ShareThisMINNEAPOLIS -- Doctors use balloon catheters to open clogged arteries. Now, a Minnesota start-up hopes to apply the same technology to people who have clogged sinuses.
Entellus Medical Inc., based in Maple Grove, has developed what it bills as a cheaper and less invasive away to treat sinusitis, or severe chronic sinus infections.
The procedure involves inserting a balloon catheter into the nasal cavity through a tiny incision under the lip, expanding the balloon in the passageway and draining excess mucus from the sinus. Entellus officials say the treatment, called FinESS, could be a better option than outright surgery; FinESS can be done in a doctor's office under local anesthesia.
"Patients can recover in hours versus days," said CEO Thomas Ressemann. "The balloon lends itself nicely to an office procedure, because there is less bleeding and no cutting of tissue."
Entellus said in June that it raised $15 million more in venture financing from Montagu Newhall Associates, Split Rock Partners and SV Life Sciences. The company is testing FinESS on 100 patients in 16 states, including Minnesota, and hopes to publish the data this year in a peer-reviewed journal.
FinESS has received approval from the U.S. Food and Drug Administration, and Entellus hopes to secure Medicare reimbursement for the procedure by 2009.
But one expert says FinESS would help only a small percentage of people who suffer from chronic sinusitis. And it's too early to know whether patients' nasal passages will close again after the balloon is removed, said Dr. Steven Koutroupas, an ear, nose and throat specialist at Allina Medical Clinic in Coon Rapids, Minn.
The idea for Entellus came in a roundabout fashion. In 2006, Ressemann and co-founder Peter Keith approached Josh Baltzell, a managing director at Eden Prairie-based Split Rock Partners, with an unrelated idea. Baltzell passed on the deal, but he suggested the duo take a look at the ear, nose and throat market, an area that is only now starting to attract more investor interest, he said.
Baltzell said he was particularly interested in technology that would allow procedures to be done in an office rather than an operating room, a distinction that could save millions of dollars.
"We are looking for ways to streamline the delivery of health care," he said.
Ressemann and Keith zeroed in on chronic sinusitis, a condition that affects an estimated 37 million people in the United States. Allergies, mold or viruses cause nasal passages to close, trapping mucus in the sinus. The mucus buildup results in an infection.
Normally, doctors use nasal washes or drugs to treat sinusitis. But chronic sufferers, those who have symptoms lasting 12 weeks or more, might need surgery to free mucus flow by removing bone and tissue from the nose. That requires general anesthesia and several days of recovery.
Rather than inventing new technology, Ressemann, an engineer who also holds an MBA, said he focused on how to make sinusitis treatment cheaper.
"One of the first things we looked at is the economics," Ressemann said. "We came at it from the other side. We set out to understand those needs before we even designed the device.
"There are a lot of good technologies out there that do a very good job at treating patients. But you have to understand how the patients get there in the first place. The best treatment meets all of the stakeholders' needs. Insurance companies want to pay less. Doctors want to get paid well for their time. Patients want a painless-as-possible procedure and (want to) get back to their normal lives as soon as possible. Understanding the economics first before we started designing was what allowed us to meet all of the three stakeholders' needs."
(Distributed by Scripps Howard News Service, www.scrippsnews.com.)
