Infraredx - 2014 Fierce 15

CEO: Donald Southard
Based: Burlington, MA
Founded: 1998

The scoop: Infraredx makes the TVC Imaging System, which combines ultrasound imaging and near-infrared spectroscopy, enabling cardiologists in the cath lab to gain information about lesion size and chemistry. In particular, the spectroscopy allows for the identification of cholesterol-rich plaque, sometimes referred to as vulnerable plaque or lipid-rich plaque.

Company officials said in an interview that the device is being used 20 to 30 times a day. It consists of a catheter containing sensors for diagnosis, controller, and display console for imaging and information display. Following FDA clearance, the TVC Imaging System has been installed in about 100 hospitals in 14 countries; the majority of the installations are in the U.S.

What makes Infraredx Fierce: Infraredx can't be faulted for lacking ambition. The company's goal is to be able to predict and ultimately prevent heart attacks using the TVC Imaging System by identifying cholesterol-rich plaque so that patients can receive stenting in advance of heart failure.

"The reason I founded this company is because if we could find those dangerous plaques and they could be stented, then you can prevent heart attacks," said Chief Medical Officer Dr. James Muller, who pioneered research in the field.

Infraredx's TVC Imaging System--Courtesy of Infraredx

Conventional stress tests and angiograms are good at detecting signs of narrowing, "but they're miserable at telling the chemistry of the artery wall and the plaque," Muller said.

Not all lesions are the same. "The differences between cholesterol-laden vulnerable plaques and calcified, fibrotic lesions are significant. The one is obviously active and dangerous, the other one has sort of spent its course. So this device tells you the difference between those two things and also tells you the size of the lesion," Muller said.

The TVC Imaging System accomplished this feat by performing not just standard ultrasound imaging but also near-infrared spectroscopy, something the competing devices don't do. By measuring a chemical's absorbance of light at various wavelengths, spectroscopy creates a unique peak-and-valley line graph that acts as a fingerprint for identifying and differentiating foreign substances, such as collagen and cholesterol-rich plaques.

Muller said it took Infraredx engineers a decade to figure out how to perform spectroscopy in the coronary artery due to its size (2 millimeters), difficult-to-access location, and anatomy (the device must not disrupt the heart's blood flow).

Other companies have taken notice of the technology. In 2013, Japanese conglomerate Nipro made a $25 million equity investment in Infraredx geared toward launching the TVC in Japan. Nipro later agreed to manufacture the device in anticipation of approval in that country. Under the 5-year agreement, Infraredx is supposed to earn $50 million in revenues. Another big backer is Philips ($PHG), which signed a nonexclusive agreement last year to sell the TVC alongside its interventional cardiovascular X-ray systems.

What to look for: Infraredx is banking on an expanded indication. Currently, the TVC is used as a lipid core plaque detector, which means that physicians can benefit from information about the presence of cholesterol-rich plaques as they prepare for surgery.

But the company's prevention goals require a broader indication from the FDA, for a vulnerable plaque detector. To that end, this year Infraredx launched the Lipid-Rich Plaque study, to uncover what they expect will be a positive correlation between cholesterol-rich (or lipid-rich) plaque and cardiovascular events within two years. The primary outcome measure is due at the end of 2018.

"In the next year or so we will take a look at some intermediate results, and if we believe them to be promising, and we believe that will happen, then we will take them to the FDA and ask them for a vulnerable plaque detector label," CEO Donald Southard told FierceMedicalDevices in an interview.  

Infraredx hopes the diagnosis of cholesterol-rich plaques will spur early intervention. "These lipid-rich vulnerable plaques, even though they're not limiting today, they're dangerous enough that they should be stentable," Muller said. 

Muller said the company aims to prevent second heart attacks in patients who have received a stent, saying 10% of those patients have heart problems within three years.

Even more ambitious are plans to prevent first heart attacks. The TVC would be part of a sophisticated screening strategy to find patients with cholesterol-rich plaque and give them early treatment. Muller described that as a "more distant dream."

In the meantime, Infraredx aims to sell more TVC Imaging Systems commercially, saying it is adding installations at a rate of 20 to 30 per quarter.

"Our intention is to continue to build, and as you build it's difficult to stay profitable," Southard said, adding that he aims to achieve profitability by the end of 2016. -- Varun Saxena (email | Twitter)

For more:
Japan approves Infraredx's intravascular ultrasound Dx imaging device
Infraredx, Nipro detail Japanese manufacturing plans for an intravascular ultrasound device
Infraredx raises more cash to back imaging system ramp-up

Infraredx - 2014 Fierce 15