Cleveland firm OCTI hopes to sell Russian optic imaging technology

OCTI developing optical coherence tomography

Using light as an imaging source has long fascinated inventors. But since radiology has produced such effective imaging modalities as CT, nuclear medicine, MRI, and ultrasound, radiologists have been skeptical on the use of light alone to image the body.

Now a Cleveland-based company is attempting to bring an optical fiber imaging device to market. Optical Coherence Tomography (OCTI) was established in 1996 to develop and eventually license optical coherence tomography (OCT) technology that is being explored by physicists at the Russian Academy of Science’s Institute of Applied Physics (IAP) in Nizhny Novgorod.

The technology is roughly similar to ultrasound in that energy is bounced between a source and its target, according to Janet Minnis Webb, president of Cleveland market research firm MedVantage and a consultant to OCTI. But OCT differs in that it measures optical rather than acoustic receptivity.

“The technology scans down to a few millimeters, so it’s almost like getting a biopsy without having to cut tissue,” Minnis Webb said.

OCT uses near infrared light to image, according to Dr. Alexander Sergeev, chief researcher of the project at IAP. Based on optical technology, the OCT device consists of a hand-held optical fiber probe that can be fitted to particular applications, and an interferometer that measures the phase differences between transmitted and received laser light. The interferometer has a sample and a reference arm; laser light is split and passes to the imaged object and to a reference mirror. The two sources of light are recombined in the interferometer, which then calculates the interference the light encountered.

The OCT device weighs about 18 lb and is connected to a computer that is loaded with a data acquisition card and software that processes data and displays images. The device produces a 2-D image much like an ultrasound image, with resolution of up to 10 microns.

“(In) tissue with absolutely homogeneous density, ultrasound produces zero,” Sergeev said. “But you will see sharp optical images because cells can scatter (light) in a different way.”

OCTI expects OCT technology to be useful in a wide range of applications, including endoscopy, laparoscopy, image-guided surgery, neurology, gynecology, dermatology, oncology, ophthalmology, and dentistry, according to Leon Pollot, attorney for OCTI and co-chair of the international practice at law firm Hahn Loeser & Parks of Cleveland.

“You can use (OCT) anywhere you can put a probe,” Pollot said.

The company hopes its technology will catch the trend toward image-guided surgery and interventional MRI, according to Minnis Webb. OCTI is looking for partners to help it complete clinical research for the device, as well as apply for clearance from the Food and Drug Administration, and ultimately manufacture and distribute the product. OCTI could seek partnerships with a large OEM or an endoscopy company, Minnis Webb said.

The process of winning the radiology community’s support of OCT may be a difficult one. Due to Russia’s more relaxed regulatory system, the Institute of Applied Physics has conducted more than 350 clinical trials of the device since the group began work four years ago. Yet even with strong clinical data, OCTI still has the task of explaining how the images gathered by the OCT device are to be interpreted.

“Dr. Sergeev and his group can map (images). They do know what they’re looking at, but obviously it has to be adapted to routine practice,” Minnis Webb said.

OCTI is not the only company working with OCT technology: MIT researchers have patented an OCT device and have licensed the technology for ophthalmic use to Humphrey Instruments/Carl Zeiss. Scientists at Case Western Reserve University, University of Vienna, and Hong Kong University of Science and Technology are also researching OCT.