By Avigayil Kadesh
Based on successful hospital trials, Israel’s
Biological Signal Processing (BSP) has received US Food and Drug Administration (FDA) approval to market and sell its HyperQ Rest System to aid in the diagnosis of patients with chest pain in the emergency room.
The company, which develops and produces novel, noninvasive tools to diagnose heart disease, previously won FDA approval for its stress ECG system, and earned Europe’s CE mark for both systems. BSP products are already being used in hospitals at major medical institutions in America, Europe, Southeast Asia and Israel.
CEO Tamir Ben-David explains that the company was founded in 2000 by Dr. Amir Beker, a graduate of the Israeli military’s elite Talpiot program and a researcher in the field of biomedical signal analysis in academia and industry.
Beker’s idea was to develop a new approach for detecting heart ischemia, otherwise known as coronary artery disease, by looking at the electrical signal of the heart in high frequency. The standard ECG (electrocardiograph) graphs the heart’s electrical signal in the low-frequency band.
“BSP wanted to evaluate how the high-frequency component, a biological signal, has a different frequency domain,” says Ben-David, a physicist with business experience in implantable medical device platforms.
“There was some scientific work done that found there is a close relationship between a change in band signal and the condition of coronary occlusion. We started with an algorithm to develop a device plus interpretation software for stress ECG evaluation, which went on the market in 2010. A year later, we started developing the platform for high-frequency evaluation for resting ECG because nothing like it was on the market.”
The American Heart Association recently released a statement that high-frequency ECG technology is an effective method for detection of coronary heart disease during a stress test. And while stress test accuracy in women is notoriously low, HyperQ has been shown to perform equally well in men and women, thus allowing for a dramatically enhanced diagnosis in women.
“We have been working with the system on a routine basis in the Nuclear Cardiology and Exercise Testing Facility at our main hospital, UCSD Medical Center, Hillcrest,” wrote Coronary Care Unit Director Dr. Ori Ben-Yehuda. “Our center performs over 1,200 nuclear stress tests per year in individuals with suspected and established coronary artery disease. The HyperQ System is also utilized for our pharmacologic stress testing. The system has been easy to use and has demonstrated excellent sensitivity and specificity. I am convinced that the HyperQ system offers an important advance in the diagnosis of ischemic heart disease.”
HyperQ Rest and its integrated software enable the test to be done while the patient is at rest, affording advanced diagnostic capabilities to hospital emergency-room personnel.
Worldwide collaboration
In 2012, BSP signed a collaboration agreement with Schiller AG, the leading ECG manufacturer in Europe and one of the top five globally. “With Schiller, we developed integration software that we launched in 2013 and reached the market at the beginning of 2014,” says Ben-David.
When used in conjunction with Schiller’s stress systems, HyperQ has been found to identify up to 80 percent more patients with ischemia compared to the traditional stress ECG.
The business model is that BSP sells a software interpretation license on request to Schiller customers. “We put a lot of effort into educating the Schiller sales force, our arms and legs in the industry,” says Ben-David. “Entering the market requires education, which is not simple.”
The effort seems to have paid off handsomely. BSP reported record revenues of $1.3 million in the first half of 2014, higher by 50 percent compared to the annual revenues of the company in 2013.
Now, reveals Ben-David, BSP is evaluating the possibility of taking its patent-protected technologies in other directions, such as implantable devices.
“We believe our technology can make a significant change in this market because currently there is no means to detect ischemia through existing technology,” he says. “We are looking for funding or collaboration.”
In addition, the company is evaluating the use of its high-frequency ECG technology in the home-care, smartphone and wearable-technology markets.
“We believe we can bring a significant impact in these markets, too,” Ben-David says.
According to the CEO, BSP’s products are unique in the field.
“Commercially, we are the only company in this field. There used to be a US company out of NASA doing something similar, but they had some technological barriers to their working system and closed down.”