Japanese firm acquires developer of optical coherence tomography

Deal sets stage for OCT application in cardiac cath

A pioneer in optical coherence tomography (OCT), LightLab Imaging of Westford, MA, was acquired Aug. 6 by a Japanese firm called Goodman based in Tokyo. The acquisition clears the way for this company to enter into an alliance with one or more major imaging vendors for the development of novel OCT applications in medical imaging, most likely cardiac catheterization.

LightLab had been exploring a deal with Siemens Medical Systems that ultimately could integrate its OCT equipment with the German company¹s Axiom Artis cardiac cath lab. Only preliminary R&D has been performed so far, as executives at the two companies have been in a holding pattern awaiting the sale, which was initiated by the German optics company Carl Zeiss. Until a few days ago, Zeiss was a major stakeholder in LightLab. The company best known for its high-performance surgical microscopes kept the OCT with surgical applications. LightLab and its new parent kept the technologies that might be used in cancer assessment and cardiovascular imaging, including the identification of vulnerable arterial plaque. Other specifics regarding the acquisition have not been disclosed.

OCT is the photonic counterpart of diagnostic ultrasound. Light waves, like ultrasonic waves, bounce off structures inside biological tissues. The frequencies of infrared light are several orders of magnitude greater than ultrasound signals, however, resulting in substantially increased image resolution. The current technology uses near-infrared wavelengths (1300 nm). Structures between 4 and 20 microns can be resolved.

In OCT, light is delivered to the imaging site through a single optical fiber 0.006 inches in diameter. The imaging guidewire contains a lens that performs a variety of imaging functions. This guidewire can be deployed independently or integrated into existing therapeutic or imaging catheters.

Siemens has the inside track to work with LightLab on the technology, having already conducted some preliminary R&D with the company. LightLab is also interested in working with technology being developed by Stereotaxis, which has entered a three-year codevelopment deal with Siemens (SCAN 7/24/02). LightLab executives are keeping their options open, however.

"Each of the big three (Philips, Siemens, and GE) has expressed interest," said David Kolstad, vice president of marketing and business development. "Whether we choose an exclusive or nonexclusive arrangement will probably depend on which provides the better opportunity for system placements. Goodman¹s thinking about it may be different from ours, which is why we haven¹t made the decision until this acquisition was done."

LightLab¹s new owner would at first appear an unlikely suitor. Rather than manufacturing, the Japanese firm¹s focus is import and wholesale of medical equipment. Other business areas include accident insurance and software development. Kolstad believes, however, that the deal makes a lot of sense. The new owner specializes in the sale of catheters used in intravenous diagnostic procedures.

"Goodman, as an acquirer, gives us immediate access to what is potentially the largest market for intravascular imaging," he said. "The U.S. and Japan are very close in terms of their market sizes for intravascular imaging. Goodman¹s strength in Japan and its market share in distributing those products is tremendous."

If LightLab allies with a major angiography OEM, the U.S. market could fall in place as well. Goodman appears to have the financial means to commercialize LightLab¹s OCT products. Clinical studies have begun at several sites in Europe and the U.S. to assess the clinical potential of OCT optimized for transesophageal, biliary, and pulmonary uses, as well as intravascular applications. The intracavitary platform, called the Optical Biopsy Forceps, is designed to help identify cancer. The development of this product, which works with specialty endoscopes, has been done in partnership with Pentax Precision. The acquisition calls for the continuation of this agreement, according to Kolstad.

The intravascular platform, called the ImageWire, is being used to investigate arterial plaques, potentially as a prelude to better deploying cardiac therapies such as stent placements in selected patients undergoing interventional procedures.

"The infusion of capital (from the acquisition) will allow us to scale up the manufacturing operations, broaden our clinical programs, and really push the product to market sooner and more broadly than we would have been able to do on our own," Kolstad said.

Intravascular applications are especially interesting to Siemens and other makers of x-ray angiography systems, which provide only a 2D silhouette of the lumen. These systems do not visualize intimal thickening or thin fibrous caps, which are hallmarks of the so-called vulnerable plaques believed to cause up to 70% of sudden cardiac deaths. Because it can image to the cellular level, OCT may be able to pick up these signs, just as it might tell the difference between normal and cancerous cells.

The intellectual properties behind this clinical potential come from the Massachusetts Institute of Technology, which did the basic research and licensed the patents to LightLab. The licensing occurred in the mid-1990s, when the company was called Coherent Diagnostic Technology, and before Kolstad and his boss, Paul Magnin, left their jobs in diagnostic ultrasound at Hewlett-Packard (SCAN 9/1/99). Back then, OCT was only starting to be recognized for its potential in medical imaging.

The recruitment by LightLab of top executives and its acquisition by Goodman attest to this potential. The weeks and months ahead may finally set the stage for that potential to be realized.