Issue: July/August 2010

The Heart of the Matter

By Rebecca Meiser

Two Case graduates are attempting to revolutionize the way heart problems are diagnosed.
The Heart of the Matter

Like Superman, Charu Ramanathan has always been intrigued by X-ray imaging and the idea that one can see exactly what’s going on inside the body without physically opening it up.

This fascination is partly what led Ramanathan from India to Case Western Reserve University’s biomedical engineering program in 1996.

Dr. Yoram Rudy, then a Case biomedical engineering professor, was doing fascinating work in the study of hearts. He’d developed a technology that allowed doctors to see a 3-D electroanatomical map of a patient’s heart, without slicing open the chest. “The technology,” says Ramanathan, was “really revolutionary.”

But the only way it would get into the marketplace was through commercialization — and Rudy, brilliant as he was, was an academic. He was more interested in studying the capabilities and constraints of the cardiac mapping science than going through the long, tedious processes involved in fundraising and developing an FDA-approved clinical prototype. He wanted to be involved in a more advisory role.

For the technology to reach the mainstream, someone would have to mother it through. And Ramanathan, who once wanted to become a doctor until she realized she didn’t want to go to medical school, decided she could be that person.

She worked with fellow Ph.D. candidate Ping Jia to co-found the medical startup company. “We started with very noble intentions,” she says. “Our goal was to help patients access this technology. … And we figured it wasn’t bad to make a couple bucks out of it as well.”

Together, Ping and Ramanathan formed CardioInsight, a Cleveland-based biomedical concern focused on the development of electrocardiographic mapping.

Ramanathan understood that Rudy’s system had lots of potential, but it wasn’t until the technology became personal that she really understood the transformative power of cardiac mapping.

Working on a clinical trial as one of Rudy’s graduate assistants about 10 years ago, Ramanathan encountered a 29-year-old professional soccer player from Europe. During the player’s preseason checkup, doctors noticed an irregularity in the athlete’s electrocardiogram. The doctors diagnosed the athlete with exercise-induced ventricular tachycardia, a cardiac defect that results in dangerously fast beating in the lower chambers of the heart. If left untreated, the condition can result in sudden death.

Dr. Albert Waldo, a cardiologist at University Hospitals, was referred the case. Immediately, he thought of Dr. Rudy’s electrocardiographic mapping technology. He called Ramanathan and Ping to perform the mapping study on the athlete.

Using the electrocardiographic mapping system, doctors were able to spot the exact origin and location of the abnormality. They then performed surgery to fix the problem. The soccer player went on to have a healthy career, and Ramanathan knew she had stumbled on a meaningful life path.

In the early days of CardioInsight, it was mainly Ping and Ramanathan working on clinical and prototype development. But as the duo progressed, they realized they needed an industry veteran CEO to help propel the company forward and navigate the commercialization processes.

So in March 2009 they recruited Steven Arless, a veteran with more than 35 years of experience in the development, marketing and sales of medical device products, to sign on as CEO and chairman.

It wasn’t a hard sell. “Electrocardiographic mapping will change the way cardio technology is performed,” Arless says. “But I knew it would take several years and several millions to get there.”

Luckily, the developers are based in Cleveland. “The infrastructure created here in Ohio for [biomedical engineering development] is really world-class,” Arless says. “Between the Cleveland Clinic, Case, Ohio government support and involved local investors, [Northeast Ohio] is a very fertile environment for creating and sustaining biomedical engineering technology.”

In the past four years, the company has raised more than $6 million in startup funds, including $550,000 from JumpStart, a Cleveland-based nonprofit that invests in early-stage startup companies with potential for growth.

“The quality of the science behind the technology and the future possibilities of cardiomapping was very compelling,” explains Lynn-Ann Gries, JumpStart’s chief investment officer and the chief cheerleader of the CardioInsight investment. “We saw great potential in the market.”

Since then, CardioInsight technology has been evaluated in 200 clinical trials in hospitals in Europe and Cleveland, where both Cleveland Clinic and University Hospitals have experimented with the product. “A lot of the doctors we’re working with have approached us,” Ramanathan says proudly.

In the next few years, the company hopes to get the electrocardiographic mapping system in use in about 50 different hospitals to really validate the commercial use of the application. “Showing we have lots of good happy customers will put us in a strong position to find business partners to take us globally,” Arless says. The belief is that the technology will go a long way in diagnosing and providing information on cardiac arrhythmia, heart conditions that can lead to sudden death.

Asked whether Ramanathan has had her own heart charted, she smiles. “I was the eighth patient I mapped,” she says. “It turns out I have just a boring, normal heart.”

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