Shares in Intersect ENT (NSDQ:XENT) yesterday tumbled over 30% over reimbursement woes, despite the medical device maker handily topping expectations on Wall Street with its 3rd quarter results. The company said that the Centers for Medicare & Medicaid Services released its 2017 Hospital Outpatient Final Rule, which included reimbursement rates for sinus surgery at a fixed amount […]
intersectent
Intersect ENT’s Resolve sinus implant meets endpoints in pivotal trial
Intersect ENT (NSDQ:XENT) said today that its Resolve sinus implant met both primary endpoints in its Resolve II pivotal trial. The Menlo Park, Calif.-based company’s Resolve steroid-releasing sinus implant is a minimally invasive treatment for patients with recurrent ethmoid sinus obstruction. The 300-patient Resolve II trial compared the bilateral Resolve implant with a sham procedure. Get the full […]
Medical society backs drug-eluting sinus implants
The American Rhinologic Society today endorsed the use of drug-eluting implants in sinus cavities for patients following surgery. A successful sinus surgery depends on proper healing and avoiding inflammation, the society said in a press release. Drug-eluting implants can reduce nasal polyps and inflammation, which can decrease a patient’s use of oral medication, according to […]
Intersect ENT claims reimbursement win for Propel drug-eluting sinus implant
Intersect ENT (NSDQ:XENT) said today that it won a positive coverage decision from CareFirst BlueCross BlueShield for its Propel and Propel Mini drug-eluting sinus implants. The devices are designed to elute the anti-inflammatory steroid mometasone furoate; Menlo Park, Calif.-based Intersect won FDA approval for the original Propel implant in August 2011 and for the Propel Mini the following September. The […]
Intersect ENT shares up on Q2 that topped rev, missed EPS
Intersect ENT (NSDQ:XENT) released 2nd quarter earnings late yesterday that topped the Street’s expectations for revenue but fell barely short on EPS, with shares ticking up at the news. The Menlo Park, Calif.-based company reported losses of $6 million, or 21¢ per share, on sales of $19.3 million for the 3 months ended June 30. […]
Intersect ENT files with FDA for drug-delivering sinus implant
Intersect ENT (NSDQ:XENT) said today it submitted a supplemental premarket approval submission to the FDA seeking approval for a new Nova steroid releasing implant for treating patients with chronic sinus disease. The new Nova device is designed with a lower profile to allow for placement in smaller sinus openings, and will expand the usable patient population for […]
Intersect ENT jumps on strong Q2 prelims
Intersect ENT (NSDQ:XENT) shares jumped today after the medical device company reported preliminary 2nd-quarter sales numbers that beat the consensus forecast on Wall Street. Menlo Park, Calif.-based Intersect said it expects to post sales of $19.3 million for the 3 months ended June 30, for a 27% top-line gain compared with Q2 2015. Analysts are predicting sales […]
Intersect ENT wins expanded FDA approval for Propel Mini
Intersect ENT (NSDQ:XENT) said today it won FDA premarket approval for an expanded indication for its Propel mini steroid releasing sinus implant designed to treat patients undergoing frontal sinus surgery. The expanded indication from the Menlo Park, Calif.-based company will allow the company to market the placement of the Propel mini in the frontal sinuses […]
Bayer taps strategy head Baumann for CEO | Personnel Moves
Bayer (ETR:BAYN) named strategy chief Werner Baumann to replace Marijn Dekkers as CEO today, prompting some industry watchers to speculate that there’s more deal-making ahead for the German firm’s non-pharma markets. Baumann, who’s slated to succeed Dekkers May 1, joined Bayer in 1988 and made a name for himself with the successful integration of rival drugmaker […]
Intersect ENT logs German reimbursement win
Intersect ENT (NSDQ:XENT) said today it clocked a German hospital reimbursement win from InEk, Germany’s Institute for Hospital Remuneration System, for its Propel sinus implant. The propel device is a small steroid releasing implant designed to improve surgical outcomes for patients with chronic sinusitis undergoing ethmoid sinus surgery. “We believe that the robust clinical evidence […]
Intersect ENT touts economic data from from Propel study
Intersect ENT (NSDQ:XENT) said today that budget impact data on its Propel steroid releasing implant for treating chronic sinusitis showed upfront costs offset by savings post-operatively. The data was presented at the International Society for Pharmaeconomics and Outcomes Research annual meeting in Milan, Italy. “A previous study demonstrated the use of Propel in sinus surgery […]