MINNEAPOLIS (WCCO) — More than a million kids receive ear tubes each year.

It’s one of the most common pediatric procedures, despite the cost and need for general anesthesia — but that’s changing.

Like many 2 year olds, Soren Webster loves adventure, especially on the water, according to mom Rachelle Reedstrom.

“Our favorite lake is White Bear, and we go boating pretty much every weekend on the pontoon and we go fishing,” Reedstrom said.

But she noticed Soren wasn’t quite himself after suffering through four ear infections in four months.

“When he started going to daycare full time he started getting ear infections. You know, he’d get sick and then get an ear infection,” she said.

It was time to get ear tubes.

“I kind of just kept putting it off, and I was like, ‘Maybe his ear infections will get better,’ but you know, I knew they wouldn’t [laughs]!” Reedstrom said.

Traditionally, ear tube procedures happen in operating rooms under general anesthesia — which can cost more than $5,000. But Reedstrom heard about a local innovation that saved thousands of dollars and could be done without putting Soren under.

Dr. Shelagh Cofer at the Mayo Clinic did Soren’s ear tube procedure with an FDA-approved device she helped developed called the Preceptis Hummingbird.

“It’s a real leap forward in our field,” Cofer said. “We use numbing medicine right on the ear drum. We use the device almost like a piercing gun.”

Dr. Cofer says she’s able to do the procedure to both ears in about three minutes.

Because it doesn’t require general anesthesia, it can be done in a clinic setting.

“It kind of fits in with the trends in healthcare where things are done minimally invasively as long as they can still be done safely and effectively,” Cofer said.

The Hummingbird is saving time, money and stress for kids and parents alike.

“He’s been more upset about not getting something he wants than this procedure [laughs]!” Reedstrom said.

The Preceptis Hummingbird is FDA approved for children 6-to-24 months old. Not all kids are good candidates, so check with your doctor. Click here for more information.

Hummingbird’s enhanced ergonomic design allows ENT surgeons to deliver and place an ear tube more efficiently in a single pass procedure

MAPLE GROVE, Minn.–(BUSINESS WIRE)–Preceptis Medical, Inc., an innovative surgical technology company dedicated to providing less invasive options for pediatric patients, today announced the launch of their next-generation Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. The next-generation Hummingbird device features an enhanced ergonomic design that allows for a more efficient ear tube delivery in children.

“The Hummingbird enables ear, nose and throat (ENT) surgeons to deliver an ear tube with a single pass, which is an important improvement over conventional instruments and allows for efficient and predictable placement in an office setting,” said Dr. Ted Truitt, M.D. of St. Cloud Ear, Nose & Throat in Minnesota. “The Hummingbird’s improved ergonomic design strengthens its already groundbreaking single-pass functionality, a unique characteristic that helps reduce surgical trauma, leading to a more tolerable ear tube procedure for young children. In-office pediatric ear tube procedures using the Hummingbird are increasingly becoming more sought after by parents.”

The Hummingbird device uniquely combines the separate tools and steps performed in standard ear tube procedures into one comprehensive device. With the Hummingbird, ENTs can now make an incision and deliver, position, and place an ear tube using a single device in a single pass. The device eliminates the need for general anesthesia and an operating room, with 99% success in the office setting.¹ The full procedure takes about five minutes, requires only a topical anesthetic, and parents can stay in the room with their child to provide further comfort.

“The Hummingbird device gives clinicians and parents an FDA-cleared, in-office alternative that avoids the costs and challenges associated with putting a young child under general anesthesia,” said Steve Anderson, Chief Executive Officer, Preceptis Medical. “Our next-generation device offers ENT surgeons an improved feel and enhanced usability based on direct feedback from our surgeons. This improved design is a testament to our team’s focus on continuous improvement and commitment to optimizing in-office ear tube procedures for children.”

Approximately one million children undergo ear tube procedures annually in an operating room in the United States alone, with 50% of all ear tube procedures in the U.S. performed in children under the age of two years old.² In-office ear tube placement using the Hummingbird can save thousands of dollars per procedure by shifting the procedure from the operating room to the office setting.

“In addition to cost benefits, pandemic restrictions over the past year have highlighted the value of office-based procedures and the evolution toward minimally invasive approaches,” said Greg Mielke, Chief Commercial Officer, Preceptis Medical. “We are seeing a heightened interest in alternatives to traditional operating room procedures from both parents and ENTs. We look forward to expanding access to our Hummingbird technology to meet this demand, with the ultimate goal of improving the lives of young children who require ear tube procedures.”

About Preceptis Medical

Preceptis Medical was founded by parents, including a pediatric anesthesiologist, who wanted to design products focused on improving the lives of children. The Hummingbird device was developed in partnership with leading pediatric ENTs to simplify ear tube procedures while reducing the risks associated with the use of general anesthesia in children. The company’s goal is to broaden the options available to ENTs and parents, focusing on the safety and comfort of the child, while reducing healthcare costs. The Hummingbird® Tympanostomy Tube System (TTS) is FDA 510(k) cleared for use in children 6-24 months. For more information, visit www.hummingbirdeartubes.com.

