Fogarty Institute Helps Advance Promising Projects from Stanford Biodesign

For several years, the Fogarty Institute has partnered with Stanford Biodesign’s Summer Extension program, which provides funding to help advance promising projects. The Institute offers these young companies 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 propel their projects forward and get closer to becoming a potentially viable company.

“The teams that come into the summer extension program are extremely motivated groups of individuals who are striving to make a positive difference in the lives of patients,” said John Morriss, FII director of invention acceleration. “It’s inspiring to see them quickly absorb the advice they are offered and put it into practice.”

This summer the Institute hosted three projects: Auricle, co-founded by Francis Wong, MD, and Jay Dhuldhoya; Spirair, co-founded by James Kintzing and Brandon McCutcheon, MD; and Calumeo, co-founded by Niki Panich, MD. Read on to find out more about the first two; and don’t miss our September newsletter to learn more about the third.

Auricle Makes Big Gains During Summer Extension Program

The partnership of Auricle co-founders Francis and Jay was born during their Innovation Fellowship at Stanford Biodesign, where they applied their different career paths toward a common goal.

Francis began his career in healthcare as a medical doctor in London, with a focus on urology and general surgery, but later moved to the U.S. to obtain his MBA and Master’s in Public Health (MPH) from UC Berkeley. He used this experience to focus on the business side of healthcare, working with several health tech and digital tech companies prior to joining the Stanford Biodesign Innovation Fellowship program.

Jay, on the other hand, knew from the beginning he wanted to work in medtech. With a Master’s in Bioengineering from Rice University, he moved to the “hot spot” of health tech, Silicon Valley. As an early engineer at a wearable therapeutics startup, he helped build a class III medical device from concept through pilot testing. This fueled a passion for the field and working with early-stage companies, which led him to apply to the Biodesign Innovation Fellowship program.

Identifying a need, developing a solution

The clinical focus of the 2019-20 fellowship was ears, nose and throat (ENT). During the year-long program, the pair identified more than 200 needs in the space, but the one that stood out and offered the most opportunity was in audiology.

Jay and Francis had found that a large number of patients in their 50s and 60s were struggling with progressive sensorineural hearing loss (SNHL), a gradual loss of hearing capacity due to noise exposure and aging that accounts for approximately 90% of reported hearing loss.

Many of these patients had hearing aids but complained that they had become less effective over time. While the patients could still hear, they had increasing trouble understanding speech due to a progressive loss of high frequency hearing, which is critical for speech comprehension. Not surprisingly, this problem has a significant impact on quality of life.

Other than hearing aids, the only other solution available is cochlear implants, an invasive surgery in which a small electrode is implanted in the cochlea.  In addition to its expense—about $30,000—the procedure can traumatize the cochlea and cause patients to lose whatever residual hearing they may have had.

Based on these findings, the pair launched Auricle, a project focused on restoring hearing and improving speech perception in adults with severe high-frequency hearing loss.

Auricle is developing a minimally invasive cochlear neurostimulation device that, unlike cochlear implants, doesn’t pose risk to residual hearing and is reversible. The team has drawn inspiration from an approach that was tried in the late ‘80s but had not been commercialized. “Many of the limitations of this previous work can be overcome with the technological advancements made in the last 30 years,” said Francis. “When we ‘rediscovered’ this forgotten technology, we were very excited because we felt confident we could push it forward and make it work for a vast number of patients,” added Jay. In the U.S. alone, nearly two million people suffer from profound to moderate low-frequency hearing issues.

Extending to the summer program

As the fellowship year came to an end, Francis and Jay decided they wanted to keep working on the problem and solution concept they had uncovered, and applied to the Biodesign Summer Extension program. “We felt very honored to be selected and very fortunate to also be connected to the Fogarty Institute,” said Francis, adding that they have already had a lot of engagement with the organization.

“The team gave a presentation at the beginning of the summer, which resulted in tremendously helpful insight and helped us refine our goals to propel the company forward. The Fogarty executive team has been incredibly invested and responsive,” said Francis.

The team’s next steps include an upcoming clinical study at Stanford and a fundraising push.

About the Stanford Biodesign Innovation Fellowship 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.

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