BB&T Contributing Editor

Panasonic (Osaka, Japan) may be the world's largest maker of consumer electronics, but when it decided to expand its rather limited efforts in the healthcare field, it turned to a modest-sized U.S. company to get off on the right foot.

In pairing up with Fairway Medical Technologies (Houston), a company whose focus is commercialization of early-stage medical devices and technologies, Panasonic placed its bets on that company's president and CEO, Morteza Naghavi, MD, whose track record in early detection and treatment for cardiovascular disease was well-known.

That relationship soon blossomed into a new entity known as CardioNexus (also Houston), which was established in 2009 as a joint venture of Fairway Medical and a new Panasonic unit known as Panasonic Healthcare, in turn a part of Panasonic Corp. of North America (Secaucus, New Jersey).

Steven Lynum, the Houston-based director of clinical products for Panasonic Healthcare, told the Houston Business Journal that the two companies met up at industry meetings. Referring to the deal as “a perfect match,“ he said that using Panasonic's technology and CardioNexus' business model, the two companies can establish themselves in the U.S. market.

Lynum said Panasonic has been producing hearing instruments, primarily for the Japanese market, for more than 50 years, “So in that sense we have been doing healthcare business for quite a while. It's not very well known, but Panasonic has been producing for more than 35 years such products as medical imaging, in vitro diagnostic and laser equipment.“

Naghavi told BB&T that the partnership grew from Panasonic's business decision to focus on “early healthcare,“ or preventive types of medicine as well as home health, segments where there isn't as much competition as in many of the more traditional market sectors. “They're really aiming at the personalized medicine space,“ he added, a market that reflects the electronics giant's base in consumer products.

Panasonic “needed partners, so they came to us at Fairway because they saw my background as a preventive cardiologist to be a good fit and we started a relationship,“ he said. With Fairway and Naghavi's track record in early detection and treatment for cardiovascular disease, that relationship soon blossomed into the entity known as CardioNexus.

Simply put, the joint venture relationship is broken down into Panasonic doing all the manufacturing while CardioNexus does all the clinical development and product positioning. The initial U.S. marketing efforts will be directed by CardioNexus, “but we'll look to Panasonic when we're ready to move globally,“ he said.

A recognized leader in heart attack prevention initiatives, Naghavi has founded four medical companies, including Volcano Corp. (San Diego), a firm focused on detection of vulnerable plaque, which went public in 2006. Volcano was based on work done by Naghavi and colleagues at the Texas Heart Institute (Houston).

Noting that the early detection of cardiovascular disease “has been an interest of cardiologists for years,“ he said that until recently the main focus has been on CV risk factors such as family history, cholesterol, blood pressure and the like. “But risk assessment has many limitations,“ Naghavi said, “and the fact is that the majority of people who come in with heart attack symptoms don't fit the traditional risk profile.“

So organizations such as the American College of Cardiology (ACC; Washington) and American Heart Association (AHA; Dallas) have recommended direct assessment of risk via methods such as measuring coronary calcium and the thickness of vessel walls, “but those assessments typically aren't available in many physicians' offices,“ he said. According to the AHA, more than 60 million Americans are at risk of a heart attack and in need of screening and preventive care.

“The obvious solution,“ Naghavi said, “is ultrasound, but the problem with traditional ultrasound is that you need a savvy operator, more costly high-resolution machines, and more of a patient's time.“ Enter CardioHealth Station, a device that he said had its genesis in work begun several years ago. The FDA-cleared product is an automated and portable cardiovascular imaging device which aims to complement traditional blood pressure and cholesterol measurement in physicians' offices to help detect the hidden risk of heart attack and stroke (see Table 1).

Saying the CardioHealth Station “looks like a big iPod,“ Naghavi cited its ease of use: “You just put the device on a patient's neck and the machine guides you; you don't even need to push a button to proceed with the exam.“

The device is intended for diagnostic use in physicians' office settings – particularly those of primary care physicians, internists and family physicians, who are “absolutely our main target,“ Naghavi said. “They're the ones who are underserved – they simply don't have these kinds of devices in their offices.“

Traditional risk factors such as cholesterol, blood pressure, etc., are not enough, he said, and they often misclassify patients. And traditional ultrasound measurement of carotid wall thickness (CIMT) is dependent on having a skilled operator to perform the studies and “is a multi-step process that is time-consuming to perform,“ the company says in its promotional materials.

“The CardioHealth report, which combines Framingham Risk Score with carotid IMT and plaque assessment, provides a more accurate assessment of a patient's risk than measuring blood pressure and cholesterol alone“ said Naghavi. “It takes us beyond the status quo and empowers internists and primary care physicians to use noninvasive imaging in their office.“

The device is “newly designed, built from the ground up,“ Naghavi said. “It's a huge advantage for doctors such as primary care physicians, internists and family physicians – it's a very revolutionary piece of equipment noteworthy for its ease of use. You don't even need to hit buttons; just place the equipment at the patient's neck and the machine guides you.“ The CardioHealth Station includes a handheld ultrasound probe to scan the carotid arteries on both sides of the neck and to detect hidden plaque buildup and increased thickness in the artery wall. Testing is performed in a matter of minutes without pain, discomfort or exposure to radiation; and the results are available immediately.

In a chart on a company compilation on the new device, CardioNexus pegs the price of its unit at some $25,000, comparing that to costs of $100,000, $80,000 and $40,000 for what might be considered competitive products from three other companies.

The physicians who have seen the equipment to date say “This is mind-blowing, it's exactly what we have needed,“ Naghavi said. “It's very revolutionary.“ CardioNexus's formal introduction of what is now known as the Panasonic CardioHealth Station took place at the annual scientific sessions of the ACC early last month in New Orleans.

“We've already seen tremendous interest in the technology, particularly among internists and primary care physicians who up until now have not had an automated non-invasive imaging technology in their office,“ said Lynum, who besides his Panasonic duties serves as an executive vice president at CardioNexus.

Besides the ACC meeting, Naghavi said Panasonic and CardioNexus will be exhibiting at 20-some medical meetings over the next several months as they roll out the CardioHealth Station.

And more indications are in the pipeline beyond risk factor profiles and IMT/plaque. Some of the others that CardioNexus indicates as areas of interest include point-of-care blood testing, blood pressure and ankle brachial index checks, and body measurements such as height, weight and body mass index (see Table 2).