Arineta gets FDA nod for cardiology CT device

Dr. Ehud Dafni Photo: Eli Yizhar
Dr. Ehud Dafni Photo: Eli Yizhar

The Israeli company has signed a strategic agreement with GE Healthcare to distribute and market the device.

Arineta has obtained US Food and Drug Administration (FDA) approval for the new cardiac mapping CT device it has developed. $13.5 million has been invested in the company since it was founded in 2006, mostly by private investors, including the Richter family, owners of Medinol and Dr. Shmuel Levinger, owner of the Eynaim chain of eye clinics.. Arineta has signed a strategic agreement with GE Healthcare, which will market Arineta's product. GE Healthcare, the global CT devices leader, markets equipment to cardiology clinics, a booming market segment of interest to the company, in addition to marketing to hospitals.

Arineta cofounder and CEO Dr. Ehud Dafni today commented on the FDA's approval, saying, "This is a milestone for the company. The US is the first market we're aiming at, and you can't market the device, or even offer marketing material to doctors, before you get approval. Some doctors, however, have already expressed interest in principle in our product, and I believe that we'll sign deals this year or early next year, and will already increase our sales in the ensuing year." Concerning the price for the product, in comparison with CT devices not specifically for cardiac patients, Dafni said, "There is a very wide range of prices for CT devices, from $300,000 for a cheap CT to $2 million for a high-end CT. We'll be substantially cheaper than a high-end device."

Dafni notes that the agreement with GE Healthcare includes royalties for Arineta on each sale by GE Healthcare, but does not include an acquisition option for GE Healthcare. "We are not interested in being acquired right now, but we are interested in an investment for production and support for marketing."

"Globes": Why is GE Healthcare not making the needed investment?

Dafni: "GE Healthcare is a customer. They're buying and marketing the device."

Arineta currently has 60 employees at its facilities in Caesarea, which are now being expanded. All of the company's production, except for off-the-shelf components, takes place in Israel.

In 2014, Arineta was selected as one of "Globes'" promising startups. Dafni told "Globes" at the time, "To be candid, our project is ambitious. There is no place in Israel with personnel that has the personnel needed to carry it out."

Arineta is developing a special CT system for 3D mapping of the heart and the blood vessels leading to it, diagnosing heart attack risks, and diagnosing heart attacks in real time. Today, when a person comes to a cardiology clinic or hospital complaining of chest pain, he is not usually diagnosed by CT, because the CT machine is too expensive and not accurate enough for this purpose, and also emits a lot of radiation.

There are two reasons for this inaccuracy. The first is that the heart is constantly moving, and it is necessary to wait for the period between heartbeats. The classic CT device does not stop quickly enough for this. Arineta's device photographs the heart in one sixth of a second. How does that work? Arineta's device emits radiation towards the heart from two directions simultaneously, while focusing solely on the heart. A special algorithm analyzes the images, and produces and accurate 3D picture from them. "40% of cardiac disease sufferers do not survive their first heart attack," Dafni explains. "This is because there is no better means of diagnosing heart disease. The problem that causes heart attacks is stenosis in the coronary arteries - three large arteries that surround the heart and feed oxygen to it. When one of these arteries is blocked because of arteriosclerosis or blood clots, the heart lacks blood, and a heart attack occurs. When the heart stops working, none of the rest of the body receives blood. The more rapidly a flow of oxygen is restored to the heart, the more long-term damage is prevented, especially scarring of the heart, which interferes with its functioning, and later causes heart failure."

Dafni adds, "Today, an inadequate supply of blood to the heart muscles, from which a blockage is deduced, can be diagnosed through nuclear medicine, but we don't know exactly where, and we send the patient for diagnostic catheterization. 60% of catheterizations, an expensive, invasive, and painful procedure, are diagnostic. In half of the cases, nothing correctable is found. According to our test, it can be decided immediately whether the patient needs medication, therapeutic catheterization, or bypass surgery. For 10 years, it has also been possible to make this diagnosis using a general CT if it is quick and accurate and very expensive, but it's like using a truck to transport four people from Haifa to Tel Aviv."

