Intersect ENT – 2013 Fierce 15

Intersect CEO Lisa Earnhardt

Based: Menlo Park, CA
Founded: 2003
CEO: Lisa Earnhardt

The Scoop: The company focuses on "clinically proven therapy solutions that enable ear, nose and throat physicians to solve clinical challenges and improve the quality of life for patients." Intersect ENT's initial target is chronic sinusitis, with its Propel steroid-releasing mini sinus implants. A Propel implant is placed on either side of the sinus in the nasal passageway and releases a steroid drug over the next month to maintain the sinus opening. Once that job is done, the implant dissolves into the body and disappears.

What Makes It Fierce: This has been a banner year for Intersect ENT, beginning with a new $30 million Series D funding round announced in February 2013 that attracted the likes of new investor Norwest Venture Partners, plus existing investors including Medtronic ($MDT), Kleiner Perkins Caufield & Byers, U.S. Venture Partners and PTV Sciences. Execs have been investing the money in hiring (130 people now and rising), plus accelerated commercialization of the Propel and Propel mini sinus implants, following premarketing approval in 2011 and a limited launch in a handful of U.S. markets. CEO Lisa Earnhardt tells FierceMedicalDevices that the sales scale-up since the new funding round has gone well.

"We started with 6 territories," Earnhardt said. "And we are now at the point where we cover 25 territories across the country and that is still growing. We are in hyper-growth mode, which is really fun and an exciting time for us all."

That aggressive sales push has led to another milestone: More than 10,000 patients have now been treated with Propel implants. At $695 per implant, that's generated serious revenue to date, something that Earnhardt said has surpassed the $10 million market and rising. Intersect ENT is also pursuing a CE mark and hopes to have that in hand by early 2014, Earnhardt said. (In the U.S., Propel has reimbursement in conjunction with existing codes for functional endoscopic sinus surgery.)

With growth also comes expansion into a larger headquarters. Intersect ENT just moved from a 7,000-square-foot facility to a state-of-the-art, 32,000-square-foot space. In June, the company won premarketing approval from the FDA to begin shipping product from the larger space, which also accommodates manufacturing.

"It is a very important milestone for the company," Earnhardt said.

What To Look For: Intersect ENT isn't profitable yet. But the company is focused on building its revenue in the coming months to reach that goal. There's also a move to expand Intersect ENT's clinical development pipeline. Its third product, dubbed S8, is a tiny implant that looks like a spider and is designed to deliver steroids directly into the sinus lining to reduce inflammation over a longer period. The company is targeting patients indicated for sinus surgery, but S8 is designed to help them with a less invasive, more cost-effective procedure in the clinic. It's now the subject of the company's RESOLVE pivotal trial. Intersect ENT is working with the FDA's office of combination products and its drug approval arm for this effort.

For more:
Special Reports: The Biggest Med Tech VC Investments of Q1 | Drug-Delivery Device Combos to Watch - Intersect ENT's sinus implant
Intersect ENT pulls in $30M Series D for sinusitis-implant sales push
Intersect ENT sees positive data on Propel from pivotal trial

-- Mark Hollmer (email | Twitter)

Intersect ENT – 2013 Fierce 15