Tomophase receives FDA 510(k) clearance to market Optical Coherence Tomography Imaging System

Tomophase Corporation, developer of the non-invasive Optical Coherence Tomography Imaging System (OCTIS™) and other devices, announced today that it has received FDA 510(k) clearance to market OCTIS.

Tomophase is a leader in the development of OCT brochoscopically-based imaging systems for interventional pulmonology. OCTIS is comprised of a single-use disposable optical catheter and imaging console. Initially OCTIS will be deployed for tissue imaging of airways and lungs, followed by diagnostic and therapeutic applications.

The National Lung Screening Trial (NLST) recently released by the NCI represents an example of how OCT will be applied. In the NLST, the risk of dying from lung cancer was reduced by 20% when the subjects, (>50,000) former smokers, were given low-dose CT scans which resulted in identifying lethal tumors at an earlier, more treatable stage. Tomophase OCTIS has the potential to monitor these patients by imaging pulmonary tissue following a CT scan using laser light rather than radiation.

"We are delighted to receive the 510(k) for our new, novel OCT Imaging System. This clearance reflects the hard work and dedication of our employees and consultants over the past five years. At the present time, there is a lot of excitement in interventional pulmonology due to the emergence of several new innovative, medical technologies and potential applications. Our company is committed to providing new medical imaging products to improve the diagnosis and treatment of diseases of the lung and airways including asthma, emphysema and lung cancer," said Ralph Johnston, President and COO.

Dr. Peter Norris, Chairman and CEO added: "Our first 510(k) represents a giant step forward in our development of OCT technology for interventional pulmonology, heretofore a greatly underserved market. We plan to consistently expand our system's capabilities in order to maximize the potential for safe, cost-effective, optical imaging, diagnostics and therapy for the management of pulmonary disease."