SinuSys executives Thomas Schreck and Dr. Jerome Hester had a very different relationship just 3 years ago. Schreck, a serial entrepreneur now on his 3rd venture, was Hester’s patient up until a fateful lunch meeting in Menlo Park, Calif., that led to the founding of SinuSys.
The pair are now busy with the commercial phase of their joint venture, having earlier this year won FDA clearance for the Vent-Os sinus dilation system.
It’s not the 1st time Schreck has joined forces with a working physician to launch a company. In 2005, he teamed up with UCSF faculty member Dr. Pamela Palmer to launch AcelRx Pharmaceuticals, a specialty pharmaceutical company where he still serves on the board.
Schreck, who is CEO at SinuSys, took a page out of his own playbook in reaching out to Hester with an idea for a novel sinus expansion system. Working with someone on the "front lines" of treatment is an important ingredient in Schreck’s recipe for success, he told MassDevice.com. Hester, the chief medical officer for SinuSys, is a practicing otolaryngologists at the California Sleep Institute.
"Dr. Hester is considered one, if not the leading [ear, nost & throat] physicians here in Silicon Valley. Why not do something similar and yet do it for probably one of the largest unmet clinical needs on the planet, which is by most estimations over 30 million patients suffering from sinusitis?" Schreck told us. "Jerry’s fighting that fight on the front lines and does it every day."
Schreck and Hester endeavored to develop a sinusitis treatment system that would be both simple and gentle, so that patients could tolerate treatment and physicians could operate in an office with minimal training. The Vent-Os device is comprised of a self-expanding capsule delivered to the sinus cavity, where it slowly widens over about an hour while patients are under local anesthesia.
Patients with sinusitis typically spend a collective 8-12 weeks every year with sinus infections and illness, and treatment options have traditionally been invasive, aggressive and complex, they said. Patients often undergo chronic drug management with antibiotics and steroids alongside surgery, Schreck said.
The concept behind the Vent-Os technology is relatively simple, but the key is in the material used to dilate the sinuses. The Vent-Os capsule is made of an osmotic material that expands spontaneously, but slowly, when exposed to moisture.
"The epiphany around being simple and gentle was really finding the minimum effective dose of a dilation system that could very gently, simply, atraumatically dilate the sinus ostia in an office-based setting," Schreck told us. "We really think this is going to expand the market dramatically away from balloon sinuplasty and, in particular, the functional endoscopic sinus surgery."
In an interview with MassDevice.com, Schreck and Hester talked about founding the company, the special sauce that makes Vent-Os unique and their plans for taking the device to market.
MassDevice.com: How did you two get together to form SinuSys?
Dr. Jerome Hester: (laughs) I guess since Tom is here, I may disclose the fact that we initially met as doctor and patient. Tom came to see me and we started our relationship there. And as he likes to say, he didn’t actually follow my advice.
We’d see each other around town, and I feel fortunate that he thought of me when he came up with this idea for taking this very elegant technology and moving into the space of the treatment of sinusitis. Basically, it was over lunch in Menlo Park when he presented the idea. We sort of brainstormed together to figure how best this could be used in the space, and that was the start about 3 years ago.
MassDevice.com: I don’t often hear of doctors and their patients teaming up to form companies. How does that relationship affect the company?
Thomas Schreck: Actually, I founded AcelRx with Dr. Pam Palmer and that was a tremendous success. When you have a physician like Dr. Palmer who has been on the front lines and really understands the pain condition, and now AcelRx is a growing company with a [new drug application] filed.
Really, I took a page from my own book and said, "Wow, Dr. Hester is considered one, if not the leading ENT physician here in Silicon Valley. Why not do something similar and yet do it for probably one of the largest unmet clinical needs on the planet, which is by most estimations over 30 million patients suffering from sinusitis?" Jerry’s fighting that fight on the front lines and does it every day, and I couldn’t have found a better friend and colleague. We seem to also have found a successful formula.
"Involving somebody who is treating patients on a daily basis does allow insight into what the real issues are, what kind of mechanisms really work best to fix those problems and, in the bigger picture, what’s missing to the armamentarium of a physician" – SinuSys CMO Dr. Jerome Hester
Hester: I think that the success we’ve had has been based on Tom’s ideas and forethought, but I do think that involving somebody who is treating patients on a daily basis does allow insight into what the real issues are, what kind of mechanisms really work best to fix those problems and, in the bigger picture, what’s missing to the armamentarium of a physician.
