Medical Device Daily
When Igal Kushnir, MD, founded Deep Breeze (Or-Akiva, Israel) in 2001, based on his invention for functional imaging of lungs by sensing vibrations, he chose the company's name based on a key feature of its primary product.
He thought the concept of noninvasive lung function monitoring without radiation was a breath of fresh air for the industry, according to U.S. Manager Michael Beck, U.S. manager for Deep Breeze.
Called Vibration Response Imaging, or VRI technology, the device has been granted FDA clearance to market in the U.S., but only for general lung monitoring. VRI is not approved — for now, at least — for diagnosis of specific lung disorders.
"The FDA has approved us for the monitoring of lung sounds," Beck told Medical Device Daily . "We are basically taking the vibrations that come from an individual's lungs, and through sophisticated algorithms turn that into a functional image of the lung."
He added: "Obviously, in different parts of the world, the uses are going to be different."
The VRI technology records lung sounds from sensors applied to a patient's back while he or she breathes. The system then uses an algorithm to convert the data into images on a computer screen.
Deep Breeze said that changes in tissue composition or alteration in airflow impact how sounds within the lungs vibrate, and subsequently how the images, dubbed VRIXP, appear on the system's computer screen.
It said the VRIXP procedure "takes only minutes" in a physician's office, and because it does not use radiation, it can be used repeatedly for continuous monitoring, without downstream side effects, according to the company
For example, it could be used in patients who have "already been diagnosed with a different modality, whether it's XR, CT or MR."
"This is a very simply, very easy, very quick technique, without radiation, to give a physician or healthcare professional a view of what's going on in the patient's lungs," Beck told MDD.
Though the device is new, the basic approach it employs is not, Beck said. "Lung sounds have been looked at for years and years and years, usually in a graphical form."
Deep Breeze is not aware of any competitors to its device. Graphical devices have previously received approval from the FDA, but not a device that produces an actual functional image, according to Beck.
The company received a CE mark in 2005 and has marketed the system in Europe since the summer of 2006. It has a direct marketing operation in Germany targeting pulmonary interventionalists at both "reference sites and installed bases" in that country, Beck said. It has distributor operations in Italy, Spain and Greece.
Deep Breeze has received approval in Europe, unlike in the U.S., to use its VRI device for diagnostic purposes.
Beck acknowledged that the company had gotten its "nose bloodied" a bit with system roll-out to the European market but that this had given the company "more and more understanding of what the product can do."
The company secured the necessary regulatory approvals to market in Korea three months ago, where it also has a "distributor operation," he said. In Korea, the system is being used by pulmonologists.
And because "preventative medicine is big in Asia," and "very, very big in Korea," the device is being used widely as a screening tool, Beck said.
Regulatory approval is expected in China in September as well, and the company has four sites there for final clinical trials of the device.
With FDA clearance for the U.S. market in its pocket, Deep Breeze plans to launch VRIXP in the U.S. at the 2007 CHEST meeting Oct. 20-25 in Chicago.
Any other uses for the device in the U.S. will require the company to re-submit to the FDA with clinical trial data.
Following the introduction at CHEST, product education will be a major component of the company's marketing efforts, Beck said, noting that this should be easily done. There have been "hands-on exhibitions" of the device at various trial sites, but the procedure for administering the test can be taught "in 10 minutes," he said.
And while Deep Breeze sells the device for between $35,000 and $45,000, in U.S. dollars abroad, the company has not yet determined a price for the U.S. market.
Going forward in the U.S., the company is conducting trials, for example, at M.D. Anderson Cancer Center (Houston), where the objective is to "look at different types of cancers and vibration response imaging and how it relates to other types of imaging modalities."
In another trial at a New Jersey trauma center and intensive care unit, the device has been used with patients on ventilators.
"[These are] potential applications," Beck said. "The first step was to get our foot in the door for the monitoring of lung sounds with the FDA."