1. High Confidence Software for Image-Guided Therapy Robert L. Galloway, PhD Professor of Biomedical Engineering, Professor of Neurosurgery, Professor of Surgery Director, Center for Technology-Guided Therapy Vanderbilt University, Nashville TN

2. Disclosure Robert L, Galloway PhD is a Founder, President and Chief Technical Officer of Pathfinder Therapeutics Inc Nashville TN

3. TGT

4. Technology-Guided Therapy The central principle behind TGT is that therapy delivery is as important as the therapeutic process.

5. Technology-Guided Therapy The use of images, not as pictures but as maps.

6. Technology-Guided Therapy Need images and knowledge of the information images convey and their spatial characteristics. Need a three (or six) dimensional tracking system. Need a methodology for the visualization of path, structures and target. Need a method of registration from physical space to image spaces (s)

7. TGT

8. Image-Guided Liver Surgery

9. Cortical Surface Mapping

10. Patient #1

11. Comparison between digital and physical labels:

12. New Surgical Applications One of the most prevalent cancers in the US Visualization of the layered structure of the rectum is important for staging and therapy Macular degeneration leading cause of adult blindness. Responds to drug treatment of the back of the eye and optic nerves. OphthalmologyColorectal Cancers

13. New Therapeutic Applications Creation of Dose distribution Guidance of the placement of sources Only available therapy for the profoundly deaf Outcome tends to be binary 1% morbidity (Facial nerve) Cochlear Implantation Gene Therapy

14. Software Design

15. ORION Software Design Video Tomogram Rotational 2-D Images Display Optotrak Polaris Shape Tape Magnetic Localizer Render Biopsy Preop Plan Transparency Graphic A-Mode US Electrophys. Biomechanical Optical Biopsy IO Quaternion SVD HTM ICP Registration Deformation Functional Correction ORION TGT

16. ORION Based on Dynamic Link Libraries so only functionality needed at runtime is loaded. Allows inclusion of new functionality without changing underlying code. Written in Visual C, Windows API and runs under Windows 98/Me/NT/2000/XP. TGT

17. New Software Design Functional Classes, Present State Display –Tomograms, rotational sets and video Localizer –Optotrak –Polaris/Aurora –Polhemus –Other Registration –Point-based quaternion and SVD –point based HTM –ICP surface Graphics –two types of overlay supported –on the fly rendering (Open GL) –Preoperative plan IO –Neurostimulator Corrections –Model Updated TGT

18. Provocation #1 HIPAA is dangerous to patients. Constraint of information and patient identification will lead to patient-information mismatches.

19. Provocation #2 Hippocrates was wrong. In analyzing software’s potential danger to one subject is to deny other potential patients timely access to the technology. Such an approach also serves as a barrier to revision.

20. Bio Robert L. Galloway, Jr. is a Professor of Biomedical Engineering, Neurological Surgery, and Surgery at Vanderbilt University. He teaches courses in Medical Instrumentation, Medical Imaging and Therapeutic Bioengineering. He has won half a dozen Excellences in Teaching and Professor of the Year awards. Galloway's research entails the design of systems for Interactive, Image-Guided Surgery, and holds 9 U.S. and international patents on devices arising from his research. He has published 75 manuscripts in refereed journals, edited books, and presented results of his work at over 90 scientific meetings. Galloway is a co-founder of Pathfinder Therapeutics Inc. and serves as President and CTO. He received a B.S. degree in Engineering. and Ph.D. from Duke, and a Masters in Engineering from UVA, all in Biomedical Engineering.