Intersect ENT ($XENT) has more than doubled its share price since an IPO last July. To help fuel its next leg of growth, the company has started pivotal testing for its latest bioabsorbable stent slated to go on the market in 2017 and raised $103 million in a follow-on offering.
On July 8, the ear, nose and throat device specialist said it would start a pivotal trial for bioabsorbable, steroid-releasing sinus implant Nova, which is designed to be used in the smaller frontal and maxillary sinus openings.
|Propel's springlike design conforms to patient's unique anatomy and props open the sinus.--Courtesy of Intersect ENT|
The company recently accelerated its expected timeline for Nova, bumping up the trial start to midyear from by year end and advancing its anticipated approval date to 2017 from the previously stated 2018. It worked with FDA to modify the pivotal trial design to enable the faster timeline. In order to do that Intersect ENT is adding an arm to study Nova to an ongoing trial specifically in the frontal sinus area it has ongoing for another bioabsorbable stent, Propel Mini.
Roughly 30% of sinus surgeries are on the smaller sinus regions for which Nova is designed, the company estimates. The company is developing a separate Nova clinical plan for the in-office setting--the company aims to have its sinus stents used in both the hospital and physician office settings.
It also has the Resolve stent in a pivotal trial; it is intended for in-office use in patients who previously had sinus surgery but have nasal polyps that returned. That is slated for an NDA filing in 2017, with a projected approval in 2018.
Intersect ENT already markets bioabsorbable sinus stents Propel and Propel Mini. During the first quarter, it had revenues of $13.4 million, up from $7.5 million a year earlier. But it's quarterly net loss expanded a bit to $5.3 million from $4.4 million the year prior.
The company's shares are up about 55% so far this year to more than $28 apiece; they priced at last year's IPO at $15.
- here are the Nova and follow-on offering releases
Special Report: Top women in medical devices - Lisa Earnhardt, Intersect ENT | FierceMedicalDevices' 2013 Fierce 15 - Intersect ENT