Imagine having a really bad cold that never goes away—congestion, runny nose, facial pressure, headache and loss of smell for more than three months. That’s what it feels like to the more than 36 million people in the U.S. who suffer from chronic rhinosinusitis (CRS), a persistent inflammatory condition of the nasal and sinus cavity lining. A common chronic disease, the condition accounts for 1 to 2% of all physician visits and is associated with $7 to 12 billion in direct U.S. healthcare costs per year.
While nasal steroid sprays are typically prescribed as the standard of care, they are largely ineffective, given that they only reach the front most portion of the nasal cavity. (Essentially where your finger can reach if you were picking your nose!) Appropriate medical therapy consists of daily nasal sprays and cyclical courses of high-dose antibiotic and steroid pills, which have significant side effects. This maximal treatment fails in 50% of patients, leaving them with the limited options of taking repetitive systemic drugs; undergoing expensive, invasive procedures; or continuing to suffer without sufficient treatment.
Recognizing a vast unmet need in the $1.75 billion market, Nasus Medical, a startup born out of Stanford Biodesign and now a Fogarty Institute company, is developing a solution for improved intra-nasal drug delivery. Their innovative device promises to allow patients to treat themselves at home when the first signs of chronic sinusitis appear.
A major issue in need of an answer
The current team, Ashley Seehusen, Ph.D., chief executive officer; Adam Gold, chief technology officer; and Shira Koss, MD, chief medical officer; met at Stanford University when they were fellows in the 2018-2019 Biodesign program. They worked for a year identifying unmet needs in the ear, nose and throat (ENT) space, and out of 250 potential issues, CRS rose to the top.
While patients with chronic sinus infections have fairly good surgical options, they lack effective, non-invasive ways to treat themselves at home in the early phases of the disease. Answering this problem would greatly improve their quality of life and alleviate suffering. Early in the needs finding process, the team met a young female patient who described the extensive process she had endured since developing symptoms — involving multiple nasal sprays, oral medications and endless doctor visits before she reached the point of needing surgery.
“Physicians begin addressing symptoms by prescribing nasal sprays, which are often used incorrectly, then they move on to cyclical prescriptions of oral medications that have significant side effects,” says Shira. “It’s a long and frustrating process for both the patient and the physician because there aren’t any effective, non-invasive options early in the treatment pathway. We wanted to develop a solution that was effective, easy and could be used at home, to empower patients to treat themselves much earlier.”
And that was the driving force behind the current Nasus device. During their fact-finding, the team realized the main challenge was getting the treatment to the right spot of the anatomy. “Doctors are prescribing nasal steroid sprays to help with inflammation, but they don’t work because the drug only reaches the front part of the nose. The sprays never get past the tortuous anatomy in the nasal passage to deliver the drug to the key spot where the inflammation prevents basic drainage of the sinuses,” said Adam.
The team has developed a device for patients to use in the comfort of their homes, which pushes past nasal inflammation and accesses the optimal anatomic target to make sprays more effective. Nasus has developed a number of prototypes that have shown promise in early-human clinical trials.
An accomplished team
“The team’s strength and synergy has been apparent from day one. We realized we have skills that are both complementary and overlapping, and that we really like working together,” said Ashley.
With a Ph.D. in Mechanical Engineering/Medical Engineering from University of Bristol, and an MBA from Babson F.W. Olin Graduate School of Business, Ashley has extensive experience in marketing roles with large medical device companies, including Medtronic and Stryker. She applied to the Biodesign program after attending the executive education course and experiencing the power of needs-based innovation.
Shira is a board certified ENT surgeon practicing at Kaiser Permanente, in addition to working with Nasus. Hailing from a family of physicians and raised and trained on the East Coast, she moved to California to join the Stanford Biodesign program with the goal of learning how to solve problems through effective device solutions, with the aim to reach patients in a broader way.
Putting his engineering background to good use, Adam has seen his career come full circle from his start in medical devices at one of the early FII startups, Novare Surgical Systems. He later worked with a number of startups and as a consultant where he saw a mix of good ideas come and go. He joined Biodesign to learn how to recognize solid ideas and needs, and launch a successful startup.
Nasus is currently refining its device for a second clinical trial at Stanford, when COVID-19 permits. The next step will be to determine the best drug to source for the device.
Joining the Fogarty Institute
Nasus worked with several Fogarty Institute team members after they graduated from the Stanford Biodesign program and greatly benefited from their mentoring. “The FII team helped us come a long way in a short period of time. They helped us understand what we don’t even know yet,” said Ashley, which led to applying to the incubator program.
The Nasus team looks forward to learning from the FII team’s depth of experience, interacting with the other companies-in-residence and offering their skill sets to contribute back to the community. Currently, the team has been participating in weekly FII Zoom calls, which allow for an easy exchange of ideas among peers, and has been conducting “video” rounds with some of their Fogarty mentors.