Oct 16

Boston Business Journal - by Eric Convey

Leaders of early-stage medical device companies are worried the Obama administration’s health system overhaul could devastate the industry and have formed a new lobbying organization whose goals include killing a proposed $40 billion, 10-year-tax targeting their products.

The issue could be extremely important for Massachusetts, with its big medical device sector. The 25 largest medical device companies in the state as compiled by the Boston Business Journal have annual sales of about $28 billion and employ more than 12,000 in Massachusetts.

The executives working with the new group are especially troubled that by taxing revenue rather than income — the plan as it stands would allocate the annual assessment based on market share — the measure would undermine the startup business model to the extent critical investors might be scared off.

“For small startups, it hits them at an extremely fragile stage — when they’re just beginning earnings,” said Dr. James E. Muller, a cardiologist and former Harvard Medical School professor who founded InfraReDx in Burlington and is an early member of Entrepreneurs for the Advancement of Medical Innovation, or EAMI. “It’s like putting the plant outside before it’s ready. The process of innovation has some very difficult years where you have to nurture the innovative process.”

Robert McNeil, managing director of Sanderling Ventures in San Mateo, Calif., and an investor in InfraReDx, said he helped launch EAMI because he fears a number of elements of the health overhaul effort will stifle innovation.

Another target will be Medicare funding rules that tend to ignore the cost of developing and testing new products, he said.

If the government undermines early-stage companies, McNeil said, venture capitalists will “just take our money and develop products in which you can earn a living.”

Supporters of the new tax say it only captures part of a windfall that companies will enjoy as the ranks of the insured grow.

Local executives at device companies already have sought help from U.S. Sen. John Kerry.

In an e-mail response to a question from the Boston Business Journal, Kerry said: “The medical device companies pave the way on new technology that saves lives and money, so anything that could stifle research and development concerns us in the short and long term.

“We should explore whether there are better ways to raise revenue than assessing across the board excise taxes on specific sectors of the health industry.”

Muller, a veteran activist who shared a 1985 Nobel Peace Prize for work against nuclear war and helped launch the once-high-profile lay Catholic group Voice of the Faithful, is no critic of activist government. He supports single-payer health care.

But the direction of the current debate has frustrated him.

Referring to his own 11-year-old company, he said: “It’s taken forever to build this device, and it’s cost an enormous amount of money. It’s taken work by 70 or more individuals — about 50 engineers, many MIT engineers, to build it. It’s a revolutionary technology that can find the plaques that cause heart attacks. And we certainly are not being helped by what’s going on in Washington.”

The new advocacy group was set up earlier this month and for now is being run by the law firm McKenna Long & Aldridge LLP.

Sep 14

InfraReDx to showcase the LipiScan™ Coronary Imaging System at the Cardiovascular Research Foundation’s (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting

Results of Initial Clinical Experience with a Novel Spectroscopy Catheter that can Identify Lipid-Core Coronary Plaques to be presented at TCT 2009

FOR IMMEDIATE RELEASE - September 11th  2009 –Burlington, MA

InfraReDx today announced its preliminary schedule of events at the Cardiovascular Research Foundation’s (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific meeting, scheduled from Monday, September 21st to Friday, September 25th, in San Francisco, CA. at the Moscone Center. This scientific meeting is one of the world’s largest events for those performing cardiac diagnostics and interventions.

The LipiScan™ Coronary Imaging System will be displayed in the “Emerging Technologies” section at booth # 2410.   Schedule of InfraReDx Events at TCT 2009 are as follows:

Monday, September 21st

On behalf of Cardiovascular Research Foundation, Dr. James Muller, founder and CEO of InfraReDx, has been invited to participate as a guest speaker titled:

“Vulnerable Plaque: Emerging Directions for Diagnosis and Treatment: Near Infrared Spectroscopy I: Technology and validation.”

  • 2:40 pm in room # 130 at the Moscone Center.

Friday, September 25th

InfraReDx sponsored Breakfast Symposium:

“Beyond Angiography:  NIR Spectroscopy and Other Methods for Plaque Characterization.”

  • 6:30 am Breakfast, 7:00 am Symposium in room #120 at the Moscone Center. Presenters include: Dr. Cindy Grines (Beaumont Hospital), Dr. Gregg W. Stone (Presbyterian/Columbia), Dr. Emmanouil Brilakis (Dallas VA), Dr. Brijeshwar Maini (Moffitt Heart and Vascular), Dr. Patrick Serruys (Erasmus Medical Center), and Dr. James E. Muller (InfraReDx).

About InfraReDx, Inc.
InfraReDx, Inc., headquartered in Burlington, Massachusetts, was founded in 1998 and is a privately-funded medical device company developing a fiber-optic, catheter-based, near-infrared (NIR) spectroscopy system to identify and characterize vulnerable plaque in the coronary arteries. For more information, visit www.infraredx.com.

About TCT 2009
TCT is organized by the Cardiovascular Research Foundation, which is dedicated to research and education in the broad subspecialty of interventional cardiology and endovascular medicine. The TCT meeting is the primary annual meeting for the world-wide interventional cardiology community. For more information, visit www.tctconference.com

Company Contacts:

Dr. Muller Contact:                         Investor Contact:                             Media Contact:
Carolyn Rogers                                 Jeff Mazur                                            Jim Dillon
InfraReDx, Inc.                                 InfraReDx, Inc.                                 InfraReDx, Inc.
(781) 345-9644                                (781) 345-9626                                (781) 345-9679
crogers@infraredx.com                jmazur@infraredx.com                jdillon@infraredx.com

Aug 1

InfraReDx, Inc. announced today the first use in patients of a novel coronary catheter that uses both light and sound to image coronary plaques. Working on a team led by Dr. Patrick Serruys, Dr. Martin van der Ent performed the procedures on May 11, 2009 in patients undergoing coronary angiography at the Thorax center.

The combination catheter provides the benefits of both IVUS and NIRS imaging in a single study of the artery. IVUS is a well-established technique that is in common use to quantify the degree of narrowing produced by a plaque, the size of the artery and the adequacy of stent expansion. NIRS is a novel technique recently cleared by the FDA for the identification of lipid core plaques, the structures suspected to cause most heart attack symptoms and complicate stenting procedures.

Prof. Serruys stated that, “The composition of atherosclerotic plaques is important in assessing the likelihood that they will cause cardiovascular events. This novel device provides composition on top of anatomy and will play a pivotal role in interventional cardiology, first in clinical trials and further on in treatment planning in individual patients.”

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