Last week, Intersect ENT garnered the FDA's ok for the Propel mometasone furoate implant that offers localized, controlled drug delivery for chronic sinusitis patients. FierceMedicalDevices recently spoke with CEO Lisa Earnhardt, who says her company is "extraordinarily excited" about the approval, as it will help improve outcomes for patients.
Propel is the first of a new category of products offering this kind of 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, Earnhardt told FMD.
The system has been clinically proven to prevent obstruction of the ethmoid sinus following surgery. The result is improved post-operative outcomes, reducing the need for additional procedures and systemic steroids that can have serious side effects, according to a company statement.
Earnhardt says the company is launching the product in certain markets this fall. These markets were chosen for a number of reasons, including disease prevalence, i.e., they are places where there are a significant number of sufferers, as well as major metropolitan markets. She added the company is focusing on commercializing the product in the U.S., but will pursue regulatory sign offs in other markets in the future. Earnhardt also told FMD the company has a full pipeline.
In early 2010, the company changed its name from Sinexus to Intersect ENT. Earnhardt said the name change reflected the mission of the company--connecting drugs and devices to physicians and patients in need. And the company is hoping its products reach ear, nose & throat surgeons.
The company which has received three rounds of venture capital funding. 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.
- check out the Intersect ENT announcement