The electrocardiogram is the frontline diagnostic tool for doctors and healthcare technicians who need to keep an eye on heart activity. ECGs (or EKGs) measure the electrical activity of the heart and report on its voltage and speed.
The problem is that it presents an incomplete picture. Vincent Renz, president and COO of New Cardio in Carnegie Center, says ECGs are useful for showing that something is wrong, but not much help pinpointing what the problem actually is. If you walk into an emergency room with a heart issue, there is only a 56 percent chance that the person reading the results — who almost always is not a cardiologist — will be able to tell you what’s wrong, Renz says.
The other 44 percent of the time, the answers are inconclusive, leading to lines like “We need to keep you overnight so we can run some more tests,” he says. The hospital adds one more patient, a person’s life gets disrupted, and the insurance hassles begin, and often enough, he says, “it turns out you had heartburn.”
New Cardio, a Santa Clara, California-based medical tech company is not trying to replace or make obselete the ECG, it is trying to make the ECG more sensitive and, thereby, more effective as a diagnostic tool. The heart’s rhythms give off a wealth of information via electrical signals. The well-intentioned ECG is just not able to tell the whole story.
Underlying New Cardio’s approach, says Renz, is a bit of throwback thinking. Between the 1950s and the 1970s vectorcardiography, modern medicine’s first major way of recording the direction and magnitude of the heart’s electrical activity and representing it visually as a series of vector loops, was the predominant method of cardiac diagnosis. The system used 12 leads around the body to trace the entire electrical avenue of the heart.
The problem was, it was a tedious process that gave tedious-to-sift-through results. Current-style ECG machines, Renz says, often measure only the front of the heart’s activity. If there is a problem on the back end, or on the bottom, he says, the odds are not in your favor that the machine would find it.
A main contributor to problems that can go undetected by an ECG is drug toxicity. Drugs that are considered cardiac-toxic can cause an arrhythmia, which sounds right up the ECG’s alley. But some arrhythmias are barely 10 milliseconds long, Renz says — too tiny a pause for a standard ECG, and dangerous enough to lead to a sudden-death heart attack known as torsade de pointes syndrome.
Many of these problems surface in clinical trials, which is where New Cardio is looking to make its first major impact.
Heart specialists are looking for what are called the Q, R, S, and T points of the electrical signals. In 2005 a new set of rules called E14 spelled out the finer points of what to look for in the results of heart activity tests during the clinical trial phase for new drugs. In essence, the rules required a deeper examination of ECG results, which Renz says are tedious and manpower-consumptive, as the information largely must be examined manually.
To read a standard batch of test results manually, say 15,000, says Renz, costs a lot of money and takes about eight weeks. New Cardio’s first product to market, QTinno (named for the vital Q-T interval in measuring cardiac electricity) is a system that eliminates the need to do it manually. The time it takes QTinno to read 15,000 ECGs is about an hour, Renz says.
Officially launched in August, QTinno has already bagged New Cardio some major clientele. The company’s first customer was not a direct user of the technology, but a major pharma company that provides the trial product to be used, thereby setting New Cardio up nicely as the default company to provide the technology to read the results. On September 9 the company added its third customer, “a Top-5 clinical research organization,” and the third actual customer to back New Cardio.
Renz did not say who is on the client list, only that they are the largest players in the clinical research field.
The company’s approach to marketing is not directly to the pharma companies, says Renz, but to clinical research organizations, ECG core labs, and the people who run trials for big pharma.
That’s phase one. Next in line is Visual3Dx, a software that uses the ECG’s 12 leads to track a more complete picture of the heart, a la the old vectorcardiography model. Tests conducted in connection with Harvard have increased the diagnostic abilities of ECGs from 56 percent effectiveness to 84 percent, Renz says. “We’re looking to produce 90 percent accuracy,” he says.
Still in development, Visual3Dx is expected to be introduced in 2011 and could become the standard in hospital-applied ECG tests, Renz says.
In 2007 there were 260 million ECGs given worldwide. “We think that’s our market potential,” he says, implying the math behind it. If New Cardio were to get $15 a pop for even a third of the total ECGs given annually, the profit potential soars easily into the billions.
With the first phase of New Cardio’s plans to crack the clinical trials market and the second to crack onsite health professionals, the third step might seem obvious. CardioBip, a personal monitoring system due out around 2012, is New Cardio’s version of the OnStar network.
This five-lead device will put the power of monitoring, if not the diagnosis, in the hands of you and me, and is an advancement over today’s three-lead Halter monitors and event monitors, which essentially just detect arrhythmia, Renz says.
Patients with known conditions can keep a closer eye on things and, rather than dealing with the $450 cost of an ECG, could get usable results more quickly for about $100.
Headquartered in California, New Cardio began in Europe, where a group of Serbian-born nuclear physicists looked for a new project after their work on the colossal particle accelerator project at CERN (the French acronym for the European Organization for Nuclear Research outside Geneva, Switzerland) was done.
One of the scientists’ wives happened to be a cardiologist, and a frustrated one. She talked often the shortcomings of EKGs, which generated the idea to make them more efficient, Renz says.
The scientists approached fellow Serb Branislav Vajdic, the inventor of flash memory and a key member of the team that developed the Pentium chip at Intel, to invest.
Vajdic is now the CEO of New Cardio and, with the technical staff, is in Santa Clara. Some of the other staff include Ihor Gussak, editor of the Journal of Electrocardiography, and Mark Kroll, formerly of St. Jude Medical and Boston Scientific, holder of 280 patents.
Renz runs the operational side of the company from its location in Carnegie Center. New Cardio moved into 212 about nine months ago, and across the campus to 103 on Monday, September 28, to accommodate growth.
Renz himself joined New Cardio from Clinphone, now Perceptive Informatics, in East Windsor, where he was COO. Raised mainly in northern New Jersey, Renz earned his bachelor’s in finance from Notre Dame in 1978 and his MBA from Indiana in 1981.
While in the midwest he met his wife, Karen, who teaches seventh grade language arts and reading in Hanover Township. She has a background in employee and labor relations, having worked for the Department of Education in Washington, D.C.
“She changed professions in order to better support our sons as they were growing up,” Renz says.After a number of years in the midwest, Renz says he made a pact with his wife — if she didn’t make him live in Indiana, he would never make her live in New Jersey. He shrugs.
But he is still drawn to the Hoosier State because of his beloved alma matter. After 30 years, Renz still holds season tickets to Fighting Irish football — and he goes back to see every home game.
Two of his sons have already graduated from there and his third is a senior there this year. “It keeps me connected,” he says.
The love of Notre Dame was nurtured by his mother, “the daughter of Irish Catholic immigrants who lived and died Notre Dame football during the Rockne era of the ‘20s and ‘30s,” he says.
His father was an executive for American Can Company for more than 45 years, and most of his responsibilities were related to information technology.
New Cardio Inc., 103 Carnegie Center, Suite 300, Princeton 08540; 408-516-5000; fax, 408-907-8923. Branislav Vajdic, CEO. Home page: www.newcardio.com.