A im ™: fast & easy 3D ultrasound guidance for surgical needle ablation

1. Aim™: fast & easy 3D ultrasound guidance for surgical needle ablation Sharif Razzaque, C Green, B Heaney, K Keller, A State InnerOptic Technology K Simo, E Hanna, R Swan, K Lau, D Sindram, I McKillop, D Iannitti, J Martinie Carolinas Medical Center

2. Needle Ablation • Energy delivered near tip of needle to treat tumors • RF, Microwave, Light • Single or Multiple Simultaneous Needles • Applications & Potential Uses • Liver • Kidney • Breast • Pancreas • Uterus • Prostate • Brain • When done by Lap. Surgeons, always with ultrasound

3. Laparoscopic AblationToday

4. Problems • Very complex spatial relationships • Ultrasound image • Laparoscopic camera image • Surgeon’s own viewpoint • Needle trajectory • Ablation Zone Geometry • Results in • Missed & Multiple tries • Injury • Incomplete Ablation • Recurrence

6. Solution: AIM • Stereoscopic 3D Visualization and Guidance • Speed & Intuitiveness over Precision & Features • No Pre-planning or Calibration • Patented, FDA Approved, Clinically Validated

8. Recent Evaluations • Open Surgery • Pig study (qualitative) • First phantom study • Novices: 22% hit rate without AIM, 83% with AIM • Experts: 57% hit rate without AIM, 100% with AIM • Clinical trial at CMC • 100% hit rate with AIM (8 patients, 31 tumors) • Laparoscopic • Phantom study • Novices: 5% hit rate without AIM, 100% with AIM • 1 experts: 57% hit rate without AIM, 100% with AIM • Pig study (qualitative)

9. Recent Evaluations • Open Surgery • Pig study (qualitative) • First phantom study • Novices: 22% hit rate without AIM, 83% with AIM • Experts: 57% hit rate without AIM, 100% with AIM % of hits, on first attempt (5mm targets) p<=0.0001

10. Recent Evaluations % of hits, on first attempt (5mm targets) • Open Surgery • Pig study (qualitative) • First phantom study • Novices: 22% hit rate without AIM, 83% with AIM • Experts: 57% hit rate without AIM, 100% with AIM • Clinical trial at CMC • 100% hit rate with AIM • Laparoscopic • Phantom study • Novices: 5% hit rate without AIM, 100% with AIM • 1 experts: 57% hit rate without AIM, 100% with AIM • Pig study (qualitative) p<=0.0001

11. Recent Evaluations • Open Surgery • Pig study (qualitative) • First phantom study • Novices: 22% hit rate without AIM, 83% with AIM • Experts: 57% hit rate without AIM, 100% with AIM • Clinical trial at CMC • 100% hit rate with AIM (8 patients, 31 tumors) • Laparoscopic • Phantom study • Novices: 5% hit rate without AIM, 100% with AIM • 1 experts: 57% hit rate without AIM, 100% with AIM • Pig study (qualitative)

12. “Novel 3D Guidance System Makes Lesion Targeting Child’s Play” First-Stab Hit Rate

13. Soon to be deployed… • Sensor built into Ablation Needle • Integrated with Ablation Generator

14. Part II Behind the curtain

16. Evolution 1995 Breast Biopsy 2008 Liver RFA 2008 DLP Optical 2008 Miracube polecart 2009 box cart … 2010 Mag Lap. 2007 HMD RUE 2008 PhaseSpace RUE 2008 NDI Polaris RUE 2011 Current Reference System

17. Evolution 1995 Breast Biopsy 2008 Liver RFA 2008 DLP Optical 2008 Miracube polecart 2009 box cart … 2010 Mag Lap. 2007 HMD RUE 2008 PhaseSpace RUE 2008 NDI Polaris RUE 2011 Current Reference System

18. Evolution 1995 Breast Biopsy 2008 Liver RFA 2008 DLP Optical 2008 Miracube polecart 2009 box cart … 2010 Mag Lap. 2007 HMD RUE 2008 PhaseSpace RUE 2008 NDI Polaris RUE 2011 Current Reference System

19. Evolution 1995 Breast Biopsy 2008 Liver RFA 2008 DLP Optical 2008 Miracube polecart 2009 box cart … 2010 Mag Lap. 2007 HMD RUE 2008 PhaseSpace RUE 2008 NDI Polaris RUE 2011 Current Reference System

20. Lessons Learned • Simplify • Hardware and Software • Clinics’ Workflow • Patent • Evaluate often • Learn during Qualitative • Prove during Quantitative • Be open to radical changes • During research, keep this goal in mind:Treating patients in non-research clinics

21. What’s next?

22. Questions?