“It can muffle the hearing and delay speech and language development,” Liu said.

Liu routinely places ear tubes in young children’s ears. Traditionally, the placement is done under anesthesia in an operating room. Surgeons  poke a hole in the eardrum, drain all the excess fluid and insert the small plastic tube to lessen the pressure and give the fluid a different pathway out of the ear.

Despite the fact that the actual procedure is quick, surgery is often a full-day ordeal for the young child, with no eating or drinking, an early check-in, post-anesthesia grogginess and, often, nausea.

A New Device

A device called the Hummingbird is a game changer for parents, Liu said. “The entire process, by the time we get the child into the room, into position, clean out the ears and put in the tubes is four to five minutes,” said Liu.

The best part, according to Liu: The child is feeling and hearing better within minutes.

The Hummingbird is shaped like its namesake bird and is a single-pass device, meaning that when the needle enters the ear canal, the tube is automatically inserted.

Although the Hummingbird was approved two years ago, the pandemic prevented many parents from learning about this new option. Cedars-Sinai was one of the initial eight institutions across the country involved in clinical trials of the Hummingbird and now the Food and Drug Administration is looking at expanding the approval to older children as well.

Liu performed a Hummingbird procedure on Cassidy in April.

“They wrapped her up kind of like an extreme swaddle and I was holding her hand and he went in and super-fast one ear was done and then the other and we’re done,” mom Brittany Clapp said. “She cried for about a minute and then was high-fiving Dr. Liu as we left the office.”

The change in Cassidy was immediate. “She heard birds chirping for the first time and was so excited,” Brittany said.

But the best part? When her daughter said, “Mama.”

Joe Delgado, chief financial officer of Preceptis Medical, had a personal reason for leaving a good job at UnitedHealth Group a few years ago.

His daughter, Vivian, now 5 years old, benefited from a tube implanted in her ears using a Preceptis Hummingbird device. The procedure was done in a doctor’s office. No hospital operating room or anesthesia was needed. That made it far less costly than the standard procedure, which can run up to $5,000, and less worrying. Vivian previously had a set of tubes inserted in the traditional manner.

“I’ll never forget the moment we handed our 9-month-old baby to the nurse to be put under general anesthesia,” Delgado said. “It was very traumatic for me and my wife. After her tubes fell out in four months, my wife and I both wanted an alternative.

“With Preceptis, the experience was dramatically different. She recovered immediately and was smiling within a minute of the procedure being completed. That’s why I’m so passionate about what we’re doing.”

There are more than 1 million pediatric ear-tube procedures in the U.S. performed annually by ear, nose and throat (ENT) doctors, mostly in operating rooms.

But after a decade of development, including $26 million in investor capital, Preceptis is gaining traction with the device that simplifies such procedures.

A 250-child study of its procedure in 2018 and 2019 was covered in the Laryngoscope, an ENT peer-reviewed journal. The Food and Drug Administration gave clearance and the American Academy of Otolaryngology endorsed the device for in-office procedures.

“We have received orders from Health Partners, St. Cloud ENT and the Mayo Clinic,” said Steve Anderson, chief executive of Preceptis. “That being said, ear-tube procedures are down 80 to 90% this year due to COVID-19. But ENT doctors, pediatricians and Preceptis expect tube procedures to start coming back in the second quarter and return to more normal in 2022.”

The Hummingbird device, which costs less than $1,000, was invented in part by Dr. Michael Loushin, an anesthesiologist. Loushin and Anderson were neighbors in Roseville when, about 15 years ago, they started talking about alternatives to surgery for children who needed tubes for ongoing ear infections.

In 2013, Preceptis won the Minnesota Cup competition for innovative business plans, as well as an industry-technology award. However, the FDA slowed the company’s jump into office procedures. The agency required that tests first be done in operating rooms with patients under sedation, but not general anesthesia. It worked. The study in 2018 and 2019 was done by ENT surgeons in their offices without anesthesia.

“It’s an enormous cost saver,” Anderson said. “The money comes right off the top. You go from operating room to office. Everybody knows that saves money. And moms like this. That’s huge. They love this thing. Every case we do the moms and dads virtually become spokespeople for us.”

Anderson has elected to conserve capital by not hiring a sales force. Preceptis instead is working directly with several care providers, including Mayo Clinic and Health Partners, on a pilot commercialization to validate the business model.

Preceptis’ most significant competitor is Tusker Medical, which received FDA approval for a drug/device combination product in 2019. It was acquired by Smith & Nephew, a British medical device company, in 2020.

Anderson said he’s not pressured to sell the company because his investors, which include affluent individuals and a Chinese medical concern, are patient. Children’s Minnesota recently put in $1 million. He has avoided traditional venture capital.

“Our investors believe in where we are going,” Anderson said. “That we can become a standard of care.”

Maple Grove-based Preceptis designs and manufactures the product in the Twin Cities.

