Date: Feb 12, 2014 Author: Don Seiffert Source: bizjournals (
click here to go to the source)
InfraRedX's TVC Imaging System is the only system which can tell the difference between potentially harmful plaque buildup in the arteries and benign buildup.
Don Seiffert
After 11 years since it was founded, InfraRedX is hoping 2014 will be transformational, with approval anticipated in its biggest market yet, a global study that could result in significantly greater use of its product, and the possibility of either going public or being acquired.
The 120-employee medical device company, 100 of which work in its Burlington, Mass., headquarters, makes the TVC Imaging System, a catheter that company founder James Muller says can be thought of as an "infrared flashlight" for use inside blood vessels. The device can be used to predict the likelihood of a blood clot that could lead to a heart attack in a particular section of a blood vessel by located so-called "vulnerable plaque."
"The problem with heart attacks is not treatment," said Muller. "It's diagnosing it."
Muller explained that the idea of vulnerable plaque was invented by himself and two other doctors at Brigham and Women's Hospital. Blood clots form when there is a break in the buildup of plaque on the insides of the vessels (the clots are not formed by the plaque itself). So-called fibrotic plaque is not likely to break, and is therefore safe, while cholesterol-heavy plaque often breaks. Muller said that InfraRedX's TVC Imaging System is the only system that can tell the difference, and helps doctors locate where a clot may occur before it actually does.
Muller said there are about 3 million stents put in worldwide every year where there are already blockages, but InfraRedX's system would potentially increase that significantly.
A study published in The Journal of Invasive Cardiology last month, co-authored by Muller, gave evidence to support the use of the TVC Imaging System to detect heart attacks. While the presence of cholesterol-heavy (or so-called "lipid core") plaque has been verified in patients who have died of heart attacks, the study used the TVC Imaging System to identify plaque for the first time in living patients who were resuscitated after a heart attack.
An early version of the product was approved in the U.S. in 2008, then a more effective version in 2010, to detect the presence of cholesterol, or lipid core, plaque. The company didn't start commercializing it until 2012, said CFO Mike Guarasci, and the privately held company has not yet turned a profit. Guarasci said it expects to sell about 10,000 of the devices this year, which cost about $700 each.
But there are two ways the company is now aiming at potentially boosting sales. The most immediate is through approval in Japan, which is expected in the next few months. Guarasci said that Japan actually represents the largest market — about half worldwide — for the TVC Imaging System. While the number of stents placed in Japan every year is less than the U.S., he said that due to both cultural and reimbursement differences, 90 percent of stent placements in that country are preceded by a catheter scan. In the U.S., which represents about 35 percent of the worldwide market, only about 15 percent of stent placements use a catheter scan.
Longer-term, Guarasci said that InfraRedX is just now kicking off two global trials that will together test the device in 10,000 patients. The goal of the trials is to seek allowance for an additional claim that the device can be used to identify patients at high risk for heart attack (rather than simply for the presence of lipid core plaque). He said the study will likely take three years to complete, but the company hopes that interim results may provide enough evidence to seek regulatory approval sooner.
At the same time, Guarasci said the company is looking at either selling the company or bringing it public based on its promise of a new way to prevent heart attacks.
"I would say we are looking at a monetization plan, and an IPO and an acquisition are both ways to do that. We are looking at both," he said.