The existing asthma test either at home or at a clinic, is designed to estimate the severity and development of an attack, decide on the suitable mode of treatment, and whether it can be administered at home, at a clinic, or solely at a hospital. The idea is important, but the problem is that it requires the patient to hold a tube in his/her mouth and breathe into as hard as he/she can, while a person experiencing a seizure is at the very point where he can't breathe hard, both because of the attack itself, and the mental stress it causes.
Many asthma patients learn to cope with the device, but children and the elderly don't always manage to use it successfully. As a result, the elderly, and parents with small children, prefer simply to rush to hospital to be on the safe side. In fact, the use of this device in children is so complex, that companies in the US are required to stipulate on the product's packaging that it will not produce reliable results when used on children.
Alongside the harm to the quality of life that elderly or child asthma patients suffer because of the frequent visits to hospital, such visits are not welcome at all at hospitals, which have to admit a never ending queue of wheezing patients, who needn't be there at all. Medical device company KarmelSonix Ltd. was founded with the aim of developing a method of measuring asthma attacks without requiring the patient himself to carry out any physical action.
KarmelSonix specializes in the mathematical analysis of sounds emanating from the body, specifically those made by asthma sufferers. The company's device, which includes a sensor, is attached to the patient's neck and chest near the windpipe, and a computerized system analyses the character of the wheeze and ascertains whether the patient could be at risk and must therefore attend a hospital, or whether he/she can be treated at home or at a clinic. The system can differentiate between a cough, wheeze, and normal breathing. The severity of the asthma is defined by those three symptoms. The mathematical algorithm which analyses the nature of the wheeze is a major part of the company's patent.
The system also includes a component that neutralizes background noise. It enables the severity of an asthmatic attack to be diagnosed at any given moment, and it can monitor the disease's cyclical patterns over time, as well as provide real time diagnosis of the effect of drugs taken by the patient. KarmelSonix's flagship device is designed for use in family doctors' and specialists' clinics, but another device for home use will be forthcoming at a later stage.
"The use of breathing sounds in the diagnosis and treatment of asthma is accepted practice, but the device most commonly used for a diagnosis like this is a stethoscope," says KarmelSonix CEO Dr. Reuven Segev. "The doctor using it can get only a qualitative indication - whether there is or isn't wheezing - but any other conclusions as to the state of the disease are based solely on the attending doctor's experience and knowledge. Our device is the first to enable a quantitative analysis of the patient's condition. We developed not only the device, but also a new index, which enables the quantification of the sounds, which are analyzed as a series of figures that support the diagnosis."
With this device, KarmelSonix has joined the latest trend in diagnosis - use of acoustic data produced by the body, by analyzing not just their presence, but also how long they last, and their frequency. KarmelSonix is a pioneer in this approach to asthma wheezing. "There was a competitor who tried to develop a device along the same lines, but they found themselves encroaching on our patents, and decided to back out," says Regev.
"A quantitative diagnosis enables a more objective diagnosis that doesn't vary from listener to listener. Another advantage is that it allows doctors to better understand the development of the disease in the patient and document it over time, so that they can plan suitable and more advanced treatment," he adds.
Another important advantage of the system, as mentioned earlier, is that there is no need for active cooperation from the patient, aside from the placing of the sensors. Thanks to this, not only can it measure patients who can't handle the existing device, but it can also measure patients while they sleep, thereby enabling the monitoring of a condition known as 'nocturnal asthma,' asthma which presents or becomes more acute when sleeping.
KarmelSonix's history is no less interesting than its product. The company was founded in 1996 as Carmel Medical by Prof. Noam Gavriely, known today as the entrepreneur behind ETView Ltd., which has developed a tracheoscopic ventilation tube with an embedded video camera, and which is set make an IPO on the Tel Aviv Stock Exchange (TASE). Carmel Medical was founded before ETView, raised $8 million, and even won US Food and Drug Administration (FDA) approval for its product, but then the bubble exploded, and the company struggled to secure funding for the most costly stage in the process - product marketing.
Regev was formerly a project manager at Rafael Armament Development Authority Ltd., worked at the high-tech group of Elbit Medical Imaging Ltd. (Nasdaq: EMITF; TASE: EMIT), and was also managing partner at Vector Investment Company Ltd. He invested $100 million in 20 companies. A year and a half ago, Gavriely asked Regev to join the management team of the companies that he had initiated and founded. KarmelSonix's VP sales is Israel Tal, and its CTO is Issac Kroin.
The three men decided to rename the company KarmelSonix and reform it as a partnership with an Australian company called PulmoSonix Pty Ltd. which also specializes in asthma treatment. "Noam got in touch with someone called Peter Marks, who was previously CEO of the Australian Stock Exchange in Melbourne, and one of the investors in PulmoSonix," recalls Regev. "He was looking for investors with marketing and regulatory experience who could help him develop the company, and offered his contacts in the Australian capital market.
"The companies decided on a joint merger with an Australian shell company. The merger entailed an ongoing process in which, subject to its performance, the historical shareholders of each company gradually get an increasingly larger stake in the new jointly owned public company. Eventually, we will own 130 million shares out of the shell's 330 million total shares." In the meantime, the company's share has risen from A$0.02 to A$0.16 today, and hit a peak of A$0.28. 80% of the joint activity is carried out in Israel. Earlier this month KarmelSonix raised A$6 million ($5.3 million) on the Australian Stock Exchange, at A$0.19 a share.
PulmoSonix has also developed a device that transmits an external acoustic signal that analyses the sounds emanated during breathing so as to provide a reliable indication about the passage of air through the patient's airways. This enables doctors to diagnose interrupted breathing in elderly asthmatic patients. The device can be used not just for asthma but also in the diagnosis of respiratory disorders caused by smoking, cystic fibrosis, emphysema, and other diseases that affect the way is exhaled from the lungs. This project recently received funding from the Victoria-Israel Science and Technology R&D Fund.
KarmelSonix's development is based, as mentioned earlier, on a product that has already won FDA approval and CE Mark Certification, although it has made several improvements to it, one of which is its adaptation for use with a laptop. In 2008, The company is likely to launch devices for monitoring respiratory disorders among hospitalized patients with acute asthma, as well as patients from designated target groups. It is also due to offer a designated device for use at community health clinics.
Published by Globes [online], Israel business news - www.globes.co.il - on October 14, 2007
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