Shares in Intersect ENT (NSDQ:XENT) fell slightly today even though the drug-device company met expectations on Wall Street with its 4th quarter results. The Menlo Park, Calif.-based company pared losses to -$4.8 million, or -17¢ per share, on sales of $24.2 million for the 3 months ended Dec. 31, for bottom-line growth of 15.8% on sales growth […]
Intersect ENT Inc.
Intersect ENT wins FDA nod for Propel Contour steroid-releasing implant
Intersect ENT (NSDQ:XENT) said today that it won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses. The Menlo Park, Calif.-based company’s portfolio of steroid-releasing implants are used in patients undergoing ethmoid, frontal or maxillary surgeries to treat chronic sinusitis. “The approval of Propel […]
Intersect ENT shares jump on Q4 prelims
Intersect ENT (NSDQ:XENT) shares jumped yesterday 11% to reach a peak of $13.20 apiece after the company released its preliminary financial results for the 4th quarter, narrowly beating analysts’ expectations on Wall Street. The Menlo Park, Calif.-based company said it expects a total revenue of $24.o – $24.2 million for Q4, slightly ahead of the […]
Intersect ENT dives on Q3 earnings, reimbursement concerns
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 40-50% […]
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 the 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. The study evaluated the change […]
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 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 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 […]