“Our goal now is to not raise a huge amount of capital, and hire a whole bunch of sales reps,” Anderson said. “We don’t think we need to do that. What we are doing now is a commercial pilot. We want to validate the business model and then we can decide to add representatives and grow or partner with a larger company.

“Eventually, after the commercial pilot, we may hire a sales force. Or we could be a good fit with a larger corporation.”

It’s encouraging to see a health care innovator that economically improves care.

Neal St. Anthony has been a Star Tribune business columnist and reporter since 1984. He can be contacted at nstanthony@startribune.com.

Greg Mielke leads commercialization efforts for Preceptis Medical as their Chief Commercial Officer and brings over 19 years of senior leadership and sales experience within the medical device industry. His most recent prior experience was serving as Vice President of Sales – West for Intersect ENT. He has held various leadership roles at Vertos Medical, Abbott and Bard. He brings a strong balance of experiences, specifically in emerging and disruptive technologies. He currently holds a B.A in Anthropology from St. Cloud State University.

Give us Preceptis Medical’s elevator pitch.

Preceptis Medical was locally founded on the premise that an alternative to conventional ear tube surgery is needed for children. Approximately 1 million pediatric ear tubes are placed each year, of which around 50% are children under the age of 2 years old. These surgeries contribute to roughly $3 billion in costs to the U.S. healthcare system each year. Our innovative technology, the Hummingbird, enables the ENT surgeon to provide patients with an office-based procedure that eliminates the operating room setting and exposure to general anesthesia. Our platform provides a safe, efficient, and cost-effective alternative to traditional OR based ear tube procedures.

How do you see your Hummingbird product playing a role in slowing the spread of COVID-19?

We see the Hummingbird playing a role in a number of ways. First, the Hummingbird uniquely eliminates the need for exposure to the operating room for a routine procedure, allowing other critical procedures to take place while conserving needed PPE. Second, because the child is not being brought into the hospital, he or she generally does not require a COVID test, which helps to eliminate another potentially traumatic experience for the child. Finally, the Hummingbird has enabled children to continue to receive ear tubes even when hospitals were shut down, which helped to reduce repeat office visits and eliminated additional antibiotics to treat ongoing ear infections.

How have you pivoted your company to address the needs that have risen since the onset of COVID-19?

The pandemic has certainly created some headwinds in our initial commercial launch with a reduction in overall global ear infections and ultimately reduced need for tube procedures. This is great news for children and is likely driven by social distancing, distance learning, and mask wearing protocols during the pandemic. Overall pediatrician visits are also down during the pandemic and technologies that help to reduce parental concerns are always well received. This situation has enabled the team to pivot toward activities and initiatives that further strengthen our organizational foundation as we emerge from the global events stronger.

What are the big milestones to come in the next few years for Preceptis Medical?

Our biggest milestone to date was our recent FDA approval for office-based ear tubes under local anesthesia. This approval was an important first step in our mission to help establish new and safe options for pediatric ear tube procedures. Our future milestones are all focused on expanding our footprint and increasing access to the Hummingbird for children across the country. We are excited for the future and the opportunity to further advance an office-based approach that will provide a safe alternative to traditional ear tubes, while potentially having a very significant impact on reducing overall healthcare costs.

What does leadership look like to you?

I have been fortunate to have been mentored and shown leadership from some amazing leaders in my career. Much of the qualities I value were shaped by these strong leaders and how they inspired their teams. Strong leadership to me is putting your people and customers first and supporting those around to your best ability. It also encompasses helping other people achieve their goals and creating mutually beneficial partnerships with customers, while serving our patients. The best leaders are always humble, empathetic and look to continually learn from those around them. Great leaders are not afraid to show weakness, are always transparent, and lead with authenticity.

What is the best advice you have received in your career?

Some of the best advice I was given early was to create and focus on long-term strategic partnerships versus trying to view each interaction as an immediate win or loss. The win comes from creating the long-term partnership and establishing mutually beneficial success. I was also told you never stop the improvement process and to learn daily from those that you serve and always stay humble. My best mentors followed the principle that your number objective is to serve your team and always put them first.

What have been the most rewarding moments in your career?

The most rewarding moments of my career have been centered on seeing people that I have hired and worked alongside advancing in their careers and achieving success. This has always been one of the most important scorecards for any leader. I also reflect on being with several innovative companies at an early stage and take great pride in being part of their success. Being part of the team at Preceptis Medical also brings many rewarding moments as our group passionately works to create increased access to our innovative offering.

What is one personal goal for the upcoming year?

One personal goal for the upcoming year is to make more time for my family to enjoy the lake and time together during what is always a short Midwest summer.

How do you relax / decompress?

I enjoy spending time with my family, supporting both of my daughter’s hockey, fly fishing, boating and relaxing time at the lake.

What do you enjoy most about the Medical Alley community?

I enjoy the strong partnership and advocacy that Medical Alley has always provided its members and the community. The Medical Alley Association successfully brings the medical community together to engage in meaningful initiatives and is a catalyst to helping shape positive change in healthcare.