The Register Citizen (Torrington, CT)
A CLEARER VIEW OF THE HEART
With surgical device selling, innovator BioSig eyes wider relevance
Ken Londoner remembers well the exhilaration he felt last summer while taking in the scene in an operating room in Austin, Texas. A computer made by his BioSig Technologies company filtered away distortions in signals collected by other equipment to give physicians a more accurate picture of the heart procedure they were performing on a patient that day.
That scene is on the cusp of playing out in up to a dozen more hospitals this year, giving other patients a new lease on life — and Connecticut another tick in its legacy of homegrown innovators.
BioSig makes devices roughly the size of a household dehumidifer that plug into the machines used by cardiac physicians during procedures to correct irregular heartbeats. The BioSig Pure EP system filters out “noise” in the readings on electrical activity in the heart that physicians are monitoring, giving them the best odds of completing the procedure to restore normal heart rhythms.
“We remove noise from
signals, and in the medical space, that’s a very valuable technical proposition,” Londoner said. “We are applying it in the field of irregular heartbeats to start, because that’s where the problem is most pronounced . ... The less clear the information is, the more likely they are to not get the surgery right.”
Arrhythmia, also known as atrial fibrillation, can be a killer, both on the spot as a cause of cardiac stoppage if not treated immediately with an automated external defibrillator; or in milder incidences over time as fluttering heartbeats raise the possibility of triggering a stroke.
The Centers for Disease Control and Prevention identified more than 26,000 deaths in 2017 due to atrial fibrillation, with the condition thought to have been a significant contributor to five times as many more. CDC estimates anywhere from 3 million to 6 million people or more are living with arrhythmia.
From hedge fund to heart innovator
Londoner uses the analogy of water being poured over an inflated balloon to describe how cell tissue at the top of the heart fires pulses, to create a cascading electric field that stimulates regular heartbeats.
Scars in the wall of the heart, from any number of causes, can jostle those pulses to spur irregular heartbeats. Physicians have developed procedures to correct those problems, via drug regimens as well as surgical procedures that “burn” the heart tissue with radio frequency energy to recalibrate the electric activity of the heart. The better the signal readings physicians get during those surgical procedures, the better the odds of successful outcomes.
Connecticut’s medical device industry is clustered largely around the Yale University and University of Connecticut medical schools in New Haven and Farmington, respectively. Covidien is the state’s largest employer in the sector, with its heritage reaching back to the surgical stapler pioneer U.S. Surgical founded in Norwalk.
BioSig calls Westport home due to Londoner doing the same, having spotted the opportunity as an investor and establishing an office close to where he lives. The company is subleasing space in Fairfield County’s newest commercial office — the Bankside at National Hall building on the west bank of the Saugatuck River, where the former headquarters of Save the Children once stood.
Londoner stumbled on the BioSig opportunity while running Red Coat Capital Management, a New York City hedge fund he founded that, at its peak, managed client assets in excess of $1 billion.
At a 2008 conference, a pioneering arrhythmia expert at Harvard Medical School named Dr. Mark Josephson introduced Londoner to engineers grappling with the problems cardiac physicians were encountering. Intrigued, Londoner spent the next year researching the issue and founded BioSig in February 2009.
Londoner underwrote the development costs himself in BioSig’s early years, prior to going public and moving its stock ticker to the Nasdaq in 2018 and developing a research partnership with the Mayo Clinic in Minnesotaj.
As of September, BioSig reported an accumulated deficit of $90 million over the course of its history as it proceeded through clinical trials with the Mayo Clinic, Mount Sinai Hospital in New York City and the UCLA Medical Center in Los Angeles.
‘A tech platform company’
After winning Food and Drug Administration approval in 2018 to sell Pure EP generally, BioSig began generating revenue in November from product sales.
BioSig has spent the past few years building a legal wall around its core technologies, filing for more than two dozen patents last year alone. Londoner said BioSig’s signal processing technology could be engineered for other applications, possible to include autonomously driven vehicles which require the instantaneous and accurate interpretation of potential hazards in their path, whether close or distant.
The company’s head of engineering is Barry Keenan, who previously developed diabetes systems at Medtronic, including work on what was billed as the world’s first artificial pancreas, a belt-mounted device that tests blood sugar levels every five minutes and administers insulin as needed. The device was cited by Time Magazine as one of the top 25 inventions of the year in 2013.
BioSig has just over 40 employees today, about 15 apiece in Westport and Los Angeles and 10 in Minnesota at the Mayo Clinic and near where BioSig’s manufacturer is located. Londoner anticipates BioSig will need to find larger space before long to accommodate hiring; he intends to keep the company’s headquarters in Connecticut, while lamenting state government’s approach toward business regulations and taxes during BioSig’s tenure as a growth-stage company.
“We’ll double the size of the company this year,” Londoner said. “When people look at our company, they (see) a medical technology company — a product company. I look at us as a tech platform company . ... The reason we are lining up all these patents is because of our know-how in taking noise out of signals.”