Medical Device Daily Senior
Getting FDA 510(k) is a victory under any context but, given how close the regulatory agency is to releasing its recommendations for tightening up the program, winning FDA clearance for the Optical Coherence Tomography Imaging System (OCTIS) was a particularly significant achievement for Tomophase (Burlington, Massachusetts) last week.
The company develops 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 company noted.
“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,“ said Ralph Johnston, the company's president/COO. “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.“
Now, the trick is to raise enough money to make the systems that the company has already received buyer interest in.
Johnston told Medical Device Daily the company has its first purchase order and needs to build five systems. “We have interventional pulmonologists waiting for our product,“ he said. The company is currently in a fundraising mode to get the money together to build the systems, he added. Johnston said the company's goal is to raise $2 million in a venture round to build the systems and get them deployed.
The technology has a lot of potential.
Last month the National Cancer Institute (Bethesda, Maryland) released initial results from a large-scale trial of screening methods to reduce deaths from lung cancer by detecting cancers at relatively early, more treatable, stages. The National Lung Screening Trial (NLST), a randomized national trial involving more than 53,000 current and former heavy smokers ages 55 to 74, compared the effects of two screening procedures for lung cancer – low-dose helical computed tomography (CT) and standard chest X-ray – on lung cancer mortality, The NLST found 20% fewer lung cancer deaths among trial participants screened with low-dose helical CT (Medical Device Daily, Nov. 10, 2010).
According to Tomophase, the NLST represents an example of how OCT will be applied. The company says its OCTIS has the potential to monitor these patients by imaging pulmonary tissue following a CT scan using laser light rather than radiation.
Tomophase was founded in 2003 and is engaged in the R&D of sophisticated fiber-optic catheters and imaging engines, used in conjunction with bronchoscopy, and initially focused on interventional pulmonology applications. The OCTIS cross-sectional tissue imaging system is capable of imaging microstructure 2-3 mm below the surface of the airways and lungs to provide valuable visualization information to the physician in the management of pulmonary diseases.
“The OCTIS is unique in that it is the first such application of OCT in interventional pulmonology,“ Johnston told MDD. He added that OCT itself is not new and that up until now it has primarily been used in ophthalmology and a couple of companies – St. Jude (St. Paul, Minnesota) and Volcano (San Diego) – are trying to use it in cardiovascular applications.
Tomophase has received two patents this year related to its OCTIS. The company received its seventh patent in the spring covering the disposable fiber-optic imaging catheter which is a key component to the imaging system (MDD, April 28, 2010). Then, last month, Tomophase received its eighth patent, this latest one covering a novel method for measuring blood in the lungs at two different wavelengths. Measuring blood at different spectral bands will allow optical differentiation of oxygenated and de-oxygenated blood, the company said. This new technology will be accomplished with the OCT imaging system, which includes an imaging console and disposable, single-use, fiber optic catheter. The company has 19 additional patent applications pending (MDD, Nov. 16, 2010).
“Our first 510(k) represents a giant step forward in our development of OCT technology for interventional pulmonology, heretofore a greatly under-served market,“ said Peter Norris, CEO/chairman of Tomophase. “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.“
Johnston says Tomophase is interested in using its OCTIS in three areas, starting with image-guided procedures such as bronchial thermoplasty. Asthmatx (Sunnyvale, California), which was acquired by Boston Scientific (Natick, Massachusetts) in October, makes the Alair bronchial thermoplasty system, a catheter-based procedure for the treatment of severe persistent asthma. The OCTIS would help doctors performing the bronchial thermoplasty see the areas of smooth muscle that need to be heated up.
The second area where OCTIS could be applied is in lung cancer patients, Johnston said, noting the findings of the NLST. He said the technology, which is approved for imaging only right now, has the “potential to image suspicious nodules that may represent pre-cancer in the lungs.“
Another longer-term application of the system, Johnston mentioned, is for drug development. He said drug companies are interested in using the technology to examine animals they test on to find out early on if the drugs they are testing are working or not.
Among the customers who have shown interest in the OCTIS, Johnston said the Heidelberg University in Germany wants to use the system to do a large lung cancer study, similar to the NLST, with a grant it recently received from the German government. “One of the five machines will go there as soon as we can“ raise enough money to make them, he said.
Amanda Pedersen, 309-351-7774;