As described in a 2020 article, Atrility’s signature device – the AtriAmp – provides continuous, real-time displays of the heart’s atrial signals.
For patients, including babies, children and some adults, this means better outcomes because precious minutes are not wasted waiting for results from a time-consuming electrocardiogram (ECG).
Several recent developments bolster Atrility’s outlook, including (1) a financial investment in Atrility by Isthmus Project, UW Health’s innovation hub; (2) the hiring of Atrility’s president and CEO, Dave Kaysen; (3) UW Health becoming Atrility’s first customer, meaning that patients are already benefiting from use of the device at American Family Children’s Hospital in Madison; and (4) winning the grand prize of the 18th annual Wisconsin Governor’s Business Plan Contest.
Elizabeth Hagerman, Ph.D., Isthmus Project’s Executive Director and Chief Innovation Officer for UW Health, says the financial investment was made based on the great promise of the AtriAmp device.
“Dr. Von Bergen identified an unmet need in his own practice and, with his team, built a solution to improve the level of care available to patients of UW Health’s Pediatric Heart Program,” Hagerman says.
“Our goal at Isthmus Project is to support UW-based health care innovation, so as we saw opportunity, Isthmus Project was eager to support Atrility in the next stage of growth and continued product development.”
In March 2021, Atrility hired a new CEO, Dave Kaysen, whose 35 years of experience with small med-tech enterprises has already proven highly valuable.
Kaysen credits Von Bergen’s original four-person team for producing an “elegant little product” with unlimited potential for growth.
“I was very impressed with what Nick and his team have done, which is why I was thrilled to sign on,” Kaysen says. “From design development to proto-typing to clearing the regulatory process to production, this small team rapidly advanced a value-added product in a relatively short window of time. Feedback from hospitals that are using the product on a trial basis has been very positive. We think the market for AtriAmp will only grow in the coming few years. Our job is to go out and make it happen.”
Kaysen is also excited to display the AtriAmp device in July at Heart Rhythm 2021, a convention in Boston sponsored by Heart Rhythm Society, a leading resource on cardiac pacing and electrophysiology. HRS
Not long after Kaysen became CEO, UW Health became Atrility’s first customer, making the AtriAmp device available in caring for babies and small children after having open-heart surgery. Physicians on the front lines confirm the value AtriAmp is adding to the care of babies and children in the pivotal hours and days following surgery.
“This is an extraordinary device,” says UW Health pediatric cardiologist Kathleen Maginot, MD. “We can immediately pinpoint the cause of an arrhythmia after a patient comes out of surgery. The AtriAmp allows us to evaluate detailed heart signals continuously rather than intermittently, then we can intervene right away when a patient might be in trouble. The consensus among our staff is, ‘How did we ever get by without it?’”
Maginot’s pediatric cardiology colleague, Dr. Margaret Greco, knows a good product when she sees one, having studied product design as an undergraduate.
“AtriAmp saves time while freeing up our busy colleagues who had to drop everything to do an ECG or atrial electrogram,” Greco says. “By greatly magnifying the heart’s electrical signals, we can catch problems much earlier and treat them accordingly.”
As a UW Health pediatric cardiac electrophysiologist, Nick Von Bergen, MD, specializes in caring for children with abnormal heart rhythms, making him a highly valued resource who is often consulted after a child comes out of heart surgery – a time when arrhythmias are common and occasionally life threatening.
When a specialist like Von Bergen is called in, he focuses on achieving an accurate, rapid diagnosis with a constant eye on safety. To achieve the best outcome, Von Bergen depends on accurate interpretation of the signals coming from the heart’s electrical activity. Historically, this information is obtained from the bedside monitor or an electrocardiogram (EKG) in which electrodes are placed on the patient’s chest.
Currently the most easily accessible data source, EKG’s fall short of being a “gold standard” for identification of arrhythmias, especially when every minute counts.
