It is the indelible image of a hospital stay, enshrined in pop culture: the sudden rise and fall of a jagged line, and the soft beep. beep. beep. of an electrocardiogram (ECG/EKG) machine. The movement of this line reveals the beating of the human heart — a digital representation of life.

Cardiologists use these lines and images to pinpoint the specific location of arrhythmia inside the heart — the more detailed information, the better. But for years, the standard of cardiac electro-imaging has remained stagnant… until recently.

BioSig Technologies, a national medical technology firm with a Rochester presence, has spent over a decade working to make the lines more detailed, accurate and exact, with increasingly encouraging results. BioSig CEO Ken Londoner says initial trials of the new PURE EP diagnostic system — an updated version of the EKG you know — validates that his team is on track to change the field of cardiac electrophysiology, through a combination of medical expertise and engineering prowess.

The images created by PURE EP are more exact than any system on the market today, making it easier for cardiac image specialists to identify and treat arrhythmias — which currently affects one out of every 18 Americans.

“Anything with added signal clarity is winning subject matter,” said Londoner. “We think we have the best signal clarity in the world. It has to be proven through medical trials, but at least in these first applications, our signals are the best.”

A more accurate diagnosis

Londoner founded BioSig in 2009 after a conversation with acclaimed Harvard Medical School physician Dr. Mark Josephson. Dr. Josephson told him there was an opportunity to improve the heart imaging industry, because standard EKG measurements are routinely muddied by interference from other electrical signals in the lab — making it near-impossible to detect tiny deviations that can signal where arrhythmia is occurring inside the heart.

“In the electrophysiology lab, they’re looking for signals that can be under 0.5 millivolts,” explains Julie Stephenson, BioSig’s VP of Clinical Affairs. “But inside these labs, they use different monitors, perhaps X-ray machines and ventilators, perhaps more. All of those devices create a level of baseline ‘noise’ that drowns out the important diagnostic signals.”

The brilliance of the PURE EP system lies in its combination of cutting-edge architecture and interactive software: the low-noise hardware is able to capture more signal than competitors, while the software and display options allow physicians to zoom in on certain areas of the EKG in real time. This helps doctors find the source of heart arrhythmias easier and faster, expediting the treatment process while promising more accurate diagnoses.

Barry Keenan, BioSig’s VP of Engineering, says it’s a better experience for the doctor — which improves the patient experience as a result.

“Our challenge has always been to amplify the signals, because they’re very, very small,” says Keenan. “The signal-to-noise ratio with [PURE EP] is very high. We have the ability to amplify the signal, not the white noise.”

Working with Mayo Clinic

While the original PURE EP concept was created in the Los Angeles area, critical BioSig achievements have been centered in Rochester for the better part of the 2010s.

After successfully developing a prototype in 2013, Londoner says he needed “unbiased opinions” on PURE EP’s effectiveness from the top experts in the field. He did research into who would best fit that bill and found Drs. Samuel Asirvatham and K.L. Venkatachalam — both premiere cardiac electrophysiology specialists, both working at Mayo Clinic in Rochester.

“The two people who had the best understanding of what we were trying to do were in the same place here in Rochester,” said Londoner. “It worked out better than we could have ever imagined.”

Dr. Asirvatham oversaw the first preclinical trials of the system throughout the mid-2010s — and once the trials showed positive results, he and Mayo Clinic offered Londoner a 10-year research and development contract. BioSig accepted in 2017, becoming the first private company to ever strike a research deal of that length with the renowned medical center.

They have leveraged the partnership to conduct additional clinical trials on the effectiveness of PURE EP imaging — the latest one using patients from Mayo’s Jacksonville, FL campus, which wrapped up in January 2021. Stephenson says the results of that trial will be revealed in late July at Boston’s annual Heart Rhythm 2021 Convention, adding the findings — coupled with positive physician testimonials and securing at least 37 patents for PURE EP — could pave the way for a bona fide BioSig breakthrough.

“We’re at a place with PURE EP where we envision this becoming the gold standard for signal acquisition and processing, in the electrophysiology space in particular,” said Stephenson.

‘We see a future’ in Rochester

The Mayo Clinic/BioSig partnership will continue through at least 2027, though the Clinic is already expanding the relationship. Earlier this year, they became one of the first hospitals to sign a commercial deal with BioSig. Systems are currently being installed at all three Mayo campuses, including Rochester. (PURE EP systems are also available for patients at eight other hospitals, including St. David’s in Austin, Texas and the University of Pennsylvania.)

Londoner says he envisions a future where BioSig’s technology is included in every cardiology clinic’s lab, with dozens of engineers and physicians working out of Rochester to build up the company’s capabilities.

“We decided to come here [to Rochester] because we see a future here,” said Londoner. “We’re choosing our hospitals very carefully, to make sure we’re going to places that will have a high degree of appreciation for the system, and Mayo is definitely in that camp. I’m biased, of course, but I foresee a very bright future.”

Today, BioSig employees from both coasts — administrators at their main corporate office in Connecticut and engineers from their Los Angeles facility — occasionally converge at their space inside the Conley Maass Building, directly above Bleu Duck Kitchen. It serves as a ‘midway point’ for these workers, but also as the home base for two people, including Sasha Gentling — lifelong Rochester resident and director of investor relations for BioSig.

“It’s exciting to be here right now, because we are one part of a national company,” said Gentling. “We’re installing [PURE EP] at Mayo, doing lots of research, finishing up studies and patient cases… There’s a lot of activity here, and it’s been fun to watch it all unfold.”

From her office window, she can see the KROC radio station building, where she spent much of her childhood — her father and grandfather operated the building. In recent years, that building has been dwarfed by multi-story apartment complexes and the new Discovery Square buildings; still, she says she is encouraged by the growth spurred by medical innovation companies moving to Rochester.

“When I see all that’s built up around us and all the new people that are involved, it feels like my community has stretched,” said Gentling. “When I look at the community now versus when I was growing up, it feels like there’s more collaboration now. There’s an opportunity to be a part of something bigger, and I feel like I’m a part of that now.”

Gentling’s feelings about the city bear a resemblance to Londoner’s feelings about his company, with over a decade of work culminating in partnerships that will keep BioSig in Rochester for at least the next decade. Medical breakthroughs do not happen overnight, he says; rather, it takes years of painstaking effort and multiple pieces of positive, real-world data.

It has taken the BioSig team over 12 years of work, but the pieces now exist for the PURE EP system to propel this firm with Rochester roots to prominence in the medical community.

“Very few people are willing to do this work,” said Londoner. “As an investor and an entrepreneur, I saw an unmet medical need that I believed could be solved through technology. I believe our team is on the verge of doing that.”