Intersect ENT nailed down $30 million in new Series D funding that attracted major investor interest from Medtronic ($MDT) and a number of other high-profile players. Executives aren't wasting any time, and they are using the cash infusion to rapidly accelerate commercial expansion plans for the company's quarter-sized implants to treat chronic sinusitis.
With that, another major goal is also in sight.
"This is what we need at this point to get to profitability," Intersect ENT's president and CEO, Lisa Earnhardt, told FierceMedicalDevices in a telephone interview. "It is our next big milestone as a business. We are fortunate that we had significant interest in this round. I feel great. My team has done such fabulous work to be able to earn the confidence of investors."
Medtronic has been an ongoing investor in the company and participated with previous investors including Kleiner Perkins Caufield & Byers, U.S. Venture Partners and PTV Sciences. New investor Norwest Venture Partners led the round.
The company won FDA PMA approval for its Propel and Propel mini sinus implants back in 2011, and they've been in limited commercial launch in 6 U.S. markets since then, Earnhardt said, as a small direct sales team focused on driving adoption "with a small number of surgeons." The device, the size of a U.S. quarter in diameter, is for use in conjunction with surgery to treat chronic sinusitis. Surgeons place one Propel on either side of the sinus in the nasal passageway and it releases a steroid drug over 30 days that's designed to maintain the sinus opening. After that, the implant bioabsorbs into the body and disappears. And Intersect touts the fact that 6,000 patients have received the implants so far.
Now the goal is to expand Propel's market. The company is focused on obtaining a CE mark "hopefully by this time next year," Earnhardt told us. And in the U.S., the new funding round will help the company expand its direct sales team. Out of 100 employees overall, about 18 people are sales-related employees, up from 6 several months ago. Plans call for boosting that number to 30, and the company "will continue to grow as the demand dictates," Earnhardt explained.
Separately, the funding will also help support clinical development of an office-based sinusitis treatment, a combination drug and device "much like Propel." This new product is designed to treat chronic sinus sufferers who face extensive polyp disease--among the most challenging patient subsets of those suffering from chronic sinusitis. The treatment is meant to be a less invasive and more cost-effective option than surgery, performed in the doctor's office. Enrollment has begun in the company's RESOLVE trial, with plans to include 100 patients at 20 sites in the U.S. For this product, however, Intersect will pursue a drug-approval pathway rather than the device-related PMA approval.
Intersect, based in Menlo Park, CA, was founded in 2003, secured its first venture funding in 2006, and has raised $90 million to date. As far as future plans, Earnhardt said Intersect is focused on long-term sustainability, with a number of options in the mix.
"We are building this company to ensure we are profitable and have sustainable growth," Earnhardt said, "and that focus is on what we can control to ensure that we are developing a high-growth, high-value-added business. In this space, a lot of exits tend to be on the M&A versus IPO [side], but we are keeping our options open."
- here's the release