“In a typical case, I may be caring for a baby whose heart rate is spiking at 190 after coming out of surgery,” says Von Bergen, “I want to know if that spike is a response to the baby requiring more fluids, or if this is a potentially more serious abnormal heart rhythm we need to address. Unfortunately, bedside monitors are not precise enough and EKGs can take up to 20 minutes to set up. By contrast, a constant stream of real-time accurate data would help us diagnose heart rhythm immediately and treat the child much sooner,” Von Bergen says. “For pediatric and adult patients, having this information can save lives, prevent strokes and reduce hospital expense.”
Another EKG flaw, Von Bergen adds, is that the atrial, or upper chamber heart signals can be very hard to discern compared with the ventricular, or lower chamber heart signals.
“When we rely on bedside monitors,” he says, “discerning accurate atrial signals from an EKG can be like trying to see a small candle burning near a bonfire,” Von Bergen says. “The atrial signals are so small relative to the much larger ventricular signals.”
Alligator Clips, Wires and Duct Tape
Sensing an opportunity for improvement, Von Bergen was confident there had to be a better way to care for his patients. He began by cobbling together alligator clips, wires and duct tape. Calling it a “prototype” would be a stretch, but his instincts were in the right place.
It might be, thought Von Bergen, a good time to reach across the University of Wisconsin-Madison campus for some additional expertise. His first stop was UW’s Biomedical Engineering Department – a resource that he thought could further evolve his invention. Von Bergen also convinced UW School of Business senior lecturer Pete Lukszys of the potential for his idea. In 2017, Von Bergen and Lukszys, along with two Biomedical Engineering students – Matt Knoespel and Phil Terrien – formed a small business called Atrility Medical, to which Lukszys enthusiastically signed on as CEO.
Knoespel and Terrien, who impressed Von Bergen as having “the right stuff” to succeed as medical device designers, impressed Von Bergen with their work ethic, smarts, and desire to create things that help people.
“They also were excited enough about this ‘ground floor’ business opportunity to turn down more lucrative job offers, and we were lucky to have them as our first two full-time employees,” Von Bergen says.
Signature invention named “AtriAmp”
Von Bergen, Lukszys, Knoespel and Terrien – call them the Atrility Four – set out to turn Von Bergen’s original alligator-clip-and-duct-tape prototype into something potentially viable from a clinical, business and engineering perspective.
They designed a device named AtriAmp, short for atrial amplifier, which supports clear, continuous displays of atrial signals in real time.
“AtriAmp’s key feature,” Von Bergen says, “allows epicardial pacing wires, which get temporarily sutured to the heart during surgery, to deliver the highest quality rhythm signal to the bedside monitor, sparing us from reliance on lower quality signals or a long wait for EKG results.”
Early discussions took place with WARF (Wisconsin Alumni Research Foundation), which licenses intellectual property created by UW innovators.
Moreover, UW Health’s Isthmus Project, through its network of clinicians, investors and advisors, connected Atrility’s team with additional support and sources of valuable feedback.
Knoespel and Terrien dedicated themselves full-time to Atrility in 2018 after graduating from UW and spent about 18 months driving the product development. This meant getting up to speed on everything from electrocardiography to the many nuances of interacting with a federal regulatory agency.
“Phil and I appreciate the FDA’s (U.S. Food & Drug Administration) incredibly high bar for safety because of the high-risk situations in which our device will be used,” Knoespel says. “We had to reconsider a lot of things, and we understand why regulation is necessary for a device like this to achieve constant quality and safety.”
More Medical Devices Envisioned
The AtriAmp, just the first of what the Atrility team hopes to be a long line of innovative medical products, has received FDA approval and is expected to begin production by fall of 2020. Manufacturing will take place at a Wisconsin-based contracted manufacturer named Axcesor, located in Grafton, just north of Milwaukee.
“We are very proud that this product will be designed, produced and distributed by Wisconsin people,” Von Bergen says. “It really is a great example of the Wisconsin Idea in which the University seeks to leverage its expertise for the greater good of the state as a whole.”
Lukszys remembers what he told Von Bergen after initially hearing the physician’s presentation for his then-abstract idea for the AtriAmp invention four years ago.
“I said ‘I think you’re on to something, Nick.’ ” Based on how eagerly physicians around the nation are awaiting their device, Lukszys and Von Bergen are on the right track.