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grown to about 100, Earnhardt says. With the new financing in hand, the company will probably grow to 150 people by year’s end, she says.
A big part of Intersect’s growth plan is based on a 100-patient clinical trial that recently began recruiting patients. This trial, to be followed by another 200-patient study, will ask patients to try a modified version of the company’s technology with potentially broader appeal. The newer device, which Intersect tentatively calls the “in-office” product, is one that doesn’t require surgery, and that a physician can insert during an office visit. Since these patients haven’t already had surgery to clear out a blocking piece of anatomy in the sinuses, this new product has to do more of the work to prop open the sinus, and is being designed with more radial strength, Earnhardt says. It will also release the steroid drug over a longer period of time, to keep the chronic inflammation tamped down.
At first, this product will be aimed at patients who have already had a sinus surgery, but have had a recurrence of their symptoms and are considering a repeat procedure. That group adds up to about 2 million people in the U.S., Earnhardt says.
Intersect ENT isn’t the only company developing new approaches for treating sinus disorders. Menlo Park, CA-based Acclarent, which developed what it calls a “balloon sinuplasty” device, was acquired by Johnson & Johnson’s Ethicon division for $785 million in January 2010. Other companies are developing different devices for sinus disorders, but Intersect ENT believes it is differentiated by its belief that devices can’t treat chronic inflammatory disorders alone. “You need to treat the underlying cause of disease, the inflammation, as well,” Earnhardt says.
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