Spirair Advances Office-Based Solution to Widespread Nasal Issue During Biodesign Summer Extension Program

Good ideas can come from anywhere, but as the Fogarty Institute has found over and over, the Stanford Biodesign Summer Extension program is a rich source for innovation. That’s why it has partnered with Stanford Biodesign to give promising projects even more hands-on expertise, including one-on-one and group mentoring, recommendations specialized to the company’s unique needs, industry connections and educational workshops.

This year, one of three companies to come to the Fogarty Institute via the program is Spirair, a startup co-founded by James Kintzing, Ph.D., and  Brandon McCutcheon, MD, who were teammates in the 2019-2020 Stanford Biodesign Innovation Fellowship. The startup is pursuing an office-based treatment for nasal septal deviation, a common condition that makes it hard to breathe freely and impacts quality of life. (Read more about the second company, Auricle, here.)

A chance encounter at the Stanford Biodesign

While earning his Ph.D. in Bioengineering at Stanford University, James took a Biodesign graduate course and became further involved as a TA and volunteer with the high school summer program. “Through these different activities, I became increasingly impressed with the quality of the program, and I especially liked the focus on need-based innovation,” said James. That led him to apply for the Fellowship, driven by his desire to work with like-minded individuals on a full-time project to move healthcare forward.

He felt fortunate to meet and be paired with Brandon during the program – the two share similar interests in that James was working on targeted therapies for brain cancer and Brandon is a neurosurgeon, inventor and entrepreneur, having previously co-founded a digital tech company.

Finding a large unmet need in the ears, nose and throat (ENT) space

While they shared a common interest in brain health, they ended up focusing on a different specialty as they identified an opportunity in the ENT space, realizing there currently is no effective way to correct nasal obstruction in an office-based setting.

They turned their attention to this issue and are now developing a minimally invasive way to treat nasal septal deviation, a condition that leads to congestion, among other symptoms, which greatly impacts patients’ quality of life and sleep patterns. As much as 80% of the U.S. population has some form of deviated septum, and an estimated 500,000 patients need septal surgery to treat nasal obstruction, with a direct cost of surgery at $4.1 billion a year.

However, there are an additional 1.1 million patients with moderate cases who could greatly benefit from Spirair’s minimally invasive solution that would transform the procedure from surgery to a 20-minute in-office procedure that allows people to return to work the same day.

“While we both had backgrounds in a different field, this really gave us an opportunity to approach a complex and compelling need with a fresh mindset,” said Brandon. “This project quickly rose to the top due to the significant patient impact and clear gap in the marketplace. While there are many ENT-related conditions that have office-based solutions, nasal septal deviation stands out as one of the areas that has been left behind.”

Tapping the expertise of the Fogarty Institute

The team wanted to move forward beyond the Fellowship and applied for and was awarded Summer Extension grant funding. Fogarty executives participated on the panel that helped identify the awardees, which gave James and Brandon their first introduction to the organization. They further developed the fruitful relationship over the summer.

“The Spirair team was a quick study – they really took advantage of all that the program offered and immediately executed many of the suggestions that were made,” says Denise Zarins, Fogarty Institute’s chief technical officer. “We are really pleased to see their extensive progress as they implemented a number of key components that will help move their company forward.”

“After our ‘physical’ at the Institute, the Fogarty executive team and our mentors came back with a very thorough development plan that included identifying key areas where we could reduce our risk and research additional questions we should answer to move us forward over the summer,” said James. Since then, the team has worked on the plan and is ready to seek funding.

About the Stanford Biodesign Innovation and Summer Extension Programs

The Biodesign Innovation Fellowship is a 10-month, fulltime, hands-on program for experienced professionals with backgrounds in engineering, medicine, and business. During the fellowship, trainees learn and apply the Biodesign innovation process to uncover and validate clinical needs, invent novel digital and device-based health technologies to address them, and prepare to bring those products to the market to improve patient care.

The Biodesign Summer Extension program provides qualifying teams from the Stanford Biodesign Innovation Fellowship and the graduate-level Biodesign Innovation course with additional funding and mentoring to pursue their projects through the summer. Recipients use this time to further de-risk their technologies, develop business plans, and line up additional funding to take their projects to the next level.

The Fogarty Institute partners with these young companies to offer its signature hands-on mentoring from each member of the executive team, in addition to a dedicated mentor, along with a comprehensive development plan and opportunity to participate in educational workshops tailored to their specific needs.

From undergoing a full company “physical,” to connecting the companies with the right people and physicians in the industry, program attendees have a unique opportunity to quickly propel with projects forward and get closer to becoming a potentially viable company.

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