Intersect ENT sees positive data on Propel from pivotal trial

Last month, we reported on Intersect ENT, which had obtained the FDA's ok for the Propel mometasone furoate implant that offers localized, controlled drug delivery for chronic sinusitis patients. This week, the company announced positive data from the ADVANCE II trial of Propel that evaluated 105 patients undergoing endoscopic sinus surgery for chronic sinusitis.

Propel is the first of a new category of products offering localized, controlled drug delivery to the sinus tissue. Inserted by a physician following endoscopic sinus surgery, the spring-like implant expands to prop open the sinus. It gradually delivers an advanced corticosteroid with anti-inflammatory properties directly to the sinus lining. The implant dissolves within 30-45 days, Intersect ENT CEO Lisa Earnhardt told FMD last month.

Propel demonstrated a 29% reduction in the need for postoperative interventions relative to controls, including a 52% reduction in surgical lysis of adhesions or scar formation and a 29% reduction in the need for oral steroids to resolve recurrent inflammation, according to the company.

In addition, a meta-analysis of 143 patients enrolled in ADVANCE II and the initial pilot study showed, relative to controls, use of  Propel yielded a 35% reduction in postoperative medical and surgical intervention, including a 40% reduction in the need for oral steroids.

"We're proud of the positive data we have amassed, which shows that Propel's localized and controlled steroid delivery confers significant benefits to patients--reducing the need for post-operative medical and surgical therapies, which may mean shorter and less painful post-op visits and better long-term outcomes," Earnhardt said in a statement.

Intersect ENT seems to be growing quite nicely. In a recent interview with the San Francisco Business Times' Ron Leuty, Earnhardt said her company currently has 40 employees. It started off the year with 25. It's also been attracting the eye of funders. Last year, it raised $30 million with the help of Medtronic and existing investors PTV Sciences, Kleiner Perkins Caufield & Byers and U.S. Venture Partners. 

- see the Intersect ENT release
- check out more from the San Francisco Business Times