LUNG DISEASE IMAGING: Patents empower first FDA-approved pulmonary imaging system

In December 2010, the U.S. Food and Drug Administration granted its first 510(k) clearance for optical coherence tomography (OCT)-based imaging for interventional pulmonology. Tomophase Corp. (Burlington, MA) will market its noninvasive Optical Coherence Tomography Imaging System (OCTIS) first for tissue imaging of airways and lungs, and later for diagnostic and therapeutic applications. The instrument incorporates a single-use disposable optical catheter and an imaging console.

The National Lung Screening Trial (NLST), recently released by the NCI, demonstrated that the risk of dying from lung cancer can be reduced by 20%. In the study, >50,000 former smokers were given low-dose CT scans, which resulted in identifying lethal tumors at an earlier, more treatable stage. Tomophase says that OCTIS has the potential to monitor such patients' progress by imaging pulmonary tissue following a CT scan.

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Tomophase uses a platform based on innovations in fiber-optics, signal processing, computing algorithm and optical probe design (the company received its seventh patent in May 2010). Within the imaging engine, an optical cross-correlator circumvents the conventional optical interferometer, and a self-cancellation mechanism rejects common-mode noise generated by the light sources and optical fiber movement. Along with a proprietary signal processing algorithm, this enables retrieval of not only the first-order tomogram, but also high-order imageries including phase-resolved tomography and differential spectral-absorbance mapping in imaged cross-sections.

OCTIS comprises an imaging console and a single-use disposable optical catheter that can direct a near infrared (NIR) beam to scan in either a forward- or sideward-looking direction. The two scan directions are switchable through lightwave control at the proximal end of the catheter system, enabling assessment in both directions with a single procedure.

According to Tomophase chairman and CEO Peter Norris, the company plans to consistently expand the system's capabilities in order to maximize the potential for optical imaging, diagnostics and therapy in this "greatly underserved market"—which includes not only cancer, but other diseases of the lung and airways, including asthma and emphysema.

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