Outstanding Lifelong Lerner Startup’s Medical Device Gains FDA Approval

UD Lerner Alumni Nick Delmonico’s Company Strados Labs is Revolutionizing the Care of Asthma and Other Respiratory Conditions

Editor’s note: This article, written by John Wasdin and Jen Hendrickson, was originally published in the May 15, 2023 edition of UDaily. It is reprinted with permission.

When Strados Lab’s founder Nick Delmonico first conceived his idea at the University of Delaware’s Horn Entrepreneurship in 2016, he was hoping to develop technology that would help patients with respiratory conditions like asthma take control of an oncoming attack.

Fast forward five or so years and now Delmonico — a 2012 UD alumnus with a bachelor of science degree in accounting from UD’s Alfred Lerner College of Business and Economics and 2017 Hen Hatch finalist — and his company are making strides in how these and other respiratory conditions are managed with their new technology RESP(r).

RESP is designed to simplify the process of monitoring lung health. The unobtrusive, hands-free device received its second FDA Class II 510(k) clearance in May 2022, 18 months after being approved for wireless reporting to provide early detection and monitoring of respiratory diseases. The second FDA approval allows for home use for Remote Patient Monitoring (RPM) and Telehealth evaluations. Patients will be able to track objective symptoms of improvement or decline associated with pulmonary disease conditions at home. The technology also has the ability to detect lung sounds associated with events like heart failure, COPD, asthma, and infectious diseases like COVID-19.

For patients and care providers, RESP provides data in a patient-friendly way, integrates with electronic health records and gives real-time cloud access to respiratory data, as well as AI predictive detection and analysis.

The device’s biosensors attach to a user’s chest and detect breathing patterns and acoustic signals like wheezing and coughing, while wirelessly communicating to a cloud-based provider portal. The RESP makes irregularities easy to notice over any given day or time period, which allows care team coordinators to remotely manage patients’ conditions.

Strados Labs raised more than $7 million in funding and looks to grow the team and expand the reach of coverage for respiratory issues. Since its startup journey, Strados has gone on to earn millions in early-stage venture capital and has recently achieved significant milestones including being named as a winner of the 2023 ATA Telehealth Innovators Challenge2022 Blue Hen 17&43 Award winner and 2022 Rising Star in the UCSF Health Hub Digital Health Awards, Remote Diagnostic Tool or Device Category, among others. Recently the technology was accepted for a pilot study on Pulmonary Fibrosis in collaboration with Boehringer Ingelheim, and was recognized by BioBuzz as one of the most intriguing companies in Philadelphia’s medtech ecosystem.

The Blue Hen ties run deep in Strados Labs as Ted Foltyn, an adjunct faculty member at Horn Entrepreneurship, has joined Delmonico’s team as a strategic adviser.

“I was inspired by the passion Nick had for helping respiratory patients with a forward-looking medical device,” said Foltyn. Foltyn’s role has been to bring commercialization insights to Strados Labs and to connect Nick to contacts he had in the medical technology community.

“Gaining FDA clearance for their RESP device is a huge milestone,” Foltyn said. “It says to the medtech world, to investors and customers that your device can be used in a clinical setting. This should also inspire our students that these are achievable goals for grads coming out of our entrepreneurial community here at UD.”

Delmonico answered questions about his entrepreneurial journey through the healthcare industry.

Q: What Horn lessons still hold true at Strados?

Delmonico: The importance of talking to customers and learning the problems they have. You need to communicate with people, learn about their pains and gains, and understand their problems before getting to a solution.

Q: What are your goals for yourself and for Strados?

Delmonico: When I started, I wanted to build a small business and learn the complex nuances of building something from scratch. I learned that I enjoyed the healthcare industry and I wanted to be able to give back and help people in that industry while working on something that I can do myself.

Q: How does it benefit the team to have RESP designed for those with respiratory issues by those with respiratory issues?

Delmonico: I’ve had asthma and other respiratory conditions since I was young, and you never forget the hospital visits. It’s difficult for patients and families as well. I came up with the idea while I was in graduate school. I said how can we help patients who have respiratory conditions like asthma know when they are experiencing symptoms like wheezing and coughing, and notify their care teams before they end up in the hospital. I worked with a professor from Thomas Jefferson University and many other doctors and patients to develop a device that can detect wheezing events. Once we knew people wanted it and had a real problem, we got into the actual building of the device.

Q: What’s next for RESP and for Strados?

Delmonico: We have our regulatory clearance so we can start marketing to doctors and healthcare systems. Next, we want new clinical customers to use it and prove that it helps doctors take care of their patients. We want to prove to patients, doctors and health insurance companies that it helps to keep people out of the hospital.

Q: Do you have any advice for students looking to make similar breakthroughs in the healthcare industry?

Delmonico: Focus on the problems in healthcare, talk to doctors, patients, payers and clinical teams. Talk to everybody, learn about their issues and ask how they would solve the problem. They know better than anybody what is wrong, and once you know the problem you can do your best to fix it.

About Horn Entrepreneurship

Horn Entrepreneurship serves as the creative engine for entrepreneurship education and advancement at the University of Delaware. Currently ranked among the best entrepreneurship programs in the U.S., Horn Entrepreneurship was built and is actively supported by successful entrepreneurs, empowering aspiring innovators as they pursue new ideas for a better world.

About the Alfred Lerner College of Business and Economics

For more than 100 years, the UD’s Lerner College has invested in its students and communities, giving back philanthropically and with its valuable skills. A top-ranked business school, the Lerner College creates impactful initiatives that advocate for diversity and inclusion across industries. Its 150-plus faculty conduct research on meaningful topics like economic development in developing nations, cybersecurity, women’s leadership, corporate social responsibility and more. Through collaborations with students and alumni, the Lerner College creates businesses that work to solve society’s greatest problems.

Lerner College Honors 2024 Alumni Award Winners

The University of Delaware’s Alfred Lerner College of Business and Economics honored seven individuals during its annual Alumni Awards of Excellence ceremony on May 31 in Lerner Hall. Presented each year to select UD and Lerner College alumni, the awards recognize...

CEEE Stock Market Game Winners Honored

When it comes to investing in and trading stocks, it is important to adapt and be flexible. That’s what more than 1,300 Delaware elementary, middle and high school students discovered this spring by participating in the 10-week Stock Market Game (SMG), a national...

Congratulations 2024 Lerner Graduates

Congratulations to the graduates of the University of Delaware’s Alfred Lerner College of Business and Economics! It was a wonderful weekend celebrating our more than 1,300 Lerner College graduates from the Class of 2024 including undergraduate, master’s and doctoral...