July 13, 2008
A New Approach to Sinusitis
Doctors use balloon catheters to open clogged arteries. Now, one local 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 vs. 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.
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.
"There are a lot of companies in the cardiovascular space," Baltzell said.
"The bar for value-added [innovation] is higher than other disease states. With ENT [ear, nose and throat], there are more opportunities and fewer participants. That's a nice formula."
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.
Finding a less expensive way
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."
The answer was to use a balloon catheter, a minimally invasive device cardiologists use to enlarge clogged arteries. Doctors inflate the balloons, which in turn enlarge nasal passages and allow the mucus to drain from the nose. Ressemann is familiar with the technology, having worked at SciMed and other medical device companies for 20 years.
By inserting the balloon directly into the sinus cavity through the upper lip, doctors can avoid damaging the delicate bone and tissue structure of the nose during surgery. That's why doctors can perform the procedure in an office rather than in a surgical center.
Too early to tell?
However, experts say using balloon technology to treat sinusitis is relatively new, and long-term results aren't clear. The biggest question is whether the passages will reseal after the balloon is removed. Ressemann says that Entellus data show patients were doing fine after six months. "Typically, if you are going to have a problem with surgery, recurrence of sinusitis, it will happen in the first six months," he said.
But Koutroupas, the ENT specialist in Coon Rapids, said six months is a "grossly inadequate" amount of time to determine whether FinESS works. It would take "at least a few years or several allergy and winter seasons to see whether the procedure holds up," he said.
While FinESS is less invasive than surgery, the procedure comes with its own risks, including possible nerve and tooth root damage, Koutroupas said.
In general, Entellus officials claim the procedure costs much less than regular surgery, but say that they need more long-term data to quantify the savings. Koutroupas, though, is skeptical.
Patients can choose effective, less-expensive treatments such as nasal washes and drugs, he said. Compared with regular surgery, nasal washes are comparable to FinESS but at a fraction of the cost, Koutroupas said.
Plus, FinESS clears only one sinus cavity, the maxillary sinus. People who suffer from chronic sinusitis experience mucus blockage in several sinuses. Koutroupas estimates that only 5 percent of people can benefit from the FinESS procedure, a figure he calls "generous."
Ressemann said FinESS is only the first step for Entellus. Over time, he wants to apply the procedure to other sinuses.
"The goal is that one day we would be able to treat a large majority of patients under local [anesthesia] in the office rather than the operating room," Ressemann said.