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Combined 15 clinical training--data

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Combined 15 clinical training--data

  1. 1. The Next Era in GI Surgery BioDynamixTM<br />Anastomosis<br />The Colon Ring<br />PRE-CLINICAL and CLINICAL DATA<br />Clinical Training Team<br />
  2. 2. Pre-Clinical Data<br />
  3. 3. Colon Ring™ vs. Stapling – Porcine<br /><ul><li>A porcine study was conducted at Washington University in St. Louis, and included 50 pigs.
  4. 4. Burst pressure is higher in the compression anastomosis at zero-time than in the stapled anastomosis, and remains higher through month 3.</li></li></ul><li>Burst Pressure<br />mmHg<br />225<br />210<br />215<br />192<br />200<br />175<br />168<br />167<br />150<br />151<br />125<br />112<br />105<br />100<br />96<br />75<br />50<br />25<br />32<br />0<br />Time "0"<br />2-3 Days<br />7-10 Days<br />1 Month<br />3 Months<br />POD<br />Stapler<br />CAR<br />Burst Pressure: Colon Ring™ vs. Staplers<br />n=50<br />
  5. 5. Colon Ring™ vs. Stapling – Porcine<br /><ul><li>Study was conducted at Washington University in St. Louis, and included 50 pigs.
  6. 6. Burst pressure is higher in the compression anastomosis at zero-time than in the stapled anastomosis, and remains higher through month 3.
  7. 7. The circumference of the compression anastomosis grew in size by 11% compared to zero time, whereas the stapled anastomosis resulted in a 12% loss in lumen size.</li></li></ul><li>Anastomotic Index<br />Percent of <br />Maximal<br />100%<br />100%<br />93%<br />90%<br />90%<br />88%<br />87%<br />80%<br />70%<br />69%<br />60%<br />7-10 Days<br />1 Month<br />3 Months<br />POD<br />Stapler<br />CAR<br />Colon RingTM Preserves Natural Lumen Size<br />
  8. 8. Colon Ring™ vs. Stapling — Porcine <br /><ul><li>Study was conducted at Washington University in St. Louis, and included 50 pigs.
  9. 9. Burst pressure is higher in the compression anastomosis at zero-time than in the stapled anastomosis, and remains higher through month 3.
  10. 10. The circumference of the compression anastomosis grew in size by 11% compared to zero time, whereas the stapled anastomosis resulted in a 12% loss in lumen size.
  11. 11. Fewer adhesions with the compression anastomosis.
  12. 12. No leaks in either type of anastomosis.
  13. 13. No biochemical difference between types of anastomoses.</li></li></ul><li>Clinical Data<br />
  14. 14. Meta-Analysis of Human Cases<br />To date more than 1050 clinical procedures were conducted.<br />Clinical work is being conducted in:<br />The US (including Canada), <br />EU (Belgium, Sweden, Germany, Austria, Greece, Holland, Italy & Turkey) <br />Israel<br />South Africa<br />Over 115 Medical Centers<br />Over 180 Surgeons<br />Patients were 60% female, 40% male<br />Average age – 62 (14 to 90)<br />Overall leak rate now approximately 2%<br />
  15. 15. Marketing Summary – March update<br />1063 procedures were recorded during 14 months of use.<br />USA – 525 (49%) ROW – 538 (51%)<br />116 Medical Centers <br />181 Surgeons (average 5.9 procedures per surgeon)<br />
  16. 16. Demographics<br />
  17. 17. Procedure Type<br />n=31<br />Chemo radiated<br />
  18. 18. Safety<br /><ul><li>30/973 Leaks - 3.1% (95% C.I. 1.9-4.4%)
  19. 19. Right – 4; Left – 24; Low Anterior - 2</li></li></ul><li>Clinical Studies<br />
  20. 20. Left-Sided Colectomy Colon Ring™ Safety Study<br />
  21. 21. Low Anterior Compression Anastomosis<br />Initiation visit was scheduled for Dec 15th & Dec 16th<br />
  22. 22. Phase IV Study:<br />What is phase IV study?<br /> Post marketing study is a study that is conducted after FDA approval for a product to gather additional information about a product's safety, efficacy, or optimal use. <br />Prospective multi-center study of the Colon Ring for creation of circular rectal anastomosis.<br />Including 20 Sites situated in Europe and the US, 300 Patients.<br />Planned to start in Q’1, 2009--delayed.<br />
  23. 23. Inclusion Criteria<br />Patient is over 18 years old.<br />Patient is scheduled for a non-emergency procedure.<br />Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures. <br />Proprietary Information<br />
  24. 24. Exclusion Criteria<br />Patient has an allergy to nickel.<br />Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensive inflammatory bowel disease.<br />Patient is participating in another clinical trial which may affect this study’s outcomes.<br />Patient has been taking regular steroid medication.<br />Patient has contraindications to general anesthesia.<br />Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.<br />Proprietary Information<br />
  25. 25. Comparison Study<br />A Comparison between Surgical Staplers and the Colon Ring for Creation of Circular Colorectal Anastomosis <br /> Including 8 sites, 150 Patients. 100 in the study arm and 50 in the control arm. <br />Planned to start in Q3 2009.<br />

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