Boston start-up CDT launches effort to commercialize optical imaging unit

HP veteran Magnin comes aboard as firm gets funding

Business acumen and engineering excellence have joined forces with the goal of making optical coherence tomography (OCT) a mainstream imaging modality. The effort is already paying dividends and more may be on the way.

Coherent Diagnostic Technology (CDT) announced Nov. 3 the receipt of a $1.8 million grant from the National Institute of Standards and Technology (NIST) to assist in the development of OCT, a light-based imaging technology capable of producing extremely high-resolution, cross-sectional images of tissues in real-time. The NIST funds are part of the Advanced Technology Program (ATP), which provides federal funds to industry for high-risk R&D projects.

The Concord, MA, company, which was incorporated only last February, has gained access to fundamental patents in OCT, as well as nine pending patents for improvement of the technique. Some of the development money will come from the U.S. government, as in the case of the $1.8 million in ATP funds. More is expected to come from alliances with major medical device companies.

“Our strategy is to try to hook up with large distribution partners in specific applications,” said Paul Magnin, president and CEO of CDT. “I can’t give the names of the partners, but they are big companies that have sales forces, service networks, and expertise in particular applications.”

CDT will either supply optical imaging devices to these companies for sale under their own names or the big-name companies will serve as distributors for CDT. The goal is to get OCT technologies to market as fast as possible and with the maximum clinical efficacy, Magnin said. CDT partners will pay all or most of the R&D freight.

“Each time we sign an agreement, we’re going to be asking for money in exchange for exclusive access to our products for their application,” said Magnin, who served as general manager of imaging systems at Hewlett-Packard before joining CDT last spring. “The first set of contracts (for the broader applications) are going to be signed between now and the end of December, and there will be other contracts for smaller applications later on.”

The major areas of clinical utility for OCT are cardiovascular, pulmonary, urinary and gastrointestinal applications. Magnin did not say which are the highest priorities.

CDT is not alone in its effort to commercialize OCT technology. Among those vying for a slice of this future market is OCTI, a Cleveland-based company intent on commercializing technology developed in Russia (SCAN 9/16/98). OCT is also being researched at academic centers, including the Science and Technology Center at Carnegie Mellon University in Pittsburgh.

Like ultrasound, optical coherence tomography generates images from echoes. These echoes are composed of light, rather than sound, which bounces off biological microstructures. Because of light scattering, penetration is limited to only a few millimeters of tissue, but resolution is excellent. OCT echoes can be computer processed into cross-sectional images with resolution between 5 and 20 micrometers—one to two orders of magnitude better than CT, MR, or ultrasound.

Leading the engineering effort at CDT is James Fujimoto, inventor of OCT and one of the founders of the company. Fujimoto, who developed the concept of OCT in 1991 while at the MIT Research Laboratory of Electronics in Cambridge, MA, envisions three possible applications of the technology.

“One is when standard biopsy is hazardous or impossible to perform,” he says. “Second is when standard excisional biopsy has unacceptable false-negative rates, such as in cancer screening when you are looking for very early neoplastic changes. Third is in guiding surgical intervention, such as when you cannot see beneath the surface of tissue or you are looking at the microstructures of nerves.”

An interventional modality. Working from Fujimoto’s blueprint, CDT executives plan to develop products that enter the body to examine suspected pathologies. Through the use of fiber optics, an OCT device might be interfaced with catheters, endoscopes, colposcopes, and laparoscopes. Light will be beamed through the catheter or scope, bounce off tissue, and return to an interferometer, wherein the light beam is divided into reference and sample beams. Interference of the two beams determines axial resolution. By scanning the signal laterally, a 2-D cross-sectional image can be computed.

Early applications of OCT will likely include evaluating coronary arteries or nerve tissue; screening for early signs of cancer, particularly when the cost of conventional biopsy is high or is accompanied by high false-negative rates; and guiding interventions when surgery is performed near sensitive structures, as in the case of stent placement or microsurgery for nerve and muscle repair.

In collaboration with physicians at Massachusetts General Hospital and Harvard Medical School, Fujimoto and his colleagues have conducted animal and in vitro tests of prototype OCT systems. The researchers have produced real-time in vivo images of frog heart tissue, as well as images of the microstructure of atherosclerotic plaque in excised human coronary arteries. Images were made at four frames per second with better than 16 micrometers resolution.

In developing clinical products, CDT plans to incorporate new high-power, high-resolution optical sources with low-cost video-rate scanning modules. Probes will be fashioned for integration into catheters and endoscopes, as well as into handheld units. Advanced signal-processing algorithms and computing hardware will reconstruct data into 2-D images. Leveraging the distribution channels of major medical device companies to sell their products will give CDT global reach and credibility.

“Our goal here is nothing short of making OCT into a major imaging modality,” Magnin said.