the PatchPump. The company is focusing on development and approval of Treyvant, a drug to treat pulmonary arterial hypertension. SteadyMed reported losses of […]
Bard, Medtronic win Medicare reimbursement add-on for DCBs
Medtronic (NYSE:MDT) and C.R. Bard (NYSE:BCR) said today that angioplasty treatments with drug-coated balloons will now be eligible for new technology add-on payments through the Centers for Medicare and Medicaid Services under Medicare’s hospital impatient prospective payment systems. The add-on payment, with a maximum of $1,036, will help cover additional costs for treating patients for peripheral artery disease with […]
Intersect Ent launches Nova sinus implant trial
Intersect ENT (NSDQ:XENT) said yesterday it enrolled the 1st patient in a trial of its Nova bioabsorbable steroid releasing sinus implant. The implant is designed to prop open the sinuses and deliver anti-inflammatory medication after surgical interventions, the Menlo Park, Calif.-based company said. “Clinical evidence to date has shown that Propel and Propel mini meaningfully […]
Delcath to settle shareholder suits for $8.5m
Delcath (NSDQ:DCTH) said yesterday that it agreed to pay $8.5 million to settle a clutch of lawsuits filed by shareholders over losses related to its development of the drug-device combination Melblez kit. The lawsuits, filed by shareholders in 2013, sought compensation for losses between April 21, 2010, and May 2, 2013, stemming from 3 separate incidents the plaintiffs claim caused […]
Diabetes: Medtronic furthers the quest for an artificial pancreas
Medtronic (NYSE:MDT) and Intarcia Therapeutics were in the spotlight at the American Diabetes Assn.’s annual scientific sessions conference in Boston last week, revealing new medical device developments in the fight against diabetes. Medtronic took center stage, announcing new developments for its artificial pancreas program, touting positive data from a user study of its MiniMed 640g and revealing plans to collaborate […]
Intersect ENT PO goes over-allotment, closes at $103m
Intersect ENT (NSDQ:XENT) said Tuesday it closed its public offering of 4.1 million shares of common stock at $25 per share. J.P. Morgan and BofA Merrill Lynch were book-runners for the offering, with Leerink Partners, Canaccord Genuity and William Blair as co-managers, the company said.. The deal included 537,300 shares sold through an underwriters option to purchase […]
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