Arineta's device has another advantage - it can be placed in cardiology clinics, not just in hospitals. "There's currently a problem of availability of CT devices where they are needed," Dafni explains. It's not so strange for cardiologists to have a CT in their clinic. Many of them already have a nuclear camera. A similar change has already taken place in dental medicine: a special scanner has been designed for teeth (there is no reason for doing a complete CT), and it has been stationed in clinics.

Dafni says now that the first market the company will aim at is invasive cardiologists those that perform catheterizations - in order to offer them a way of deciding which patients really need catheterization, and which do not. The product will also be used to diagnose patients for valve replacement in catheterization. Today, all patients undergo an ordinary CT before the process in order to determine which valve they need and whether the procedure is possible for them.

Is it not slightly risky to give this decision to the doctor who makes a profit from catheterizations?

"It depends on how intelligent he is. Some doctors tell me that they prefer CT diagnosis, because it frees up time for diagnostic catheterizations, and spending the time in therapeutic catheterization, which is more significant for the patient, is more interesting, and in the US, more profitable. In other countries, such as the UK, there are not enough catheterization rooms today for general CT. In China, many patients pay out of their own pockets to have a CT instead of catheterization."

So is the health system what will provide motivation for replacing diagnostic catheterization with a less invasive and expensive procedure?

"The health system has its own logic. It takes time for it to do smart things, but it eventually does them."

Four major companies dominate the CT market: GE Healthcare, Philips, Siemens, and Toshiba. Dafni previously said, "Everyone is following what we're doing. When we succeed, the other entities will also enter the competition."

The FDA approval was given without (human) clinical trials, but the company has performed tests on over 200 people to date for marketing purposes, and also on animals. The company device has been placed in Carmel Medical Center.

Dafni founded Arineta with serial entrepreneur Yosi Morik, who is also one of the leading investors in the company. Morik previously told "Globes" that once he got the idea, he knew that only Dafni could make it happen, because he was one of the leading CT developers at Elscint, an activity that later became the CT division of Philips, the leading company in the field. "In my previous life, I was a professor of nuclear physics at the Weizmann Institute," Dafni says. "I joined Elscint in the 1990s as chief physicist of the CT division. I was reduced to, or wound up doing, management of CT projects.

"In 2004-2005, Yosi came to me with this idea, and I wasn't interested, because I calculated that the market wasn't ready for it. In 2006, though, it looked like the need had increased and matured, and the direction emerged as a promising one, so we founded the company. The process took more time than we expected, but when we began accelerated development in 2011-2012, it made very nice progress. The good news is that during those years, the need for the device did not decline; it grew, and no competitors emerged. On the way, we assembled an amazing development team with capabilities that can be used for development of more products in the future."

Dafni commented on the history of the CT field, saying, "The last real revolution in CT was when a scanner was developed with two slices (a scanner that simultaneously photographs two cross-sectional images at different heights of the body) at Elscint 24 years ago. It happens to be my invention and that of David Ruimi, who is working with us now. That's the basis for every CT with slices there is today, up to 360 slices (in other words, with scanning the body at every height in order to obtain a 3D image, instead of a 2D image, like in an X-ray). At Arineta, we're not doing what everyone else does; we use multiple sources of radiation. We have only two right now, but we're developing a new generation of multiple sources in the entire imaging industry."

So you have made a breakthrough in the entire CT sector. Have you been rewarded appropriately?

"I was an employee, so I didn't get rich from these inventions, but I've done all right. The CT division was sold for $300 million, thanks to the four-slice scanner whose development I managed. The one who made money on it at the time was Moti Zisser. Another project I managed was sold for over $1 billion. They gave me respect, but not money

"My goal is not money; it's to be a brand, like Frigidaire. I want it to be clear to everyone that every cardiac patient should pass through this device, and for everyone to not understand how there once was no such device. The investors will get what they deserve on the way. I want us to be a great startup, not just a success."

Published by Globes [online], Israel business news - - on August 16, 2016

© Copyright of Globes Publisher Itonut (1983) Ltd. 2016

Dr. Ehud Dafni Photo: Eli Yizhar
Dr. Ehud Dafni Photo: Eli Yizhar
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