Fresh on the heels of signing an exclusive global license agreement with the University of Iowa Research Foundation for its patent-pending Atrial Fibrillation (AF) ablation technology, IOWA Approach announced late Monday, Nov. 24, that it has received an equity investment from Boston Scientific Corporation.

Funding from Boston Scientific, a worldwide developer, manufacturer and marketer of medical devices, will be used to advance product engineering and for additional pre-clinical activities for IOWA Approach’s technology.

AF is a serious cardiac disorder and leading cause of stroke that affects more than 2.5 million Americans, with an additional 200,000 patients diagnosed annually as the population ages. AF is estimated to cost the healthcare system more than $25 billion a year.

Drug therapies work in a minority of patients but often only serve to mask the underlying problem. Treating AF with ablation has become accepted medical therapy and approximately 400,000 procedures are conducted each year.

However, current treatment options are complex, lengthy, and costly. The ablation technique developed by IOWA Approach provides a simple and cost-effective alternative: ready access to the outside of the heart, one lesion to isolate all the pulmonary veins using a loop catheter, and a safe yet powerful energy source that rapidly makes continuous, transmural lesions.

"IOWA Approach's system may have the potential to overcome the shortcomings of current ablation techniques to become the gold standard," says Allan Zingeler, president and CEO of IOWA Approach. "Our approach has two major advantages: simplicity and speed. Our ablation method requires no expensive 3D mapping, no sophisticated imaging, no intracardiac echo and no transseptal puncture. Moreover, the time to make the entire continuous and transmural lesion isolating all of the pulmonary veins takes less than one minute. Simplicity and speed are why we are excited about our potential clinical utility and broad commercial practicality."

Steven Mickelsen, a visiting faculty fellow at the UI, is the founder and chief scientific officer of IOWA Approach. Mickelsen received GAP funding from the University of Iowa Research Foundation (UIRF) in the UI Office of Research and Economic Development to build and test his prototypes. He also worked with the UIRF and UI Ventures to bring in additional state investment into IOWA Approach to continue early development.

The exclusive license struck between IOWA Approach and the UI provides the company the sole ability to bring the technology to market during the life of the patents, an exclusivity that helps attract additional investment, said UIRF Director Zev Sunleaf. UIRF executed 32 options and licenses in FY2014, a 10 percent increase over the previous year.

“The university is delighted that this important and innovative medical technology, initially developed here at the University of Iowa, is gaining traction on its path to reaching patients and improving healthcare,” says David Conrad, UI assistant vice president for economic development. “Our mission is to support and create a culture of entrepreneurship at the university, thereby creating a framework for economic progress for the State of Iowa in the modern, global economy. Steven’s invention and his tenacity make IOWA Approach exactly the type of initiative our mandate is all about.”

Building on his 15-plus years of experience inside electrophysiology cath-labs and his medical education, Mickelsen conceived and built the prototypes for multiple devices that combine the benefits of minimally invasive approaches to treating AF from the inside of the heart, with surgical approaches that treat the outside of the heart. His invention is designed to make ablating AF safer, faster, more accessible and less expensive for millions of people.

“While there is undoubtedly more work and challenges ahead, our momentum in advancing this innovation into a commercial reality has all of us excited and engaged,” says Zingeler. “Steven’s insight and the quality of his science and applied research we believe will translate into broad clinical adoption and provide a real boon to patient care.”

Vivek Reddy, director of the Cardiac Arrhythmia Service at Mount Sinai Hospital in New York City, agrees.

“In my practice, I’m regularly ablating AF patients; however, every procedure is necessarily an intricate procedure, requiring many medical devices, many lesions and accordingly, I am only able to perform a few cases a day,” Reddy says. “Much better would be a more straightforward, more efficient approach to treating this condition, allowing electrophysiologists to effectively perform the procedure in a time-efficient and safe manner.”

The investment by Boston Scientific comes as IOWA Approach prepares for its first human cases in 2016.

The Boston Scientific Corporation’s medical devices are used in a range of interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology. Boston Scientific is well known for the development of the Taxus Stent, a drug-eluting stent used to open clogged arteries.

The UI Research Foundation and UI Ventures are part of the University of Iowa Office of Research and Economic Development, which supports and advances research, scholarship, and creative activity on the campus. Through a broad variety of activities and services, it seeks to play an important role in the underpinning of these creative activities in the public and private sectors of Iowa and beyond.