Company Overview of Intersect ENT, Inc.
Intersect ENT, Inc., a commercial stage drug-device company, provides therapeutic solutions for patients with ear, nose, and throat conditions in the United States. It offers PROPEL and PROPEL mini drug releasing implants for patients undergoing sinus surgery to treat chronic sinusitis. The company is also developing RESOLVE, a steroid releasing implant for refractory disease for the treatment of patients in the physician office setting; and NOVA, a steroid releasing implant to fit the ostia, or openings, of the dependent sinuses following enlargement of the sinuses. The company was formerly known as Sinexus, Inc. and changed its name to Intersect ENT, Inc. in November 2009. Intersect ENT, I...
1555 Adams Drive
Menlo Park, CA 94025
Founded in 2003
Key Executives for Intersect ENT, Inc.
Chief Executive Officer, President and Director
Total Annual Compensation: $442.4K
Chief Financial Officer
Total Annual Compensation: $357.9K
Chief Operating Officer and Vice President of R&D & Operations
Total Annual Compensation: $324.1K
Vice President of Clinical Affairs
Total Annual Compensation: $263.7K
Compensation as of Fiscal Year 2015.
Intersect ENT, Inc. Key Developments
Intersect ENT, Inc. Announces Positive Clinical Results of Pivotal Study of RESOLVE In-Office Steroid Releasing Implant
Oct 17 16
Intersect ENT, Inc. announced positive results from RESOLVE II, a randomized, blinded, multi-center clinical trial designed to assess the safety and efficacy of the company’s investigational RESOLVE steroid releasing implant. Placed during a routine physician office visit, the RESOLVE steroid releasing implant is designed to provide a less invasive treatment option for patients with recurrent ethmoid sinus obstruction that might otherwise warrant a repeat surgical procedure. The RESOLVE II pivotal phase III study evaluated the implant in 300 adult chronic sinusitis patients, all of whom were indicated for revision sinus surgery at study entry due to recurrent symptoms and obstructive inflammation. Patients were randomized to one of two groups: a treatment group consisting of bilateral RESOLVE implant placement in the office, or a control group consisting of a sham procedure. Robert Kern, M.D., of Northwestern University and Pablo Stolovitzky, M.D., of ENT of Georgia served as national co-principal investigators of the study. The study met both co-primary efficacy endpoints: Reduction in Polyp Grade. An independent panel of surgeons blinded to treatment assignment evaluated the change in mean bilateral polyp grade from baseline to day 90 based on video endoscopies. A statistically significant (p=0.007) difference in mean change from baseline favoring the treatment group was observed. Reduction in Sense of Nasal Obstruction and Congestion. The change in mean Nasal Obstruction/Congestion score was measured from baseline to day 30, as scored by patients using a daily diary. A statistically significant (p=0.007) difference in mean change from baseline favoring the treatment group was observed. Secondary endpoints achieving statistical significance through day 90 include the proportion of patients still indicated for repeat sinus surgery and improvements in sense of smell, sense of nasal obstruction, and total symptom score. Safety was evaluated by endoscopic examination and evaluation of adverse events. One serious device-related adverse event, an intranasal bleed requiring intervention, was observed. Approximately 635,000 patients suffer from recurrent chronic sinusitis following sinus surgery each year. Patients with recurrent disease currently have limited treatment options, which include high-dose oral steroids and repeat surgery. Intersect ENT plans to submit a New Drug Application (NDA) in the first quarter of 2017 for regulatory approval from the U.S. Food and Drug Administration (FDA) to market the RESOLVE product. Six-month results from the original RESOLVE study demonstrated that control patients were at 3.6 times higher risk of remaining indicated for revision sinus surgery compared to patients receiving the RESOLVE implant.
Intersect ENT, Inc. Reports Unaudited Earnings Results for the Second Quarter and Six Months Ended June 30, 2016; Provides Earnings Guidance for the Third Quarter and Full Year of 2016
Aug 2 16
Intersect ENT, Inc. reported unaudited earnings results for the second quarter and six months ended June 30, 2016. For the quarter, the company’s revenue was $19.317 million compared to $15.198 million a year ago. This increase in revenue is primarily attributable to continuing expansion of the adoption of PROPEL and PROPEL mini, including for the newly expanded indication for PROPEL mini. Loss from operations was $6.183 million against $5.861 million a year ago. Net loss was $5.959 million or $0.21 per basic and diluted share compared to $5.813 million or $0.23 per basic and diluted share a year ago.
For the six months, the company’s revenue was $36.009 million compared to $28.570 million a year ago. Loss from operations was $14.589 million against $11.227 million a year ago. Net loss was $14.180 million or $0.50 per basic and diluted share compared to $11.151 million or $0.46 per basic and diluted share a year ago.
The company expects full year revenue at the low end of the previous guidance range of $78 million to $80 million. The company is raising its outlook for gross margin to 82% to 83%, versus previous guidance of 80% to 81%.
The company’s outlook for third quarter 2016 revenue is approximately $17.8 million. The company is maintaining its outlook for operating expenses of approximately $92 million and continues to expect a net use of cash for the year of approximately $25 million.
Intersect ENT Announces FDA Submission of NOVA Bioabsorbable Steroid Releasing Implant for Patients With Chronic Sinus Disease
Aug 1 16
Intersect ENT Inc. announced that the company has submitted a supplemental premarket approval submission (PMA-s) to the U.S. Food and Drug Administration to seek approval for its new NOVA steroid releasing implant for patients with chronic sinus disease. NOVA’s unique hourglass shape and lower profile is designed to allow for placement in smaller sinus openings, and may expand the applicable patient population for steroid releasing implants. The NOVA cohort of the PROGRESS study was a prospective, randomized, blinded, multi-center trial of 80 patients designed to assess the safety and efficacy of the implant when placed in the frontal sinuses following surgery. As previously announced, the study met its primary efficacy endpoint, demonstrating a statistically significant 65% relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or need for oral steroid prescription, compared to surgery alone with standard post-operative care. The device placement success rate was 100% and there were no device-related adverse events through 90-day follow-up.
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