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Business: Not Only the Savage Beast
Jay L. Abramoff
Erez Gavish encountered an unexpected difficulty during an early-September trip to South Korea, where he was lining up potential distributors for his company�s revolutionary device, which uses musical tones to lower blood pressure. He had difficulty holding on to the 10 samples of the device he had brought with him, which goes under the name of "RESPeRATE."
"Each company I visit wants to buy, not keep as samples, but buy, every device that I have with me," he relates over the phone from Seoul. "It�s been hard to persuade them to allow me to keep even one device to show the next company."
The Korean reception has reinforced the optimism of company co-founders Erez and his biophysicist father Benny, a former Hebrew University professor and part-time ballroom dancing teacher, who came upon the idea in the mid-1980s. The staff at InterCure, the company they founded to develop RESPeRATE in 1993, now suggest that the product -- which received Food and Drug Administration approval for over-the-counter sale in the United States in July -- could generate hundreds of millions of dollars in revenue in the U.S. alone by 2005.
The vehicle for bringing in all that money is a simple device, a little bit larger than a portable CD player, attached by wires to a small sensor and a set of ordinary earphones. One of two computers inside the little machine processes information gathered by the sensor to determine the wearer�s breathing rate; the other composes a series of musical tones which the patient uses to guide and eventually lower the rhythm of his or her breathing. Over time, says the senior Gavish, slower breathing rates "reduce blood pressure, cutting the risk of heart disease, stroke and other circulatory ailments."
The brain, he explains, interprets long breaths, specifically extended exhalation, as a signal to for it to dilate blood vessels so that blood flows more freely, which in turn lowers blood pressure. The enthusiastic response in Korea was not a complete surprise: Yoga is but one example of Asian cultures� longtime understanding of the connection between breath control and good health.
The device is all based on a realization which came to the biophysicist in the mid-1980s, of music�s effect on breathing, and its eventual effect on the circulatory system. First he tried his theory on his wife�s headaches. A subsequent trial at the Hyatt Hotel health club near Mt. Scopus in Jerusalem used synthesizers to alter the breathing rates of members.
Gavish left the university in 1987 and devoted the next six years to refining his theory and developing the machine that would translate the idea into a working prototype of the breath-control device. In 1994, he and son Erez -- an industrial engineer who Gavish p�re says "has the soul of a marketer" -- formed InterCure, using their own capital, with the help of their family, which had considerable real estate holdings all over Israel. Over the next few years, the Gavishes raised $13 million from a group of private investors, including businessman Ya�akov Shahar, the owner of the Maccabi Haifa soccer club; Medica, an Israeli venture capital fund that concentrates on biotechnology; and True North Palladin Partners, a North American investment bank. The fledgling firm also benefited from R&D; grants from the Office of the Chief Scientist in the Ministry of Industry and Trade, which suggested expanding the original plan for a breathing-control device into a treatment for high blood pressure.
First clinical trials in Israel, using 20 copies of the prototype, began in the mid-1990s. In the trials, says Benny Gavish, "systolic blood pressure (the higher number in, say 120 over 80) was lowered by as much as 14 points, while diastolic pressure (the lower figure) came down by up to nine points. Each point of blood pressure reduction reduces the risk of heart disease, stroke and other serious health problems measurably."
The RESPeRATE device has been marketed in Israel since getting Health Ministry approval in 2000. Local sales have been limited so far because there�s been no concentrated marketing effort, says Uri Avni, the company�s Israel-based general manager, "and we�ve relied mostly on word-of-mouth publicity." And though the Health Ministry says it cannot afford to include the device in the "basket" of services provided at no cost under the national health insurance scheme, InterCure is trying to convince the local health maintenance organizations to provide it to members with hypertension. "We think that in the long run, they�ll be able to save a lot of money they now spend on drugs," Avni says.
The big breakthrough, though, came with FDA approval in July. Since then, InterCure�s tiny facility in the industrial area of Lod, not far from Ben-Gurion International Airport, has been buzzing with activity. The offices, which double as an assembly plant for the RESPeRATE device, can turn out about 1,000 units a month, and CEO Paul Shiels, who runs the marketing operation from InterCure�s U.S. branch in New Jersey, is already in touch with Asian subcontractors who will be phased in as demand increases.
"Our hard work seems to be paying off," says the senior Gavish. "InterCure is going to make the average American physician, who prescribes hypertension treatment, as aware of the connection between controlled breathing and overall physical health as the people of the Far East."
RESPeRATE is realtively simple to use: Patients attach a sensor on an elastic band around the abdominal area. The sensor�s patented technology, which InterCure developed, calculates the wearer�s breathing rate by the expansion and contraction of the body, and transmits it to the main unit. The RESPeRATE device, which is light enough to take on a jog, records that rate, composes a series of individualized musical notes (beginning with two primary tones, one for inhalation and one for exhalation) and transmits them to an attached speaker or headphones.
Once the main computer-processor detects that the wearer has learned to regulate his or her breathing, it begins to change the tempo of its "music." The tones become more complex as the device senses the user�s response, adding additional instruments and layers of notes, which Benny Gavish admits aren�t quite Beethoven.
"Breathing rates do not adhere to music standards, but using music to control breathing was the key to the success of the product," he says, disclosing that InterCure hired a Hebrew University music professor to consult on the notes, "and we developed software that could produce music that would be completely dynamic, and not limited to conventional rhythms."
Each daily session with the device lasts about 15 minutes, and Gavish says that a person with hypertension will see tangible results within three weeks. In addition, the device itself produces a record of treatment -- for interpretation by a physician.
The Gavishes are optimistic that RESPeRATE, which is priced in the United States at $299, will become a bestseller. "First of all, it is not a drug, so there are no negative side effects or dangerous drug interaction risks," Benny Gavish says. "Secondly, a patient can�t �cheat,� since all of the usage and breathing data is recorded. A doctor who prescribes a medication cannot be absolutely sure the patient took the drug. In this case, they can."
Immediately on getting the FDA OK in July, InterCure began shipping completed devices to the United States. Sales efforts have barely begun, and so far the numbers are very small (about 1,000 devices sold in early September). According to one InterCure projection, sales in the United States alone could reach $20 million in 2004, and $100 million in 2005.
The Gavishes say they would like to convert InterCure into a local industry. But considering the size of the market -- the 57 million Americans who suffer from hypertension are all potential customers, as are 500,000 Israelis with high blood pressure -- they think it�s inevitable that, when sales volumes increase appreciably, they�ll have to transfer most of the assembly to a low labor-cost country in Asia.
Benny Gavish notes that it took 50 years for the stethoscope to catch on in England, "because doctors there thought it made them look silly." RESPeRATE, he hopes, won�t take that long.
Business
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