iCardiac Technologies Inc., a Rochester, N.Y.-based commercializer of cardiac safety technologies developed at the University of Rochester Medical Center, has raised an undisclosed amount of Series B funding. A regulatory filing indicates that the deal price was nearly $6 million. Participants included Advantage Capital Partners, Stonehenge Growth Capital and Trillium Group.
iCardiac Technologies, Inc. announced today that it has completed a Series B funding round to support further research into a Personalized Cardiac Safety system, an approach developed at the company to assess cardiac risk associated with a wide range of on-market and in-development drugs.
“We believe strongly in the potential of Personalized Cardiac Safety to transform the way the pharmaceutical industry and physicians approach cardiac risk,” said President and Chief Operating Officer Alex Zapesochny. “Obtaining this funding is an important step toward commercializing a concept that has looked very promising in early research studies.”
Advantage Capital Partners, Stonehenge Growth Capital, LLC, Trillium Group, and other investors, all provided an undisclosed amount of funding for the initiative.
Since the 1990s, a wide range of drugs from anti-migraines and antihistamines to diuretics have been found to cause heart arrhythmias in certain people. In rare cases, arrhythmias can lead to sudden cardiac death. The FDA now mandates that all drugs in development go through a Thorough QT study to determine if a drug prolongs the QT interval on an electrocardiogram, or ECG. QT prolongation has been associated in clinical studies with heart arrhythmias.
While iCardiac Technologies currently provides quantitative analysis to make Thorough QT study results more precise, it also has developed a method, using its own advanced ECG-based biomarkers, of testing an individual's susceptibility to drug-induced arrhythmias. The series B funding will support further early-stage research and development of a device that enables physicians to evaluate cardiac risk for an individual patient before prescribing a drug.
“The industry now follows a one size fits all approach to cardiac safety,” says Zapesochny. “The problem with that approach is there will always be people, because of their genetic makeup or other drugs they may be taking, that respond adversely to drugs proven to be safe for the vast majority of people. Instead of trying to develop medicines that are absolutely safe for all people, our approach would identify patients who can safely take the drugs.”
The relationship between prolonged QT and fatal arrhythmias is far from clear. Drugs that do not trigger QT prolongation on an ECG have been known to cause fatal arrhythmias, while some that do prolong the QT interval have proven to be benign. Moreover, the inherent diversity of the human genome precludes a one-size fits all approach. Drugs proven safe for the vast majority of humans often will affect a few individuals out of every 100,000 of the population adversely.
A solution that makes it easy to determine who can safely take certain drugs and who cannot would have profound effects on the productivity and cost of drug development. Cardiac safety testing today has become an obstacle to drug development that decreases productivity and increases cost. According to a 2006 report in The Scientist, seven percent of U.S. drug expenditures are spent on treatments that trigger adverse responses. Since 1985, 24 drugs have been withdrawn from the U.S. market because of safety concerns, of which nine were for cardiac safety issues.
About iCardiac Technologies
iCardiac Technologies, Inc. develops and implements advanced ECG-based cardiac safety biomarkers. iCardiac's advanced ECG-based cardiac safety analysis service stems from more than 30 years of research at the University of Rochester, a leading institution for ventricular arrhythmias and cardiac repolarization. iCardiac's analysis service provides drug developers with more precise and cost-effective methods for QT interval measurement. At the same time, it provides Beyond QT,SM a suite of advanced ECG-based cardiac safety markers that deliver more insight for determining the cardiac risk profile of drugs in development. For more information, visit: www.icardiac.com.