Safe, simple, and less expensive.

¹Truitt, TO, Kosko, JR, Nimmons, GL, et al. In‐office insertion tympanostomy tubes in children using single‐pass device. Laryngoscope Investigative Otolaryngology. 2021;1-7.

²IBM Marketscan® Commercial Claims and Medicaid Database.

Contact:
Greg Mielke
Preceptis Medical
763.568.7810
Greg@preceptismedical.com

Media:
Jessica Stebing
Health+Commerce
260.336.6202
jstebing@healthandcommerce.com

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.

In the United States approximately 1 million children undergo ear tube placement every year. The tubes are typically needed when there’s excess fluid in the middle ear and to address chronic ear infections. The tubes help to prevent this fluid build-up but require placement under general anesthesia.

General anesthesia can be distressing for children and parents, and Preceptis Medical, a medtech company based in Minnesota, has developed an in-office solution for ear tube placement that requires only a local anesthetic. The Hummingbird device allows an ENT surgeon to place an ear tube in a single pass, and provides a convenient and less expensive option for ear tube placement.

A multicenter study recently investigated the safety, tolerability, and efficacy of the approach, and the results were published in journal Laryngoscope Investigative Otolaryngology.

Medgadget had the opportunity to speak with Steve Anderson, Preceptis Medical’s CEO, about the Hummingbird and the latest study results.

Conn Hastings, Medgadget: Please give us an overview of ear tubes and the reason they are inserted.

Steve Anderson, Preceptis Medical: Ear tubes, also called tympanostomy tubes (TT), are the primary surgical treatment option for children that have persistent fluid buildup in their middle ear and/or chronic middle ear infections.

If left untreated, these infections can lead to hearing loss that can result in delayed speech development and poor school performance. During the procedure, tiny cylinders are implanted to create an airway that ventilates the middle ear and prevents the accumulation of fluids behind the eardrum. The tubes usually fall out on their own six to twelve months after the procedure and the holes will heal on their own.

Medgadget: What are the limitations associated with how the tubes are currently inserted?

Steve Anderson: Approximately one million children undergo ear tube procedures annually in an operating room in the United States alone. These procedures are done under general anesthesia due to the surgical limitations and pain associated with using standard instruments to treat children.

Ear tube procedures conducted in an operating room can be traumatic for both children and parents well before the procedure begins and after it ends. Preoperative fasting to avoid reactions to general anesthesia can increase the child’s anxiety about the procedure. It is also estimated that 57% of children experience post-general anesthetic delirium symptoms, such as restlessness, agitation, thrashing, crying or moaning, and disorientation.

Medgadget: Please give us an overview of the Hummingbird device, and how it works.

Steve Anderson: The FDA-cleared Hummingbird Tympanostomy Tube System (TTS) is a breakthrough pediatric technology that reduces surgical trauma for patients and enables safe and efficient in-office ear tube placement for children. The Hummingbird is proven to eliminate the need for general anesthesia with 99% procedure success in the office.

The Hummingbird TTS allows ENT surgeons to provide parents and their children a safe, convenient, and less expensive option for pediatric ear tube procedures by eliminating the need for general anesthesia and an operating room.

The Hummingbird creates an incision and places an ear tube in one single pass. The device combines the separate steps and tools for making an incision, positioning the ear tube, and placing the tube using standard instruments required for traditional procedures. Using the Hummingbird, an incision is made using the cutting sheath at the tip of the device and the tube is placed by scrolling back on the slider.

With the Hummingbird, ear tube procedures are completed right in the comfort of the doctor’s office using only a topical anesthetic to numb the eardrum. The office-based procedure takes about five minutes, and parents can stay in the room with their child to provide further comfort. Children recover quickly and can return to normal activities immediately following the procedure.

Medgadget: How was the device conceived and designed? What inspired Preceptis Medical to develop such a solution?

Steve Anderson: Preceptis Medical was founded by parents, including a pediatric anesthesiologist, who wanted to design products focused on improving the lives of children. The founders understood the stress and costs associated with putting young children to sleep for surgery. They developed the Hummingbird in partnership with leading pediatric ENTs to simplify ear tube procedures while reducing the risks associated with the use of general anesthesia in children. The company’s goal is to broaden the options available to ENTs and parents, focusing on the safety and comfort of the child, while reducing healthcare costs.

Medgadget: Is the device easy to use? Does it require much training before a clinician can use it?

Steve Anderson: The device was designed collaboratively with pediatric ENTs to be straightforward for ENT surgeons to learn to use. Surgeons are trained on the Hummingbird in the comfort of their office on a simulated head model. The surgeons are then observed over a series of in vivo cases to complete the certification requirements.

