Baritec Inc. Baritec GaBP Ring Certification. Marcio Café, M.D. Mark J. Kannia, Sales / Marketing Director C.Bruce Fields, Project Engineer CSTO

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1 Baritec Inc Baritec GaBP Ring Certification Marcio Café, M.D. Mark J. Kannia, Sales / Marketing Director C.Bruce Fields, Project Engineer Presented to Minister of Heath. Brazil. December 2005

2 C.S.T.O. Severe obesity - generally described as patients with BMI >30 and particularly morbid obesity - generally described as patients with BMI >40 or BMI >35 with comorbidities, is a disease that is chronic and recalcitrant to any therapy that presently exists including surgery.

3 Obesity Is A Hereditary Disease The exact method of genetic translation is not known at this time. The expression of obesity varies with social, cultural, environmental, economic and psychological influences.

4 Obesity is currently a world epidemic even though it is more preponderant in the advanced countries with abundance for caloric intake.

5 OBESITY WORLD EPIDEMIC

6 Complications of Obesity Correlation with extent and duration of obesity and also with the body fat distribution

7 Medical Complications 1 - Diabetes Type II 2 - Hypertension 3 - Gallbladder Disease 4 - Gastrointestinal Disorders 5 - Menstrual Irregularities

8 6 - Degenerative Arthritis 7 - Venous Stasis Ulcers 8 - Pulmonary Hypoventilation Syndrome, Sleep Apnea, Snoring 9 - Coronary Artery Disease and Arterial Sclerotic Disease 10- Increased Incidence of Malignancies: Ovaries, Cervix, Uterus, Breasts, Prostate and Gallbladder CSTO Medical Complications

9 Medical Complications 11 - Increased Risks with Surgeries 12 - Accident Proneness 13 - Pseudotumor Cerebri 14 - Difficulties with Physical Examinations and other types of Radiological Evaluations because of the size.

10 Social Complications 1 - Clothing Limitation 2 - Limitation in Performing Daily Acts of Living, Poor Hygiene and Sanitation 3 - Limited Access to Chairs, Seats and Passage Ways 4 - Limitation in Walking, Climbing Stairs 5 - Sexual Limitations

11 1- Cost of futile weight loss modalities ($63 billion / yr) 2- cost of treating various medical conditions due to obesity (estimated at $94.8 bil / yr) 3- indirect cost as lost output caused by death and disability due to obesity ($28.9 bil / yr) 4- number of work days lost attributable to obesity related illness (153.6 mil days/ yr = $14.06 billion ) Economic CSTO Complications The overall cost of obesity > $200 billion/yr

12 Economic CSTO Complications 5- Lack of Insurance Coverage or Increased Premiums 6- Cost of Special Clothing and Devices to Perform Daily Acts of Living 7- High Rate of School Drop Out 8- Difficulty Obtaining Good Jobs 9- Cost of Extra Food Consumed

13 Psychiatric CSTO Complications 1- Depression 2- Suicide 3- Neurotic Disorders 4- Social Withdrawal 5- Guilt, Self Hate

14 Complications of Obesity Obesity is the last bastion of overt discrimination that is tolerated in the USA. This prejudice extends to those taking care of the obese, including Bariatric surgeons.

15 Up to only recently both the medical community and the lay community were not aware of the significance of obesity. This resulted in mischaracterization, prejudice and a lot of quackery in the treatment of obesity.

16 TREATMENT AND MANAGEMENT OF OBESITY NON-SURGICAL TREATMENT SURGICAL TREATMENT

17 Non Surgical Treatment Of Obesity DIET EXERCISE BEHAVIORAL MODIFICATION DRUGS SOCIAL SUPPORT

18 Non surgical treatment of obesity results in 98% recividism rate. Weight loss may be easy to obtain but weight loss maintenance is very difficult.

19 Surgery, Bariatric Surgery, currently offers the only long term control for obesity

20 Surgery for obesity is a tool that must be used by the patient to effect and maintain weight loss. It is not a cure.

21 Resolution of Comorbid Conditions COMPLETE RESOLUTION OF : Diabetes Sleep Apnea Gastroesophageus Reflux Chronic Fatigue Syndrome Venous Stasis Chronic Leg Ulcers PARTIAL RESOLUTION OF : Hypertention Arthritis Depression Panniculitis

22 Quality of Life CSTO Improvement Increased Activity Increased Social Interactions Increased Sexual Satisfaction Job and Educational Opportunities Increased Self Esteem

23 Obesity Surgery In USA 40,000 cases in ,000 Cases in ,000 cases in 2004

24 Obesity Surgery In Brazil 50,000 Cases in 2004 Annual growth of 20% >75% are Fobi-Pouch Operations (Ring banded Gastric Bypass)

25 FOBI-POUCH OPERATION

26 The Effect of the Band CSTO Silastic Ring( Band ) ( 6 cm circumference) Space between Band and Stomach Wall (0.1 cm) 0.3cm 1.9cm 1.2cm 0.3cm Lumen ( 1.2 cm) Non-Banded GBP Stoma at 4yrs Stomach Wall ( 0.3 cm) Banded GBP Stoma at 4yrs Increased pouch capacity due to dilated stoma and proximal jejunum

27 Advantages Of The Fobi-Pouch Operation 1. Decreased Incidence of Leaks 2. Decreased Incidence of Gastro-gastric Fistula Formation 3. Increased Weight Loss Due to the Band 4. Increased Weight Loss Maintenance Due to the Band 5. Access to the Bypassed Segment of the Gastrointestinal Tract for Diagnostic and/or Therapeutic Purposes DILATED GASTRIC STOMA GASTRIC STOMA WITH A BAND WITHOUT A BAND Increased pouch capacity with dilated proximal jejunum

28 COMPARATIVE WEIGHT LOSS VBG, RYGBP, 2 BGBP AND BGBP PEWL (%) Y 2Y 3Y 4Y 5Y 6Y 7Y 8Y 9Y TIME POST-OP VBG RYGBP VBG TO BGBP BGBP Fobi M IFSO Presentation Japan 2004

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30 GaBP Ring By: Baritec

31 GaBP Ring By: Baritec 2003

32 Laparoscopic BGBP with the GaBP Ring

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34 BGPB Success rate - 90% 90% of patients with documented seven to ten years follow-up lost and maintained at least 50% percent excess weight loss

35 Two Centers Evaluating the GaBP Ring in Brazil Baritec GaBP Ring CSTO Implanted in 278 Patients in the USA. Follow up of up to 31 months. No Band erosion or complications related to the GaBP Ring Eight Clinical Centers evaluating placement and safety of The GaBP Ring Pending FDA Approval in USA Certified for Use in Europe

36 CONCLUSION The Baritec GaBP Ring facilitates placement of the band in the Gastric bypass operation. The GaBP Ring placement decreases surgical time. The GaBP Ring is a safe, cost effective and reproducible device.

37 CONCLUSION The Baritec GaBP Ring provides a prefabricated device in various sizes, standardized and sterilized to replace the surgeon fashioned device currently used by surgeons in the Fobi-Pouch Operation

38 GaBP Ring By: Baritec

39 GaBP Ring By: Baritec 2003