Intersect ENT, a California-based medical devices company with chronic sinusitus drug-delivery solutions, presented a company overview Tuesday at the JP Morgan Healthcare Conference in San Francisco. Chronic sinusitis, which can cause headaches, congestion, facial pain and breathing problems among other issues, affects one of seven adults in the U.S. The company’s tapped this largely unmet clinical need with two implants that deliver localized drugs, and is well on its way to meeting patients with a third option.
But the hot healthcare startup’s true genius lies in moving tech from the heart to the head.
The company has completed enrollment for its RESOLVE study. This randomized clinical trial will investigate the company’s third product, an in-office solution for patients with chronic sinusitus. In the study, the company will look at how the drug-eluting implant might work for patients indicated for revision sinus surgery.
According to the company website, “the product releases mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining, then dissolves. The implant has more radial strength than the PROPEL products in order to dilate the obstructed sinus and releases the steroid over a longer period of time.”
The current standard of care: upping the dosage of steroids (either orally or through irrigation), with all their potential for side effects, or undergoing yet another surgery (or two, or three), President and CEO Lisa Earnhardt said.
“Instead of taking them back to the OR, (the product would be) placed by a physician with local anesthesia in a matter of minutes to treat inflammation,” Earnhardt said.
Commercialization for the product is “a couple years out,” but the company will likely begin its second Phase III trial this year.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In true CEO-speak, Earnhardt calls the new device a “quintessential win-win-win,” and if the device succeeds in its trials and FDA route, she’s right.
In theory, it would cut costs from patient, payer and provider. The patient gets immediate relief and doesn’t have to take time off work. The physician can perform the procedure more quickly, freeing him up to see more patients. And the cost of a surgery (or, for those with multiple revisive surgeries on the horizon, the cost of several operations) is avoided.
Reasons for success
There’s a lot of reason to believe in the device if the company’s short history is any indicator. The team’s won two PMA approvals for its chronic sinusitis Propel and Propel Mini, essentially dissolving drug-eluting stents that release steroids for patients who undergo chronic sinusitis surgery.
These quickly achieved milestones have been met with strong investments. The company’s investors include such heavyweights as Medtronic (MDT), PTV Sciences, Norwest Venture Partners, U.S. Venture Partners and Kleiner, Perkins, Caufield and Byers. They joined to kick off the startup’s 2013 with a bang: a $30 million Series D bang.
The biggest lesson from the bankable, smart approach of the company’s engineering? Fit near-existing technologies to different anatomies. The dissolving drug-eluting stent from the heart to the head, from a man’s nasal passages (Propel) to a woman’s (the “Mini”) and so on.
(It’s no coincidence, Earnhardt said, the leadership team has strong ties to drug delivery primarily in drug-eluting stents designed for the cardiovascular space. Earnhardt worked for Boston Scientific (BSX) as the president of its cardiac surgery division.)
Near-future milestones
Intersect ENT’s also made a serious U.S. sales push, which Earnhardt said will continue. The number one priority for the foreseeable future: “ensuring patient access to therapy, in terms of covering the country in representation and educating physicians about the technology,” she said.
The second prong of that goal is working to make certain the procedure is reimbursed, Earnhardt said.
Though the United States is the company emphasis for now, Earnhardt said Intersect ENT anticipates CE Marks for Propel and Propel Mini this year.
To read why MedCity Editor-in-Chief Veronica Combs considers Earnhardt a reason to be optimistic about healthcare, click here.
To check out Earnhardt’s 2014 New Year’s resolution, click here.
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