The device’s simplicity is a key reason why interest from both surgeons and parents has been very strong, further reinforcing the unmet need and desire for alternative options to procedures performed in the operating room.

Medgadget: Please give us an overview of your recent published study assessing the safety, tolerability, and efficacy of the approach.

Steve Anderson: Results from a prospective, multicenter study assessing in-office pediatric ear tube placement using the Hummingbird were recently published in Laryngoscope Investigative Otolaryngology. The study showed that ear tube placement with the Hummingbird device in awake young children using only a topical anesthetic was safe, successful, and well tolerated.

The study enrolled 211 children age 6–24 months who were treated at 10 sites by 13 ENT investigators. TT placement was successfully and safely completed in the office setting in 99% of cases for this age group, with a median intraoperative procedure time of fewer than five minutes for bilateral TT placement. Tolerability of the procedure was validated by assessments from the ENT surgeons and their staff members, as well as procedure reviews from independent clinicians.

Additionally, a survey showed that 97% of parents with children treated with the Hummingbird would recommend the procedure to other parents. Further, the American Academy of Otolaryngology released a Position Statement supporting in-office TT placement in appropriate children.

With the results of the study, strong interest from ENT surgeons, and favorable feedback from parents, Preceptis believes that in-office ear tube procedures may become the standard of care for pediatric ear tube placement.

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.

ST. CLOUD, Minn. (FOX 9) – A Minnesota-based medical company is the latest offering a different option for kids suffering from ear infections.

Having tubes put in kids’ ears is one of the most common procedures for babies and toddlers under 2 years old with nearly a million going into the operating room every year. Now, it doesn’t have to be performed in a hospital or surgery center.

“It’s a completely different kid now,” said mother Leanne Pearson.

One-year-old Elaina Pearson is hearing better then she has in months after suffering through five ear infections between January and March.

“We didn’t even notice with her being so young, she couldn’t hear that well,” explained Leanne.

Leanne finally hit a breaking point with antibiotics and made an appointment for tubes to be placed in her daughter’s ears under the usual general anesthetic in early April. But her appointment was cancelled due to COVID and restrictions on elective surgeries at the time. That is when St. Cloud, Minnesota ear nose and throat offered an alternative. This time, no general anesthetic required.

“It was a no-brainer for me at that point,” she said. “Because I was a little nervous anyways having your child have that stuff in their system.”

Dr. Ted Truitt is the primary author and one of the lead investigators for a clinical trial which brought together a group including the Mayo Clinic, HealthPartners, and Cedar-Sinai for one of the final steps before FDA approval of what’s called the Hummingbird procedure. It’s just the second procedure of it’s kind allowing doctors to put tubes in and help ventilate the eardrum as it should — without having to be in a hospital operating room or surgical center.

Elaina received her tubes within five minutes right in Dr. Truitt’s clinic.

The Hummingbird procedure (Supplied)

“This Hummingbird device is a one-pass system where we are both able to make the opening into the eardrum and drop the tube into the eardrum in just one motion,” the doctor explained.

The moment protections stabilizing Elaina lifted, she was back in mom’s arms. Dr. Truitt says he loves having an alternative for patients.

“Even though it’s a quick anesthetic, I think it’s safer for kids if we can possibly avoid it,” he explained.

For the Leanne, the quickest option to protecting her baby girl’s hearing and speech development was music to everyone’s ears.

Publish Date: April 27, 2017

The U.S. Food and Drug Administration (FDA) is notifying the public that we have approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. These changes include:

• A new Warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.
• Addition of information to the sections of the labels about pregnancy and pediatric use to describe studies in young animals and pregnant animals that showed exposure to general anesthetic and sedation drugs for more than 3 hours can cause widespread loss of nerve cells in the developing brain; and studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning.

General anesthetic and sedation drugs are necessary for patients, including young children and pregnant women, who require surgery or other painful and stressful procedures. In the U.S., surgeries during the third trimester of pregnancy requiring general anesthesia are performed only when medically necessary and rarely last longer than 3 hours. We are advising that in these situations, pregnant women should not delay or avoid surgeries or procedures during pregnancy, as doing so can negatively affect themselves and their infants.

Similarly, surgeries or procedures in children younger than 3 years should not be delayed or avoided when medically necessary. Consideration should be given to delaying potentially elective surgery in young children where medically appropriate.

Parents, caregivers, and pregnant women should talk to their health care professionals if they have any questions or concerns about general anesthesia and sedation drugs.

Health care professionals should continue to follow their usual practices of patient counseling including discussing the benefits and risks of surgeries or procedures that require general anesthesia and sedation drugs.

We will continue to monitor the use of these drugs in children and will update the public if additional information becomes available.

We urge patients and health care professionals to report side effects involving general anesthetics and sedation drugs or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.