Task 1A. Perform studies of bleeding detection in a flow-phantom model: Successfully detected and treated sites in a phantom developed with Defense Advanced Research Projects Agency (DARPA) and FDA in a blind test with an automated system.
Task 1B. Perform studies to determine pressure and temperature in ex vivo tissue exposed to HIFU: Published several papers, which led to invitation to join IEC (International Electrotechnical Commission) working group on HIFU standards and the AIUM (American Institute of Ultrasound in Medicine) sub-committee on Transiently Increased Outputs, and to measure acoustic output of Philips clinical HIFU machine. Also, discovered and submitted patent application for a method to emulsify tissue with ultrasound.
Task 2A. Develop new stone detection techniques based on radiation force and reverberation responsible for twinkling artifact: As part of our graduate student's dissertation, discovered that bubbles are responsible for the twinkling artifact. We have developed, implemented, tested, and patented new software to better detect stones.
Task 2B. Test stone sizing technology in tissue: Published paper, filed U.S. and international utility patent applications, and are negotiating licensing. We have initiated human clinical studies to test ultrasound stone sizing versus CT.
Task 3A. We utilized the YUANDE HIFU tumor ablation device as a test platform: Performed a number of studies.
Task 3B. Engineer and optimize an image-guided, two-frequency HIFU system for renal stone comminution: We will work with Exploration Medical Capabilities (ExMC) Human Research Program Element to implement on the FUS system capability to detect, reposition, and comminute stones. All are implemented in a prototype for which we are pursuing an investigational device exemption (IDE) with the FDA. We have developed a concept of expelling small stones from a kidney before they require comminution or surgery. A system to detect and reposition stones based on an OEM diagnostic ultrasound platform has been built and demonstrated to be safe and effective in studies in a porcine model. Commercialization efforts are well underway. Our technology was called a "game changer" in the plenary session of the American Urological Association (AUA) Annual meeting in May 2012.
Task 4A. Perform in vivo tests of the imaging protocols developed in Task 2: our paper is in press comparing twinkling to standard B-mode for stone detection in patients. New algorithm for stone detection implemented on clinical machine and tests of the algorithm initiated on human subjects. Data from 15 subjects has been collected.
Task 4B. Performed studies to determine the potential for HIFU-induced stone comminution as well as any associated tissue injury. We used our stone repositioning system to fragment stones in an excised porcine kidney in which they were grown. In vivo tests scheduled for Oct 22, 2012. In vivo studies of our stone clearance system have been shown to be safe and effective. Several studies of safety in pigs have been complete and are in press. These data have been presented to the FDA as part of our application for investigational device exemption for a human feasibility study.