TechniScan launches clinical study of Warm Bath Ultrasound system in Rochester

TechniScan, (OTC Bulletin Board: TSNI) a medical device company engaged in the development and commercialization of an automated 3D breast ultrasound imaging system, today announced that it has launched a clinical study in Rochester, Minn., its third new clinical site to commence in the last five months.

TechniScan's Warm Bath Ultrasound (WBU) system is designed to capture three-dimensional images of the breast as a woman lies prone on a table and state-of-the-art ultrasound technology is used in a warm water tank to image the breast anatomy. Its revolutionary new method of imaging produces information and whole breast images that are not available with traditional reflection ultrasound or whole breast ultrasound systems presently on the market.

To date, TechniScan has scanned over 800 women in clinical studies in Salt Lake City and Ogden, Utah as well as Orange and San Diego, California. These past clinical studies focused on key factors like image quality, repeatability, and establishing protocols for testing baseline values for positive and negative predictive capabilities of the system.

According to Dr. John Klock, TechniScan's chief medical officer, the most recently completed clinical work continues to support that refraction-corrected reflection images highlight connective tissue features within the breast, whereas the speed-of-sound images show fibroglandular, ductal and terminal lobular units with high resolution.  

Image consistency and reproducibility, whether it is weeks, months or a year between exams, are critical to support precise and reliable assessment of breast lesions. Clinical studies in San Diego recently evaluated the ability of the system to reliably reproduce images from the same woman.

"We have clearly demonstrated that the system can reliably reproduce images based on reflection and sound transmission and that those images will have significant clinical utility," said David Robinson TechniScan's president and CEO.

"Volumetric whole-breast imaging provides a substantial practical advantage over conventional very-small-field-of-view sonography. We are greatly aided by the ability to produce repeatable whole-breast comparisons – left to right and present to past. These comparisons are the nuts and bolts of breast imaging, by any modality," said Michael Andre, Ph.D., adjunct professor of radiology and director of medical physics at University of California, San Diego School of Medicine.

Building on this prior clinical work, the current clinical studies in Freiberg, Germany, San Diego and Rochester will involve at least 500 women with various types of breast lesions.  Major objectives of the 12-month study will be to compare WBU to conventional breast sonography and MRI as well as to examine the WBU system's ability to differentiate between normal, benign and malignant breast tissue. These clinical studies in the U.S. are funded by a Small Business Innovation Research Grant (SBIR) from the National Cancer Institute.

TechniScan's current study sites include the University Medical Center Freiburg in Germany, Moores UCSD Cancer Center, and the latest clinical study site in Rochester, Minnesota as well as limited imaging studies that support product development in Genoa, Italy and Salt Lake City, Utah.

"Overall we expect to image another 600 or more patients in our clinical program over the next 6-12 months," said Robinson. "These studies will provide us with critical information about the clinical utility and application of the WBU capabilities."

"The feedback that we are receiving from our scientists and radiologists at our study sites gives us good reasons to remain cautiously optimistic," said Klock.

Researchers involved in the studies will also utilize TechniScan's groundbreaking imaging network, which provides them with the ability to archive, store, and retrieve WBU images and relevant medical records and to collaborate with other research sites.  

"Our vision is to begin to create a database of thousands of breast images as well as the underlying and related image data," said Robinson. "With complete anonymity, women can contribute their mammograms, breast MRI's and WBU images along with related pathology and other information to provide researchers around the world an unprecedented opportunity to study breast cancer. TechniScan's imaging network will also allow timely and efficient collaboration of patient's records for her medical team's use. The concept is simple, yet revolutionary within the medical system and represents a key competitive advantage of the TechniScan system."

SOURCE TechniScan