Intersect ENT (NSDQ:XENT) yesterday released disappointing 3rd quarter earnings that fell well below Street expectations, sending shares plummeting. Intersect ENT reported losses of $9.7 million, or 35¢ per share, on sales of $14.2 million for the 3 months ended September 30. That amounts to a 65.5% increase in losses on sales growth of 56.4% compared with […]
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Intersect ENT files for expanded Propel PMA
Intersect ENT (NSDQ:XENT) said Tuesday it submitted a supplemental premarket approval application to the FDA to expand the indication on its Propel mini steroid releasing implant to cover frontal sinus surgeries. The new indication would allow the drug-device combo to be used in the frontal sinuses, located behind the eyebrows, the Menlo Park, Calif.-based company […]
Intersect ENT touts sinus-implant study results
Intersect ENT (NSDQ:XENT) said today results from 3 clinical studies of its Propel, Resolve and Nova products showed positive results. The data was presented at the American Rhinologic Society’s annual meeting in Dallas. Each of the studies evaluated steroid releasing sinus implants placed in minimally invasive in-office procedures to reduce inflammation for patients with chronic […]
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, […]
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 […]
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 […]
Nevro, Intersect ENT, Ocular Therapeutix announce follow-on offerings
A trio of medical device companies that went public last year are planning follow-on offerings to raise more cash. Nevro Corp. (NYSE:NVRO), Intersect ENT (NSDQ:XENT) and Ocular Therapeutix (NSDQ:OCUL) all revealed plans for the flotations this week. Menlo Park, Calif.-based Nevro priced its 1.8-million-share offering yesterday at $51 per share, saying stockholders would put up another […]
Ex-FDA chief Hamburg moves to Institute of Medicine | Personnel Moves
Dr. Margaret Hamburg, who resigned as FDA commissioner in February, was named foreign secretary of the U.S. Institute of Medicine this week.
Hamburg spent 6 years leading the federal safety watchdog, overseeing a massive revamp of its medical device, drug, food and tobacco regulation.
JenaValve taps medtech vet Keltjens for interim CEO | Personnel Moves
JenaValve tapped a medtech veteran with a string of successful exits behind him as interim chairman & CEO, replacing another medical device vet, David Drachman, after just 7 months.
Intersect ENT study aims to bring sinus implants to more patients
California device maker Intersect ENT (NSDQ:XENT) announced this week that it enrolled the 1st patient in its PROGRESS clinical trial, evaluating the company’s Propel Mini sinus implant for treatment of frontal sinusitis.