It really helps and I think that we have made a great team in doing that. It’s been a very worthwhile partnership that is something that I think will benefit a tremendous number of patients.
MassDevice.com: Give me the elevator pitch on your Vent-Os sinus dilation technology.
Schreck: The elevator pitch is really an invention around repositioning osmosis for the very simple, elegant gentle, treatment of sinusitis. It’s really an in situ osmotic dilator that can be placed by any physician who’s kind of a casual ENT practitioner, who doesn’t want or need to be trained for complex balloon sinuplasty – which requires, in some cases, interventional cardiology training because it’s very complex, it’s abrupt and it’s acute. The epiphany was finding a very simple, gradual dilation which could be done in the office by any ENT practitioner.
MassDevice.com: What’s the market for treating sinusitis?
Hester: The fascinating part of this is, in the U.S. alone, there are estimated to be roughly 30 million people with chronic sinusitis. All of us have the occasional sinus infection that may go away by itself or with a short course of antibiotics, but the population that we’re talking about has, by definition, 8 to 12 weeks of infection and illness every single year. During this time they can be fatigued and obviously it impacts their quality of life quite significantly.
The problem is that the options up to this point have been much more aggressive techniques, or complex techniques, or chronic medical management, which leads to the use and perhaps the overuse of antibiotics and steroids. Our goal was to find a procedural treatment that truly was simple enough and easily tolerated by the patient, so that this would have a niche to fit more of those patients, that it would be a treatment that would take away the complexity and perhaps risk of any other procedural treatment, but also reduce the amount of antibiotics and steroid exposure and therefore improve their quality of life quite significantly.
"In the U.S. alone, there are an estimated 30 million people with chronic sinusitis" – SinuSys CMO Dr. Jerome Hester
Schreck: It’s really meant for those patients that are really suffering from ad nauseam steroids and antibiotics, and are looking for a very simple, in-office, gentle procedure. They’re not really ready for or wouldn’t want to have an acute, abrupt balloon dilation. This offers the opportunity to give them something, again, that’s simple, gentle.
The epiphany around the simple and gentle was really finding the minimum effective dose of a dilation system that’s osmotic that could very gently, simply, atraumatically dilate the sinus ostia in an office-based setting. We really think that this is going to expand the market dramatically away from balloon sinuplasty and, in particular, the functional endoscopic sinus surgery and really offer the physician and patient, for the first time, a unique, simple, atraumatic device that almost anybody can do.
It really harkens back to the tool-set of the ENT. It’s very friendly and accommodates their practice very easily. It doesn’t take any training, it doesn’t take any sophistication. We’re seeing systems placed literally in seconds to minutes. The patient then has to wait for the dilation process to undergo itself and that’s a 46-to-60 minute process.
It’s uniquely situated for the physician and the patient to just have a wonderful experience that we think will completely mitigate the needs and requirements for drugs, but also able to stave off the surgery altogether. That’s very important, because when you restore ventilation in the sinusitis sufferer, more often than not, you can improve outcomes. They feel much better and we think this is now the new paradigm to really expand the market and get away from balloons to a friendly in-office procedure.
MassDevice.com: SinuSys just won FDA clearance for the Vent-Os system. What’s the plan for penetrating the market?
Schreck: We’re in the process of hiring territory managers, launching in 8 selected territories across the U.S. We’ve hired the majority of the territory managers with a direct sales force, really targeting the value-added territories around the country which, as you can imagine, heat and humidity often accompany sinusitis. It’s definitely prevalent in the Southeast, the Northeast Corridor, in the Ohio River Valley, the Chicago area. Also in our territory, we’ve hired territory managers here in northern California but also southern California.
It’s really about expanding the footprint domestically in the U.S. It will be about success in the first 4 to 8 select territories and then substantially improving that footprint as we penetrate and create the market option that I think the market is really looking for. It’ll be an initial 8 territories, but we’re optimistic that in the next coming years that it could well double and triple in size.
[Editor’s note: This interview has been lightly edited and cut for clarity.]