Healthcare Equipment and Supplies
Company Overview of Intersect ENT Inc.
Company Overview
Sinexus, Inc., a medical device company, engages in developing therapies for ear, nose, and throat physicians in the United States. It develops a therapeutic device for the treatment of chronic sinusitis. Sinexus, Inc. was founded in 2003 and is based in Palo Alto, California.
1049 Elwell Court
Palo Alto, CA 94303
United States
Founded in 2003
Key Executives for Intersect ENT Inc.
Intersect ENT Inc. Key Developments
Intersect ENT Inc. Presents at MedTech Investing Conference, May-08-2013 11:35 AM. Venue: Graves 601 Hotel, 601 First Avenue North, Minneapolis, MN 55401, United States. Speakers: Lisa D. Earnhardt, Chief Executive Officer and President.
Intersect ENT Inc. announced the start of RESOLVE, a prospective, randomized, blinded, multi-center clinical trial to study the use of the company's newest steroid delivery implant for patients with chronic sinusitis. Intersect ENT's new product, which is placed during a routine physician office visit, is designed as a treatment alternative for patients with recurrent sinus obstruction. Like the company's PROPEL(TM) and PROPEL(TM) mini implants used in the operating room setting to improve surgical outcomes, the product being studied releases mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining to resolve inflammation. The product has more radial strength than the PROPEL products in order to dilate the re-obstructed sinus, and releases the steroid over a longer period of time to keep inflammation at bay. The RESOLVE Study will enroll 100 patients, at up to 20 U.S. sites, who suffer from chronic sinusitis due to recurrent sinus obstruction so severe that revision surgery is warranted. Chronic sinusitis is a condition in which patients' sinuses become swollen and inflamed, leading to difficulty breathing, facial pain or headache, and reduced sense of smell and taste. The condition is common, affecting 31 million people in the U.S., and greatly impacts quality of life. Chronic sinusitis often requires a complex combination of surgical and medical treatments. Each year, 500,000 patients undergo sinus surgery to treat the condition. Although sinus surgery is effective, majority of patients experience recurrent symptoms within the first year; as many as 25% then undergo revision surgery due to recurrent obstruction of the sinus cavity. The RESOLVE study is designed to evaluate Intersect ENT's implant in patients with polyps, which is the most challenging chronic sinusitis patient population. Polyps recur in up to 60% of patients following endoscopic sinus surgery (ESS) and are the cause for revision surgery. Co-Principal Investigators for the study are Keith D. Forwith, M.D., Ph.D. of Advanced ENT & Allergy in Louisville, KY, and Joseph Han, M.D., director of Rhinology and Endoscopic Sinus/Skull Base Surgery and professor at the Eastern Virginia Medical School.
Intersect ENT Inc. announced that U.S. Food and Drug Administration (FDA) approval of the company's second steroid-releasing product, PROPEL(TM) mini, allowing more patients suffering from chronic sinusitis to benefit from localized drug delivery. The PROPEL(TM) mometasone furoate implant, approved last year by the FDA, is a spring-like implant that is inserted by a physician following endoscopic sinus surgery. The implant expands to prop open the sinus, gradually delivers an advanced steroid with anti-inflammatory properties directly to the sinus lining, then dissolves into the body. The result is improved surgical outcomes, reducing the need for additional surgical procedures and for systemic steroids, which can have serious side effects. PROPEL mini, the second in a pipeline of localized drug delivery products in development by the company, is a smaller version of PROPEL. PROPEL mini offers the same clinical benefits and dose of mometasone furoate provided by PROPEL, allowing patients with less extensive surgery and smaller anatomy to benefit from improved surgical outcomes. Intersect ENT initiated sales of PROPEL in limited regions of the country over the past year. PROPEL mini will be offered in select hospitals starting this month and will be launched nationwide in conjunction with a planned sales force expansion in 2013.
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